Journal articles: 'Serology Longitudinal studies'

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Oliveira, Ana Maria da Silva Sousa, Mariana Azevedo Carvalho, Luis Nacul, Fábio Roberto Cabar, Amanda Wictky Fabri, Stela Verzinhasse Peres, Tatiana Assuncao Zaccara, et al. "Post-Viral Fatigue Following SARS-CoV-2 Infection during Pregnancy: A Longitudinal Comparative Study." International Journal of Environmental Research and Public Health 19, no. 23 (November 26, 2022): 15735. http://dx.doi.org/10.3390/ijerph192315735.

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Studies reported post-COVID-19 fatigue in the general population, but not among pregnant women. Our objectives were to determine prevalence, duration, and risk factors of post-viral fatigue among pregnant women with SARS-CoV-2. This study involved 588 pregnant women with SARS-CoV-2 during pregnancy or delivery in Brazil. Three groups were investigated: G1 (n = 259, symptomatic infection during pregnancy); G2 (n = 131, positive serology at delivery); G3 (n = 198, negative serology at delivery). We applied questionnaires investigating fatigue at determined timepoints after infection for G1, and after delivery for all groups; fatigue prevalence was then determined. Cox regression was used to estimate hazard ratio (HR) and 95% CI of the risk of remaining with fatigue in G1. Overall fatigue prevalence in G1 at six weeks, three months and six months were 40.6%, 33.6%, and 27.8%, respectively. Cumulative risk of remaining with fatigue increased over time, with HR of 1.69 (95% CI: 0.89–3.20) and 2.43 (95% CI: 1.49–3.95) for women with moderate and severe symptoms, respectively. Multivariate analysis showed cough and myalgia as independent risk factors in G1. Fatigue prevalence was significantly higher in G1 compared to G2 and G3. Post-viral fatigue prevalence is higher in women infected during pregnancy; fatigue’s risk and duration increased with the severity of infection.

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COOKE, B. D., A. J. ROBINSON, J. C. MERCHANT, A. NARDIN, and L. CAPUCCI. "Use of ELISAs in field studies of rabbit haemorrhagic disease (RHD) in Australia." Epidemiology and Infection 124, no. 3 (June 2000): 563–76. http://dx.doi.org/10.1017/s0950268899003994.

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ELISA techniques developed for the veterinary diagnosis of Rabbit Haemorrhagic Disease (RHD) in domestic rabbits were used for studying the epidemiology of RHD in Australian wild rabbits. The combination of ELISA techniques that distinguished IgA, IgG and IgM antibody responses and a longitudinal data set, mainly based on capture-mark-recapture of rabbits, provided a reliable basis for interpreting serology and set the criteria used to classify rabbits' immunological status. Importantly, young with maternal antibodies, immune rabbits and rabbits apparently re-exposed to RHD were readily separated. Three outbreaks of RHD occurred in 1996–7. The timing of RHD outbreaks was mainly driven by recruitment of young rabbits that generally contracted RHD after they lost their maternally derived immunity. Young that lost maternal antibodies in summer were not immediately infected, apparently because transmission of RHDV slows at that time, but contracted RHD in the autumn when conditions were again suitable for disease spread.

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Ciniselli, Chiara Maura, Mara Lecchi, Mariangela Figini, Cecilia C. Melani, Maria Grazia Daidone, Daniele Morelli, Emanuela Zito, Giovanni Apolone, and Paolo Verderio. "COVID-19 Vaccination in Health Care Workers in Italy: A Literature Review and a Report from a Comprehensive Cancer Center." Vaccines 10, no. 5 (May 7, 2022): 734. http://dx.doi.org/10.3390/vaccines10050734.

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The coronavirus disease 2019 pandemic still represents a global public health emergency, despite the availability of different types of vaccines that reduced the number of severe cases, the hospitalization rate and mortality. The Italian Vaccine Distribution Plan identified healthcare workers (HCWs) as the top-priority category to receive access to a vaccine and different studies on HCWs have been implemented to clarify the duration and kinetics of antibody response. The aim of this paper is to perform a literature review across a total of 44 studies of the serologic response to COVID-19 vaccines in HCWs in Italy and to report the results obtained in a prospective longitudinal study implemented at the Fondazione IRCCS Istituto Nazionale Tumori (INT) of Milan on 1565 HCWs. At INT we found that 99.81% of the HCWs developed an antibody response one month after the second dose. About six months after the first serology evaluation, 100% of the HCWs were still positive to the antibody, although we observed a significant decrease in its levels. Overall, our literature review results highlight a robust antibody response in most of the HCWs after the second vaccination dose. These figures are also confirmed in our institutional setting seven months after the completion of the cycle of second doses of vaccination.

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Hudson, L., F. Guhl, N. de Sanchez, D. Bridge, C. A. Jaramillo, and A. Young. "Longitudinal studies of the immune response of Colombian patients infected with Trypanosoma cruzi and T. rangeli." Parasitology 96, no. 3 (June 1988): 449–60. http://dx.doi.org/10.1017/s0031182000080094.

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SUMMARYTwo groups of patients were examined for anti-Trypanosoma cruzi antibodies by immunofluorescence and ELISA (i) inhabitants of the village and surrounding rural area of Tibu, Norte de Santander, Colombia (n = 327) and (ii) employees of the Empresa Colombiana de Petroleos (ECOPETROL, n = 849). The latter group had a lower rate of positive serology (12 as compared to 29%) but the distributions of antibody titres were very similar in the two groups. A total of 119 serum samples (37 village and 82 ECOPETROL, including 25 seronegative controls) were analysed for their ability to immunoprecipitate the 7 major polypeptides of T. cruzi trypomastigotes of Mr > 72 kDa. Although 10 sera from positive patients showed no immunoprecipitation, all of the remaining positive sera contained antibodies which reacted with the 150, 90 and 85 kDa polypeptides. When the T. cruzi immunofluorescence positive, immunoprecipitation negative sera were retested by ELISA using GP90, all were negative thus suggesting that the patients had had a misdiagnosed T. rangeli infection. The new diagnosis was confirmed by immunofluorescence and ELISA with T. rangeli epimastigotes. Longitudinal studies were carried out on 19 patients from the ECOPETROL group for up to 3–5 years. Five seropositive patients showed a change in their anti-trypomastigote immunoprecipitation profiles over this period; one by loss of a previously recognized high molecular weight band and four others by conversion from a negative to a positive immunoprecipitation profile. These latter patients presented initially with uncomplicated T. rangeli infection but then acquired a T. cruzi superinfection. These patients represent the nucleus of a group in which prospective studies will identify the effect of T. rangeli infection on the course of subsequent South American trypanosomiasis and Chagas' disease.

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Al-Samkari, Hanny, and David J. Kuter. "Antiplatelet Antibody Testing in Immune Thrombocytopenia and Evans Syndrome: Longitudinal Serologic Evolution and Relation to Clinical Features." Blood 132, Supplement 1 (November 29, 2018): 1137. http://dx.doi.org/10.1182/blood-2018-99-118403.

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Abstract Introduction : Antiplatelet antibody (APA) testing is considered an adjunct laboratory test in the diagnosis of immune thrombocytopenia (ITP). While it is not routinely obtained owing to inconsistent sensitivity and specificity in prior studies (Neunert et al, 2011), the definition of ITP used in these studies was not standardized. Additionally, potential clinical utility of this testing beyond diagnosis has been suggested, such as correlations between certain serologic patterns and response to IVIG (Peng et al, 2014). In consideration of these prior findings, we undertook a retrospective analysis of APA testing [glycoprotein-specific testing done by the commercial PakAuto assay (Immucor, Brookfield, WI), a monoclonal antibody immobilization of platelet antigens (MAIPA) assay, with all testing performed by the same laboratory] utilizing standardized ITP and Evans syndrome (ES) diagnostic criteria for patient inclusion. We examined serologic evolution over time and relation of antibody positivity to disease severity and response to therapies. Methods : Data collected for analysis included dates and results of APA testing (including disease status and platelet count at time of testing), patient demographics, and disease characteristics. Satisfaction of the 2011 American Society of Hematology (ASH) ITP diagnostic criteria were required for ITP patient inclusion and standard definitions of disease severity and response to treatment from the ASH guidelines were used in analysis. Logistic regression was used to model the probability of disease severity (non-severe, severe, or refractory) and treatment response (to corticosteroids or IVIG) based on serologic findings. Longitudinal serologic evolution in patients with multiple APA assays were analyzed. Results : A total of 214 APA assays from 115 ITP patients and 12 ES patients were collected; results from eluate testing (direct assay) only were used in analysis. Baseline patient characteristics are listed in Table 1. Of 7 possible positive test serologic patterns, only 4 were seen (Figure 1); antibodies against both GPIIb/IIIa and GPIb/IX were required for the presence of antibodies against GPIa/IIa. A multinomial logistic regression model including disease severity, age, sex, duration of disease, and platelet count at time of APA assay found a statistically significant predictive relationship between an increasing number of positive antibodies and disease severity [relative to non-severe ITP, relative risk ratio for severe ITP and refractory ITP was 1.89 (P=0.001) and 2.38 (P=0.004), respectively, per one additional positive antibody, Figure 2]. Multiple logistic regression models including antibody positivity to each platelet glycoprotein (GPIIb/IIIa, GPIb/IX, or GPIa/IIa), age, sex, disease duration and splenectomy status found a significant predictive relation between presence of anti-GPIa/IIa and non-response to corticosteroid treatment (odds ratio, 0.082, P=0.008). No significant relation was found between an antibody and non-response to IVIG. Fifty patients had multiple (2 to 5) APA assays performed over months to years. In evaluation of serologic evolution over time, all 7 patients who entered clinical remission also converted from a positive to a negative serology; 22 patients had stable serologic findings over time; 5 patients had a reduction in number of positive antibodies; and 18 patients demonstrated evidence for epitope spreading, with an increase in the number of positive antibodies (Figure 3). The sensitivity of a positive APA assay for the presence of active ITP was 91%. The sensitivity and specificity of a negative APA assay for remission in a patient with previously confirmed ITP (N=40 assays in patients with clinical remission in the study) were 88% and 91%, respectively. Conclusions : The MAIPA-based direct APA assay is sensitive for the presence of active ITP in patients satisfying 2011 ASH diagnostic criteria. To our knowledge, this is the first study demonstrating that a higher number of positive glycoprotein-specific antibodies may predict for more severe disease as defined by 2011 ASH disease severity criteria. Anti-GPIa/IIa antibodies only occur in the setting of pre-existing positivity for both anti-GPIIb/IIIa and anti-GPIb/IX antibodies, possibly due to a distinctive sequence of epitope spreading. Serologic testing typically turns negative when a patient enters clinical remission. Disclosures Al-Samkari: Agios: Consultancy. Kuter:Novartis: Consultancy; Pfizer: Consultancy; Syntimmune: Consultancy; Argenx: Consultancy; Dova Pharmaceuticals: Consultancy, Membership on an entity's Board of Directors or advisory committees; ONO: Consultancy; Amgen Inc.: Consultancy; Bioverativ: Consultancy, Research Funding; Principia: Research Funding; Rigel: Consultancy, Research Funding; BMS: Research Funding; Protalex: Research Funding.

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Gebrecherkos, Teklay, Yazezew Kebede Kiros, Feyissa Challa, Saro Abdella, Atsbeha Gebreegzabher, Dereje Leta, Abraham Desta, et al. "Longitudinal profile of antibody response to SARS-CoV-2 in patients with COVID-19 in a setting from Sub–Saharan Africa: A prospective longitudinal study." PLOS ONE 17, no. 3 (March 23, 2022): e0263627. http://dx.doi.org/10.1371/journal.pone.0263627.

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Background Serological testing for SARS-CoV-2 plays an important role for epidemiological studies, in aiding the diagnosis of COVID-19, and assess vaccine responses. Little is known on dynamics of SARS-CoV-2 serology in African settings. Here, we aimed to characterize the longitudinal antibody response profile to SARS-CoV-2 in Ethiopia. Methods In this prospective study, a total of 102 PCR-confirmed COVID-19 patients were enrolled. We obtained 802 plasma samples collected serially. SARS-CoV-2 antibodies were determined using four lateral flow immune-assays (LFIAs), and an electrochemiluminescent immunoassay. We determined longitudinal antibody response to SARS-CoV-2 as well as seroconversion dynamics. Results Serological positivity rate ranged between 12%-91%, depending on timing after symptom onset. There was no difference in positivity rate between severe and non-severe COVID-19 cases. The specificity ranged between 90%-97%. Agreement between different assays ranged between 84%-92%. The estimated positive predictive value (PPV) for IgM or IgG in a scenario with seroprevalence at 5% varies from 33% to 58%. Nonetheless, when the population seroprevalence increases to 25% and 50%, there is a corresponding increases in the estimated PPVs. The estimated negative-predictive value (NPV) in a low seroprevalence scenario (5%) is high (>99%). However, the estimated NPV in a high seroprevalence scenario (50%) for IgM or IgG is reduced significantly to 80% to 85%. Overall, 28/102 (27.5%) seroconverted by one or more assays tested, within a median time of 11 (IQR: 9–15) days post symptom onset. The median seroconversion time among symptomatic cases tended to be shorter when compared to asymptomatic patients [9 (IQR: 6–11) vs. 15 (IQR: 13–21) days; p = 0.002]. Overall, seroconversion reached 100% 5.5 weeks after the onset of symptoms. Notably, of the remaining 74 COVID-19 patients included in the cohort, 64 (62.8%) were positive for antibody at the time of enrollment, and 10 (9.8%) patients failed to mount a detectable antibody response by any of the assays tested during follow-up. Conclusions Longitudinal assessment of antibody response in African COVID-19 patients revealed heterogeneous responses. This underscores the need for a comprehensive evaluation of seroassays before implementation. Factors associated with failure to seroconvert needs further research.

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Schwab, Nicholas, Tilman Schneider-Hohendorf, Tammy Hoyt, Catharina C. Gross, Sven G. Meuth, Luisa Klotz, John F. Foley, and Heinz Wiendl. "Anti-JCV serology during natalizumab treatment: Review and meta-analysis of 17 independent patient cohorts analyzing anti-John Cunningham polyoma virus sero-conversion rates under natalizumab treatment and differences between technical and biological sero-converters." Multiple Sclerosis Journal 24, no. 5 (August 29, 2017): 563–73. http://dx.doi.org/10.1177/1352458517728814.

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Background: Anti-John Cunningham virus (JCV) serology has been studied with varying results concerning longitudinal changes. Objectives and methods: Results from 17 published natalizumab-treated multiple sclerosis (MS) patient cohorts were analyzed with common parameters and subsequently verified in two large independent cohorts with 722 and 499 patients from Germany and the United States. Results: Published studies and the verification showed (1) a mean of 10.80% sero-negative patients presented with sero-status change to positivity per year; (2) patients, who sero-convert to index values <0.9, convert from near the threshold and have a high probability of reverting with time; (3) patients, who convert to index values >0.9, start with low index values; (4) while JCV sero-positive patients with low index values sometimes revert to sero-negativity, patients with high index values almost never revert; and (5) the conversion rate of natalizumab-treated patients is three to four times higher than the biological conversion by age. Conclusion: JCV sero-conversion was comparable using standardized parameters and indicates influence of natalizumab on JCV immune control. Converters to low index values are probably consistently infected with JCV with varying low levels of activity, in line with their low risk to develop progressive multifocal leukoencephalopathy (PML). Patients with high index values rarely revert back to sero-negativity.

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Luo, Y. R., C. Yun, A. H. Wu, K. L. Lynch, and I. Chakraborty. "Longitudinal Study of SARS-CoV-2 Antibody Characteristics Using Label-Free Immunoassays." American Journal of Clinical Pathology 156, Supplement_1 (October 1, 2021): S32. http://dx.doi.org/10.1093/ajcp/aqab191.063.

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Abstract Introduction/Objective Since the start of the COVID-19 pandemic, much research has focused on the kinetics and magnitude of humoral immune response. With the advantages of monitoring real-time immunoreactions, label-free immunoassay (LFIA) is becoming a powerful tool in serology studies. We have developed LFIAs to measure SARS- CoV-2 antibody avidity and neutralization activity in a cohort of COVID-19 patients and determine if they correlate with antibody concentration. Serial serum samples collected from mild to severe COVID-19 patients were measured out to 8 months post-symptom onset to determine the durability of the neutralizing antibody response. Methods/Case Report Based on thin-film interferometry technology, we established a label-free IgG avidity assay and a label-free surrogate virus neutralization test (LF-sVNT). For measurement, sensing probes pre-coated with receptor-binding domain (RBD) of SARS-CoV-2 spike protein are applied to serum samples containing SARS-CoV-2 antibodies. The label-free IgG avidity assay measures the binding strength between RBD and IgG under urea dissociation. The LF-sVNT analyzes the binding ability of RBD to ACE2 after neutralizing RBD with antibodies. Results (if a Case Study enter NA) IgG avidity indices and neutralizing antibody titers (IC50) were determined from serum samples (n=246) from COVID-19 patients (n=113). IgG concentrations were measured using a fluorescent immunoassay. The neutralizing antibody titers showed a weak correlation with IgG concentrations and no correlation with IgG avidity indices. Over the time course up to 8 months post-symptom onset, IgG concentrations and neutralizing antibody titers presented similar trends: an initial rise, plateau and then in some cases a gradual decline after 40 days. The IgG avidity indices, in the same cases, plateaued after the initial rise. Conclusion The results demonstrated that LFIA could be used an excellent solution in the determination of SARS- CoV-2 antibody characteristics. The study found that IgG concentration and neutralizing antibody titer declined over time, while IgG avidity index remained constant after reaching a plateau. The decline of antibody neutralization activity can be attributed to the reduction in antibody quantity rather than the deterioration of antibody quality, as measured by antibody avidity.

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Tamimi, Tarek A., Malik Sallam, Deema Rayyan, Randa Farah, Dana Alkhulaifat, Abdallah Al-Ani, Reem Elmusa, Said Sharawi, Omar Tanash, and Yaser Rayyan. "Clinical Characteristics of Autoimmune Hepatitis in a Middle Eastern Population: A Tertiary Care Center Experience." Journal of Clinical Medicine 12, no. 2 (January 12, 2023): 629. http://dx.doi.org/10.3390/jcm12020629.

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Autoimmune hepatitis (AIH) is an immune-mediated inflammatory liver disease of uncertain cause, and its manifestations appear to vary by race and ethnicity. The literature on AIH in the Middle East, including Jordan, is scarce; therefore, this study aimed to determine the clinical characteristics of AIH in an understudied population. This retrospective chart review study was conducted on AIH patients who presented to Jordan University Hospital over a seven-year period (2014–2020). Retrieved data included sociodemographics, liver function tests, autoimmune serologic markers, viral hepatitis serology, findings on liver biopsies, treatment regimens, post-therapy outcomes and treatment-related complications. The total number of AIH patients included in the study was 30, divided as follows: type 1 AIH (n = 17, 56.7%), type 2 AIH (n = 2, 6.7%), seronegative AIH (n = 9, 30.0%), and two patients who had AIH-primary biliary cirrhosis overlap syndrome (6.7%). The mean age at diagnosis was 44 years (standard deviation: 17 years), with a female predominance (n = 25, 83.3%). Acute presentation was seen among 18 patients (60.0%). Mild to moderate fibrosis (F1 and F2 on METAVIR scoring system) without cirrhosis was observed among patients who underwent liver biopsies (10/19, 52.6%). The majority of patients (73.3%) were initially treated with prednisone, with azathioprine combination in 16.7% of the patients. At 6 months post initial treatment, twenty patients (66.7%) achieved biochemical remission, four patients had incomplete response, two patients failed to improve (one died during the induction of remission period due to AIH-related complications), and four patients were lost to follow-up. This study provided an updated overview of AIH in Jordan. The results showed typical female predominance, and interestingly high rates of acute presentation and seronegative disease. Future longitudinal studies are recommended to address the nature and long-term prognosis of AIH in Jordan.

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Lee, Paul H., Anna L. Guyatt, Catherine John, Altaf Ali, Xueyang Wang, Alexander T. Williams, Bo Zhao, et al. "Extended Cohort for E-health, Environment and DNA (EXCEED) COVID-19 focus." Wellcome Open Research 6 (December 16, 2021): 349. http://dx.doi.org/10.12688/wellcomeopenres.17437.1.

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Background: New data collection in established longitudinal population studies provides an opportunity for studying the risk factors and sequelae of the novel coronavirus disease 2019 (COVID-19), plus the indirect impacts of the COVID-19 pandemic on wellbeing. The Extended Cohort for E-health, Environment and DNA (EXCEED) cohort is a population-based cohort (N>11,000), recruited from 2013 in Leicester, Leicestershire and Rutland. EXCEED includes consent for electronic healthcare record (EHR) linkage, spirometry, genomic data, and questionnaire data. Methods: Between May 2020 and July 2021, a new questionnaire was deployed in EXCEED, which captured COVID-19 symptoms, general physical and mental health, plus socioeconomic and environmental factors during the pandemic. An online system was developed to invite new participants to join EXCEED, with informed consent being provided online. New and existing participants then completed the COVID-19 questionnaire online. A subset of the new questionnaire respondents were invited to participate in COVID-19 serology substudies, using home antibody testing kits. Results: In total, 3,693 participants provided COVID-19 infection status (median age 62.9 (IQR 54.7-69.2), 58.9% female). Trends of monthly incidence proportions of COVID-19 in EXCEED (self-report or symptom-predicted) approximated local and national figures. Regression analysis of 2,768 participants with linked EHR data showed no obvious monotonic relationship between number of chronic diseases (of 16 pre-specified diseases) and COVID-19 infection. There were 2,144 participants with valid results from a kit allowing differentiation between antibodies due to vaccination or infection. Of these, 8.5% had results consistent with previous COVID-19 infection, and 85.9% had evidence of COVID-19 vaccination, but without evidence of infection. Conclusions: Enriching EXCEED with a new COVID-19 questionnaire and serology data may improve understanding of the risk factors, clinical sequelae and broader impacts of the COVID-19 pandemic in the general population. Controlled access to these data for bona fide researchers is via application to the EXCEED study.

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Letizia, Andrew G., Catherine E. Arnold, Bishwo N. Adhikari, Logan J. Voegtly, Lindsay Glang, Gregory K. Rice, Carl W. Goforth, et al. "Immunological and Genetic Investigation of SARS-CoV-2 Reinfection in an Otherwise Healthy, Young Marine Recruit." Pathogens 10, no. 12 (December 8, 2021): 1589. http://dx.doi.org/10.3390/pathogens10121589.

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We used epidemiologic and viral genetic information to identify a case of likely reinfection in an otherwise healthy, young Marine recruit enrolled in the prospective, longitudinal COVID-19 Health Action Response for Marines (CHARM) study, and we paired these findings with serological studies. This participant had a positive RT-PCR to SARS-CoV-2 upon routine sampling on study day 7, although he was asymptomatic at that time. He cleared the infection within seven days. On study day 46, he had developed symptoms consistent with COVID-19 and tested positive by RT-PCR for SARS-CoV-2 again. Viral whole genome sequencing was conducted from nares swabs at multiple time points. The day 7 sample was determined to be lineage B.1.340, whereas both the day 46 and day 49 samples were B.1.1. The first positive result for anti-SARS-CoV-2 IgM serology was collected on day 49 and for IgG on day 91. This case appears most consistent with a reinfection event. Our investigation into this case is unique in that we compared sequence data from more than just paired specimens, and we also assayed for immune response after both the initial infection and the later reinfection. These data demonstrate that individuals who have experienced an infection with SARS-CoV-2 may fail to generate effective or long-lasting immunity, similar to endemic human beta coronaviruses.

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Karakus, Sezen, Alan N. Baer, and Esen K. Akpek. "Clinical Correlations of Novel Autoantibodies in Patients with Dry Eye." Journal of Immunology Research 2019 (January 13, 2019): 1–8. http://dx.doi.org/10.1155/2019/7935451.

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Background. Diagnostic criteria for Sjögren’s syndrome (SS) are continually being updated in pursuit of more precise and earlier diagnosis to prevent its complications. Owing to the high rate of false negative traditional serological markers, the need for better serological testing remains. Objective. To investigate the clinical significance of three recently discovered novel autoantibodies, anti-salivary gland protein 1 (SP1), anti-carbonic anhydrase 6 (CA6), and anti-parotid secretory protein (PSP), in a cohort of dry eye patients with suspected underlying inflammatory/autoimmune disease. Methods. Medical records of 136 patients with a primary diagnosis of dry eye who underwent laboratory testing between April 2014 and July 2017 were reviewed retrospectively. Data regarding demographic information, ocular and systemic symptoms, previous medical diagnoses, serological test results, and minor salivary gland biopsy results were collected. Dry eye evaluations included tear osmolarity, Schirmer test without anesthesia, conjunctival lissamine green staining, and corneal fluorescein staining in the order listed here. Results. Of the 136 patients, 9 (9/136, 6.6%) presented with a history of SS, and 9 additional patients (9/127, 7%) received a new diagnosis of SS as a result of evaluations. Fifty-six patients (56/136, 41%) tested positive for at least one of the novel autoantibodies. Fifty-four percent (6/11) of patients with primary SS who underwent the novel serological testing had a positive anti-PSP. Of those, 2 (2/11, 18%) had negative traditional serology and had to undergo minor salivary gland biopsy for definitive diagnosis. Anti-CA6 was associated with increased corneal and conjunctival staining after adjusting for age, sex, and other serologic markers (HR=1.5, 95% CI=1.20-1.97, and p=0.009 and HR=1.4, 95% CI=1.04-1.76, and p=0.02, respectively). Conclusions. This cross-sectional study demonstrated that anti-CA6 is seen in patients with severe aqueous-deficient dry eye. Whether these patients have an early stage of SS or a different type of autoimmune condition may be determined through longitudinal studies.

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Major-Smith, Daniel, Sarah Matthews, Thomas Breeze, Michael Crawford, Hannah Woodward, Nicholas Wells, Ruth Mitchell, Lynn Molloy, Kate Northstone, and Nicholas John Timpson. "The Avon Longitudinal Study of Parents and Children - A resource for COVID-19 research: Antibody testing results, April – June 2021." Wellcome Open Research 6 (October 20, 2021): 283. http://dx.doi.org/10.12688/wellcomeopenres.17294.1.

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The Avon Longitudinal Study of Parents and Children (ALSPAC) is a prospective population-based cohort which recruited pregnant women in 1990-1992 and has followed these women, their partners (Generation 0; G0) and their offspring (Generation 1; G1) ever since. The study reacted rapidly and repeatedly to the coronavirus disease 2019 (COVID-19) pandemic, deploying multiple online questionnaires and a previous home-based antibody test in October 2020. A second antibody test, in collaboration with ten other longitudinal population studies, was completed by 4,622 ALSPAC participants between April and June 2021. Of participants with a valid spike protein antibody test result (4,241; 8.2% void), indicating antibody response to either COVID-19 vaccination or natural infection, 3,172 were positive (74.8%). Generational differences were substantial, with 2,463/2,555 G0 participants classified positive (96.4%) compared to 709/1,686 G1 participants (42.1%). Of participants with a valid nucleocapsid antibody test result (4,199; 9.2% void), suggesting potential and recent natural infection, 493 were positive (11.7%); with 248/2,526 G0 participants (9.8%) and 245/1,673 G1 participants (14.6%) testing positive, respectively. We also compare results for this round of testing to that undertaken in October 2020. Future work will combine these test results with additional sources of data to identify participants’ COVID-19 infection and vaccination status. These ALSPAC COVID-19 serology data are being complemented with linkage to health records and Public Health England pillar testing results as they become available, in addition to four previous questionnaire waves and a prior antibody test. Data have been released as an update to the previous COVID-19 datasets. These comprise: 1) a standard dataset containing all participant responses to all four previous questionnaires with key sociodemographic factors; and 2) individual participant-specific release files enabling bespoke research across all areas supported by the study. This data note describes the second ALSPAC antibody test and the data obtained from it.

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Major-Smith, Daniel, Sarah Matthews, Thomas Breeze, Michael Crawford, Hannah Woodward, Nicholas Wells, Ruth Mitchell, Lynn Molloy, Kate Northstone, and Nicholas John Timpson. "The Avon Longitudinal Study of Parents and Children - A resource for COVID-19 research: Antibody testing results, April – June 2021." Wellcome Open Research 6 (January 24, 2022): 283. http://dx.doi.org/10.12688/wellcomeopenres.17294.2.

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The Avon Longitudinal Study of Parents and Children (ALSPAC) is a prospective population-based cohort which recruited pregnant women in 1990-1992 and has followed these women, their partners (Generation 0; G0) and their offspring (Generation 1; G1) ever since. The study reacted rapidly and repeatedly to the coronavirus disease 2019 (COVID-19) pandemic, deploying multiple online questionnaires and a previous home-based antibody test in October 2020. A second antibody test, in collaboration with ten other longitudinal population studies, was completed by 4,622 ALSPAC participants between April and June 2021. Of 4,241 participants with a valid spike protein antibody test result (8.2% were void), indicating antibody response to either COVID-19 vaccination or natural infection, 3,172 were positive (74.8%). Generational differences were substantial, with 2,463/2,555 G0 participants classified positive (96.4%) compared to 709/1,686 G1 participants (42.1%). Of 4,199 participants with a valid nucleocapsid antibody test result (9.2% were void), suggesting potential and recent natural infection, 493 were positive (11.7%); 248/2,526 G0 participants (9.8%) and 245/1,673 G1 participants (14.6%) tested positive, respectively. We also compare results for this round of testing to that undertaken in October 2020. Future work will combine these test results with additional sources of data to identify participants’ COVID-19 infection and vaccination status. These ALSPAC COVID-19 serology data are being complemented with linkage to health records and Public Health England pillar testing results as they become available, in addition to four previous questionnaire waves and a prior antibody test. Data have been released as an update to the previous COVID-19 datasets. These comprise: 1) a standard dataset containing all participant responses to all four previous questionnaires with key sociodemographic factors; and 2) individual participant-specific release files enabling bespoke research across all areas supported by the study. This data note describes the second ALSPAC antibody test and the data obtained from it.

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Reinecke, Birthe, Mara Klöhn, Yannick Brüggemann, Volker Kinast, Daniel Todt, Alexander Stang, Marcha Badenhorst, et al. "Clinical Course of Infection and Cross-Species Detection of Equine Parvovirus-Hepatitis." Viruses 13, no. 8 (July 26, 2021): 1454. http://dx.doi.org/10.3390/v13081454.

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Since its first discovery by Arnold Theiler in 1918, serum hepatitis also known as Theiler’s disease has been reported worldwide, causing idiopathic acute hepatitis and liver failure in horses. Recent studies have suggested a novel parvovirus, named equine parvovirus hepatitis (EqPV-H), to be associated with Theiler’s disease. Despite the severity and potential fatality of EqPV-H infection, little is known about the possibility of developing chronic infections and putative cross-species infection of equine sister species. In the present longitudinal study, we employed qPCR analysis, serology, and biochemical testing as well as pathology examination of liver biopsies and sequence analysis to investigate potential chronic EqPV-H infection in an isolated study cohort of in total 124 horses from Germany over five years (2013–2018). Importantly, our data suggest that EqPV-H viremia can become chronic in infected horses that do not show biochemical and pathological signs of liver disease. Phylogenetic analysis by maximum likelihood model also confirms high sequence similarity and nucleotide conservation of the multidomain nuclear phosphoprotein NS1 sequences from equine serum samples collected between 2013–2018. Moreover, by examining human, zebra, and donkey sera for the presence of EqPV-H DNA and VP1 capsid protein antibodies, we found evidence for cross-species infection in donkey, but not to human and zebra. In conclusion, this study provides proof for the occurrence of persistent EqPV-H infection in asymptomatic horses and cross-species EqPV-H detection in donkeys.

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Shmagel, Anna, Grace Skemp-Dymond, Lisa Langsetmo, John T. Schousboe, Kristine Ensrud, and Robert Foley. "Population-Wide Associations between Common Viral Pathogens and Self-Reported Arthritis: NHANES 2009-2012." International Journal of Rheumatology 2018 (October 1, 2018): 1–7. http://dx.doi.org/10.1155/2018/7684942.

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Objective. Persistent infectious agents have been implicated in chronic and recurrent inflammation, which may trigger or worsen many types of arthritis. Our objective was to determine whether exposure to herpes simplex virus (HSV) and human papillomavirus (HPV) is associated with self-reported arthritis among US adults. Methods. We used data from two consecutive cycles of the National Health and Nutrition Examination Survey (NHANES) from 2009 until 2012 (N of examined adults ages 20-69 = 9483). Participants were classified as having arthritis by self-report. Viral serology for HSV-1 and HSV-2 and HPV PCR studies from oral rinse and vaginal swabs were available for analysis. We compared HSV-1 and HSV-2 seropositivity as well as oral and vaginal HPV DNA positivity between participants with self-reported arthritis vs. those without, adjusting for age, gender, race, income, education, BMI, and the use of immunosuppressive medications. We used three comparator outcomes, gout, kidney stones, and hypertension, to evaluate whether the associations were specific or not to arthritis. Results. Arthritis was associated with older age, female gender, non-Hispanic White and Non-Hispanic Black race, higher BMI, and lower socioeconomic status. HSV-2 seropositivity, but not HSV-1 seropositivity, was independently associated with arthritis after adjustment for age, gender, race, income, education, BMI, and the use of immunosuppressive medications: AOR 1.48 (1.10-1.99). Oral HPV DNA positivity was also independently associated with arthritis: AOR 1.63 (1.17-2.28). After adjustment, there was no statistically significant difference in vaginal HPV DNA positivity between those with vs. those without arthritis: AOR 1.22 (0.90-1.66). There were no significant associations between viral exposures and any of the comparator outcomes. Conclusions. HSV-2 seropositivity and oral HPV DNA positivity were associated with self-reported arthritis and not with comparator outcomes, after adjustment for multiple potential confounders. These findings should be confirmed in longitudinal studies.

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Everhart, James E., Deanna Kruszon-Moran, and Guillermo Perez-Perez. "Reliability of Helicobacter pylori and CagA Serological Assays." Clinical and Vaccine Immunology 9, no. 2 (March 2002): 412–16. http://dx.doi.org/10.1128/cdli.9.2.412-416.2002.

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ABSTRACT Background serological assays for Helicobacter pylori are commonly used without knowledge of reliability. This information is needed to define the ability of serological tests to determine either new cases of infection or loss of infection in longitudinal studies. We evaluated the reproducibility and the interrelationships of serological test results for H. pylori and cytotoxin-associated gene product A (CagA) enzyme-linked immunoassays within a subset of participants in a population-based study. Stored samples from 1,229 participants in the third U.S. National Health and Nutrition Examination Survey were replicate serologically tested for H. pylori and CagA. Overall disagreement was 3.4% between duplicate tests for H. pylori (or 2.3% if equivocal results were disregarded). Six percent of samples positive on the first test had an immune serum ratio at least 30% lower on repeat testing. The odds ratio for H. pylori seropositivity on retesting was 2.8 (95% confidence interval [CI] = 1.8 to 4.5) when CagA serology was positive versus when it was negative. CagA antibody was found among 47.8% of H. pylori-equivocal and 7.0% of H. pylori-negative samples. CagA-positive yet H. pylori-negative samples were more likely to occur among Mexican Americans (odds ratio, 5.2; 95% CI = 2.4 to 11.4) and non-Hispanic blacks (odds ratio, 5.5; 95% CI = 2.3 to 13.0) than among non-Hispanic whites. Relying on repeated H. pylori serological tests over time to determine infection rates may result in misinterpretation due to limits in test reproducibility. CagA testing may have a role in verifying infection.

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La’ulu, Sonia L., Brenda B. Suh-Lailam, K. Wayne Davis, Joely A. Straseski, and Anne E. Tebo. "Comparative analysis of neutrophil gelatinase-associated lipocalin and other laboratory markers for lupus nephritis: a cross-sectional investigation." Annals of Clinical Biochemistry: International Journal of Laboratory Medicine 54, no. 2 (September 28, 2016): 240–45. http://dx.doi.org/10.1177/0004563216651888.

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Background Lupus nephritis is one of the most serious complications of systemic lupus erythematosus. This study evaluates the prevalence and correlation between neutrophil gelatinase-associated lipocalin and other biomarkers associated with renal involvement in systemic lupus erythematosus. Methods Paired serum and urine specimens from 50 suspected systemic lupus erythematosus patients, characterized by antinuclear antibodies detected by indirect immunofluorescence assay and varying positive concentrations of anti-double stranded DNA antibodies by Crithidia luciliae immunofluorescence assay, were investigated. Of these 50 patients, 18 were identified with renal involvement based upon laboratory serology. Patients and healthy control serum samples ( n = 50) were also evaluated for high avidity double stranded DNA IgG antibodies, anti-C1q IgG antibodies, and serum creatinine. The prevalence and relationship between biomarkers were evaluated using statistical methods. Results Serum and urine neutrophil gelatinase-associated lipocalin concentrations were significantly elevated in patients compared to controls, with a prevalence of 24% and 36%, respectively. These concentrations were also more markedly increased in systemic lupus erythematosus patients with renal involvement than those without. Spearman’s correlations between neutrophil gelatinase-associated lipocalin and other biomarkers tested ranged from 0.06 to 0.66 in all patients. Combined concordance as determined by Cronbach alpha coefficient between biomarkers was reduced from 0.71 to 0.58 (serum) and 0.62 (urine) when neutrophil gelatinase-associated lipocalin was removed. Conclusions Neutrophil gelatinase-associated lipocalin concentrations are elevated and demonstrate variable associated with other laboratory markers for renal involvement in systemic lupus erythematosus. Prospective longitudinal studies are needed to determine the optimal biomarker combinations for use in routine management of systemic lupus erythematosus patients at-risk for lupus nephritis.

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Öhman, Hanna, Tiina Rantsi, Päivi Joki-Korpela, Aila Tiitinen, and Heljä-Marja Surcel. "Prevalence and persistence of Chlamydia trachomatis-specific antibodies after occasional and recurrent infections." Sexually Transmitted Infections 96, no. 4 (July 18, 2019): 277–82. http://dx.doi.org/10.1136/sextrans-2018-053915.

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ObjectivesPopulation-based Chlamydia trachomatis seroepidemiological studies help to identify trends in chlamydia infection. However, an improved understanding of the antibody response to infection is required when using serology to estimate cumulative incidence. Thus, the objectives of this longitudinal, retrospective, biobank-based study were to assess the appearance and persistence of C. trachomatis major outer membrane protein (MOMP)-specific serum IgG antibodies after infection and to evaluate the role of antibodies in providing protective immunity against recurrent infection.MethodsData of notified C. trachomatis infections in Finland were obtained from the National Infectious Diseases Register. Serum samples were acquired from the Finnish Maternity Cohort. 411 women with single chlamydia infection and 62 women with recurrent infections, and for whom suitable paired serum samples were available, were included in the study. Antibody appearance, persistence after infection and the impact of recurrent infections were evaluated. IgG antibodies specific for MOMP were measured from serum using an ELISA method.ResultsAnti-C. trachomatis MOMP-specific IgG antibodies were detected in 65.5% (269/411) of women within 3 months of notification of infection. In the absence of recurrent infection, seroprevalence declined to 34.5% (142/411) 3–10 years after the initial infection. The serum antibody levels at baseline correlated positively with seroprevalence at follow-up. Reinfection boosted the humoral immune response by increasing seroprevalence and the serum antibody levels. Seroprevalence within 3 months after first notification of infection was 65.5% (19/29) in women who were later diagnosed with recurrent infection, comparable with women with single notification of infection (65.5%, 269/411).ConclusionsApproximately one-third of women with single notification of chlamydia infection remain seropositive 3–10 years after the initial infection. The concentration of antibodies remained stable during the follow-up. Recurrent infection boosted the humoral immune response, but reinfection occurred despite the presence of pre-existing antibodies.

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Soboka, Matiwos, Esayas Kebede Gudina, Mulatu Gashaw, Hiwot Amare, Melkamu Berhane, Hailemichale Desalegn, Dagimawi Tewolde, et al. "Depression among people with dyspepsia and H. pylori infection: A community based cross-sectional study in Ethiopia." PLOS ONE 17, no. 10 (October 6, 2022): e0275424. http://dx.doi.org/10.1371/journal.pone.0275424.

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Background Depression is the most common mental health problem, and frequently associated with physical illnesses. A link between depression, dyspepsia and Helicobacter pylori (H. pylori) infection has previously been reported. However, there is limited data regarding the association between these conditions from sub-Saharan Africa where they are highly prevalent. Objective This study aimed at elucidating the potential associations between depression, dyspepsia and H. pylori infection in Ethiopia. Methods We conducted a community based cross-sectional study involving urban and rural residents aged 13 years or older in Jimma Zone, southwest Ethiopia. A total of 871 participants were evaluated using a structured case reporting format for symptoms of dyspepsia and the patient health questionnaire (PHQ-9) for depression. Additionally, participants were assessed for H. pylori infection using stool antigen and serology tests. A multivariate logistic regression was used to identify the association between depression, dyspepsia and H. pylori infection after controlling for potential confounders. Results The prevalence of PHQ-9 scores indicative of probable case of depression among all participants was 10.9%. The prevalence of probable case of depression among patients who had at least one symptom of dyspepsia was 13.3% (X2 = 15.1 = p-value<0.001), while it was 11.9% (X2 = 1.23, p-value = 0.26) among patients who had H. pylori infection. Out of patients who took medications for their heartburn in the past 30 days, 14.9% (X2 = 3.6, p-value = 0.06) had probable case of depression. Dyspepsia symptoms such as epigastric discomfort (aOR = 2.59, 95%CI = 1.14, 5.87), postprandial fullness (aOR = 1.70, 95%CI = 1.48, 5.51), nausea (aOR = 1.71, 95%CI = 1.04, 2.82) excessive belching (aOR = 0.53, 95%CI = 0.31, 0.92) were associated with probable case of depression. However, being H. pylori test positive, gender, and age were not associated with probable case of depression. Conclusions There was an increased prevalence of probable case of depression among patients who had dyspepsia symptoms and H. pylori infection. Longitudinal studies are needed to examine possible further determinants of association between symptoms of dyspepsia and probable case of depression.

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Nofal, Rofida, Hadi Sawaf, and Lida Zeinali. "Splenic Infarction Induced By Epstein-Barr Virus Infection in a Patient with Sickle Cell Trait." Blood 126, no. 23 (December 3, 2015): 4600. http://dx.doi.org/10.1182/blood.v126.23.4600.4600.

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Abstract Introduction Although sickle cell trait (SCT) is considered a benign condition, evidence has been accumulating for related complications, including isothenuria, hematuria, exercise-induced death and splenic infarction.Most splenic infarctions are reported during a hypoxic state.Non-hypoxic related splenic infarction in a patient with SCT and EBV infection has been reported once.Here we present the second case of such association. Case Report An otherwise healthy 7-year-old African American male presented with worsening LUQ abdominal pain associated with emesis, dark-colored urine and low-grade fever. There was no history of trauma. Family history was positive for SCD. On presentation, the patient had a temperature of 38.2 °C and was tachycardic. Physical examination revealed scleral icterus and conjunctival pallor. Abdomen was soft, but the spleen was tender and palpable 6 cm below the costal margin. Laboratory studies showed hemoglobin of 7.2 g/dL, MCV 72.6 fL, leukocytes 14 X 109/L with 73% neutrophils, platelet count 136 X 109/L, and reticulocyte count 8%. Peripheral blood smear didn't reveal sickling, spherocytosis nor elliptocytosis. Total bilirubin was 3.5 mg/dL, direct bilirubin 0.6 mg/dL, ALT 13 U/L, AST 57 IU/L, LDH 476 IU/L. The Direct Coombs were negative. The D-dimer was positive. The Abdominal X-ray was negative, however abdominal ultrasound showed an enlarged spleen, 13.1 cm in longitudinal diameter. An Abdominal MRI showed splenic enlargement, 13 cm in longitudinal diameter, with non-enhancing 4 cm density in anterior aspect and minimal left pleural effusion. The thrombophilia work-up was negative. EB VCA IgG and IgM antibodies levels were high (> 8 and 1 AI, respectively), consistent with late acute infection. The CMV serology was negative. G6PD screening was negative. Hemoglobin electrophoresis revealed HbA 63.9%, HbA2 3.1%, HbF 0.0%, and HbS 33%. Patient was managed conservatively with RBCs transfusion, hydration and pain control and discharged home once stable. Discussion SCT is generally considered a benign hematological condition, still evidence has been accumulating for related complications. In United States, SCT affects 6-9% of the African American population, and 0.01-0.05% of the remaining population. Splenic infarction is commonly associated with SCD, but rarely with SCT. Reported cases of splenic infarction in SCT have been predominantly related to hypoxic states, primarily in a high altitude setting. Still there have been limited reports in non-hypoxic conditions. (Kark JA and Ward FT Semin Hematol1994).One case of non-hypoxic related splenic infarction in a patient with SCT and acute EBV infection was reported (Symeonidis A et al Acta Haematol 2001). Here we report the second case. We present a non-obese, previously healthy male with no evidence of hypoxia, high altitude setting, or intensive exercise. He suffered a splenic infarction during the acute phase of EBV infection. His initial presentation was consistent with hemolytic anemia and indirect hyperbilirubinemia, which led to further work-up and the diagnosis of SCT. We postulate that hemolysis resulted from hypersplenism. Possible factors leading to infarction in SCT are the induction of sickling and the presence of a hypercoagulable state. The exposure of these HbAS erythrocytes to lower pH and hypoxia in the splenic circulation likely promotes sickling and, as a consequence, splenic infarcts. Subjects with HbAS have significantly increased levels of D-dimer, thrombin-antithrombin TAT complexes, prothrombin fragment 1.2 (F1.2) and absolute monocytosis. The African American population has a 7% risk of VTE attributable to HbAS compared to an attributable risk of 3% for prothrombin G20210A mutation in the Caucasian population. Contributing factors to splenic infarction in the presence of acute EBV infection can be thrombophilia, thrombotic microangiopathy and rapid splenic enlargement. Moreover, during an EBV infection, acute expansion of splenic red and white pulp, as well as increased blood flow and loosening of the reticular network, make the organ friable. HbS existing under such conditions may be quite unstable, which can induce sickling. Disclosures No relevant conflicts of interest to declare.

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Ojeda, Diego S., María Mora Gonzalez Lopez Ledesma, Horacio M. Pallarés, Guadalupe S. Costa Navarro, Lautaro Sanchez, Beatriz Perazzi, Sergio M. Villordo, et al. "Emergency response for evaluating SARS-CoV-2 immune status, seroprevalence and convalescent plasma in Argentina." PLOS Pathogens 17, no. 1 (January 14, 2021): e1009161. http://dx.doi.org/10.1371/journal.ppat.1009161.

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We report the emergency development and application of a robust serologic test to evaluate acute and convalescent antibody responses to SARS-CoV-2 in Argentina. The assays, COVIDAR IgG and IgM, which were produced and provided for free to health authorities, private and public health institutions and nursing homes, use a combination of a trimer stabilized spike protein and the receptor binding domain (RBD) in a single enzyme-linked immunosorbent assay (ELISA) plate. Over half million tests have already been distributed to detect and quantify antibodies for multiple purposes, including assessment of immune responses in hospitalized patients and large seroprevalence studies in neighborhoods, slums and health care workers, which resulted in a powerful tool for asymptomatic detection and policy making in the country. Analysis of antibody levels and longitudinal studies of symptomatic and asymptomatic SARS-CoV-2 infections in over one thousand patient samples provided insightful information about IgM and IgG seroconversion time and kinetics, and IgM waning profiles. At least 35% of patients showed seroconversion within 7 days, and 95% within 45 days of symptoms onset, with simultaneous or close sequential IgM and IgG detection. Longitudinal studies of asymptomatic cases showed a wide range of antibody responses with median levels below those observed in symptomatic patients. Regarding convalescent plasma applications, a protocol was standardized for the assessment of end point IgG antibody titers with COVIDAR with more than 500 plasma donors. The protocol showed a positive correlation with neutralizing antibody titers, and was used for clinical trials and therapies across the country. Using this protocol, about 80% of convalescent donor plasmas were potentially suitable for therapies. Here, we demonstrate the importance of providing a robust and specific serologic assay for generating new information about antibody kinetics in infected individuals and mitigation policies to cope with pandemic needs.

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Trahtemberg, Uriel, Robert Rottapel, Claudia C. Dos Santos, Arthur S. Slutsky, Andrew Baker, and Marvin J. Fritzler. "Anticardiolipin and other antiphospholipid antibodies in critically ill COVID-19 positive and negative patients." Annals of the Rheumatic Diseases 80, no. 9 (April 26, 2021): 1236–40. http://dx.doi.org/10.1136/annrheumdis-2021-220206.

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BackgroundReports of severe COVID-19 being associated with thrombosis, antiphospholipid antibodies (APLA), and antiphospholipid syndrome have yielded disparate conclusions. Studies comparing patients with COVID-19 with contemporaneous controls of similar severity are lacking.Methods22 COVID-19+ and 20 COVID-19– patients with respiratory failure admitted to intensive care were studied longitudinally. Demographic and clinical data were obtained from the day of admission. APLA testing included anticardiolipin (aCL), anti-β2glycoprotien 1 (β2GP1), antidomain 1 β2GP1 and antiphosphatidyl serine/prothrombin complex. Antinuclear antibodies (ANAs) were detected by immunofluorescence and antibodies to cytokines by a commercially available multiplexed array. Analysis of variance was used for continuous variables and Fisher’s exact test was used for categorical variables with α=0.05 and the false discovery rate at q=0.05.ResultsAPLAs were predominantly IgG aCL (48%), followed by IgM (21%) in all patients, with a tendency towards higher frequency among the COVID-19+. aCL was not associated with surrogate markers of thrombosis but IgG aCL was strongly associated with worse disease severity and higher ANA titres regardless of COVID-19 status. An association between aCL and anticytokine autoantibodies tended to be higher among the COVID-19+.ConclusionsPositive APLA serology was associated with more severe disease regardless of COVID-19 status.Trial registration numberNCT04747782

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Ogata, Alana F., Adam M. Maley, Connie Wu, Tal Gilboa, Maia Norman, Roey Lazarovits, Chih-Ping Mao, et al. "Ultra-Sensitive Serial Profiling of SARS-CoV-2 Antigens and Antibodies in Plasma to Understand Disease Progression in COVID-19 Patients with Severe Disease." Clinical Chemistry 66, no. 12 (November 30, 2020): 1562–72. http://dx.doi.org/10.1093/clinchem/hvaa213.

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Abstract Background Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) has infected over 21 million people worldwide since August 16, 2020. Compared to PCR and serology tests, SARS-CoV-2 antigen assays are underdeveloped, despite their potential to identify active infection and monitor disease progression. Methods We used Single Molecule Array (Simoa) assays to quantitatively detect SARS-CoV-2 spike, S1 subunit, and nucleocapsid antigens in the plasma of patients with coronavirus disease (COVID-19). We studied plasma from 64 patients who were COVID-19 positive, 17 who were COVID-19 negative, and 34 prepandemic patients. Combined with Simoa anti-SARS-CoV-2 serological assays, we quantified changes in 31 SARS-CoV-2 biomarkers in 272 longitudinal plasma samples obtained for 39 patients with COVID-19. Data were analyzed by hierarchical clustering and were compared to longitudinal RT-PCR test results and clinical outcomes. Results SARS-CoV-2 S1 and N antigens were detectable in 41 out of 64 COVID-19 positive patients. In these patients, full antigen clearance in plasma was observed a mean ± 95% CI of 5 ± 1 days after seroconversion and nasopharyngeal RT-PCR tests reported positive results for 15 ± 5 days after viral-antigen clearance. Correlation between patients with high concentrations of S1 antigen and ICU admission (77%) and time to intubation (within 1 day) was statistically significant. Conclusions The reported SARS-CoV-2 Simoa antigen assay is the first to detect viral antigens in the plasma of patients who were COVID-19 positive to date. These data show that SARS-CoV-2 viral antigens in the blood are associated with disease progression, such as respiratory failure, in COVID-19 cases with severe disease.

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Pohl, Robert, Stephan-Werner Krämer, Christoph Stallmann, Enno Swart, Pauline Marquardt, Achim-Jens Kaasch, Christian-Joachim Apfelbacher, and Hans-Gert Heuft. "Study protocol for the SeMaCo study: A longitudinal regional cohort study to assess COVID-19 seroprevalence in blood donors." F1000Research 10 (September 29, 2021): 982. http://dx.doi.org/10.12688/f1000research.53845.1.

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Introduction: Serologic studies are crucial for clarifying the regional dynamics of the SARS-CoV-2 coronavirus pandemic as well as the success of a vaccination campaign against COVID-19. We describe a cohort study investigating the seroprevalence of antibodies against SARS-CoV-2 in Magdeburg (Saxony-Anhalt, Germany). Protocol and study design: The SeMaCo study (Serologische Untersuchungen bei Blutspendern des Großraums Magdeburg auf Antikörper gegen SARS-CoV-2) is a longitudinal, regional cohort study to assess the seroprevalence of COVID-19 in blood donors from Magdeburg (Capital of Saxony-Anhalt) and surrounding areas. We consider blood donors as a surrogate for the healthy, working-age population of Saxony-Anhalt. The study primarily aims to measure the prevalence and kinetics of IgG antibodies against SARS-CoV-2 in first time and repeat blood donors over a period of 21 months. The study explores four survey periods of three to four months each (January–April 21, July–October 21, February–April 22, July–October 22). At each visit, we will assess the attitude towards vaccination, the antibody response following vaccination, as well as undesired vaccination effects. Furthermore, we will collect data on occupational activities, housing conditions and the frequency of family and other social contacts. Discussion: The SeMaCo study extends the spectrum of seroepidemiological investigations in Germany. A longitudinal observation with repeated testing and serial interviews can provide a more accurate view on the dynamics of COVID-19 prevalence and spread than repeated cross-sectional studies. Based on interim results from similar studies, we expect a seroprevalence of SARS-CoV-2 antibodies below 5% in the first survey period. SeMaCo will influence policy decisions and preventative measures.

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Malik, Raza, Patrick Kennedy, Deepak Suri, Ashley Brown, Rob Goldin, Janice Main, Howard Thomas, and Mark Thursz. "The Role of Liver Fibrosis Assessment in the Management of Patients with Chronic Hepatitis B Infection: Lessons Learned from a Single Centre Experience." Hepatitis Research and Treatment 2011 (October 30, 2011): 1–5. http://dx.doi.org/10.1155/2011/524027.

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Background & Aims. Assess the clinical utility of the Prati criteria and normal ALT (<40 IU/L) in a cohort of patients with chronic hepatitis B infection (CHB). Methods. Serology, radiology, and histology were obtained in 140 patients with CHB. Results. HBeAg+ group: 7 patients (7/56−12% HBeAg+ group) misclassified as “immunotolerant”, with HBV DNA > 6 log copies/ml and normal ALT, who in fact had moderate/severe fibrosis on liver biopsy. HBeAg− group: 10 patients with normal ALT and moderate/severe fibrosis on liver biopsy; 4 of these patients had >3 log copies/ml HBV DNA levels and 6 patients misclassified as “inactive carriers” with negative HBV DNA levels normal ALT and moderate/severe fibrosis (6/84−7% HBeAg− group). Two male HBeAg+ and three male HBeAg- patients with ALT between 20 and 30 IU/L and moderate/severe fibrosis on liver biopsy would have been further mischaracterised using the Prati criteria for normal ALT. Age and ethnic group were more important predictors of moderate/severe fibrosis in multivariate analysis. Conclusion. HBeAg status, age, ethnic origin with longitudinal assessment of LFTs and viral load should be studied in patients with “normal ALT” at the upper end of normal range (ALT 20–40 IU/L) to appropriately classify patients and identify patients for liver fibrosis assessment to inform treatment decisions.

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Broom, Annette K., Michael D. A. Lindsay, Robert J. Condon, Aileen J. Plant, John S. Mackenzie, and Anthony E. Wright. "Epizootic activity of Murray Valley encephalitis virus in an aboriginal community in the southeast Kimberley region of Western Australia: results of cross-sectional and longitudinal serologic studies." American Journal of Tropical Medicine and Hygiene 67, no. 3 (September 1, 2002): 319–23. http://dx.doi.org/10.4269/ajtmh.2002.67.319.

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Avery, Michael B., Brooke L. Belanger, Amy Bromley, Arindom Sen, and Alim P. Mitha. "Mesenchymal Stem Cells Exhibit Both a Proinflammatory and Anti-Inflammatory Effect on Saccular Aneurysm Formation in a Rabbit Model." Stem Cells International 2019 (July 22, 2019): 1–15. http://dx.doi.org/10.1155/2019/3618217.

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Several studies have demonstrated a potential interaction between mesenchymal stem cells (MSCs) and saccular aneurysms. In this study, we sought to determine whether allogenic bone marrow-derived MSCs had the ability to prevent aneurysm formation in a known rabbit elastase aneurysm model. MSCs were injected intravenously in experimental rabbits at the time of surgical creation and two weeks postcreation and compared with control rabbits receiving vehicle injection. Angiography was used to compare aneurysm measurements four weeks postcreation, and aneurysms were harvested for histological properties. Serum was collected longitudinally to evaluate cytokine alterations. Serum from control animals was also utilized to perform in vitro tests with MSCs to compare the effect of the serologic environment in animals with and without aneurysms on MSC proliferation and cytokine production. While aneurysm morphometric comparisons revealed no differences, significant cytokine alterations were observed in vitro and in vivo, suggesting both anti-inflammatory and proinflammatory processes were occurring in the presence of MSCs. Histological analyses suggested that tunica intima hyperplasia was inhibited in the presence of MSCs.

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Sashi, Dominic, Isaac K. Phiri, Mwelwa Chembensofu, Chummy S. Sikasunge, Pierre Dorny, John Noh, Sarah Gabriël, and Kabemba E. Mwape. "2020; 2(1): 8-16PublishedOnline:01/10/2020 (https://journals.unza.zm/index.php?journal=medicine) DOI: 10.21617/jprm2020.213ISSN: 2415-038X (Print)Received: 14August2020Accepted: 16August 2020Published: 1October2020RESEARCH ARTICLEOpen AccessComparison of Serologic Diagnosis of Taeniosis and Cysticercosis in Field Samples from Eastern Zambia." Journal of Preventive and Rehabilitative Medicine 2, no. 1 (November 24, 2020): 8–16. http://dx.doi.org/10.21617/jprm2020.213.

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Background:Neurocysticercosis is a leading cause of epilepsy in Taenia soliumendemic regions of the world accounting for about 30% of all epileptic cases. The main aim of this study was to do aComparison of Serologic Diagnosis of Taeniosis and Cysticercosis in Field Samples from Eastern Zambia.Methods: Retrospectively collectedSamples through community-based cross sectional and longitudinal studies which looked at the prevalence and incidence of human T. solium infections, respectively, and described in earlier reports were selected for this laboratory based study. Samples, with coproantigen ELISA and serum antigen ELISA which the results were known were randomly selected for this study.Results: A total of 886 serum samples were analyzed. The rT24 /rES33 EITB detected a taeniosis and cysticercosis prevalence of 5.9% and 9.5%, respectively. On performance the Kappa statistics revealed a fair agreement of rT4/rES33 EITB (Kappa value of 0.2781-0.2117) compared to coproantigen ELISA and serum antigen ELISA. Although there is not a good agreement between the antibody and antigen test.Conclusion: This study found that the performance of rT4/rES33 EITB compared to copro antigen ELISA and serum antigen ELISA were fair and because the agreement was not good between the antibody and antigen test the, selection of a test must be carefully made, with consideration of what is needed. Keywords:Taenia solium diagnosis; coproantigen ELISA; immunodiagnosis; Ag-ELISA; recombinant T24/ES33 EITB

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Amicosante, M., G. Paone, F. Ameglio, EL Bianchi, E. Piccolella, L. Richeldi, A. Bisetti, M. Luisetti, and C. Saltini. "Antibody repertoire against the A60 antigen complex during the course of pulmonary tuberculosis." European Respiratory Journal 6, no. 6 (June 1, 1993): 816–22. http://dx.doi.org/10.1183/09031936.93.06060816.

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The A60 antigen complex is a Mycobacterium bovis (BCG) highly immunodominant antigen containing both B and T-cell epitopes. Clinical-serological studies show that elevated anti-A60 titres are present during tuberculosis. We wished to analyze in detail antibody responses against A60 components during the course of tuberculosis. A mixed longitudinal study was designed including individuals at the onset of tuberculosis, during treatment and after resolution of the disease. The anti-A60 repertoire was analyzed using a western blot assay with A60 as the antigen. While PPD- normals recognized only the 65 kDa heat shock protein (HSP), PPD+ normal individuals displayed low levels of anti-A60 antibodies against dominant antigens. There were immunoglobulin M (IgM) and immunoglobulin G (IgG) consistent with response to a latent infection. Onset tuberculosis was characterized by IgM and IgG antibodies against 52 to 28 kDa antigens; IgM response being limited to earlier phases of the disease. In contrast, IgM antibodies against 25 to 14 kDa antigens appeared only 2-6 months after disease onset. The antibody repertoire of chemotherapy-treated, resolved tuberculosis was exclusively IgG in isotype, as for a memory-type response. Thus, western blot analysis with A60 identifies typical antibody patterns associated with different clinical phases of tuberculosis infection. Such approach may help in identifying new single antigens for serologic diagnosis of active tuberculosis.

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Fabrizi, Fabrizio, Federica Tripodi, Roberta Cerutti, Luca Nardelli, Carlo M. Alfieri, Maria F. Donato, and Giuseppe Castellano. "Recent Information on Pan-Genotypic Direct-Acting Antiviral Agents for HCV in Chronic Kidney Disease." Viruses 14, no. 11 (November 20, 2022): 2570. http://dx.doi.org/10.3390/v14112570.

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Background: Hepatitis C virus (HCV) is still common in patients with chronic kidney disease. It has been recently discovered that chronic HCV is a risk factor for increased incidence of CKD in the adult general population. According to a systematic review with a meta-analysis of clinical studies, pooling results of longitudinal studies (n = 2,299,134 unique patients) demonstrated an association between positive anti-HCV serologic status and increased incidence of CKD; the summary estimate for adjusted HR across the surveys was 1.54 (95% CI, 1.26; 1.87), (p < 0.0001). The introduction of direct-acting antiviral drugs (DAAs) has caused a paradigm shift in the management of HCV infection; recent guidelines recommend pan-genotypic drugs (i.e., drugs effective on all HCV genotypes) as the first-choice therapy for HCV, and these promise to be effective and safe even in the context of chronic kidney disease. Aim: The purpose of this narrative review is to show the most important data on pan-genotypic DAAs in advanced CKD (CKD stage 4/5). Methods: We recruited studies by electronic databases and grey literature. Numerous key-words (‘Hepatitis C’ AND ‘Chronic kidney disease’ AND ‘Pan-genotypic agents’, among others) were adopted. Results: The most important pan-genotypic combinations for HCV in advanced CKD are glecaprevir/pibrentasvir (GLE/PIB) and sofosbuvir/velpatasvir (SOF/VEL). Two clinical trials (EXPEDITION-4 and EXPEDITION-5) and some ‘real-world’ studies (n = 6) reported that GLE/PIB combinations in CKD stage 4/5 gave SVR12 rates ranging between 86 and 99%. We retrieved clinical trials (n = 1) and ‘real life’ studies (n = 6) showing the performance of SOF/VEL; according to our pooled analysis, the summary estimate of SVR rate was 100% in studies adopting SOF/VEL antiviral combinations. The drop-out rate (due to AEs) in patients on SOF/VEL ranged between 0 and 4.8%. Conclusions: Pan-genotypic combinations, such as GLE/PIB and SOF/VEL, appear effective and safe for HCV in advanced CKD, even if a limited number of studies with small sample sizes currently exist on this issue. Studies are under way to assess whether successful antiviral therapy with DAAs will translate into better survival in patients with advanced CKD.

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Jafari, Aria, David Campbell, Bruce H. Campbell, Henry Nono Ngoitsi, Titus M. Sisenda, Makaya Denge, Benjamin C. James, and Susan R. Cordes. "Thyroid Surgery in a Resource-Limited Setting: Feasibility and Analysis of Short- and Long-term Outcomes." Otolaryngology–Head and Neck Surgery 156, no. 3 (December 27, 2016): 464–71. http://dx.doi.org/10.1177/0194599816684097.

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Objective The present study reviews a series of patients who underwent thyroid surgery in Eldoret, Kenya, to demonstrate the feasibility of conducting long-term (>1 year) outcomes research in a resource-limited setting, impact on the quality of life of the recipient population, and inform future humanitarian collaborations. Study Design Case series with chart review. Setting Tertiary public referral hospital in Eldoret, Kenya. Subjects and Methods Twenty-one patients were enrolled during the study period. A retrospective chart review was performed for all adult patients who underwent thyroid surgery during humanitarian trips (2010-2015). Patients were contacted by mobile telephone. Medical history and physical examination, including laryngoscopy, were performed, and the SF-36 was administered (a quality-of-life questionnaire). Laboratory measurements of thyroid function and neck ultrasound were obtained. Results The mean follow-up was 33.6 ± 20.2 months after surgery: 37.5% of subtotal thyroidectomy patients and 15.4% of lobectomy patients were hypothyroid postoperatively according to serologic studies. There were no cases of goiter recurrence or malignancy. All patients reported postoperative symptomatic improvement and collectively showed positive pre- and postoperative score differences on the SF-36. Conclusion Although limited by a small sample size and the retrospective nature, our study demonstrates the feasibility of long-term surgical and quality-of-life outcomes research in a resource-limited setting. The low complication rates suggest minimal adverse effects of performing surgery in this context. Despite a considerable rate of postoperative hypothyroidism, it is in accordance with prior studies and emphasizes the need for individualized, longitudinal, and multidisciplinary care. Quality-of-life score improvements suggest benefit to the recipient population.

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., Mehrunisa, Sana Jahangir, Abdullah Choudhry, Fahad Bin Ghaffar, Vijay Kumar Bhojwani, and Abdul Majid. "Significant different Perceptions of the Viral Dynamics and the Immune System to Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-COV-2) Exposure." Pakistan Journal of Medical and Health Sciences 16, no. 3 (March 31, 2022): 837–39. http://dx.doi.org/10.53350/pjmhs22163837.

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Aim: The knowledge of viral characteristics in addition immune reply to severe respiratory disorder (Sars Syndrome Coronavirus 2 (SARS-CoV-2) contamination still has significant gaps. Methods: In a retrospective longitudinal cohort analysis of 140 cases having PCR-established SARS-CoV-2 disease, researchers analyzed those parameters and demonstrated their correlation with symptom manifestations (mean age, 44 years; 54 percent male; 48 percent through comorbidities). Breathing models (n = 76) remained obtained for viral culture, serum specimens (n = 32) for IgM/IgG levels, and plasma samples (n = 82) for inflammatory cytokines and chemokines. The illness burden remained connected to the findings of viral culture, serologic tests, also immunological markers. Results: Fifty-eight (58%) cases established viral pneumonia, including 22 (18%) requiring supplementary oxygen and 14 (11%) requiring invasive mechanical ventilation. Twenty of the 77 individuals were positive for viral culture from respiratory samples (24 percent). When the PCR cycle threshold (Ct) value remained more than 31 or greater than 15 days following indication onset, no virus was recovered. Seroconversion happened at a median (IQR) of 13.6 (10–20) days for IgM and 16.1 (14–22) days for IgG; 56/63 patients (88.2 percent) seroconverted on day 15 or later. Health hazard appeared linked to quicker seroconversion as well as greater peak IgM and IgG levels. Conclusion: Researchers discovered that viral viability significantly related having such a lower PCR Ct charge in the initial stages of disease. The seriousness of the illness was linked to a greater antibody level. Overcharged pro-inflammatory immune markers provide marks for host-directed immunotherapy, that would have been investigated in randomized precise studies. Keywords: Coronavirus 2 (SARS-CoV-2), immune response, acute respiratory syndrome.

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Ugarte-Gil, M. F., J. Hanly, M. B. Urowitz, C. Gordon, S. C. Bae, J. Romero-Diaz, J. Sanchez-Guerrero, et al. "OP0289 LLDAS (LOW LUPUS DISEASE ACTIVITY STATE), LOW DISEASE ACTIVITY (LDA) AND REMISSION (ON- OR OFF-TREATMENT) PREVENT DAMAGE ACCRUAL IN SYSTEMIC LUPUS ERYTHEMATOSUS (SLE) PATIENTS IN A MULTINATIONAL MULTICENTER COHORT." Annals of the Rheumatic Diseases 80, Suppl 1 (May 19, 2021): 177–78. http://dx.doi.org/10.1136/annrheumdis-2021-eular.1133.

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Background:Remission, LDA and LDAS have been proposed as treatment goals for SLE. However, the independent impact of these states on damage accrual has not been fully evaluated.Objectives:To determine the independent impact of remission (both off & on treatment), LDA, and LLDAS on damage accrual.Methods:We studied a long-term longitudinal multinational SLE cohort, including patients completing at least two annual assessments. Remission off-treatment was defined as a SLEDAI (excluding serology) =0, without prednisone and immunosuppressive (IS) drugs. Remission on-treatment was defined as a SLEDAI (excluding serology) =0, prednisone daily dose<=5 mg/d and maintenance IS drugs. LDA was defined as a SLEDAI (excluding serology) <=2, without prednisone or IS drugs. LLDAS was defined as a SLEDAI <=4 with no activity in major organ systems, with no new features of lupus disease activity compared to the previous assessment, prednisone daily dose<=7.5 mg/d and maintenance IS drugs. Antimalarials were allowed in all groups. Damage accrual was ascertained with the SLICC/ACR damage index (SDI). Univariable and multivariable generalized estimated equation (GEE) negative binomial regression models were used. To create mutually exclusive groups, disease activity was divided into five states: remission off-treatment, remission on-treatment (minus remission off treatment), LDA (minus remission), LLDAS (minus remission and LDA) and not-optimally controlled. The proportion of the time that patients were in the specific state at each visit since cohort entry was determined. Possible effect modifiers and confounders adjusted for included sex, age at diagnosis, race/ethnicity, education, baseline disease duration, follow-up time, the highest-ever glucocorticoid dose prior to cohort entry, antimalarials and SDI. Time-dependent covariates were determined at the same annual visit as disease activity state; the outcome was the increase in the SDI and it was assessed at the subsequent visit.Results:There were 1,652 patients, 1464 (88.6%) were female, mean age at diagnosis was 34.6 (SD 13.4) years and mean baseline disease duration was 5.5 (SD 4.1) months. Patients had a mean follow-up of 6.5 (SD 4.3) years, 11686 visits were included. 763 patients (46.2%) had an increase in SDI score ≥1 during follow-up. 2483 (21.2%) of the visits were classified as remission off-treatment, 2276 (19.5%) as remission on-treatment, 544 (4.7%) as LDA, 657 (5.6%) as LLDAS and 5726 (49.0%) as not-optimally controlled. Being in remission off-treatment, remission on-treatment, LDA and LLDAS were predictive of a lower probability of damage accrual [remission off-treatment IRR=0.403, 95% CI 0.301-0.541); remission on-treatment IRR=0.313 (95% CI 0.218-0.451) LDA: IRR=0.469 (CI 95% CI 0.272-0.809); LLDAS IRR=0.440 (95% CI 0.241-0.803)]. The multivariable model is summarized in Table 1.Table 1.Multivariable GEE model of the impact of disease activity states on damage accrual.Incidence Rate Ratio95% CIDisease activity stateRemission off treatment0.4030.301-0.541Remission on treatment0.3130.218-0.451LDA0.4690.272-0.809LLDAS0.4400.241-0.803Gender, male1.2741.086-1.495Age at diagnosis1.0241.020-1.029EthnicityCaucasian USRef.Caucasian other1.0170.849-1.217African1.4671.211-1.776Asian0.8630.693-1.075Hispanic1.2661.034-1.550Other1.1210.759-1.656Educational level, years0.9770.957-0.996Disease duration at baseline0.9600.801-1.150Follow-up time0.9420.923-0.960Antimalarial use0.7860.681-0.908Highest prednisone dose before baseline1.0021.001-1.007SDI before1.1001.050-1.1152LLDAS: Low lupus disease activity state LDA: Low disease activity SDI: SLICC/ACR Damage IndexConclusion:Remission on- and off-treatment, LDA and LLDAS were associated with less damage accrual, even adjusting for possible confounders and effect modifiers. This highlights the importance of treating to target in SLE.Disclosure of Interests:Manuel F. Ugarte-Gil Grant/research support from: Pfizer, Janssen, John Hanly: None declared, Murray B Urowitz: None declared, Caroline Gordon Speakers bureau: UCB, Consultant of: Center for Disease Control, Astra-Zeneca, MFP, Sanofi, UCB, Sang-Cheol Bae: None declared, Juanita Romero-Diaz: None declared, Jorge Sanchez-Guerrero: None declared, Sasha Bernatsky: None declared, Ann E Clarke Consultant of: AstraZeneca, BristolMyersSquibb, GlaxoSmithKline, and Exagen Diagnostics, Daniel J Wallace Grant/research support from: Exagen, David Isenberg: None declared, Anisur Rahman: None declared, Joan T Merrill: None declared, Paul Fortin: None declared, Dafna D Gladman Consultant of: Abbvie, Janssen, Pfizer, Novartis, Amgen, Grant/research support from: Abbvie, Janssen, Pfizer, Novartis, Amgen, Ian N. Bruce: None declared, Michelle A Petri: None declared, Ellen M Ginzler Grant/research support from: Aurinia pharmaceutical, M.A. Dooley: None declared, Rosalind Ramsey-Goldman: None declared, Susan Manzi: None declared, Andreas Jonsen: None declared, Ronald van Vollenhoven Speakers bureau: AbbVie, Galapagos, GSK, Janssen, Pfizer, UCB, Consultant of: Abbvie, AstraZeneca, Biogen, Biotest, Celgen, Galapagos, Gilead, Janssen, Pfizer, Sanofie, Servier, UCB, Vielabo, Grant/research support from: BMS, GSK, Lilly, UCB, Cynthia Aranow: None declared, Meggan Mackay: None declared, Guillermo Ruiz-Irastorza: None declared, S. Sam Lim: None declared, Murat Inanc: None declared, Kenneth C Kalunian Consultant of: Roche, Biogen, Janssen, AstraZeneca, Eli Lilly, Genetech, Gilead, ILTOO, Nektar, Viela, Equillium, Bristol-Meyers Squibb, Soren Jacobsen Grant/research support from: BMS, Christine Peschken: None declared, Diane L Kamen: None declared, Anca Askanase Consultant of: Abbvie, Grant/research support from: Glaxo Smith Kline, Astra Zeneca, Janssen, Eli Lilly and Company, Mallinckrodt, Pfizer, Bernardo Pons-Estel Consultant of: GSK, Janssen, Graciela S Alarcon: None declared.

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Groseanu, L., A. Balanescu, V. Bojinca, D. Opris-Belinski, I. Saulescu, D. Mazilu, S. Daia-Iliescu, et al. "AB0580 GENDER DIFFERENCES IN SYSTEMIC SCLEROSIS- IMPACT ON DISEASE PHENOTYPE AND PROGNOSIS." Annals of the Rheumatic Diseases 79, Suppl 1 (June 2020): 1586.1–1587. http://dx.doi.org/10.1136/annrheumdis-2020-eular.3350.

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Background:The low overall prevalence of systemic sclerosis (SSc) and the low proportion of male patients have resulted in a scarcity of studies assessing sex differences in SSc patients, and contradictory results.Objectives:To evaluated sex influence on disease characteristics at baseline and then to estimate the effects of sex on disease progression and survival.Methods:We performed a retrospective observational study using data extract from the EULAR scleroderma trials and research (EUSTAR) cohort 096. 173 patients were analysed (26 males).The severity of organ system involvement was defined as described previously (1).Results:Males were significantly older at symptom onset (p=0.007) and at first center visit (p=0.009). There were no differences regarding disease duration at first visit or the interval between the onset of Raynaud syndrome and other non-Raynaud manifestations (p=0.06). Male patients were significantly more likely to have ever smoked (p<0.001), males more often had severe or end-stage peripheral vascular involvement (p=0.01). Modified Rodnan skin score (mRSS) was significantly higher in males (p=0.004). We found no difference regarding musculoarticular involvement, except for digital contractures (p=0.001) and tendon friction rubs (p=0,044). Males more often had interstitial lung disease (ILD) (p=0.013) which was also more frequently severe or end-stage (p = 0.003). Cardiac involvement was more common in males: pulmonary hypertension (PAH) (p = 0.018), arrhytmias (p=0.012), left ventricle ejection fraction<45% (p=0.014). The frequency of scleroderma renal crisis (SRC) was higher in males (p=0.025). Gastrointestinal involvement did not differ between groups EScSG (European Scleroderma Study Group) disease activity scores were higher in males (p=0.001). The isolated presence of antitopoisomerase-1 or anticentromere antibodies did not differ between groups. Mortality rate was similar between sexes, although male sex is a independent predictor for the death associated with ILD, SRC, arrythmiasIn multivariate analysis, male sex was independently associated with a higher risk of diffuse cutaneous subtype (OR: 1.56, (1.35 to 1.84); p<0.001), a higher frequency of severe vascular disease (OR: 1.38 (1.11 to 1.67); p<0.001), severe digital contractures (OR:1.92(1.68 to 2,42); p<0.001), interstitial lung disease OR: 1.22 (0.9 to 1.47); p<0.001), severe heart involvement (OR: 1.56 (1.22 to 2,1); p<0.001) and SRC (OR: 3.31 (1.87 to 5620); p<0.003). In the longitudinal analysis, after a mean follow-up of 7.2 (±2.6) years, male sex was predictive of new onset of scleroderma renal crisis (HR: 3.66 (1.82 to 4.86); p=0.006) and heart failure (HR: 1.9 (1.36 to 3.18); p=0.01).Conclusion:In essence, the disease prophyle in females is that of younger age of onset, longer disease duration at first center visit, less severe peripheral vascular involvement, the most frequent cause of death being PAH. In contrast, males are older at onset, present earlier in their disease, have dcSSc, more severe peripheral vascular disease, higher mRSS, more frequent and severe ILD, more frequent heart involvement, higher risk of PAH and SRC, the most common cause of death being ILD. These results raise the point of including sex in the management and the decision-making process.References:[1]Peoples C, Medsger TA Jr, Lucas M et al Gender differences in systemic sclerosis: relationship to clinical features, serologic status and outcomes.J Scleroderma Relat Disord. 2016;1(2):177–240Disclosure of Interests:Laura Groseanu Speakers bureau: novartis, eli-lilly, ucb, pfizer,sandoz, Andra Balanescu Consultant of: pfizer, Speakers bureau: Abbvie, Eli-Lilly, Novartis, Pfizer, Roche, Sandoz, UCB, Violeta Bojinca Speakers bureau: Eli-Lilly, Novartis, Pfizer, Daniela Opris-Belinski Speakers bureau: Abbvie, Eli-Lilly, Novartis, Pfizer, Roche, Ioana Saulescu Speakers bureau: Eli-Lilly, Pfizer, Diana Mazilu: None declared, Sanziana Daia-Iliescu Speakers bureau: sandoz, Andreea Borangiu: None declared, Florian Berghea Paid instructor for: abbvie, Speakers bureau: gideon richter, egis, novartis,ucb, cosmin-laurentiu constantinescu: None declared, CLAUDIA COBILINSCHI Speakers bureau: novartis, Maria Magdalena Negru: None declared, mihai abobului Speakers bureau: gideon richter, Ruxandra Ionescu Consultant of: Consulting fees from Abbvie, Eli-Lilly, Novartis, Pfizer, Roche, Sandoz, Speakers bureau: Consulting and speaker fees from Abbvie, Eli-Lilly, Novartis, Pfizer, Roche, Sandoz

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Korentzelos, Dimitrios, Vandana Baloda, Yujung Jung, Bradley Wheeler, Michael R. Shurin, and Sarah E. Wheeler. "COVID-19 mRNA Vaccines May Cause False Reactivity in Some Serologic Laboratory Tests, Including Rapid Plasma Reagin Tests." American Journal of Clinical Pathology, March 30, 2022. http://dx.doi.org/10.1093/ajcp/aqac025.

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Abstract Objectives Acute viral infections and some vaccines have been shown to increase false positivity in serologic assays. We assessed if the messenger RNA coronavirus disease 2019 (COVID-19) vaccines could cause false reactivity in common serologic assays in a pilot longitudinal cohort. Methods Thirty-eight participants with sera available prevaccination, 2 weeks after each vaccine dose, and monthly thereafter for up to 5 months were tested for common infectious disease serologies and antiphospholipid syndrome (APS) serology markers on the BioPlex 2200, Sure-Vue rapid plasma reagin (RPR), and Macro-Vue RPR. Twenty-two participants received the Moderna vaccine and 16 received the Pfizer vaccine. Results Most assays had no change in reactivity over the course of the sample draws, including APS markers. Epstein-Barr virus immunoglobulin G (IgG), measles IgG, and rubella immunoglobulin M all had possible false reactivity in one to two participants. RPR tests demonstrated false reactivity, with baseline nonreactive participant samples becoming reactive following vaccination. There were more false reactive participants (7/38) in the BioPlex RPR than in the Sure-Vue (2/38) and Macro-Vue (1/38) tests. All falsely reactive RPR tests were in participants who received the Moderna vaccine. Conclusions Serologic assays with results that do not fit the clinical picture following COVID-19 vaccination should be repeated. Effects of false reactivity can last more than 5 months in some assays. In particular, RPR is susceptible to false reactivity, and there is variability among assays. Larger longitudinal studies are needed to determine the incidence and window of false reactivity.

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Herrington, David M., John W. Sanders, Thomas F. Wierzba, Martha Alexander-Miller, Mark Espeland, Alain G. Bertoni, Allison Mathews, et al. "Duration of SARS-CoV-2 sero-positivity in a large longitudinal sero-surveillance cohort: the COVID-19 Community Research Partnership." BMC Infectious Diseases 21, no. 1 (August 30, 2021). http://dx.doi.org/10.1186/s12879-021-06517-6.

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Abstract Background Estimating population prevalence and incidence of prior SARS-CoV-2 infection is essential to formulate public health recommendations concerning the COVID-19 pandemic. However, interpreting estimates based on sero-surveillance requires an understanding of the duration of elevated antibodies following SARS-CoV-2 infection, especially in the large number of people with pauci-symptomatic or asymptomatic disease. Methods We examined > 30,000 serology assays for SARS-CoV-2 specific IgG and IgM assays acquired longitudinally in 11,468 adults between April and November 2020 in the COVID-19 Community Research Partnership. Results Among participants with serologic evidence for infection but few or no symptoms or clinical disease, roughly 50% sero-reverted in 30 days of their initial positive test. Sero-reversion occurred more quickly for IgM than IgG and for antibodies targeting nucleocapsid protein compared with spike proteins, but was not associated with age, sex, race/ethnicity, or healthcare worker status. Conclusions The short duration of antibody response suggests that the true population prevalence of prior SARS-CoV-2 infection may be significantly higher than presumed based on earlier sero-surveillance studies. The impact of the large number of minimally symptomatic COVID-19 cases with only a brief antibody response on population immunity remains to be determined.

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Huynen, Pascale, Céline Grégoire, Stéphanie Gofflot, Laurence Seidel, Nathalie Maes, Laura Vranken, Sandra Delcour, et al. "Long-term longitudinal evaluation of the prevalence of SARS-CoV-2 antibodies in healthcare and university workers." Scientific Reports 12, no. 1 (March 25, 2022). http://dx.doi.org/10.1038/s41598-022-09215-8.

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AbstractAsymptomatic and pauci-symptomatic cases contribute to underestimating the prevalence of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infections. Moreover, we have few studies available on the longitudinal follow-up of SARS-CoV-2 antibodies after natural infection. We tested staff members of a Belgian tertiary academic hospital for SARS-CoV-2 IgG, IgM, and IgA antibodies. We analyzed the evolution of IgM and IgG after 6 weeks, and the persistence of IgG after 3 and 10 months. At the first evaluation, 409/3776 (10.8%) participants had a positive SARS-CoV-2 serology. Among initially seropositive participants who completed phases 2 and 3, IgM were still detected after 6 weeks in 53.1% and IgG persisted at 12 weeks in 82.0% (97.5% of those with more than borderline titers). IgG levels were higher and increased over time in symptomatic but were lower and stable in asymptomatic participants. After 10 months, 88.5% of participants had sustained IgG levels (97.0% of those with more than borderline titers).

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Tosif, Shidan, Melanie R. Neeland, Philip Sutton, Paul V. Licciardi, Sohinee Sarkar, Kevin J. Selva, Lien Anh Ha Do, et al. "Immune responses to SARS-CoV-2 in three children of parents with symptomatic COVID-19." Nature Communications 11, no. 1 (November 11, 2020). http://dx.doi.org/10.1038/s41467-020-19545-8.

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Abstract Compared to adults, children with severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) have predominantly mild or asymptomatic infections, but the underlying immunological differences remain unclear. Here, we describe clinical features, virology, longitudinal cellular, and cytokine immune profile, SARS-CoV-2-specific serology and salivary antibody responses in a family of two parents with PCR-confirmed symptomatic SARS-CoV-2 infection and their three children, who tested repeatedly SARS-CoV-2 PCR negative. Cellular immune profiles and cytokine responses of all children are similar to their parents at all timepoints. All family members have salivary anti-SARS-CoV-2 antibodies detected, predominantly IgA, that coincide with symptom resolution in 3 of 4 symptomatic members. Plasma from both parents and one child have IgG antibody against the S1 protein and virus-neutralizing activity detected. Using a systems serology approach, we demonstrate higher levels of SARS-CoV-2-specific antibody features of these family members compared to healthy controls. These data indicate that children can mount an immune response to SARS-CoV-2 without virological confirmation of infection, raising the possibility that immunity in children can prevent the establishment of SARS-CoV-2 infection. Relying on routine virological and serological testing may not identify exposed children, with implications for epidemiological and clinical studies across the life-span.

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Campbell, Christopher, Douglas Roblin, Nikhil Padmanabhan, Daniel Romero, Jessica Joe, Lily Fathi, Thomas Whiting, et al. "Saliva-based SARS-CoV-2 serology using at-home collection kits returned via mail." Scientific Reports 12, no. 1 (August 18, 2022). http://dx.doi.org/10.1038/s41598-022-17057-7.

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AbstractSerology provides tools for epidemiologic studies, and may have a role in vaccine prioritization and selection. Automated serologic testing of saliva, especially specimens that are self-collected at home and sent to a laboratory via the mail without refrigeration, could be a highly-scalable strategy for population-wide testing. In this prospective study, non-vaccinated patients were recruited after PCR testing to self-collect saliva and return their specimens via mail. Longitudinal specimens were analyzed in order to monitor seroconversion in the weeks after a diagnostic PCR test for SARS-CoV-2. Diverse users self-collected saliva and returned specimens via mail in compliance with shipping regulations. At our pre-established threshold (0.963 AU/mL), salivary IgG reactivity to full-length spike protein achieved 95.8% sensitivity and 92.4% specificity at 2–4 weeks after diagnostic testing, which is comparable to the typical sensitivity and specificity achieved for serum testing. Reactivity to N antigen also was detected with 92.6% sensitivity and 90.7% specificity at 4–8 weeks after diagnostic testing. Moreover, serologic testing for endemic coronaviruses performed in multiplex with SARS-CoV-2 antigens has the potential to identify samples that may require retesting due to effects of pre-analytical factors. The easy-to-use saliva collection kit, coupled with thresholds for positivity and methods of flagging samples for retest, provides a framework for large-scale serosurveillance of SARS-CoV-2.

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Kandane-Rathnayake, Rangi, Worawit Louthrenoo, Vera Golder, Shue-Fen Luo, Yeong-Jian J. Wu, Aisha Lateef, Jiacai Cho, et al. "Independent associations of lymphopenia and neutropenia in patients with systemic lupus erythematosus: a longitudinal, multinational study." Rheumatology, March 10, 2021. http://dx.doi.org/10.1093/rheumatology/keab217.

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Abstract Objective The prevalence and associations of leucopenia in SLE remain incompletely understood. We evaluated associations of disease activity and medication use with leucopenia (lymphopenia and neutropenia) in a multinational, prospectively followed SLE cohort. Methods Data from the Asia Pacific Lupus Collaboration cohort, in which disease activity and medications were prospectively captured from 2013 to 2018, were used. Predictors of lymphopenia (lymphocyte count <0.8 × 109/l) and neutropenia (neutrophil count <1.5 × 109/l) were examined using multiple failure, time-dependent survival analyses. Results Data from 2330 patients and 18 287 visits were analysed. One thousand and eighteen patients (43.7%) had at least one episode of leucopenia; 867 patients (37.2%) had lymphopenia, observed in 3065 (16.8%) visits, and 292 (12.5%) patients had neutropenia, in 622 (3.4%) visits. After multivariable analyses, lymphopenia was associated with overall disease activity, ESR, serology, prednisolone, AZA, MTX, tacrolimus, CYC and rituximab use. MTX and ciclosporin were negatively associated with neutropenia. Lupus low disease activity state was negatively associated with both lymphopenia and neutropenia. Conclusion Both lymphopenia and neutropenia were common in SLE patients but were differentially associated with disease and treatment variables. Lymphopenia and neutropenia should be considered independently in studies in SLE.

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Laine, Hanna K., Tim Waterboer, Kari Syrjänen, Seija Grenman, Karolina Louvanto, and Stina Syrjänen. "Seroprevalence of polyomaviruses BK and JC in Finnish women and their spouses followed-up for three years." Scientific Reports 13, no. 1 (January 17, 2023). http://dx.doi.org/10.1038/s41598-023-27850-7.

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AbstractBK (BKPyV) and JC (JCPyV) polyomavirus infections are commonly subclinical and known infrequently to cause serious clinical diseases. Longitudinal follow-up studies regarding JCPyV and BKPyV serological outcomes are scanty. We analyzed JCPyV and BKPyV IgG-antibodies in 327 pregnant women and their 132 spouses, enrolled in the longitudinal Finnish Family HPV cohort at Turku University Hospital, Finland. Blood samples taken at baseline, and at 12-, 24-, and 36-month follow-up visits were analyzed for capsid protein VP1-antibodies using multiplex serology. Seroprevalence was constant for both BKPyV and JCPyV across the follow-up, varying between 95–99% and 59–68%, respectively, in women and between 96–97% and 66–72%, respectively, in their spouses. Seroconversion to BKPyV and JCPyV was detected in 15% and 18% of the women and in 13% and 19% of the men, respectively. Waning of BKPyV and JCPyV antibodies was infrequent, present in only 5% of the women (both viruses) and in 1.5% of the male spouses (only BKPyV). The number of lifetime sexual partners (p = 0.038) was lower among JCPyV seropositive men. To conclude, seropositivity to BKPyV and JCPyV is common among marital couples in Finland, with only slight differences between genders. In men, the sexual behavior might be associated with JCPyV seroprevalence.

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Ocansey, Bright, Benjamin Otoo, Abraham Adjei, Chris Kosmidis, Jane Afriyie-Mensah, Japheth Opintan, and David Denning. "P143 Incidence of chronic pulmonary aspergillosis in a cohort of bacteriologically confirmed TB patients at a tertiary hospital in Ghana." Medical Mycology 60, Supplement_1 (September 2022). http://dx.doi.org/10.1093/mmy/myac072.p143.

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Abstract Poster session 2, September 22, 2022, 12:30 PM - 1:30 PM Objectives Chronic pulmonary aspergillosis (CPA) is a common complication of tuberculosis. Previous studies on CPA in TB had involved general TB patients with a majority not bacteriologically proven. Although, ruling out evidence of TB is critical in diagnostic algorithms for CPA, in rare cases, CPA may occur in patients with active TB. This prospective longitudinal study aimed to determine the incidence of CPA at three timepoints in a cohort of bacteriologically confirmed TB patients placed on anti-TB therapy in Ghana. Methods Consecutive patients in whom MTB was detected by molecular analysis (GeneXpert MTB) and subsequently placed on anti-TB treatment were enrolled. They were screened for CPA at baseline or the time of TB diagnosis (0-1 week), end of treatment (6-7 months), and post-treatment (12-13 months). Screening involved assessment of signs and symptoms, quality of life (QoL) using St. George's Respiratory Questionnaire, imaging investigations (chest radiograph and/or CT scan), and mycology testing (LDBio Aspergillus IgG & IgM ICT and culture). CPA cases were defined based on a diagnostic algorithm developed for resource-constrained settings. During follow-up timepoints, CT scan was done when Aspergillus serology changed from negative to positive. GeneXpert MTB or acid-fast bacillus (AFB) smear results were obtained from laboratory records during follow-up timepoints. Results A total of 46 patients were enrolled at baseline, of whom 34 (74%) were resurveyed at the end of treatment. Only 13 patients have been screened post-treatment so far. There were 6 (13%) relapse cases. At baseline, Aspergillus serology was positive in 4 (8.7%) patients and later increased to 6 (17.6%) and now 3 (23.1%) at the end and post-treatment respectively. Specifically, 4 (8.7%), 2 (6.9%), and 1 (10.0%) patient(s) met the criteria for CPA at baseline, end of treatment, and post-treatment respectively. All four cases of CPA described at baseline occurred in relapse patients. Among these patients, the initial MTB load determined by GeneXpert MTB was either trace or very low and follow-up AFB smear and/or GeneXpert MTB were negative between 2 to 3 months. Among relapse patients, average years since the primary episode of TB was four in those with CPA versus nine in those without CPA. Persistent cough and hemoptysis were the common symptoms of CPA. All CPA patients had cavitation, irregular intraluminal lining of cavity, and all but one had pleural thickening and/or paracavitary fibrosis. Two CPA patients at baseline have been rescreened post-treatment, one still has features of CPA and one had died. Also, the two CPA patients at the end of treatment continue to have CPA features when rescreened. Quality of life score improved significantly at the end of treatment for TB without CPA (51.4-3.8) while for those with putative CPA co-infection the improvement was less (53.8-25.7). Conclusion CPA should be considered in patients with suspected TB relapse, a very low or trace GeneXpert MTB, and positive Aspergillus serology. These patients had a less satisfactory symptom improvement after TB treatment. Aspergillus serology testing at the beginning of TB relapse therapy may provide prognostic information.

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Bürgi, Justus J., Matthias Rösslein, Oliver Nolte, Peter Wick, Regine Garcia Boy, Siegfried Stranders, Günter Dollenmaier, et al. "Mild COVID-19 induces early, quantifiable, persistent troponin I elevations in elder men." Frontiers in Cardiovascular Medicine 9 (December 1, 2022). http://dx.doi.org/10.3389/fcvm.2022.1053790.

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ImportanceElderly patients, especially men, are at risk of increased morbidity from coronavirus disease 2019 (COVID-19). Long-term data on troponin I levels in longitudinal observational studies of outpatients with mild to moderate COVID-19 are scarce.ObjectiveThis controlled cohort study aimed to evaluate the course of troponin I concentrations over a long period in convalescent COVID-19 outpatients with mild to moderate symptoms.Setting and participantsIn this cohort study, individuals with PCR-confirmed, mild to moderate SARS-CoV-2 infection as well as control individuals with confirmed negative PCR and negative SARS-CoV-2 serology were included. Study visits were performed from April 2020 through July 2021 (initialized during the first wave of the corona pandemic in Switzerland). A study visit in patients comprised blood draws every week in the first month and additionally after 8 weeks. This course was repeated in patients observed long-term.ResultsThis study enrolled 278 individuals from the Canton of St. Gallen, Switzerland, aged 12–92 years (59.5% women), who had mild to moderate COVID-19 symptoms (outpatients only) and a diagnosis confirmed by positive RT-PCR. Fifty-four of the participants with confirmed SARS-CoV-2 infection were followed for 14 months with repeat cycles of the testing protocol. In addition, 115 symptomatic patients that were PCR and serology negative were enrolled in the same time period as a control group. In COVID-19 patients, low-level troponin I concentrations (cTnI) were significantly increased from baseline until week 9 after positive RT-PCR diagnosis in men older than 54 years [ΔcTnI = 5.0 ng/L (median); 95% CI 4.1–6.0; p = 0.02]. The troponin I concentration remained elevated throughout 14 months in men older than 54 years within the cohort with a prolonged observation period. This statistically significant change in troponin I concentration was not dependent on co-morbidities in this group. ALT, Creatinine, BNP, and D-Dimer values after convalescence did not differ in comparison to the control cohort.ConclusionIn this analysis of individuals with confirmed SARS-CoV-2 infection, hs troponin I levels of men aged 54 or older significantly increased after infection. They remained elevated for at least 14 months after diagnosis. This suggests the possibility of an ongoing, long-term, low-grade myocardial injury. Further studies with focus on elderly patients and a prolonged observational period are necessary to elucidate whether the phenomenon observed is associated with detectable structural changes to the heart muscle or is without further clinical consequences.

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Welch, Michael, Karen Krueger, Jianqiang Zhang, Pablo Piñeyro, Ronaldo Magtoto, Chong Wang, Luis Giménez-Lirola, Erin Strait, Mark Mogler, and Phillip Gauger. "Detection of porcine parainfluenza virus type-1 antibody in swine serum using whole-virus ELISA, indirect fluorescence antibody and virus neutralizing assays." BMC Veterinary Research 18, no. 1 (March 21, 2022). http://dx.doi.org/10.1186/s12917-022-03196-6.

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Abstract Background Porcine parainfluenza virus 1 (PPIV-1) is a respiratory virus in the family Paramyxoviridae and genus Respirovirus. It is closely related to bovine parainfluenza virus 3, human parainfluenza virus 1, and Sendai virus. Recent reports suggest PPIV-1 is widespread in swine herds in the United States and abroad. However, seroprevalence studies and the ability to evaluate cross neutralization between heterologous strains is not possible without validated antibody assays. This study describes the development of an indirect fluorescence antibody (IFA) assay, a whole virus enzyme-linked immunosorbent assay (wv-ELISA) and a serum virus neutralization (SVN) assay for the detection of PPIV-1 antibodies using 521 serum samples collected from three longitudinal studies and two different challenge strains in swine. Results The area under the curve (AUC) of the wv-ELISA (95% CI, 0.93–0.98) was significantly higher (p = 0.03) compared to the IFA (95% CI, 0.90–0.96). However, no significant difference was observed between the IFA and wv-ELISA when compared to the SVN (95% CI, 0.92–0.97). All three assays demonstrated relatively uniform results at a 99% true negative rate, with only 11 disagreements observed between the IFA, wv-ELISA and SVN. Conclusions All three serology assays detected PPIV-1 antibody in swine serum of known status that was collected from experimental studies. The SVN detected seroconversion earlier compared to the IFA and the wv-ELISA. Both the wv-ELISA and the SVN had similar diagnostic performance, while the IFA was not as sensitive as the wv-ELISA. All three assays are considered valid for routine diagnostic use. These assays will be important for future studies to screen seronegative swine for research, determine PPIV-1 seroprevalence, and to evaluate vaccine efficacy against PPIV-1 under experimental and field conditions.

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Fernandez Valledor, A., P. Jorda, C. Pajuelo, D. Vinas, J. Hernandez, V. Culotta, M. J. Pinazo, et al. "P1810May early myocardial involvement detection in chagas disease have a prognosis impact?" European Heart Journal 40, Supplement_1 (October 1, 2019). http://dx.doi.org/10.1093/eurheartj/ehz748.0562.

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Abstract Background Brain natriuretic peptide (BNP) and novel echocardiographic techniques such as speckle-tracking and a comprehensive evaluation of diastolic function can detect early myocardial involvement in patients with Chagas disease. However, there is lack of longitudinal studies that can confirm whether this early myocardial involvement translates into a worse prognosis. Purpose To assess if early myocardial involvement detected by BNP or a comprehensive echocardiographic evaluation was associated with future events in Chagas disease. Methods 182 consecutive individuals from endemic areas who underwent T. cruzi screening where prospectively included from 2007 to 2014. ECG, BNP and a comprehensive echocardiography including diastolic function and longitudinal myocardial strain were performed. Four different groups were defined: healthy controls (N=77); Chagas indeterminate form (positive serology, normal ECG and left ventricle (LV) diameter (<55 mm), LV ejection fraction (>50%) and no segmental abnormalities, N=88); Chagas patients with abnormal ECG but normal LV dimensions and motility (N=7); and Chagas patients with LV diameter>55 mm or LV ejection fraction<50% or segmental abnormalities (N=13). The primary outcome included advanced atrioventricular block, sustained ventricular tachycardia, heart failure, heart transplant or death. Kaplan Meier with Long rank test and Cox regression analysis was used. Results Mean age was 37±9 and 34% were male. Median follow-up was 63 months (range 1 to 137). The primary endpoint occurred in a total of 11 (10%) individuals: 2 (2.4%) in the Indeterminate group; 3 (43%) in the abnormal ECG group; and 6 (46%) in the group with abnormal LV dimension or motility, with no events among controls (long-rank test<0.01, Figure). In the global population, age, BNP, diastolic dysfunction parameters and longitudinal strain at the inferior and lateral walls were significant predictors. In the cohort of Chagas patients with normal standard echocardiography (N=92), ECG abnormalities (HR=49, p=0.001), Em (HR=0.68, p=0.03), deceleration time (HR=0.01, p=0.01), left atrial diameter (HR=1.24, p<0.01) and longitudinal strain at the midventricular lateral wall (HR=0.75, p=0.028) remained significantly associated with outcome. Cumulative survival without events Conclusions Outcome was significantly more frequent in Chagas patients with abnormalities in ECG or standard echocardiography. In early forms of the disease, myocardial involvement detected by BNP or a comprehensive echocardiography was associated with prognosis, and may help to individualize treatment and follow-up.

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Nieuwenburg, Silvia Achia, Ricardo Jamie Sprenger, Maarten Franciscus Schim van der Loeff, and Henry John Christiaan de Vries. "Clinical outcomes of syphilis in HIV-negative and HIV-positive MSM: occurrence of repeat syphilis episodes and non-treponemal serology responses." Sexually Transmitted Infections, February 19, 2021, sextrans—2020–054887. http://dx.doi.org/10.1136/sextrans-2020-054887.

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ObjectivesHIV-positive men who have sex with men (MSM) may be at a higher risk of repeat syphilis, have different clinical manifestations and have a different serological response to treatment compared with HIV-negative MSM. The objective of this study was to assess whether HIV-negative and HIV-positive MSM with infectious syphilis (primary, secondary or early latent) differed in history of previous syphilis episodes, disease stage and non-treponemal titre of initial and repeat episodes, and the titre response 6 and 12 months after treatment. Furthermore, determinants associated with an inadequate titre response after treatment were explored.MethodsThis retrospective analysis used data of five longitudinal studies (four cohorts; one randomised controlled trial) conducted at the STI clinic in Amsterdam, the Netherlands. Participants were tested for syphilis and completed questionnaires on sexual risk behaviour every 3–6 months. We included data of participants with ≥1 syphilis diagnosis in 2014–2019. Pearson’s χ² test was used to compare HIV-negative and HIV-positive MSM in occurrence of previous syphilis episodes, disease stage of initial and repeat syphilis episode and non-treponemal titre treatment responses.ResultsWe included 355 participants with total 459 syphilis episodes. HIV-positive MSM were more likely to have a history of previous syphilis episodes compared with HIV-negative MSM (68/90 (75.6%) vs 96/265 (36.2%); p<0.001). Moreover, HIV-positive MSM with repeat syphilis were less often diagnosed with primary syphilis (7/73 (9.6%) vs 36/126 (28.6%)) and more often diagnosed with secondary syphilis (16/73 (21.9%) vs 17/126 (13.5%)) and early latent syphilis (50/73 (68.5%) vs 73/126 (57.9%)) (p=0.005). While not significantly different at 12 months, HIV-negative MSM were more likely to have an adequate titre response after 6 months compared with HIV-positive MSM (138/143 (96.5%) vs 66/74 (89.2%); p=0.032).ConclusionsIn repeat syphilis, HIV infection is associated with advanced syphilis stages and with higher non-treponemal titres. HIV infection affects the serological outcome after treatment, as an adequate titre response was observed earlier in HIV-negative MSM.

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Visaria, Aayush, Shivani Reddy, Akarsh Sharma, Bharath Nagaraj, and Fariha Hameed. "Abstract EP41: Relationship Between Body Mass Index And Low Total Bilirubin In US Adults." Circulation 145, Suppl_1 (March 2022). http://dx.doi.org/10.1161/circ.145.suppl_1.ep41.

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Background: Low total bilirubin (TBili) is associated with increased cardiovascular risk, in part mediated by adipose tissue-related hormones. determined whether excess adiposity (measured by BMI) is associated with low TBili levels. Methods: Our study population consisted of 14,129 (6,902 male and 7,227 non-pregnant female) adults aged ≥20 years from the 1999-2018 National Health and Nutrition Examination Surveys. Participants with elevated liver enzymes (AST>80 or ALT >112 IU/L; AST/ALT >5), excessive alcohol consumption (>20 drinks/week for males; >10 for females), iron overload (transferrin >50%), anemia (hemoglobin<12 g/dl if female; <13 g/dl if male), elevated TBili (≥1.2 mg/dl), low albumin (<3.5 g/dl), or positive hepatitis B/C serology were excluded. We categorized measured BMI into 7 categories (<18.5, 18.5-22.9, 23.0-24.9, 25.0-27.4, 27.5-29.9, 30-34.9, ≥35). Low TBili, our primary outcome, was defined as <0.4 mg/dl for both males and females. We used sex-stratified multivariable logistic regression, sequentially adjusting for demographics, cardiometabolic factors, and liver function. Results: Among 14,129 adults (mean age [SD] of 47 [15] years, 51% female, 69% White), nearly 32% had BMI ≥30. Both males and females with BMI ≥30 had >50% odds of low TBili compared to a BMI of 23-24.9, even after adjustment for covariates (Table). There was no significant association between overweight range BMIs and low TBili. Adjustment for serum albumin most significantly attenuated the associations between obese-range BMIs and low TBili, especially in males. Further classifying each BMI category into high and normal waist circumference (WC;<88cm for female, <102cm for male) groups revealed that high WC individuals, even with BMI of 23-24.9, had increased odds of low TBili (OR [95% CI]: 2.35 [1.40, 3.94]). Conclusions: Obese BMI is associated with higher likelihood of low TBili. Longitudinal studies are needed to determine directionality of association and risk of downstream cardiovascular disease.

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Jackson-Thompson, Belinda M., Emilie Goguet, Eric D. Laing, Cara H. Olsen, Simon Pollett, K. Monique Hollis-Perry, Santina E. Maiolatesi, et al. "Prospective Assessment of SARS-CoV-2 Seroconversion (PASS) study: an observational cohort study of SARS-CoV-2 infection and vaccination in healthcare workers." BMC Infectious Diseases 21, no. 1 (June 9, 2021). http://dx.doi.org/10.1186/s12879-021-06233-1.

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Abstract Background SARS-CoV-2 is a recently emerged pandemic coronavirus (CoV) capable of causing severe respiratory illness. However, a significant number of infected people present as asymptomatic or pauci-symptomatic. In this prospective assessment of at-risk healthcare workers (HCWs) we seek to determine whether pre-existing antibody or T cell responses to previous seasonal human coronavirus (HCoV) infections affect immunological or clinical responses to SARS-CoV-2 infection or vaccination. Methods A cohort of 300 healthcare workers, confirmed negative for SARS-CoV-2 exposure upon study entry, will be followed for up to 1 year with monthly serology analysis of IgM and IgG antibodies against the spike proteins of SARS-CoV-2 and the four major seasonal human coronavirus - HCoV-OC43, HCoV-HKU1, HCoV-229E, and HCoV-NL63. Participants will complete monthly questionnaires that ask about Coronavirus Disease 2019 (COVID-19) exposure risks, and a standardized, validated symptom questionnaire (scoring viral respiratory disease symptoms, intensity and severity) at least twice monthly and any day when any symptoms manifest. SARS-CoV-2 PCR testing will be performed any time participants develop symptoms consistent with COVID-19. For those individuals that seroconvert and/or test positive by SARS-CoV-2 PCR, or receive the SARS-CoV-2 vaccine, additional studies of T cell activation and cytokine production in response to SARS-CoV-2 peptide pools and analysis of Natural Killer cell numbers and function will be conducted on that participant’s cryopreserved baseline peripheral blood mononuclear cells (PBMCs). Following the first year of this study we will further analyze those participants having tested positive for COVID-19, and/or having received an authorized/licensed SARS-CoV-2 vaccine, quarterly (year 2) and semi-annually (years 3 and 4) to investigate immune response longevity. Discussion This study will determine the frequency of asymptomatic and pauci-symptomatic SARS-CoV-2 infection in a cohort of at-risk healthcare workers. Baseline and longitudinal assays will determine the frequency and magnitude of anti-spike glycoprotein antibodies to the seasonal HCoV-OC43, HCoV-HKU1, HCoV-229E, and HCoV-NL63, and may inform whether pre-existing antibodies to these human coronaviruses are associated with altered COVID-19 disease course. Finally, this study will evaluate whether pre-existing immune responses to seasonal HCoVs affect the magnitude and duration of antibody and T cell responses to SARS-CoV-2 vaccination, adjusting for demographic covariates.

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Joy, G., J. Artico, H. Kurdi, C. Lau, RD Adam, KM Menacho, I. Pierce, et al. "Prospective case-control study of cardiovascular abnormalities six months following mild COVID-19 in healthcare workers." European Heart Journal - Cardiovascular Imaging 22, Supplement_2 (June 1, 2021). http://dx.doi.org/10.1093/ehjci/jeab090.064.

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Abstract Funding Acknowledgements Type of funding sources: Public Institution(s). Main funding source(s): Barts Charity UCLH Charity OnBehalf COVIDsortium Background Recent CMR studies have reported cardiac abnormalities after COVID-19 are common, even after mild, non-hospitalised illness with evidence of ongoing myocardial inflammation. Such a prevalence of chronic myocarditis after mild disease has prompted societal concerns in diverse domains, and suggests that screening should be considered post COVID-19, even in asymptomatic individuals. Cardiovascular magnetic resonance (CMR) has proven utility for diagnosis in patients with COVID-19 infection and elevated troponin from unclear causes by measuring cardiac structure, function, myocardial scar (late gadolinium enhancement) and oedema (T1 and T2 mapping). Objectives We aimed to determine the prevalence and extent of late cardiac and cardiovascular sequelae after mild non-hospitalised SARS-CoV-2 infection. Methods Participants were recruited from COVIDsortium, a three-hospital prospective study of 731 healthcare workers who underwent first wave weekly symptom, PCR and serology assessment over 4 months, with seroconversion in 21.5% (n = 157). At 6 months post infection, 74 seropositive and 75 age-, sex-, ethnicity-matched seronegative controls were recruited for cardiovascular phenotyping (comprehensive phantom-calibrated Cardiovascular Magnetic Resonance and blood biomarkers). Analysis was blinded, using objective AI analytics where available. Results 149 subjects (mean age 37 years, range 18-63, 58% female) were recruited. Seropositive infections had been mild with case definition/non-case definition/asymptomatic disease in 45(61%), 18(24%) and 11(15%) with one person hospitalised (for 2 days). Between seropositive and seronegative groups, there were no differences in cardiac structure (left ventricular volumes, mass; atrial area), function (ejection fraction, global longitudinal shortening, aortic distensibility), tissue characterisation (T1, T2, ECV mapping, late gadolinium enhancement) or biomarkers (troponin, NT-proBNP). With abnormal defined by the 75 seronegatives (2 standard deviations from mean, e.g. EF < 54%, septal T1 > 1072ms, septal T2 > 52.4ms), individuals had abnormalities including reduced EF (n = 2, minimum 50%), T1 elevation (n = 6), T2 elevation (n = 9), LGE (n = 13, median 1%, max 5% of myocardium), biomarker elevation (borderline troponin elevation in 4; all NT-proBNP normal). These were distributed equally between seropositive and seronegative individuals. Conclusions Cardiovascular abnormalities are no more common in seropositive vs seronegative otherwise healthy, workforce representative individuals 6 months post mild SARS-CoV-2 infection. Our study provides societal reassurance for the cardiovascular health of working-aged individuals with convalescence from mild SARS-CoV-2. Screening asymptomatic individuals following mild diseases is not indicated.

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Journal articles on the topic 'Serology Longitudinal studies'

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