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Serological assays to measure dimeric IgA antibodies in SARS-CoV-2 infections.

ABSTRACT: Current serological tests cannot differentiate between total immunoglobulin A (IgA) and dimeric IgA (dIgA) associated with mucosal immunity. Here, we describe two new assays, dIgA-ELISA and dIgA-multiplex bead assay (MBA), that utilize the preferential binding of dIgA to a chimeric form of secretory component, allowing the differentiation between dIgA and monomeric IgA. dIgA responses elicited through severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection were measured in (i) a longitudinal panel, consisting of 74 samples (n = 20 individuals) from hospitalized cases of coronavirus disease 2019 (COVID-19); (ii) a longitudinal panel, consisting of 96 samples (n = 10 individuals) from individuals with mild COVID-19; (iii) a cross-sectional panel with PCR-confirmed SARS-CoV-2 infection with mild COVID-19 (n = 199) and (iv) pre-COVID-19 samples (n = 200). The dIgA-ELISA and dIgA-MBA demonstrated a specificity for dIgA of 99% and 98.5%, respectively. Analysis of dIgA responses in the longitudinal panels revealed that 70% (ELISA) and 50% (MBA) of patients elicited a dIgA response by day 20 after PCR diagnosis with a SARS-CoV-2 infection. Individuals with mild COVID-19 displayed increased levels of dIgA within the first 3 weeks after diagnosis but responses appeared to be short lived, compared with sustained IgA levels. However, in samples from hospitalized patients with COVID-19 we observed high and sustained levels of dIgA, up to 245 days after PCR diagnosis. Our results suggest that severe COVID-19 infections are associated with sustained levels of plasma dIgA compared with mild cases.

SUBMITTER: Wei Z

PROVIDER: S-EPMC10952984 | biostudies-literature | 2023 Oct

REPOSITORIES: biostudies-literature

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Serological assays to measure dimeric IgA antibodies in SARS-CoV-2 infections.

Wei Zihui Z Angrisano Fiona F Eriksson Emily M EM Mazhari Ramin R Van Huy H Zheng Shuning S Center Rob J RJ Boo Irene I McMahon James J Lau Jillian J Kiernan-Walker Nicholas N Ruybal-Pesántez Shazia S Mueller Ivo I Robinson Leanne J LJ Anderson David A DA Drummer Heidi E HE

Immunology and cell biology 20230818 9

Current serological tests cannot differentiate between total immunoglobulin A (IgA) and dimeric IgA (dIgA) associated with mucosal immunity. Here, we describe two new assays, dIgA-ELISA and dIgA-multiplex bead assay (MBA), that utilize the preferential binding of dIgA to a chimeric form of secretory component, allowing the differentiation between dIgA and monomeric IgA. dIgA responses elicited through severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection were measured in (i) a l ...[more]

PMID: 37593973

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Project description:The onset of the coronavirus disease 2019 (COVID-19) pandemic resulted in hundreds of in vitro diagnostic devices (IVDs) coming to market, facilitated by regulatory authorities allowing "emergency use" without a comprehensive evaluation of performance. The World Health Organization (WHO) released target product profiles (TPPs) specifying acceptable performance characteristics for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) assay devices. We evaluated 26 rapid diagnostic tests and 9 enzyme immunoassays (EIAs) for anti-SARS-CoV-2, suitable for use in low- and middle-income countries (LMICs), against these TPPs and other performance characteristics. The sensitivity and specificity ranged from 60.1 to 100% and 56.0 to 100%, respectively. Five of 35 test kits reported no false reactivity for 55 samples with potentially cross-reacting substances. Six test kits reported no false reactivity for 35 samples containing interfering substances, and only one test reported no false reactivity with samples positive for other coronaviruses (not SARS-CoV-2). This study demonstrates that a comprehensive evaluation of the performance of test kits against defined specifications is essential for the selection of test kits, especially in a pandemic setting. IMPORTANCE The markets have been flooded with hundreds of SARS-CoV-2 serology tests, and although there are many published reports on their performance, comparative reports are far fewer and tend to be limited to only a few tests. In this report, we comparatively assessed 35 rapid diagnostic tests or microtiter plate enzyme immunoassays (EIAs) using a large set of samples from individuals with a history of mild to moderate COVID-19, commensurate with the target population for serosurveillance, which included serum samples from individuals previously infected, at undetermined time periods, with other seasonal human coronaviruses, Middle East respiratory syndrome coronavirus (MERS-CoV), and SARS-CoV-1. The significant heterogeneity in their performances, with only a few tests meeting WHO target product profile performance requirements, highlights the importance of independent comparative assessments to inform the use and procurement of these tests for both diagnostics and epidemiological investigations.

Dataset Information

Serological assays to measure dimeric IgA antibodies in SARS-CoV-2 infections.

Publications

Serological assays to measure dimeric IgA antibodies in SARS-CoV-2 infections.

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