Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) seroprevalence: Navigating the absence of a gold standard
Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) seroprevalence: Navigating the absence of a gold standard
ABSTRACT BackgroundMultiple anti-SARS-CoV-2 immunoassays are available, but no gold standard exists. We assessed four assays using various methodological approaches to estimate SARS-COV-2 seroprevalence during the first COVID-19 wave in Canada. MethodsThis serial cross-sectional study was conducted using plasma samples from healthy blood donors between April-September 2020. Qualitative assessment of SARS-CoV-2 IgG antibodies was based on four assays: Abbott Architect SARS-Cov-2 IgG assay (target nucleocapsid) (Abbott-NP) and three in-house IgG ELISA assays (target spike glycoprotein (Spike), spike receptor binding domain (RBD), and nucleocapsid (NP)). Seroprevalence was estimated using multiple composite reference standards (CRS) and by a series of Bayesian Latent Class Models (BLCM) (using uninformative, weakly, and informative priors). Results8999 blood samples were tested. The Abbott-NP assay consistently estimated seroprevalence to be lower than the ELISA-based assays. Discordance between assays was common, 13 unique diagnostic phenotypes were observed. Only 32 samples (0.4%) were positive by all four assays. BLCM using uninformative priors predicted seroprevalence increased from 0.7% (95% credible interval (CrI); 0.4, 1.0%) in April/May to 0.8% (95% CrI 0.5, 1.2%) in June/July to 1.1% (95% CrI 0.7, 1.6) in August/September. Results from CRS were very similar to the BLCM. Assay characteristics varied considerably over time. Overall spike had the highest sensitivity (89.1% (95% CrI 79.2, 96.9%), while the sensitivity of the Abbott-NP assay waned from 65.3% (95% CrI 43.6, 85.0%) in April/May to 45.9% (95% CrI 27.8, 65.6) by August/September. DiscussionWe found low SARS-CoV-2 seroprevalence rates at the end of the first wave and estimates derived from single assays may be biased. SummaryMultiple anti-SARS-CoV-2 immunoassays are available, but no gold standard exists. We used four unique assays to estimate very low SARS-COV-2 seroprevalence during the first COVID-19 wave in Canada. Caution should be exercised when interpretating seroprevalence estimates from single assays.
Saeed Sahar、Abe Kento、Fazel-Zarandi Mahya、Wang Jenny、Colwill Karen、Yi QiLong、Rathod Bhavisha、Gingras Anne-Claude、Tuite Ashleigh、Wood Heidi、O?ˉBrien Sheila F.、Fisman David、Drews Steven
Epidemiology and Surveillance, Canadian Blood ServicesLunenfeld-Tanenbaum Research Institute at Mt. Sinai Hospital||Department of Molecular Genetics, University of TorontoLunenfeld-Tanenbaum Research Institute at Mt. Sinai HospitalLunenfeld-Tanenbaum Research Institute at Mt. Sinai HospitalLunenfeld-Tanenbaum Research Institute at Mt. Sinai HospitalEpidemiology and Surveillance, Canadian Blood Services||School of Epidemiology and Public Health, University of OttawaLunenfeld-Tanenbaum Research Institute at Mt. Sinai HospitalLunenfeld-Tanenbaum Research Institute at Mt. Sinai Hospital||Department of Molecular Genetics, University of TorontoDalla Lana School of Public Health, University of TorontoNational Microbiology Laboratory, Public Health Agency of CanadaEpidemiology and Surveillance, Canadian Blood Services||School of Epidemiology and Public Health, University of OttawaDalla Lana School of Public Health, University of TorontoMicrobiology Department, Canadian Blood Services||Department of Laboratory Medicine & Pathology, Division of Diagnostic and Applied Microbiology, University of Alberta
医学研究方法基础医学医药卫生理论
SARS-CoV-2seroprevalenceimmunoassaysBayesian Latent Class Analysis
Saeed Sahar,Abe Kento,Fazel-Zarandi Mahya,Wang Jenny,Colwill Karen,Yi QiLong,Rathod Bhavisha,Gingras Anne-Claude,Tuite Ashleigh,Wood Heidi,O?ˉBrien Sheila F.,Fisman David,Drews Steven.Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) seroprevalence: Navigating the absence of a gold standard[EB/OL].(2025-03-28)[2025-08-02].https://www.medrxiv.org/content/10.1101/2021.05.11.21256992.点此复制
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