Abstract
Many SARS-CoV-2 antibody detection assays have been developed but their differential performance is not well described. In this study we compared an in-house (KWTRP) ELISA which has been used extensively to estimate seroprevalence in the Kenyan population with WANTAI, an ELISA which has been approved for widespread use by the WHO. Using a wide variety of sample sets including pre-pandemic samples (negative gold standard), SARS-CoV-2 PCR positive samples (positive gold standard) and COVID-19 test samples from different periods (unknowns), we compared performance characteristics of the two assays. The overall concordance between WANTAI and KWTRP was 0.97 (95% CI, 0.95-0.98). For WANTAI and KWTRP, sensitivity was 0.95 (95% CI 0.90-0.98) and 0.93 (95% CI 0.87-0.96), respectively. Specificity for WANTAI was 0.98 (95% CI, 0.96-0.99) and 0.99 (95% CI 0.96-1.00) while KWTRP specificity was 0.99 (95% CI, 0.98-1.00) and 1.00 using pre-pandemic blood donors and pre-pandemic malaria cross-sectional survey samples respectively. Both assays show excellent characteristics to detect SARS-CoV-2 antibodies.
Highlights
In December 2019, a severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) emerged in Wuhan and rapidly spread around the globe causing a pandemic
We developed an in-house (KWTRP) ELISA based on the whole trimeric spike protein and validated it extensively on local samples and international standards
WANTAI specificity was slightly lower than KWTRP specificity using both negative sample sets, the 2018 prepandemic coastal Kenya blood donors and the 2018 malaria crosssectional survey samples
Summary
In December 2019, a severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) emerged in Wuhan and rapidly spread around the globe causing a pandemic. SARS-CoV-2 is an enveloped positive sense RNA virus with the genome encoding structural and non-structural proteins in the 3′ and 5′ regions respectively [1]. Nucleic acid amplification tests (NAAT) remain reference standard for SARS-CoV-2 diagnosis, serological assays have become very useful tools for estimating viral transmission and seroprevalence espe cially in regions where there is limited NAAT coverage, like Kenya. We developed an in-house (KWTRP) ELISA based on the whole trimeric spike protein and validated it extensively on local samples and international standards. The validation process included participation in a WHO-sponsored multi-laboratory study of SARS-CoV-2 antibody as says [2]. We have since used the KWTRP ELISA to estimate SARS-CoV-2 seroprevalence in several target groups [3,4,5]
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