Performance of anti-SARS-CoV-2 IgG/IgM rapid diagnostic test in N’Djamena, Chad: evidence from a clinical perspective during an outbreak response
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Authors
The utility of rapid serological tests for anti-SARS-CoV-2 antibodies, particularly in a tropical context, is not well-defined. We evaluated the performance of the Genrui IgG/IgM rapid diagnostic test (RDT; Genrui Biotech Inc., Shenzhen, China) against an enzyme-linked immunosorbent assay (ELISA), which serves as the gold standard. This cross-sectional study was conducted in N’Djamena, Chad, in July 2022. A total of 198 samples from individuals attending a facility for COVID-19 diagnosis were tested using both the Genrui RDT and the DIATHEVA COVID-19 IgG ELISA kit (DIATHEVA S.r.l., Fano, Italy). IgG seropositivity with ELISA was 84.8%, significantly higher than the 54% found with the RDT, representing a 30.8% difference. The RDT showed a sensitivity of 60% and a specificity of 80%, with poor agreement with ELISA (Cohen’s κ=0.22). Positive and negative predictive values (PPVs and NPVs) were 94% and 26%, respectively. The rapid IgM/IgG test from Genrui Biotech Inc. has a significantly suboptimal performance for detecting anti-SARS-CoV-2 antibodies. This highlights the need for performing ELISA on non-reactive RDT cases during serosurveys or post-vaccine response assessments.
Supporting Agencies
The present study was supported by the MAGIS Foundation, the Italian Agency for Development Cooperation, and the European and Developing Countries Clinical Trials Partnership, EDCTP PERECT-Study RIA2020 EF3000.Doctoral School of Advanced Sciences for Sustainable Development, Evangelic University of Cameroon, Bandjoun, Cameroon.
Doctoral School of Advanced Sciences for Sustainable Development, Evangelic University of Cameroon, Bandjoun, Cameroon; Laboratory of Immunology, National Research Council, Rome, Italy.
Doctoral School of Advanced Sciences for Sustainable Development, Evangelic University of Cameroon, Bandjoun, Cameroon.
Faculty of Sciences and Technology, Evangelical University of Cameroon, Bandjoun, Cameroon.
Faculty of Medicine and Biomedical Sciences, University of Yaoundé 1, Cameroon.
Faculty of Medicine and Biomedical Sciences, University of Yaoundé 1, Cameroon; Laboratory of Immunology, National Research Council, Rome, Italy.
National Public Health Emergency Operations Coordination Centre, Yaoundé, Cameroon.
Faculty of Health Sciences, University of Buea, Cameroon; Bambino Gesù Pediatric Hospital, Rome, Italy; National AIDS Control Committee, Ministry of Public Health, Yaoundé, Cameroon; Virology Laboratory, Chantal Biya International Reference Centre for Research on HIV and AIDS Prevention and Management, Yaoundé, Cameroon.
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