Diagnostic Performance of SARS-CoV-2 IgM/IgG Rapid Test Kits for the Detection of the Novel Coronavirus in Ethiopia

PURPOSE: Rapid severe acute respiratory syndrome coronavirus 2 test kits are crucial for bridging diagnostic gaps in health facilities and community screening mainly in resource limited settings However, there is no objective evidence on their diagnostic performance Thus, the study aimed to evaluate comparative diagnostic performance of three selected SARS-CoV-2 IgG/IgM rapid test kits in Ethiopia METHODS: A cross-sectional study was conducted among 200 clients between May and July 2020 in Addis Ababa, Ethiopia The performance of three SARS-CoV-2 rapid test kits EGENE, CTK BIOTECKs Onsite, and ACON Biotech were evaluated using blood specimens against RT-PCR on respiratory swabs Sensitivity, specificity, and agreement with each other and to RT-PCR were computed using Vassarstats, MedCalc and SPSS version 23 statistical software RESULTS: Test kits showed a heterogeneous comparative diagnostic performance in their sensitivity and specificity The sensitivity was 61 18% (95% CI: 49 96-71 37%), 74 12% (95% CI: 63 28-82 74%) and 83 53% (95% CI: 73 57-90 38%) for kit A, B and C, respectively Similarly, the specificity was 96 52% (90 81-98 88%), 94 78% (88 52-97 86%) and 94 78% (88 52-97 86%) for test kit A, B and C, respectively The test kits have an agreement with RT-PCR with kappa value of 0 60 (0 48-0 83), 0 71 (0 65-0 93), and 0 80 (0 76-1 04) for A, B, and C, respectively There was a significant difference on diagnostic performance among the three test kits and PCR with a p-value < 0 001 Cochran's Q test CONCLUSION: The diagnostic performance of the test kits was promising and recommended for COVID-19 diagnostics in combination with RT-PCR to detect more infected patients It allows determining the seroprevalence of the virus and true extent of SARS-COV-2 community spread in resource limited settings We underline countries to evaluate rapid diagnostic test kits before diagnostic use