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

Authors Sisay A, Tesfaye A, Desale A, Ataro I, Woldesenbet Z, Nigusse B, Tayachew A, Kebede A, Desta AF

Received 10 November 2020

Accepted for publication 22 December 2020

Published 27 January 2021 Volume 2021:14 Pages 171—180

DOI https://doi.org/10.2147/JMDH.S290711

Checked for plagiarism Yes

Review by Single anonymous peer review

Peer reviewer comments 2

Editor who approved publication: Dr Scott Fraser


Abay Sisay,1,2 Abraham Tesfaye,2,3 Adino Desale,4 Israel Ataro,5 Zerihun Woldesenbet,6 Bisrat Nigusse,7 Adamu Tayachew,4,8 Adisu Kebede,4 Adey F Desta1

1Department of Microbial Cellular and Molecular Biology, College of Natural and Computational Sciences, Addis Ababa University, Addis Ababa, Ethiopia; 2Department of Medical Laboratory Sciences, College of Health Sciences, Addis Ababa University, Addis Ababa, Ethiopia; 3Diagnostic Unit, Center for Innovative Drug Development and Therapeutic Trials for Africa, CDT-Africa, Addis Ababa, Ethiopia; 4National Laboratories Capacity Building Directorate, Ethiopian Public Health Institutes, EPHI, Addis Ababa, Ethiopia; 5Health Extension Program and Primary Health Care Directorate, Federal Democratic Republic of Ethiopia, Ministry of Health, Addis Ababa, Ethiopia; 6Department of Medical Laboratory, Yekatit 12 Hospital Medical College, Addis Ababa, Ethiopia; 7Program Management Unit, Ethiopian Public Health Laboratory Association, Addis Ababa, Ethiopia; 8National Influenza and Arbovirus Reference Laboratory, Ethiopian Public Health Institutes, EPHI, Addis Ababa, Ethiopia

Correspondence: Abay Sisay Email [email protected]

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.

Keywords: COVID-19, diagnostic performance, Ethiopia, rapid test, sensitivity, specificity

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