Diagnostic Performance of SARS-CoV-2 IgM/IgG Rapid Test Kits for the Detection of the Novel Coronavirus in Ethiopia.
COVID-19
Ethiopia
diagnostic performance
rapid test
sensitivity
specificity
Journal
Journal of multidisciplinary healthcare
ISSN: 1178-2390
Titre abrégé: J Multidiscip Healthc
Pays: New Zealand
ID NLM: 101512691
Informations de publication
Date de publication:
2021
2021
Historique:
received:
10
11
2020
accepted:
22
12
2020
entrez:
4
2
2021
pubmed:
5
2
2021
medline:
5
2
2021
Statut:
epublish
Résumé
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. 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. 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. 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.
Identifiants
pubmed: 33536760
doi: 10.2147/JMDH.S290711
pii: 290711
pmc: PMC7850445
doi:
Types de publication
Journal Article
Langues
eng
Pagination
171-180Informations de copyright
© 2021 Sisay et al.
Déclaration de conflit d'intérêts
We, the authors declare that we have no conflicts of interest for this work.
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