Evaluation of the performance of the novel Coronavirus (2019-nCov) IgM/IgG test kit for use in testing Covid-19 in Uganda

Abstract

Globally, the response to the Severe Acute Respiratory Syndrome- Cov-2 (SARS-CoV-2) pandemic is highly limited by diagnostic methods. Currently, World Health Organization (WHO) recommends the use of molecular assays for confirmation of SARS-CoV-2 infection which are highly expensive and require specialized laboratory equipment. This is a limitation in mass testing and in low resource settings. In this study, the performance of Novel Coronavirus (2019-nCov) IgM/IgG test kit was evaluated to determine if it was suitable for use in COVID-19 Testing in Uganda. Method A total of 148 plasma samples were used to evaluate the performance of Novel Coronavirus IgM/IgG test. Sixty samples were confirmed as positive for COVID-19. These were categorized according to the day when tested positive by Real Time PCR as follows: Day 0-3, Day 4-7, Day 8-14 and Day 15-28. The samples were collected from patients at Mbarara Regional Referral Hospital and Masaka Regional Referral Hospital. The negative samples used in this performance evaluation were 88 and these were obtained from the National Biorepository at UNHLS/CPHL. They were samples archived from 2018 and hence unlikely to be exposed to SARS-CoV-2. The testing of the samples was carried out following the manufacturer’s instructions on the kit insert and the results obtained were recorded on the Study Record Form. The data obtained was transferred to Microsoft excel. The sensitivity, specificity, positive predictive value and negative predictive value of the Novel Coronavirus IgM/IgG test kit were calculated. Results The sensitivity, specificity, positive predictive value and negative predictive value were 62%, 95%, 90% and 79% respectively. Discussion The Novel Coronavirus IgM/IgG test kit showed a moderate performance and hence it is necessary to compare this assay to other serological tests like Enzyme- linked Immunosorbent Assay based tests.