ABSTRACT
Background: The performance of serological antibody tests to SARS-CoV-2 infection varies widely and little is known about their performance in Africa. We assessed the performance of CoronaCHEK Lateral Flow Point of Care Tests on samples from Rakai, Uganda and Baltimore, Maryland, USA. Methods: Samples from subjects known to be SARS-CoV-2 PCR+ (Uganda: 50 samples from 50 individuals, and Baltimore: 266 samples from 38 individuals) and samples from pre-pandemic individuals collected prior to 2019 (Uganda: 1077 samples, Baltimore: 580 samples) were analyzed with the CoronaCHEK assay per manufacturers protocol. Sensitivity by duration of infection and specificity among pre-pandemic samples were assessed for the IgM and IgG bands separately and for any reactivity. Poisson regression models were used to calculate prevalence ratios (PR) for factors associated with a false-positive test among pre-pandemic samples. Results: In Baltimore samples, sensitivity for any reactivity increased with duration of infection with 39% (95% CI 30, 49) during 0-7 days since first positive PCR, 86% (95% CI 79, 92) for 8-14 days, and 100% (95% CI 89,100) after 15 days (See Figure). In Uganda, sensitivity was 100% (95% CI 61,100) during 0-7 days, 75% (95%CI 53, 89) for 8-14 days, and 87% (95%CI 55, 97) after 14 days since first positive PCR. Specificity results among pre-pandemic samples from Uganda was 96.5% (95% CI 97.5, 95.2), significantly lower than the 99.3% (95% CI 98.2, 99.8) observed in samples from Baltimore (p<0.01). In Ugandan samples, individuals with a false positive result were more likely to have had a fever more than a month prior to sample acquisition (PR 2.9, 95% CI 1.1, 7.0). Conclusion: Sensitivity of the CoronaCHEK appeared to be significantly higher in Ugandan samples from individuals within their first week of infection compared to their Baltimorean counterparts. By the second week of infection the sensitivity appeared the same between geographic areas. The specificity was significantly lower in Ugandan samples than those from Baltimore. False positive results from pre-pandemic Uganda appear to be correlated with the convalescent disease state, potentially indicative of a highly cross-reactive immune response in these individuals from East Africa.