Performance evaluation of SARS-CoV-2 rapid diagnostic tests in Nigeria: A cross-sectional study.

ABSTRACT

The COVID-19 pandemic challenged health systems globally. Reverse transcription polymerase chain reaction (RT-PCR) is the gold standard for detecting the presence of SARS-CoV-2 in clinical samples. Rapid diagnostic test (RDT) kits for COVID-19 have been widely used in Nigeria. This has greatly improved test turnover rates and significantly decreased the high technical demands of RT-PCR. However, there is currently no nationally representative evaluation of the performance characteristics and reliability of these kits. This study assessed the sensitivity, specificity, and predictive values of ten RDT kits used for COVID-19 testing in Nigeria. This large multi-centred cross-sectional study was conducted across the 6 geo-political zones of Nigeria over four months. Ten antigen (Ag) and antibody (Ab) RDT kits were evaluated, and the results were compared with RT-PCR. One thousand, three hundred and ten (1,310) consenting adults comprising 767 (58.5%) males and 543 (41.5%) females participated in the study. The highest proportion, 757 (57.7%), were in the 20-39 years' age group. In terms of diagnostic performance, Lumira Dx (61.4, 95% CI 52.4-69.9) had the highest sensitivity while MP SARS and Panbio (98.5, 95% CI 96.6-99.5) had the highest specificity. For predictive values, Panbio (90.7, 95% CI 79.7-96.9) and Lumira Dx (81.2, 95% CI 75.9-85.7) recorded the highest PPV and NPV respectively. Ag-RDTs had better performance characteristics compared with Ab-RDTs; however, the sensitivities of all RDTs in this study were generally low. The relatively high specificity of Ag-RDTs makes them useful for the diagnosis of infection in COVID-19 suspected cases where positive RDT may not require confirmation by molecular testing. There is therefore the need to develop RDTs in-country that will take into consideration the unique environmental factors, interactions with other infectious agents, and strains of the virus circulating locally. This may enhance the precision of rapid and accurate diagnosis of COVID-19 in Nigeria.