Background
The World Health Organization (WHO) declared the outbreak of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2 or COVID-19) as a pandemic on 12th March 2020 (1). The pandemic which began after a cluster of cases of pneumonia with unknown etiology was reported in the Hubei province of Wuhan, China (2,3) The novel coronavirus was identified as the etiological agent that was spreading rapidly to other cities in China and other countries worldwide (4). Globally, the number of confirmed cases and deaths reported to the World Health Organization (WHO) as of 7th November 2022 are 632,895,390 and 6,596,852, respectively (5). In Ghana, the first confirmed case was recorded on 12th March 2020 (6), and the number of confirmed cases reported to the World Health Organization from all regions of the country stood at 170,972, with 1,461 deaths as of 7th November 2022 (5).
In the heat of the pandemic, various rRT-PCR laboratories were set up, and other existing laboratories were revamped to increase the preparedness of the country in terms of testing suspected cases (7). However, rRT-PCR is costly, time consuming and requires specially trained personnel to execute (8). The rapid immunochromatographic antigen test tries to fulfill this task and may be used directly and instantly, offering results within a few minutes. This permits speedy decision making, which strongly affects clinical management outcomes (9). The aim of this study was to assess the quality performance of three (3) COVID-19 rapid antigen test kits, the DG Rapid RDT, SD Rapid RDT and SS Rapid RDT on the Ghanaian market, as the reliance on such RDTs continues to grow. The specific objectives were to determine and compare the sensitivity, specificity, and predictive values of the three antigen test kits to known rRT-PCR tested samples. Others include comparing the sensitivity, specificity, and predictive values of the test kits to the kits manufacturer’s claims; contrasting the sensitivity, specificity, and predictive values of the test kits with the known Ct values obtained from rRT-PCR tested samples; and evaluating the overall agreement of these test kits against the gold standard rRT-PCR.