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.