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\begin{document}

\title{Diagnostic Performance Evaluation of Three COVID-19 Rapid
Immunochromatographic Test Kits on Clinical Samples Tested by rRT-PCR.}



\author[1]{Eric Nyarko NY}%
\author[2]{Simon Bani B}%
\author[2]{Ebenezer Amakye K}%
\author[2]{Shanthi Akomeah}%
\author[3]{Derrick N.D. Dodoo}%
\author[4]{Clement Aidoo}%
\author[4]{Magdalene Fynn-Buadu}%
\author[5]{Monica Adom}%
\author[6]{Fathea Bani}%
\author[7]{Christian Obirikorang}%
\affil[1]{University of Ghana Medical School}%
\affil[2]{University for Development Studies School of Allied Health Sciences}%
\affil[3]{Baldwin University College}%
\affil[4]{Accra Technical University}%
\affil[5]{Princess Marie Louise Children’s Hospital}%
\affil[6]{University for Development Studies School of Medicine}%
\affil[7]{Kwame Nkrumah University of Science and Technology College of Health Sciences}%


\vspace{-1em}



  
  \date{June 10, 2024}


\begingroup
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\selectlanguage{english}
\begin{abstract}
\textbf{Background}: COVID-19 has imposed significant burden on
healthcare systems worldwide. The need for simple, rapid, and affordable
diagnostic tests to support the existing costly and demanding polymerase
chain reaction (PCR) assay is very necessary. \textbf{Methods:} This
study evaluated the performance characteristics of three (3) COVID-19
rapid antigen test kits: DG Rapid, SD Rapid and SS Rapid. They were
compared with the gold standard real-time reverse transcriptase- PCR
(rRT-PCR) for the detection of SARS-CoV-2 nucleocapsid antigen in 75
archived samples. \textbf{Results:} Of the 75 samples tested, 38
(50.7\%) were positive and 37 (49.3\%) were negative for SARS-CoV-2 RNA
by rRT-PCR assay. No false positive was recorded. The DG Rapid kit
detected 30 (78.9\%) true positives and 8 (21.1\%) false negatives. SD
Rapid kit detected 28 (73.7\%) true positives and 10 (26.3\%) false
negatives, while the SS Rapid kit detected 19 (50.0\%) true positives
and 19 (50.0\%) false negatives. Specificity of each test kit was 100\%
(CI 95\%), but the sensitivity of the DG Rapid, SD Rapid, and SS Rapid
kits was 79\%, 74\%, and 50\% (CI 95\%), respectively. Higher
sensitivities among samples with Ct values \textless{}29.99 were
recorded for each kit. Also, the DG Rapid kit demonstrated 79\%
excellent agreement with rRT-PCR, while the SD Rapid and SS Rapid kits
demonstrated good agreement with rRT-PCR with 73\% and 50\% Cohen's
kappa values, respectively. \textbf{Conclusion:} The study suggests that
DG Rapid and SD Rapid kits are reliable alternatives to rRT-PCR for the
detection of SARS-CoV-2 infection, especially in resource-limited
settings like Ghana.%
\end{abstract}%



\sloppy


\emph{Title\textbf{:}}

\textbf{Diagnostic Performance Evaluation of Three COVID-19 Rapid
Immunochromatographic Test Kits on Clinical Samples Tested by rRT-PCR.}

\emph{Authors:}

Simon B Bani\textsuperscript{1}, Ebenezer K Amakye\textsuperscript{1},
Shanthi Akomeah\textsuperscript{1}, Eric NY Nyarko\textsuperscript{2*},
Derrick N.D. Dodoo\textsuperscript{3}, Clement Aidoo\textsuperscript{4},
Magdalene Fynn-Buadu\textsuperscript{4}, Monica Adom\textsuperscript{5},
Fathea Bani\textsuperscript{6}, Christian
Obirikorang\textsuperscript{7,8}

\textsuperscript{1} Department of Biomedical Laboratory Sciences, School
of Allied Health Sciences, University for Development Studies

\textsuperscript{2}Department of Chemical Pathology, University of Ghana
Medical School, College of Health Sciences, University of Ghana

\textsuperscript{3}Department of Medical Laboratory Science, Baldwin
University College

\textsuperscript{4}Department of Medical Laboratory Technology, Accra
Technical University

\textsuperscript{5}Department of Medical Laboratory Sciences, Princess
Marie Louise Children's Hospital, Accra

\textsuperscript{6}School of Medicine and Health Sciences, University
for Development Studies, Tamale, Ghana.

\textsuperscript{7}Department of Molecular Medicine, School of Medicine
and Dentistry, Kwame Nkrumah University of Science and Technology, Ghana

\textsuperscript{8}Global Health and Infectious Diseases Group, Kumasi
Centre for Collaborative Research, Ghana

*\textbf{Corresponding author}

Eric NY Nyarko

Department of Chemical Pathology,

University of Ghana Medical School,

University of Ghana, Ghana

eynyarko@ug.edu.gh

\textbf{ABSTRACT}

\textbf{Background} : COVID-19 has imposed significant burden on
healthcare systems worldwide. The need for simple, rapid, and affordable
diagnostic tests to support the existing costly and demanding polymerase
chain reaction (PCR) assay is very necessary.

\textbf{Methods:} This study evaluated the performance characteristics
of three (3) COVID-19 rapid antigen test kits: DG Rapid, SD Rapid and SS
Rapid. They were compared with the gold standard real-time reverse
transcriptase- PCR (rRT-PCR) for the detection of SARS-CoV-2
nucleocapsid antigen in 75 archived samples.

\textbf{Results:} Of the 75 samples tested, 38 (50.7\%) were positive
and 37 (49.3\%) were negative for SARS-CoV-2 RNA by rRT-PCR assay. No
false positive was recorded. The DG Rapid kit detected 30 (78.9\%) true
positives and 8 (21.1\%) false negatives. SD Rapid kit detected 28
(73.7\%) true positives and 10 (26.3\%) false negatives, while the SS
Rapid kit detected 19 (50.0\%) true positives and 19 (50.0\%) false
negatives. Specificity of each test kit was 100\% (CI 95\%), but the
sensitivity of the DG Rapid, SD Rapid, and SS Rapid kits was 79\%, 74\%,
and 50\% (CI 95\%), respectively. Higher sensitivities among samples
with Ct values \textless{}29.99 were recorded for each kit. Also, the DG
Rapid kit demonstrated 79\% excellent agreement with rRT-PCR, while the
SD Rapid and SS Rapid kits demonstrated good agreement with rRT-PCR with
73\% and 50\% Cohen's kappa values, respectively.

\textbf{Conclusion:} The study suggests that DG Rapid and SD Rapid kits
are reliable alternatives to rRT-PCR for the detection of SARS-CoV-2
infection, especially in resource-limited settings like Ghana.

\textbf{Keywords:} COVID-19, SARS-CoV-2, polymerase chain reaction
(PCR), rapid antigen test kits.

\textbf{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 7\textsuperscript{th} November 2022 are 632,895,390 and
6,596,852, respectively (5). In Ghana, the first confirmed case was
recorded on 12\textsuperscript{th} 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
7\textsuperscript{th} 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.

\textbf{Methods}

\textbf{Study design, site, participants, test method and data
analysis.}

Study Design, Site and Archival Sample Selection Criteria

This study was an experimental retrospective study of archived CoViD-19
rRT-PCR samples. Ethical approval was sought and obtained from the
University for Development Studies review board (UDS/IRB/115/22). Three
packets (75pcs) each of DG Rapid, SD Rapid, and SS Rapid were randomly
sampled from the Ghanaian market. The study was conducted at a Food and
Drugs Authority/Health Facilities Regulatory Agency (FDA/HeFRA)
registered SARS-CoV-2 rRT-PCR testing facility in the Greater Accra
Region of Ghana, between June 2022 and July 2022. The eligibility
criteria for this study involved using clinical samples that were
previously tested for COVID-19 using the rRT-PCR technique. However,
samples which are insufficient, inadequately labelled, or other sample
quality issues were excluded from the study. There were no restrictions
on age, gender, or ethnicity.

Sample and Data Analysis

Seventy-five (75) frozen archived nasopharyngeal samples -- consisting
of 38 positive and 37 negative rRT- PCR tested COVID-19 samples were
obtained for the evaluation of the three (3) brands of the
immunochromatographic RDT kits. The archived samples were selected using
a flow chart (supplementary figure 1, SF1 ). It is worth noting that
these samples were retested using rRT-PCR (the reference test, S0 )
prior to the immunochromatographic assays (the index test, S1 ). The
three immunochromatographic antigen kits (i.e., DG Rapid, SD Rapid, and
SS Rapid) consist of qualitative membrane-based immunoassays and detect
SARS-CoV-2 nucleocapsid antigen. All assays were performed by a single
operator for each brand of test kit, with two blind operators reading
the results. In case of discrepancies, a third operator was consulted,
especially for faint test lines. All tests were performed according to
the manufacturer's instructions (10--12). The results generated were
entered into Microsoft Excel-365 and analyzed using IBM SPSS Statistics
version 23. A Flow chart of the method from sample selection to data
analysis can be found in supplementary figure 1 (SF1)

\textbf{Results}

\textbf{Detection made by the three brands of COVID-19 test kits.}

\textbf{Table 1} shows the results of some quality characteristics for
the three different test kits: DG Rapid, SD Rapid, and SS Rapid. The
results indicate that the DG Rapid and SD Rapid groups had higher
percentages of true positives (TPs) and lower percentages of false
negatives (FNs) than the SS Rapid group. However, all test kits recorded
a 100\% true negative (TN) and zero cases of false positives (FPs),
suggesting high specificity for all three kits.

\textbf{Table 1. Results distribution for TP, TN, FN, and FP}\selectlanguage{english}
\begin{longtable}[]{@{}lllll@{}}
\toprule
\begin{minipage}[b]{0.19\columnwidth}\raggedright\strut
Test kits\strut
\end{minipage} & \begin{minipage}[b]{0.19\columnwidth}\raggedright\strut
True Positive n (\%)\strut
\end{minipage} & \begin{minipage}[b]{0.19\columnwidth}\raggedright\strut
True Negative n (\%)\strut
\end{minipage} & \begin{minipage}[b]{0.19\columnwidth}\raggedright\strut
False Negative n (\%)\strut
\end{minipage} & \begin{minipage}[b]{0.19\columnwidth}\raggedright\strut
False Positive n (\%)\strut
\end{minipage}\tabularnewline
\midrule
\endhead
\begin{minipage}[t]{0.17\columnwidth}\raggedright\strut
DG Rapid\strut
\end{minipage} & \begin{minipage}[t]{0.17\columnwidth}\raggedright\strut
30 (78.9)\strut
\end{minipage} & \begin{minipage}[t]{0.17\columnwidth}\raggedright\strut
37 (100.0)\strut
\end{minipage} & \begin{minipage}[t]{0.17\columnwidth}\raggedright\strut
8 (21.1)\strut
\end{minipage} & \begin{minipage}[t]{0.17\columnwidth}\raggedright\strut
0\strut
\end{minipage}\tabularnewline
\begin{minipage}[t]{0.17\columnwidth}\raggedright\strut
SD Rapid\strut
\end{minipage} & \begin{minipage}[t]{0.17\columnwidth}\raggedright\strut
28 (73.7)\strut
\end{minipage} & \begin{minipage}[t]{0.17\columnwidth}\raggedright\strut
37 (100.0)\strut
\end{minipage} & \begin{minipage}[t]{0.17\columnwidth}\raggedright\strut
10 (26.3)\strut
\end{minipage} & \begin{minipage}[t]{0.17\columnwidth}\raggedright\strut
0\strut
\end{minipage}\tabularnewline
\begin{minipage}[t]{0.17\columnwidth}\raggedright\strut
SS Rapid\strut
\end{minipage} & \begin{minipage}[t]{0.17\columnwidth}\raggedright\strut
19 (50.0)\strut
\end{minipage} & \begin{minipage}[t]{0.17\columnwidth}\raggedright\strut
37 (100.0)\strut
\end{minipage} & \begin{minipage}[t]{0.17\columnwidth}\raggedright\strut
19 (50.0)\strut
\end{minipage} & \begin{minipage}[t]{0.17\columnwidth}\raggedright\strut
0\strut
\end{minipage}\tabularnewline
\bottomrule
\end{longtable}

\emph{Table 1: TP, TN, FN and FP determined in numbers and percentages
among the three brands.} \emph{The table displays the} \emph{number of
observations (n) and percentage (\%) of results for each category}

\emph{in parentheses.}

\textbf{Diagnostic performance of COVID-19 immunochromatographic rapid
test (ICT) kits.}

\textbf{Table 2} presents the sensitivity, specificity, positive
predictive value (PPV), negative predictive value (NPV), and overall
accuracy of the three different ICT kits.

The sensitivity of DG Rapid and SD Rapid was relatively high, with
values of 78.9\% and 73.7\%, respectively, while the sensitivity of SS
Rapid was lower at 50.0\%. All three kits demonstrated 100.0\%
specificity and 100\% PPV. The NPVs of DG Rapid, SD Rapid, and SS Rapid
were 82.2\%, 78.7\%, and 66.1\%, respectively.

The overall accuracy was highest for DG Rapid at 89.3\%, followed by SD
Rapid at 86.7\%, and SS Rapid at 74.7\%. These results suggest that DG
Rapid and SD Rapid may be more effective than SS Rapid for detecting
SARS-CoV-2 RNA.

\textbf{Table 2. Sensitivity, Specificity, PPV, NPV and Overall Accuracy
of the ICT kits}\selectlanguage{english}
\begin{longtable}[]{@{}llllll@{}}
\toprule
Parameters & Sensitivity (\%) & Specificity (\%) & PPV (\%) & NPV (\%) &
Overall Accuracy (\%)\tabularnewline
\midrule
\endhead
DG Rapid & 78.9 & 100.0 & 100.0 & 82.2 & 89.3\tabularnewline
SD Rapid & 73.7 & 100.0 & 100.0 & 78.7 & 86.7\tabularnewline
SS Rapid & 50.0 & 100.0 & 100.0 & 66.1 & 74.7\tabularnewline
\bottomrule
\end{longtable}



\emph{Table 2: Sensitivity, Specificity, PPV, NPV, and Overall Accuracy
of the Kits}

\textbf{Comparison of Overall Accuracy and Cohen's kappa coefficient of
the Manufacturers and the Operators}

\textbf{Table 3} presents a comparison of the overall accuracy and
Cohen's kappa coefficient of three different manufacturers' ICT kits and
the operators' COVID-19 immunochromatographic rapid test (ICT) kits.
Overall accuracy varies with disease prevalence, and it may mislead if
the study population differs from the actual population. Cohen's kappa
coefficient was used as an alternative to compare the prediction
performance of the ICT kits to rRT-PCR with kappa values indicating
agreement levels; \textgreater{}75\% implying excellent/total agreement,
40-75\% good agreement, and \textless{}40\% poor agreement with rRT-PCR.

When the manufacturers' and operators' analysis are compared, the
overall accuracy and Cohen's kappa coefficient of the operators'
analysis is lower than that of the manufacturers' analysis for all three
kits. Nonetheless, the results still indicate that the DG Rapid kit is
the most reliable ICT kit in both manufacturers' and operators'
analysis.\selectlanguage{english}
\begin{longtable}[]{@{}lllll@{}}
\toprule
Parameters & Manufacturers' Overall Accuracy (\%) & Manufacturers'
Cohen's kappa (\%) & Operators' Overall Accuracy (\%) & Operators'
Cohen's kappa (\%)\tabularnewline
\midrule
\endhead
DG Rapid & 98.8 & 97.3 & 89.3 & 78.7\tabularnewline
SD Rapid & 98.4 & 89.1 & 86.7 & 73.4\tabularnewline
SS Rapid & 99.2 & 96.5 & 74.7 & 49.7\tabularnewline
\bottomrule
\end{longtable}

\textbf{Table 3. Comparison of overall accuracy and Cohen's kappa
coefficient of}

\textbf{manufacturers' ICT kits and the post surveillance analysis by
operators'}

\emph{Table 3: Comparative} \emph{analysis of overall accuracy and
Cohen's kappa coefficient between manufacturers' ICT kits and the
operators' ICT kits}

\textbf{Diagnostic Performance Characteristics of the Operators' ICT
Kits Based on rRT-PCR Ct Value Categories}

To determine the diagnostic performance characteristics of the test kits
in comparison with viral load, the cycle threshold (Ct) values were
classified into 19.00 -- 29.99, 30.00 -- 34.99 and \textgreater{}35.00
to determine the threshold at which the test kits would have the best
performance.

The results show that the DG Rapid and SD Rapid kits had higher
sensitivity and Cohen's kappa coefficient than the SS Rapid kit in
detecting SARS-CoV-2 across all Ct value categories. However, all three
kits showed high specificity and PPV in all Ct value categories.
Specifically, Cohen's kappa coefficient indicated substantial or
excellent agreement between the ICT kits and rRT-PCR results at lower Ct
values (19.00 - 29.99 and 30.00 - 34.99) for the DG Rapid and SD Rapid
kits, but only good agreement for the SS Rapid kit. However, for Ct
values \textgreater{}35.00, all three kits had poor agreement with
rRT-PCR.

\textbf{Table 4: Diagnostic Performance Characteristics of the
Operators' ICT Kits Based On rRT-PCR Ct Value Categories.}\selectlanguage{english}
\begin{longtable}[]{@{}llllllllll@{}}
\toprule
\begin{minipage}[b]{0.10\columnwidth}\raggedright\strut
Test kits (N=75)\strut
\end{minipage} & \begin{minipage}[b]{0.10\columnwidth}\raggedright\strut
rRT-PCR Ct values\strut
\end{minipage} & \begin{minipage}[b]{0.10\columnwidth}\raggedright\strut
Sensitivity (\%)\strut
\end{minipage} & \begin{minipage}[b]{0.10\columnwidth}\raggedright\strut
Sensitivity (\%)\strut
\end{minipage} & \begin{minipage}[b]{0.10\columnwidth}\raggedright\strut
Specificity (\%)\strut
\end{minipage} & \begin{minipage}[b]{0.10\columnwidth}\raggedright\strut
Specificity (\%)\strut
\end{minipage} & \begin{minipage}[b]{0.10\columnwidth}\raggedright\strut
PPV (\%)\strut
\end{minipage} & \begin{minipage}[b]{0.10\columnwidth}\raggedright\strut
NPV (\%)\strut
\end{minipage} & \begin{minipage}[b]{0.10\columnwidth}\raggedright\strut
Overall Accuracy (\%)\strut
\end{minipage} & \begin{minipage}[b]{0.10\columnwidth}\raggedright\strut
Cohen's kappa coefficient (\%)\strut
\end{minipage}\tabularnewline
\midrule
\endhead
\begin{minipage}[t]{0.10\columnwidth}\raggedright\strut
DG Rapid (n=24)\strut
\end{minipage} & \begin{minipage}[t]{0.10\columnwidth}\raggedright\strut
19.00 - 29.99\strut
\end{minipage} & \begin{minipage}[t]{0.10\columnwidth}\raggedright\strut
91.7\strut
\end{minipage} & \begin{minipage}[t]{0.10\columnwidth}\raggedright\strut
100\strut
\end{minipage} & \begin{minipage}[t]{0.10\columnwidth}\raggedright\strut
100\strut
\end{minipage} & \begin{minipage}[t]{0.10\columnwidth}\raggedright\strut
100\strut
\end{minipage} & \begin{minipage}[t]{0.10\columnwidth}\raggedright\strut
100\strut
\end{minipage} & \begin{minipage}[t]{0.10\columnwidth}\raggedright\strut
94.9\strut
\end{minipage} & \begin{minipage}[t]{0.10\columnwidth}\raggedright\strut
96.7\strut
\end{minipage} & \begin{minipage}[t]{0.10\columnwidth}\raggedright\strut
93.0\strut
\end{minipage}\tabularnewline
\begin{minipage}[t]{0.10\columnwidth}\raggedright\strut
DG Rapid (n=7)\strut
\end{minipage} & \begin{minipage}[t]{0.10\columnwidth}\raggedright\strut
30.00 - 34.99\strut
\end{minipage} & \begin{minipage}[t]{0.10\columnwidth}\raggedright\strut
85.7\strut
\end{minipage} & \begin{minipage}[t]{0.10\columnwidth}\raggedright\strut
100\strut
\end{minipage} & \begin{minipage}[t]{0.10\columnwidth}\raggedright\strut
100\strut
\end{minipage} & \begin{minipage}[t]{0.10\columnwidth}\raggedright\strut
100\strut
\end{minipage} & \begin{minipage}[t]{0.10\columnwidth}\raggedright\strut
100\strut
\end{minipage} & \begin{minipage}[t]{0.10\columnwidth}\raggedright\strut
97.4\strut
\end{minipage} & \begin{minipage}[t]{0.10\columnwidth}\raggedright\strut
97.7\strut
\end{minipage} & \begin{minipage}[t]{0.10\columnwidth}\raggedright\strut
91.0\strut
\end{minipage}\tabularnewline
\begin{minipage}[t]{0.10\columnwidth}\raggedright\strut
DG Rapid (n=7)\strut
\end{minipage} & \begin{minipage}[t]{0.10\columnwidth}\raggedright\strut
\textgreater{}35.00\strut
\end{minipage} & \begin{minipage}[t]{0.10\columnwidth}\raggedright\strut
28.6\strut
\end{minipage} & \begin{minipage}[t]{0.10\columnwidth}\raggedright\strut
100\strut
\end{minipage} & \begin{minipage}[t]{0.10\columnwidth}\raggedright\strut
100\strut
\end{minipage} & \begin{minipage}[t]{0.10\columnwidth}\raggedright\strut
100\strut
\end{minipage} & \begin{minipage}[t]{0.10\columnwidth}\raggedright\strut
100\strut
\end{minipage} & \begin{minipage}[t]{0.10\columnwidth}\raggedright\strut
88.1\strut
\end{minipage} & \begin{minipage}[t]{0.10\columnwidth}\raggedright\strut
88.6\strut
\end{minipage} & \begin{minipage}[t]{0.10\columnwidth}\raggedright\strut
40.2\strut
\end{minipage}\tabularnewline
\begin{minipage}[t]{0.07\columnwidth}\raggedright\strut
SD Rapid (n=24)\strut
\end{minipage} & \begin{minipage}[t]{0.07\columnwidth}\raggedright\strut
19.00 - 29.99\strut
\end{minipage} & \begin{minipage}[t]{0.07\columnwidth}\raggedright\strut
88.9\strut
\end{minipage} & \begin{minipage}[t]{0.07\columnwidth}\raggedright\strut
100\strut
\end{minipage} & \begin{minipage}[t]{0.07\columnwidth}\raggedright\strut
100\strut
\end{minipage} & \begin{minipage}[t]{0.07\columnwidth}\raggedright\strut
100\strut
\end{minipage} & \begin{minipage}[t]{0.07\columnwidth}\raggedright\strut
100\strut
\end{minipage} & \begin{minipage}[t]{0.07\columnwidth}\raggedright\strut
92.5\strut
\end{minipage} & \begin{minipage}[t]{0.07\columnwidth}\raggedright\strut
95.3\strut
\end{minipage} & \begin{minipage}[t]{0.07\columnwidth}\raggedright\strut
90.2\strut
\end{minipage}\tabularnewline
\begin{minipage}[t]{0.10\columnwidth}\raggedright\strut
SD Rapid (n=7)\strut
\end{minipage} & \begin{minipage}[t]{0.10\columnwidth}\raggedright\strut
30.00 - 34.99\strut
\end{minipage} & \begin{minipage}[t]{0.10\columnwidth}\raggedright\strut
71.4\strut
\end{minipage} & \begin{minipage}[t]{0.10\columnwidth}\raggedright\strut
100\strut
\end{minipage} & \begin{minipage}[t]{0.10\columnwidth}\raggedright\strut
100\strut
\end{minipage} & \begin{minipage}[t]{0.10\columnwidth}\raggedright\strut
100\strut
\end{minipage} & \begin{minipage}[t]{0.10\columnwidth}\raggedright\strut
100\strut
\end{minipage} & \begin{minipage}[t]{0.10\columnwidth}\raggedright\strut
94.9\strut
\end{minipage} & \begin{minipage}[t]{0.10\columnwidth}\raggedright\strut
95.5\strut
\end{minipage} & \begin{minipage}[t]{0.10\columnwidth}\raggedright\strut
80.8\strut
\end{minipage}\tabularnewline
\begin{minipage}[t]{0.10\columnwidth}\raggedright\strut
SD Rapid (n=7)\strut
\end{minipage} & \begin{minipage}[t]{0.10\columnwidth}\raggedright\strut
\textgreater{}35.00\strut
\end{minipage} & \begin{minipage}[t]{0.10\columnwidth}\raggedright\strut
28.6\strut
\end{minipage} & \begin{minipage}[t]{0.10\columnwidth}\raggedright\strut
100\strut
\end{minipage} & \begin{minipage}[t]{0.10\columnwidth}\raggedright\strut
100\strut
\end{minipage} & \begin{minipage}[t]{0.10\columnwidth}\raggedright\strut
100\strut
\end{minipage} & \begin{minipage}[t]{0.10\columnwidth}\raggedright\strut
100\strut
\end{minipage} & \begin{minipage}[t]{0.10\columnwidth}\raggedright\strut
88.1\strut
\end{minipage} & \begin{minipage}[t]{0.10\columnwidth}\raggedright\strut
88.6\strut
\end{minipage} & \begin{minipage}[t]{0.10\columnwidth}\raggedright\strut
40.2\strut
\end{minipage}\tabularnewline
\begin{minipage}[t]{0.10\columnwidth}\raggedright\strut
SS Rapid (n=24)\strut
\end{minipage} & \begin{minipage}[t]{0.10\columnwidth}\raggedright\strut
19.00 - 29.99\strut
\end{minipage} & \begin{minipage}[t]{0.10\columnwidth}\raggedright\strut
58.3\strut
\end{minipage} & \begin{minipage}[t]{0.10\columnwidth}\raggedright\strut
100\strut
\end{minipage} & \begin{minipage}[t]{0.10\columnwidth}\raggedright\strut
100\strut
\end{minipage} & \begin{minipage}[t]{0.10\columnwidth}\raggedright\strut
100\strut
\end{minipage} & \begin{minipage}[t]{0.10\columnwidth}\raggedright\strut
100\strut
\end{minipage} & \begin{minipage}[t]{0.10\columnwidth}\raggedright\strut
78.7\strut
\end{minipage} & \begin{minipage}[t]{0.10\columnwidth}\raggedright\strut
83.6\strut
\end{minipage} & \begin{minipage}[t]{0.10\columnwidth}\raggedright\strut
62.9\strut
\end{minipage}\tabularnewline
\begin{minipage}[t]{0.10\columnwidth}\raggedright\strut
SS Rapid (n=7)\strut
\end{minipage} & \begin{minipage}[t]{0.10\columnwidth}\raggedright\strut
30.00 - 34.99\strut
\end{minipage} & \begin{minipage}[t]{0.10\columnwidth}\raggedright\strut
57.1\strut
\end{minipage} & \begin{minipage}[t]{0.10\columnwidth}\raggedright\strut
100\strut
\end{minipage} & \begin{minipage}[t]{0.10\columnwidth}\raggedright\strut
100\strut
\end{minipage} & \begin{minipage}[t]{0.10\columnwidth}\raggedright\strut
100\strut
\end{minipage} & \begin{minipage}[t]{0.10\columnwidth}\raggedright\strut
100\strut
\end{minipage} & \begin{minipage}[t]{0.10\columnwidth}\raggedright\strut
92.5\strut
\end{minipage} & \begin{minipage}[t]{0.10\columnwidth}\raggedright\strut
93.2\strut
\end{minipage} & \begin{minipage}[t]{0.10\columnwidth}\raggedright\strut
69.2\strut
\end{minipage}\tabularnewline
\begin{minipage}[t]{0.10\columnwidth}\raggedright\strut
SS Rapid (n=7)\strut
\end{minipage} & \begin{minipage}[t]{0.10\columnwidth}\raggedright\strut
\textgreater{}35.00\strut
\end{minipage} & \begin{minipage}[t]{0.10\columnwidth}\raggedright\strut
14.3\strut
\end{minipage} & \begin{minipage}[t]{0.10\columnwidth}\raggedright\strut
100\strut
\end{minipage} & \begin{minipage}[t]{0.10\columnwidth}\raggedright\strut
100\strut
\end{minipage} & \begin{minipage}[t]{0.10\columnwidth}\raggedright\strut
100\strut
\end{minipage} & \begin{minipage}[t]{0.10\columnwidth}\raggedright\strut
100\strut
\end{minipage} & \begin{minipage}[t]{0.10\columnwidth}\raggedright\strut
86.0\strut
\end{minipage} & \begin{minipage}[t]{0.10\columnwidth}\raggedright\strut
86.4\strut
\end{minipage} & \begin{minipage}[t]{0.10\columnwidth}\raggedright\strut
21.9\strut
\end{minipage}\tabularnewline
\bottomrule
\end{longtable}

\emph{Table 4: A negative rRT-PCR is defined as having a Ct-value
\textgreater{}40, while a positive rRT-PCR is defined as a Ct -value
\textless{}40. N represents the total number of samples analyzed, while
n represents only samples that tested positive. Thirty-seven (37)
samples tested negative.}

\textbf{Comparison of Overall Accuracy and Cohen's kappa coefficient
based on rRT-PCR Ct values for Operators' ICT Kits}

The various rRT-PCR Ct value categories were compared with the overall
accuracy and Cohen's kappa coefficient to ascertain if the Ct values
affected any of these diagnostic performance indicators. The results
show that the DG Rapid and SD Rapid kits had higher overall accuracy and
Cohen's kappa coefficient than the SS Rapid kit across all Ct value
categories. The DG Rapid kit had the highest overall accuracy and
Cohen's kappa coefficient for Ct values of 19.00 - 29.99 and 30.00 -
34.99, while the SD Rapid kit had the second highest overall accuracy
and Cohen's kappa coefficient for the same ranges. The SS Rapid kit had
the lowest overall accuracy and Cohen's kappa coefficient across all Ct
value categories. However, for Ct values \textgreater{}35.00, all three
kits recorded the lowest overall accuracy and Cohen's kappa coefficient.\selectlanguage{english}
\begin{longtable}[]{@{}llll@{}}
\toprule
\begin{minipage}[b]{0.24\columnwidth}\raggedright\strut
Test kits. (N=75)\strut
\end{minipage} & \begin{minipage}[b]{0.24\columnwidth}\raggedright\strut
rRT-PCR Ct values\strut
\end{minipage} & \begin{minipage}[b]{0.24\columnwidth}\raggedright\strut
Overall Accuracy (\%)\strut
\end{minipage} & \begin{minipage}[b]{0.24\columnwidth}\raggedright\strut
Cohen's kappa coefficient (\%)\strut
\end{minipage}\tabularnewline
\midrule
\endhead
\begin{minipage}[t]{0.24\columnwidth}\raggedright\strut
DG Rapid (n=24)\strut
\end{minipage} & \begin{minipage}[t]{0.24\columnwidth}\raggedright\strut
19.00 - 29.99\strut
\end{minipage} & \begin{minipage}[t]{0.24\columnwidth}\raggedright\strut
96.7\strut
\end{minipage} & \begin{minipage}[t]{0.24\columnwidth}\raggedright\strut
93.0\strut
\end{minipage}\tabularnewline
\begin{minipage}[t]{0.24\columnwidth}\raggedright\strut
DG Rapid (n=7)\strut
\end{minipage} & \begin{minipage}[t]{0.24\columnwidth}\raggedright\strut
30.00 - 34.99\strut
\end{minipage} & \begin{minipage}[t]{0.24\columnwidth}\raggedright\strut
97.7\strut
\end{minipage} & \begin{minipage}[t]{0.24\columnwidth}\raggedright\strut
91.0\strut
\end{minipage}\tabularnewline
\begin{minipage}[t]{0.24\columnwidth}\raggedright\strut
DG Rapid (n=7)\strut
\end{minipage} & \begin{minipage}[t]{0.24\columnwidth}\raggedright\strut
\textgreater{}35.00\strut
\end{minipage} & \begin{minipage}[t]{0.24\columnwidth}\raggedright\strut
88.6\strut
\end{minipage} & \begin{minipage}[t]{0.24\columnwidth}\raggedright\strut
40.2\strut
\end{minipage}\tabularnewline
\begin{minipage}[t]{0.24\columnwidth}\raggedright\strut
SD Rapid (n=24)\strut
\end{minipage} & \begin{minipage}[t]{0.24\columnwidth}\raggedright\strut
19.00 - 24.99\strut
\end{minipage} & \begin{minipage}[t]{0.24\columnwidth}\raggedright\strut
95.3\strut
\end{minipage} & \begin{minipage}[t]{0.24\columnwidth}\raggedright\strut
90.2\strut
\end{minipage}\tabularnewline
\begin{minipage}[t]{0.24\columnwidth}\raggedright\strut
SD Rapid (n=7)\strut
\end{minipage} & \begin{minipage}[t]{0.24\columnwidth}\raggedright\strut
30.00 - 34.99\strut
\end{minipage} & \begin{minipage}[t]{0.24\columnwidth}\raggedright\strut
95.5\strut
\end{minipage} & \begin{minipage}[t]{0.24\columnwidth}\raggedright\strut
80.8\strut
\end{minipage}\tabularnewline
\begin{minipage}[t]{0.24\columnwidth}\raggedright\strut
SD Rapid (n=7)\strut
\end{minipage} & \begin{minipage}[t]{0.24\columnwidth}\raggedright\strut
\textgreater{}35.00\strut
\end{minipage} & \begin{minipage}[t]{0.24\columnwidth}\raggedright\strut
88.6\strut
\end{minipage} & \begin{minipage}[t]{0.24\columnwidth}\raggedright\strut
40.2\strut
\end{minipage}\tabularnewline
\begin{minipage}[t]{0.24\columnwidth}\raggedright\strut
SS Rapid (n=24)\strut
\end{minipage} & \begin{minipage}[t]{0.24\columnwidth}\raggedright\strut
19.00 - 24.99\strut
\end{minipage} & \begin{minipage}[t]{0.24\columnwidth}\raggedright\strut
83.6\strut
\end{minipage} & \begin{minipage}[t]{0.24\columnwidth}\raggedright\strut
62.9\strut
\end{minipage}\tabularnewline
\begin{minipage}[t]{0.24\columnwidth}\raggedright\strut
SS Rapid (n=7)\strut
\end{minipage} & \begin{minipage}[t]{0.24\columnwidth}\raggedright\strut
30.00 - 34.99\strut
\end{minipage} & \begin{minipage}[t]{0.24\columnwidth}\raggedright\strut
93.2\strut
\end{minipage} & \begin{minipage}[t]{0.24\columnwidth}\raggedright\strut
69.2\strut
\end{minipage}\tabularnewline
\begin{minipage}[t]{0.24\columnwidth}\raggedright\strut
SS Rapid (n=7)\strut
\end{minipage} & \begin{minipage}[t]{0.24\columnwidth}\raggedright\strut
\textgreater{}35.00\strut
\end{minipage} & \begin{minipage}[t]{0.24\columnwidth}\raggedright\strut
86.4\strut
\end{minipage} & \begin{minipage}[t]{0.24\columnwidth}\raggedright\strut
21.9\strut
\end{minipage}\tabularnewline
\bottomrule
\end{longtable}

\textbf{Table 5. Comparison of overall accuracy and Cohen's kappa
coefficient of operators' ICT kits based on rRT-PCR Ct value
categories.}

\emph{Table 5: Comparative} \emph{analysis of overall accuracy and
Cohen's kappa coefficient among the operators' ICT kits based on their
Ct value categories. N represents the total number of samples analyzed,
while n represents only samples that tested positive. Thirty-seven (37)
samples tested negative.}

\textbf{Discussion}

This study evaluated the diagnostic performance characteristics of these
brands of COVID-19 ICT test kits on the Ghanaian market, namely, DG
Rapid (DGT), SD Rapid (SD), and SS Rapid (SS). Rapid antigen tests offer
several advantages, including affordability, faster turnaround time, and
the ability to diagnose patients at their point-of-care. These
advantages are essential and critical, especially in resource-limited
settings, where rRT-PCR testing may not be readily available. This study
demonstrated that DG Rapid and SD Rapid antigen test kits performed
relatively better in detecting SARS-CoV-2 than SS Rapid.

The findings for DG Rapid and SD Rapid are consistent with previous
studies that have reported the effectiveness of rapid antigen tests in
detecting COVID-19 (13). These studies showed a relatively lower
sensitivity with SARS-CoV-2 antigen rapid diagnostic test kits (Ag-RDTs)
compared to the clinical reference standard, which is the real-time
reverse transcriptase- polymerase chain reaction (rRT-PCR). A recent
systematic review and meta-analysis that evaluated the accuracy of
commercially available SARS-CoV-2 Ag-RDTs revealed a pooled sensitivity
of 71.2\% (13). A sensitivity of 70\% and 59\% (95\% CI) respectively
was observed in 262 study participants in Uganda and Cameroon,
respectively, using the SD Rapid RDT (14,15). In Cameroon, the RDTs'
sensitivity of 59\% (95\% CI) increased to 69\% (95\% CI) when only
symptomatic participants were considered. Another study conducted at a
teaching hospital in northern Ghana evaluated the sensitivity of the SD
Rapid RDT with 193 participants as 64\% (95\% CI) (16). Our study,
however, found a sensitivity of 74\% (95\% CI) for SD Rapid RDT, which
is comparable to what was observed in Uganda and Cameroon. Moreover,
among the three brands, DG Rapid demonstrated a higher sensitivity of
79\% (95\% CI), followed by SD Rapid with 74\% (95\% CI). However, the
SS Rapid RDT demonstrated a lower sensitivity of 50\% (95\% CI) compared
to the other two brands. This lower sensitivity for SS Rapid may limit
its usefulness as a standalone diagnostic tool, as it may lead to false
negative results. False negative results may result in a delay in
diagnosis, thereby increasing the risk of virus transmission. It is
noteworthy that these values of sensitivity observed in our study are
much below the performance reported by the manufacturers (DG Rapid,
2022; SD Rapid, 2020; SS Rapid, 2021). Possible explanations for the
lower sensitivity observed could be due to factors such as variations in
the batch of ICT kits used, variations in the concentration of extracted
antigens, differences in processing techniques, and variations in the
storage conditions of the kits, especially in the market (18).

In this study, the specificity was 100\% (95\% CI), which is comparable
to the 100\% (95\% CI) stated by the manufacturers but higher than the
92\% (95\% CI) documented in the studies conducted in both Uganda and
Cameroon. The possible explanations given for the lower specificity in
these other studies were cross-reacting antibodies from previous
infections or variations in environmental testing temperatures (24\selectlanguage{ngerman}°C -
37°C) in the general wards and the COVID-19 isolation center where the
tests were carried out (16). The high specificity exhibited by all three
test kits in our study is an important attribute as it ensures that
individuals without the virus are correctly identified, reducing the
risk of false-positive results. False positives can lead to unwarranted
quarantine, isolation, and treatment, with significant social and
economic consequences.

Regarding overall accuracy, this study reported values of 89\% (for DG
Rapid), 87\% (SD Rapid), and 75\% (SS Rapid) at 95\% CI for the three
SARS-CoV-2 ICT kits, which are lower than the manufacturers' claims of
99\%, 98\%, and 99\%, respectively. However, it is essential to
recognize that overall accuracy can vary with disease prevalence, making
it less reliable as a single summary measure of a test's validity. The
prevalence-dependent nature of overall accuracy introduces challenges,
leading to warnings against its use. Estimates of overall accuracy can
be misleading when obtained from populations with significantly
different disease prevalence from the target population where the test
is intended for application (19).

To assess the agreement between the ICT kits and rRT-PCR, Cohen's kappa
coefficient was employed. Specifically, it was used to determine the
level of agreement between the performance of the ICT kits and rRT-PCR.
Our findings indicated that only DG Rapid demonstrated excellent
agreement, while SD Rapid and SS Rapid exhibited good agreement compared
to rRT-PCR. This observation could be because DG Rapid demonstrated a
higher sensitivity of 79\% and a higher NPV of 82\% compared to the
other brands. Other performance indicators, specifically, specificity
and PPV, were the same (100\%) for all three brands and thus did not
have an impact on the kappa value calculation. In a study conducted in
India, Cohen's kappa calculated for SD Rapid and rRT-PCR showed a good
agreement, with a Cohen's kappa of 64.4\%(20). Another study conducted
in Ethiopia found that a SARS-CoV-2 antigen rapid test kit and rRT-PCR
had a kappa value of agreement of 73.5\% which indicates good agreement
between the two tests (21). While we could not find specific research
articles on DG and SS Rapid kits, the evidence from the study conducted
in both India and Ethiopia suggests a consistent trend of good agreement
between SARS-CoV-2 antigen rapid test kits such as SD Rapid and rRT-PCR.

By convention, a lower Ct value signifies a higher viral load, while a
higher Ct value suggests a lower viral load (13). All three brands
demonstrated better detection limits for higher viral load (Ct values
\selectlanguage{english}[?]29.99), which is often the case in the pre-symptomatic phase (1--3 days
before the onset of symptoms) and the early symptomatic phase (during
the first 5 -- 7 days of illness) of SARS-CoV-2 infection (22).
Conversely, they displayed less favorable detection limits for Ct values
\textgreater{}35.00.. Consequently, the DG Rapid ICT kits exhibit a
lower detection threshold when Ct values exceed 35.00, despite their
excellent agreement with rRT-PCR. It is essential to acknowledge that
our study utilized frozen archived nasopharyngeal samples, which may not
represent the current situation accurately. The performance of these
antigen test kits can be influenced by factors such as viral load and
the type of specimen used for testing(13). Therefore, it is crucial to
evaluate the performance of these rapid antigen test kits on fresh
samples and in real-life settings.

\textbf{Conclusion}

The study findings indicate that the DG Rapid and SD Rapid kits can be
considered reliable substitutes for rRT-PCR in detecting SARS-CoV-2
infection, particularly in areas with scarce resources and limited
access to PCR testing. The study also indicates that these test kits
exhibit a high level of sensitivity in samples with Ct values lower than
29.99, indicating that they would have good performance in patients with
a high viral load (Ct values \selectlanguage{english}[?]29.99). These findings support the use of
rapid antigen tests as an alternative diagnostic tool for COVID-19.

This study recommends a continuous quality assessment program by
relevant regulatory and monitoring agencies to not allow a potential
positive case to return with a false negative result. Given these
findings, we also recommend a further study with a larger fresh sample
size to be done on the other existing COVID-19 RDT kits on the Ghanaian
market, as rRT-PCR testing is expensive and ubiquitously unavailable.

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\textbf{Declarations}

\textbf{Ethical Approval}

Ethical approval was obtained from the University for Development
Studies Institutional Review Board (UDS/RB/115/22). Consent to use the
anonymized CoViD-19 tested samples, was obtained from the appropriate
authority within the FDA/HeFRA registered testing facility.

\textbf{Funding}

This research did not receive any specific grant from funding agencies
in the public, commercial, or not-for-profit sectors.

\textbf{Availability of data and materials}

The datasets used and/or analyzed during the current study are available
with this submission as supplementary material/related files.

\textbf{Acknowledgements}

We are grateful to the Health Squared Medical Centre for their Site and
logistic support.

\textbf{Conflict of Interest Statement}

Authors declare that they have no conflicts of interest.

\textbf{Author Contributions}

SB Bani and C. Obirikorang were involved in conceptualization,
methodology, supervision, writing the original draft, review and editing
of the final draft.

EK Amakye, S Akomeah and ENY Nyarko were involved in conceptualization,
methodology, data analysis, writing of the original draft, and review
and editing of the final draft.

F Bani, DND Dodoo, C Aidoo, M Fynn-Buadu, and M Adom were involved in
data collection, sample analysis, software, data curation and writing -
review and editing.

All the authors have read and approved the final manuscript for
publication.

\textbf{Competing interests}

We, the authors of this manuscript declare that we have no competing
interests.

\selectlanguage{english}
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\end{document}

