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. 2021 Mar:104:282-286.
doi: 10.1016/j.ijid.2020.10.073. Epub 2020 Oct 30.

Field evaluation of the performance of a SARS-CoV-2 antigen rapid diagnostic test in Uganda using nasopharyngeal samples

Aminah Nalumansi  1 , Tom Lutalo  1 , John Kayiwa  1 , Christine Watera  1 , Stephen Balinandi  1 , Jocelyn Kiconco  1 , Joweria Nakaseegu  1 , Denis Olara  1 , Emmanuel Odwilo  1 , Jennifer Serwanga  2 , Bernard Kikaire  1 , Deogratius Ssemwanga  2 , Susan Nabadda  3 , Isaac Ssewanyana  3 , Diane Atwine  4 , Henry Mwebesa  4 , Henry Kyobe Bosa  5 , Christopher Nsereko  6 , Matthew Cotten  7 , Robert Downing  1 , Julius Lutwama  1 , Pontiano Kaleebu  8
Affiliations

Field evaluation of the performance of a SARS-CoV-2 antigen rapid diagnostic test in Uganda using nasopharyngeal samples

Aminah Nalumansi et al. Int J Infect Dis. 2021 Mar.

Abstract

Objectives: There is a high demand for SARS-CoV-2 testing to identify COVID-19 cases. Real-time quantitative PCR (qRT-PCR) is the recommended diagnostic test but a number of constraints prevent its widespread implementation, including cost. The aim of this study was to evaluate a low cost and easy to use rapid antigen test for diagnosing COVID-19 at the point of care.

Methods: Nasopharyngeal swabs from suspected COVID-19 cases and low-risk volunteers were tested with the STANDARD Q COVID-19 Ag Test and the results were compared with the qRT-PCR results.

Results: In total, 262 samples were collected, including 90 qRT-PCR positives. The majority of samples were from males (89%) with a mean age of 34 years and only 13 (14%) of the positives were mildly symptomatic. The sensitivity and specificity of the antigen test were 70.0% (95% confidence interval (CI): 60-79) and 92% (95% CI: 87-96), respectively, and the diagnostic accuracy was 84% (95% CI: 79-88). The antigen test was more likely to be positive for samples with qRT-PCR Ct values ≤29, with a sensitivity of 92%.

Conclusions: The STANDARD Q COVID-19 Ag Test performed less than optimally in this evaluation. However, the test may still have an important role to play early in infection when timely access to molecular testing is not available but the results should be confirmed by qRT-PCR.

Keywords: Antigen; COVID-19; Performance; Rapid diagnostic test; SARS-CoV-2; qRT-PCR.

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Conflict of interest statement

All authors declare no competing interests.

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