Field evaluation of the performance of seven Antigen Rapid diagnostic tests for the diagnosis of SARs-CoV-2 virus infection in Uganda.

Autor: Bwogi J; Uganda Virus Research Institute, Entebbe, Uganda., Lutalo T; Uganda Virus Research Institute, Entebbe, Uganda., Tushabe P; Uganda Virus Research Institute, Entebbe, Uganda., Bukenya H; Uganda Virus Research Institute, Entebbe, Uganda., Eliku JP; Uganda Virus Research Institute, Entebbe, Uganda., Ssewanyana I; Central Public Health Laboratories, Kampala, Uganda., Nabadda S; Central Public Health Laboratories, Kampala, Uganda., Nsereko C; Entebbe Regional Referral Hospital, Entebbe, Uganda., Cotten M; Medical Research Council/Uganda Virus Research Institute & London School of Hygiene and Tropical Medicine, Uganda Research Unit, Entebbe, Uganda., Downing R; Uganda Virus Research Institute, Entebbe, Uganda., Lutwama J; Uganda Virus Research Institute, Entebbe, Uganda., Kaleebu P; Uganda Virus Research Institute, Entebbe, Uganda.; Medical Research Council/Uganda Virus Research Institute & London School of Hygiene and Tropical Medicine, Uganda Research Unit, Entebbe, Uganda.
Jazyk: angličtina
Zdroj: PloS one [PLoS One] 2022 May 10; Vol. 17 (5), pp. e0265334. Date of Electronic Publication: 2022 May 10 (Print Publication: 2022).
DOI: 10.1371/journal.pone.0265334
Abstrakt: Objective: The objective of this study was to evaluate the performance of seven antigen rapid diagnostic tests (Ag RDTs) in a clinical setting to identify those that could be recommended for use in the diagnosis of SARS-CoV-2 infection in Uganda.
Methods: This was a cross-sectional prospective study. Nasopharyngeal swabs were collected consecutively from COVID-19 PCR positive and COVID-19 PCR negative participants at isolation centers and points of entry, and tested with the SARS-CoV-2 Ag RDTs. Test sensitivity and specificity were generated by comparing results against qRT-PCR results (Berlin Protocol) at a cycle threshold (Ct) cut-off of ≤39. Sensitivity was also calculated at Ct cut-offs ≤29 and ≤33.
Results: None of the Ag RDTs had a sensitivity of ≥80% at Ct cut-off values ≤33 and ≤39. Two kits, Panbio™ COVID-19 Ag and VivaDiag™ SARS-CoV-2 Ag had a sensitivity of ≥80% at a Ct cut-off value of ≤29. Four kits: BIOCREDIT COVID -19 Ag, COVID-19 Ag Respi-Strip, MEDsan® SARS-CoV-2 Antigen Rapid Test and Panbio™ COVID-19 Ag Rapid Test had a specificity of ≥97%.
Conclusions: This evaluation identified one Ag RDT, Panbio™ COVID-19 Ag with a performance at high viral load (Ct value ≤29) reaching that recommended by WHO. This kit was recommended for screening of patients with COVID -19-like symptoms presenting at health facilities.
Competing Interests: RD is a consultant at Abbott. Therefore he did not participate in the investigation of Panbio™ COVID-19 Ag Rapid test performance. This does not alter our adherence to PLOS ONE policies on sharing data and materials.
Databáze: MEDLINE
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