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

Title: Field evaluation of the performance of seven Antigen Rapid diagnostic tests for the diagnosis of SARs-CoV-2 virus infection in Uganda.
Authors: Bwogi, Josephine; Lutalo, Tom; Tushabe, Phionah; Bukenya, Henry; Eliku, James Peter; Ssewanyana, Isaac; Nabadda, Susan; Nsereko, Christopher; Cotten, Matthew; Downing, Robert; Lutwama, Julius; Kaleebu, Pontiano; EPI Laboratory team; UVRI -COVID 19 Technical team
Publisher Information: Public Library of Science
Publication Year: 2022
Collection: London School of Hygiene & Tropical Medicine: LSHTM Research Online
Description: 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.
Document Type: article in journal/newspaper
File Description: text
Language: English
ISSN: 1932-6203
Relation: https://researchonline.lshtm.ac.uk/id/eprint/4666109/1/journal.pone.0265334.pdf; Bwogi, JosephineORCID logo; Lutalo, Tom; Tushabe, PhionahORCID logo; Bukenya, Henry; Eliku, James Peter; Ssewanyana, Isaac; Nabadda, Susan; Nsereko, Christopher; Cotten, Matthew ORCID logo; Downing, Robert; +4 more.Lutwama, Julius; Kaleebu, Pontiano ORCID logo; EPI Laboratory team; and UVRI -COVID 19 Technical team (2022) Field evaluation of the performance of seven Antigen Rapid diagnostic tests for the diagnosis of SARs-CoV-2 virus infection in Uganda. PloS one, 17 (5). e0265334-. ISSN 1932-6203 DOI:10.1371/journal.pone.0265334
DOI: 10.1371/journal.pone.0265334
Availability: https://researchonline.lshtm.ac.uk/id/eprint/4666109/; https://researchonline.lshtm.ac.uk/id/eprint/4666109/1/journal.pone.0265334.pdf; https://doi.org/10.1371/journal.pone.0265334
Rights: cc_by_4
Accession Number: edsbas.29D8174B
Database: BASE