Field evaluation of the performance of seven Antigen Rapid diagnostic tests for the diagnosis of SARs-CoV-2 virus infection in Uganda.
<h4>Objective</h4>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.<h4>Methods</h4>This wa...
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Public Library of Science (PLoS)
2022-01-01
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| Series: | PLoS ONE |
| Online Access: | https://journals.plos.org/plosone/article/file?id=10.1371/journal.pone.0265334&type=printable |
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| author | Josephine Bwogi Tom Lutalo Phionah Tushabe Henry Bukenya James Peter Eliku Isaac Ssewanyana Susan Nabadda Christopher Nsereko Matthew Cotten Robert Downing Julius Lutwama Pontiano Kaleebu EPI Laboratory team UVRI -COVID 19 Technical team |
| author_facet | Josephine Bwogi Tom Lutalo Phionah Tushabe Henry Bukenya James Peter Eliku Isaac Ssewanyana Susan Nabadda Christopher Nsereko Matthew Cotten Robert Downing Julius Lutwama Pontiano Kaleebu EPI Laboratory team UVRI -COVID 19 Technical team |
| author_sort | Josephine Bwogi |
| collection | DOAJ |
| description | <h4>Objective</h4>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.<h4>Methods</h4>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.<h4>Results</h4>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%.<h4>Conclusions</h4>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. |
| format | Article |
| id | doaj-art-e1145814dc984936aead23b30a1a8799 |
| institution | OA Journals |
| issn | 1932-6203 |
| language | English |
| publishDate | 2022-01-01 |
| publisher | Public Library of Science (PLoS) |
| record_format | Article |
| series | PLoS ONE |
| spelling | doaj-art-e1145814dc984936aead23b30a1a87992025-08-20T02:31:39ZengPublic Library of Science (PLoS)PLoS ONE1932-62032022-01-01175e026533410.1371/journal.pone.0265334Field evaluation of the performance of seven Antigen Rapid diagnostic tests for the diagnosis of SARs-CoV-2 virus infection in Uganda.Josephine BwogiTom LutaloPhionah TushabeHenry BukenyaJames Peter ElikuIsaac SsewanyanaSusan NabaddaChristopher NserekoMatthew CottenRobert DowningJulius LutwamaPontiano KaleebuEPI Laboratory teamUVRI -COVID 19 Technical team<h4>Objective</h4>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.<h4>Methods</h4>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.<h4>Results</h4>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%.<h4>Conclusions</h4>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.https://journals.plos.org/plosone/article/file?id=10.1371/journal.pone.0265334&type=printable |
| spellingShingle | Josephine Bwogi Tom Lutalo Phionah Tushabe Henry Bukenya James Peter Eliku Isaac Ssewanyana Susan Nabadda Christopher Nsereko Matthew Cotten Robert Downing Julius Lutwama Pontiano Kaleebu EPI Laboratory team UVRI -COVID 19 Technical team Field evaluation of the performance of seven Antigen Rapid diagnostic tests for the diagnosis of SARs-CoV-2 virus infection in Uganda. PLoS ONE |
| title | Field evaluation of the performance of seven Antigen Rapid diagnostic tests for the diagnosis of SARs-CoV-2 virus infection in Uganda. |
| title_full | Field evaluation of the performance of seven Antigen Rapid diagnostic tests for the diagnosis of SARs-CoV-2 virus infection in Uganda. |
| title_fullStr | Field evaluation of the performance of seven Antigen Rapid diagnostic tests for the diagnosis of SARs-CoV-2 virus infection in Uganda. |
| title_full_unstemmed | Field evaluation of the performance of seven Antigen Rapid diagnostic tests for the diagnosis of SARs-CoV-2 virus infection in Uganda. |
| title_short | Field evaluation of the performance of seven Antigen Rapid diagnostic tests for the diagnosis of SARs-CoV-2 virus infection in Uganda. |
| title_sort | field evaluation of the performance of seven antigen rapid diagnostic tests for the diagnosis of sars cov 2 virus infection in uganda |
| url | https://journals.plos.org/plosone/article/file?id=10.1371/journal.pone.0265334&type=printable |
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