Field evaluations of four SARS-CoV-2 rapid antigen tests during SARS-CoV-2 Delta variant wave in South Africa

Abstract Background Rapid antigen tests detecting SARS-CoV-2 were shown to be a useful tool in managing the COVID-19 pandemic. Here, we report on the results of a prospective diagnostic accuracy study of four SARS-CoV-2 rapid antigen tests in a South African setting. Methods Rapid antigen test evalu...

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Main Authors: Natasha Samsunder, Gila Lustig, Slindile Ngubane, Thando Glory Maseko, Santhuri Rambaran, Sinaye Ngcapu, Stanley Nzuzo Magini, Lara Lewis, Cherie Cawood, Ayesha B. M. Kharsany, Quarraisha Abdool Karim, Salim Abdool Karim, Kogieleum Naidoo, Aida Sivro
Format: Article
Language:English
Published: BMC 2023-07-01
Series:Diagnostic and Prognostic Research
Subjects:
Online Access:https://doi.org/10.1186/s41512-023-00151-3
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author Natasha Samsunder
Gila Lustig
Slindile Ngubane
Thando Glory Maseko
Santhuri Rambaran
Sinaye Ngcapu
Stanley Nzuzo Magini
Lara Lewis
Cherie Cawood
Ayesha B. M. Kharsany
Quarraisha Abdool Karim
Salim Abdool Karim
Kogieleum Naidoo
Aida Sivro
author_facet Natasha Samsunder
Gila Lustig
Slindile Ngubane
Thando Glory Maseko
Santhuri Rambaran
Sinaye Ngcapu
Stanley Nzuzo Magini
Lara Lewis
Cherie Cawood
Ayesha B. M. Kharsany
Quarraisha Abdool Karim
Salim Abdool Karim
Kogieleum Naidoo
Aida Sivro
author_sort Natasha Samsunder
collection DOAJ
description Abstract Background Rapid antigen tests detecting SARS-CoV-2 were shown to be a useful tool in managing the COVID-19 pandemic. Here, we report on the results of a prospective diagnostic accuracy study of four SARS-CoV-2 rapid antigen tests in a South African setting. Methods Rapid antigen test evaluations were performed through drive-through testing centres in Durban, South Africa, from July to December 2021. Two evaluation studies were performed: nasal Panbio COVID-19 Ag Rapid Test Device (Abbott) was evaluated in parallel with the nasopharyngeal Espline SARS-CoV-2 Ag test (Fujirebio), followed by the evaluation of nasal RightSign COVID-19 Antigen Rapid test Cassette (Hangzhou Biotest Biotech) in parallel with the nasopharyngeal STANDARD Q COVID-19 Ag test (SD Biosensor). The Abbott RealTime SARS-CoV-2 assay was used as a reference test. Results Evaluation of Panbio and Espline Ag tests was performed on 494 samples (31% positivity), while the evaluation of Standard Q and RightTest Ag tests was performed on 539 samples (13.17% positivity). The overall sensitivity for all four tests ranged between 60 and 72% with excellent specificity values (> 98%). Sensitivity increased to > 80% in all tests in samples with cycle number value < 20. All four tests performed best in samples from patients presenting within the first week of symptom onset. Conclusions All four evaluated tests detected a majority of the cases within the first week of symptom onset with high viral load.
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spelling doaj.art-505b48ee824d48f691d115c05059f3992023-07-30T11:27:00ZengBMCDiagnostic and Prognostic Research2397-75232023-07-01711610.1186/s41512-023-00151-3Field evaluations of four SARS-CoV-2 rapid antigen tests during SARS-CoV-2 Delta variant wave in South AfricaNatasha Samsunder0Gila Lustig1Slindile Ngubane2Thando Glory Maseko3Santhuri Rambaran4Sinaye Ngcapu5Stanley Nzuzo Magini6Lara Lewis7Cherie Cawood8Ayesha B. M. Kharsany9Quarraisha Abdool Karim10Salim Abdool Karim11Kogieleum Naidoo12Aida Sivro13Centre for the AIDS Programme of Research in South Africa (CAPRISA)Centre for the AIDS Programme of Research in South Africa (CAPRISA)Centre for the AIDS Programme of Research in South Africa (CAPRISA)Centre for the AIDS Programme of Research in South Africa (CAPRISA)Centre for the AIDS Programme of Research in South Africa (CAPRISA)Centre for the AIDS Programme of Research in South Africa (CAPRISA)Centre for the AIDS Programme of Research in South Africa (CAPRISA)Centre for the AIDS Programme of Research in South Africa (CAPRISA)Epicentre AIDS Risk Management (Pty) LimitedCentre for the AIDS Programme of Research in South Africa (CAPRISA)Centre for the AIDS Programme of Research in South Africa (CAPRISA)Centre for the AIDS Programme of Research in South Africa (CAPRISA)Centre for the AIDS Programme of Research in South Africa (CAPRISA)Centre for the AIDS Programme of Research in South Africa (CAPRISA)Abstract Background Rapid antigen tests detecting SARS-CoV-2 were shown to be a useful tool in managing the COVID-19 pandemic. Here, we report on the results of a prospective diagnostic accuracy study of four SARS-CoV-2 rapid antigen tests in a South African setting. Methods Rapid antigen test evaluations were performed through drive-through testing centres in Durban, South Africa, from July to December 2021. Two evaluation studies were performed: nasal Panbio COVID-19 Ag Rapid Test Device (Abbott) was evaluated in parallel with the nasopharyngeal Espline SARS-CoV-2 Ag test (Fujirebio), followed by the evaluation of nasal RightSign COVID-19 Antigen Rapid test Cassette (Hangzhou Biotest Biotech) in parallel with the nasopharyngeal STANDARD Q COVID-19 Ag test (SD Biosensor). The Abbott RealTime SARS-CoV-2 assay was used as a reference test. Results Evaluation of Panbio and Espline Ag tests was performed on 494 samples (31% positivity), while the evaluation of Standard Q and RightTest Ag tests was performed on 539 samples (13.17% positivity). The overall sensitivity for all four tests ranged between 60 and 72% with excellent specificity values (> 98%). Sensitivity increased to > 80% in all tests in samples with cycle number value < 20. All four tests performed best in samples from patients presenting within the first week of symptom onset. Conclusions All four evaluated tests detected a majority of the cases within the first week of symptom onset with high viral load.https://doi.org/10.1186/s41512-023-00151-3COVID-19SARS-CoV-2Antigen rapid diagnostic testPerformance evaluation
spellingShingle Natasha Samsunder
Gila Lustig
Slindile Ngubane
Thando Glory Maseko
Santhuri Rambaran
Sinaye Ngcapu
Stanley Nzuzo Magini
Lara Lewis
Cherie Cawood
Ayesha B. M. Kharsany
Quarraisha Abdool Karim
Salim Abdool Karim
Kogieleum Naidoo
Aida Sivro
Field evaluations of four SARS-CoV-2 rapid antigen tests during SARS-CoV-2 Delta variant wave in South Africa
Diagnostic and Prognostic Research
COVID-19
SARS-CoV-2
Antigen rapid diagnostic test
Performance evaluation
title Field evaluations of four SARS-CoV-2 rapid antigen tests during SARS-CoV-2 Delta variant wave in South Africa
title_full Field evaluations of four SARS-CoV-2 rapid antigen tests during SARS-CoV-2 Delta variant wave in South Africa
title_fullStr Field evaluations of four SARS-CoV-2 rapid antigen tests during SARS-CoV-2 Delta variant wave in South Africa
title_full_unstemmed Field evaluations of four SARS-CoV-2 rapid antigen tests during SARS-CoV-2 Delta variant wave in South Africa
title_short Field evaluations of four SARS-CoV-2 rapid antigen tests during SARS-CoV-2 Delta variant wave in South Africa
title_sort field evaluations of four sars cov 2 rapid antigen tests during sars cov 2 delta variant wave in south africa
topic COVID-19
SARS-CoV-2
Antigen rapid diagnostic test
Performance evaluation
url https://doi.org/10.1186/s41512-023-00151-3
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