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Sensitivity and specificity of two WHO approved SARS-CoV2 antigen assays in detecting patients with SARS-CoV2 infection

BACKGROUND: SARS-CoV-2 rapid antigen (Ag) detection kits are widely used in addition to quantitative reverse transcription PCR PCR (RT-qPCR), as they are cheaper with a rapid turnaround time. As there are many concerns regarding their sensitivity and specificity, in different settings, we evaluated...

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Autores principales: Jeewandara, Chandima, Guruge, Dinuka, Pushpakumara, Pradeep Darshana, Madhusanka, Deshan, Jayadas, Tibutius Thanesh, Chaturanga, Indika Prasad, Aberathna, Inoka Sepali, Danasekara, Saubhagya, Pathmanathan, Thilagaraj, Jayathilaka, Deshni, Somathilaka, Gayasha, Kuruppu, Heshan, Gomes, Laksiri, Gunasekara, Vitjith, Wijayamuni, Ruwan, Ogg, Graham S., Malavige, Gathsaurie Neelika
Formato: Online Artículo Texto
Lenguaje:English
Publicado: BioMed Central 2022
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8938642/
https://www.ncbi.nlm.nih.gov/pubmed/35317731
http://dx.doi.org/10.1186/s12879-022-07240-6
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author Jeewandara, Chandima
Guruge, Dinuka
Pushpakumara, Pradeep Darshana
Madhusanka, Deshan
Jayadas, Tibutius Thanesh
Chaturanga, Indika Prasad
Aberathna, Inoka Sepali
Danasekara, Saubhagya
Pathmanathan, Thilagaraj
Jayathilaka, Deshni
Somathilaka, Gayasha
Kuruppu, Heshan
Gomes, Laksiri
Gunasekara, Vitjith
Wijayamuni, Ruwan
Ogg, Graham S.
Malavige, Gathsaurie Neelika
author_facet Jeewandara, Chandima
Guruge, Dinuka
Pushpakumara, Pradeep Darshana
Madhusanka, Deshan
Jayadas, Tibutius Thanesh
Chaturanga, Indika Prasad
Aberathna, Inoka Sepali
Danasekara, Saubhagya
Pathmanathan, Thilagaraj
Jayathilaka, Deshni
Somathilaka, Gayasha
Kuruppu, Heshan
Gomes, Laksiri
Gunasekara, Vitjith
Wijayamuni, Ruwan
Ogg, Graham S.
Malavige, Gathsaurie Neelika
author_sort Jeewandara, Chandima
collection PubMed
description BACKGROUND: SARS-CoV-2 rapid antigen (Ag) detection kits are widely used in addition to quantitative reverse transcription PCR PCR (RT-qPCR), as they are cheaper with a rapid turnaround time. As there are many concerns regarding their sensitivity and specificity, in different settings, we evaluated two WHO approved rapid Ag kits in a large cohort of Sri Lankan individuals. METHODS: Paired nasopharangeal swabs were obtained from 4786 participants for validation of the SD-Biosensor rapid Ag assay and 3325 for the Abbott rapid Ag assay, in comparison to RT-qPCR. A short questionnaire was used to record symptoms at the time of testing, and blood samples were obtained from 2721 of them for detection of SARS-CoV-2 specific antibodies. RESULTS: The overall sensitivity of the SD-Biosensor Ag kit was 36.5% and the Abbott Ag test was 50.76%. The Abbott Ag test showed specificity of 99.4% and the SD-Biosensor Ag test 97.5%. At Ct values < 25, the sensitivity was 71.3% to 76.6% for the SD-Biosensor Ag test and 77.3% to 88.9% for the Abbott Ag test. The Ct values for all genes (RdRP, S, E and N) tested with all RT-qPCR kits were significantly lower for the positive results of the Abbott Ag test compared to the SD-Biosensor test. 209 (48.04%) individuals who had antibodies gave a positive RT-qPCR result, and antibody positivity rates were higher at Ct values > 30 (46.1 to 82.9%). 32.1% of those who gave a positive result with the SD-Biosensor Ag test and 26.3% of those who gave positive results with the Abbott Ag test had SARS-CoV-2 antibodies at the time of detection. CONCLUSIONS: Both rapid Ag tests appeared to be highly sensitive in detecting individuals at lower Ct values, in a community setting in Sri Lanka, but it will be important to further establish the relationship to infectivity.
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spelling pubmed-89386422022-03-22 Sensitivity and specificity of two WHO approved SARS-CoV2 antigen assays in detecting patients with SARS-CoV2 infection Jeewandara, Chandima Guruge, Dinuka Pushpakumara, Pradeep Darshana Madhusanka, Deshan Jayadas, Tibutius Thanesh Chaturanga, Indika Prasad Aberathna, Inoka Sepali Danasekara, Saubhagya Pathmanathan, Thilagaraj Jayathilaka, Deshni Somathilaka, Gayasha Kuruppu, Heshan Gomes, Laksiri Gunasekara, Vitjith Wijayamuni, Ruwan Ogg, Graham S. Malavige, Gathsaurie Neelika BMC Infect Dis Research Article BACKGROUND: SARS-CoV-2 rapid antigen (Ag) detection kits are widely used in addition to quantitative reverse transcription PCR PCR (RT-qPCR), as they are cheaper with a rapid turnaround time. As there are many concerns regarding their sensitivity and specificity, in different settings, we evaluated two WHO approved rapid Ag kits in a large cohort of Sri Lankan individuals. METHODS: Paired nasopharangeal swabs were obtained from 4786 participants for validation of the SD-Biosensor rapid Ag assay and 3325 for the Abbott rapid Ag assay, in comparison to RT-qPCR. A short questionnaire was used to record symptoms at the time of testing, and blood samples were obtained from 2721 of them for detection of SARS-CoV-2 specific antibodies. RESULTS: The overall sensitivity of the SD-Biosensor Ag kit was 36.5% and the Abbott Ag test was 50.76%. The Abbott Ag test showed specificity of 99.4% and the SD-Biosensor Ag test 97.5%. At Ct values < 25, the sensitivity was 71.3% to 76.6% for the SD-Biosensor Ag test and 77.3% to 88.9% for the Abbott Ag test. The Ct values for all genes (RdRP, S, E and N) tested with all RT-qPCR kits were significantly lower for the positive results of the Abbott Ag test compared to the SD-Biosensor test. 209 (48.04%) individuals who had antibodies gave a positive RT-qPCR result, and antibody positivity rates were higher at Ct values > 30 (46.1 to 82.9%). 32.1% of those who gave a positive result with the SD-Biosensor Ag test and 26.3% of those who gave positive results with the Abbott Ag test had SARS-CoV-2 antibodies at the time of detection. CONCLUSIONS: Both rapid Ag tests appeared to be highly sensitive in detecting individuals at lower Ct values, in a community setting in Sri Lanka, but it will be important to further establish the relationship to infectivity. BioMed Central 2022-03-22 /pmc/articles/PMC8938642/ /pubmed/35317731 http://dx.doi.org/10.1186/s12879-022-07240-6 Text en © The Author(s) 2022 https://creativecommons.org/licenses/by/4.0/ Open AccessThis article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third party material in this article are included in the article's Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article's Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this licence, visit http://creativecommons.org/licenses/by/4.0/ (https://creativecommons.org/licenses/by/4.0/) . The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/ (https://creativecommons.org/publicdomain/zero/1.0/) ) applies to the data made available in this article, unless otherwise stated in a credit line to the data.
spellingShingle Research Article
Jeewandara, Chandima
Guruge, Dinuka
Pushpakumara, Pradeep Darshana
Madhusanka, Deshan
Jayadas, Tibutius Thanesh
Chaturanga, Indika Prasad
Aberathna, Inoka Sepali
Danasekara, Saubhagya
Pathmanathan, Thilagaraj
Jayathilaka, Deshni
Somathilaka, Gayasha
Kuruppu, Heshan
Gomes, Laksiri
Gunasekara, Vitjith
Wijayamuni, Ruwan
Ogg, Graham S.
Malavige, Gathsaurie Neelika
Sensitivity and specificity of two WHO approved SARS-CoV2 antigen assays in detecting patients with SARS-CoV2 infection
title Sensitivity and specificity of two WHO approved SARS-CoV2 antigen assays in detecting patients with SARS-CoV2 infection
title_full Sensitivity and specificity of two WHO approved SARS-CoV2 antigen assays in detecting patients with SARS-CoV2 infection
title_fullStr Sensitivity and specificity of two WHO approved SARS-CoV2 antigen assays in detecting patients with SARS-CoV2 infection
title_full_unstemmed Sensitivity and specificity of two WHO approved SARS-CoV2 antigen assays in detecting patients with SARS-CoV2 infection
title_short Sensitivity and specificity of two WHO approved SARS-CoV2 antigen assays in detecting patients with SARS-CoV2 infection
title_sort sensitivity and specificity of two who approved sars-cov2 antigen assays in detecting patients with sars-cov2 infection
topic Research Article
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8938642/
https://www.ncbi.nlm.nih.gov/pubmed/35317731
http://dx.doi.org/10.1186/s12879-022-07240-6
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