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Performance Evaluation of the STANDARD(TM) Q COVID-19 and Panbio(TM) COVID-19 Antigen Tests in Detecting SARS-CoV-2 during High Transmission Period in Mozambique

(1) Background: Laboratory-based molecular assays are the gold standard to detect SARS-CoV-2. In resource-limited settings, the implementation of these assays has been hampered by operational challenges and long turnaround times. Rapid antigen detection tests are an attractive alternative. Our aim i...

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Autores principales: Sitoe, Nádia, Sambo, Júlia, Nguenha, Neuza, Chilaule, Jorfelia, Chelene, Imelda, Loquiha, Osvaldo, Mudenyanga, Chishamiso, Viegas, Sofia, Cunningham, Jane, Jani, Ilesh
Formato: Online Artículo Texto
Lenguaje:English
Publicado: MDPI 2022
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8871422/
https://www.ncbi.nlm.nih.gov/pubmed/35204566
http://dx.doi.org/10.3390/diagnostics12020475
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author Sitoe, Nádia
Sambo, Júlia
Nguenha, Neuza
Chilaule, Jorfelia
Chelene, Imelda
Loquiha, Osvaldo
Mudenyanga, Chishamiso
Viegas, Sofia
Cunningham, Jane
Jani, Ilesh
author_facet Sitoe, Nádia
Sambo, Júlia
Nguenha, Neuza
Chilaule, Jorfelia
Chelene, Imelda
Loquiha, Osvaldo
Mudenyanga, Chishamiso
Viegas, Sofia
Cunningham, Jane
Jani, Ilesh
author_sort Sitoe, Nádia
collection PubMed
description (1) Background: Laboratory-based molecular assays are the gold standard to detect SARS-CoV-2. In resource-limited settings, the implementation of these assays has been hampered by operational challenges and long turnaround times. Rapid antigen detection tests are an attractive alternative. Our aim is to evaluate the clinical performance of two SARS-CoV-2 rapid antigen tests during a high transmission period. (2) Methods: A total of 1277 patients seeking SARS-CoV-2 diagnosis were enrolled at four health facilities. Nasopharyngeal swabs for rapid antigen and real time PCR testing were collected for each patient. Sensitivity, specificity, positive and negative predictive values, misclassification rate, and agreement were determined. (3) Results: The overall sensitivity of Panbio COVID-19 was 41.3% (95% CI: 34.6–48.4%) and the specificity was 98.2% (95% CI: 96.2–99.3%). The Standard Q had an overall sensitivity and specificity of 45.0% (95% CI: 39.9–50.2%) and 97.6% (95% CI: 95.3–99.0%), respectively. The positive predictive value of a positive test was 93.3% and 95.4% for the Panbio and Standard Q Ag-RDTs, respectively. A higher sensitivity of 43.2% and 49.4% was observed in symptomatic cases for the Panbio and Standard Q Ag-RDTs, respectively. (4) Conclusions: Despite the overall low sensitivity, the two evaluated rapid tests are useful to improve the diagnosis of symptomatic SARS-CoV-2 infections during high transmission periods.
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spelling pubmed-88714222022-02-25 Performance Evaluation of the STANDARD(TM) Q COVID-19 and Panbio(TM) COVID-19 Antigen Tests in Detecting SARS-CoV-2 during High Transmission Period in Mozambique Sitoe, Nádia Sambo, Júlia Nguenha, Neuza Chilaule, Jorfelia Chelene, Imelda Loquiha, Osvaldo Mudenyanga, Chishamiso Viegas, Sofia Cunningham, Jane Jani, Ilesh Diagnostics (Basel) Article (1) Background: Laboratory-based molecular assays are the gold standard to detect SARS-CoV-2. In resource-limited settings, the implementation of these assays has been hampered by operational challenges and long turnaround times. Rapid antigen detection tests are an attractive alternative. Our aim is to evaluate the clinical performance of two SARS-CoV-2 rapid antigen tests during a high transmission period. (2) Methods: A total of 1277 patients seeking SARS-CoV-2 diagnosis were enrolled at four health facilities. Nasopharyngeal swabs for rapid antigen and real time PCR testing were collected for each patient. Sensitivity, specificity, positive and negative predictive values, misclassification rate, and agreement were determined. (3) Results: The overall sensitivity of Panbio COVID-19 was 41.3% (95% CI: 34.6–48.4%) and the specificity was 98.2% (95% CI: 96.2–99.3%). The Standard Q had an overall sensitivity and specificity of 45.0% (95% CI: 39.9–50.2%) and 97.6% (95% CI: 95.3–99.0%), respectively. The positive predictive value of a positive test was 93.3% and 95.4% for the Panbio and Standard Q Ag-RDTs, respectively. A higher sensitivity of 43.2% and 49.4% was observed in symptomatic cases for the Panbio and Standard Q Ag-RDTs, respectively. (4) Conclusions: Despite the overall low sensitivity, the two evaluated rapid tests are useful to improve the diagnosis of symptomatic SARS-CoV-2 infections during high transmission periods. MDPI 2022-02-12 /pmc/articles/PMC8871422/ /pubmed/35204566 http://dx.doi.org/10.3390/diagnostics12020475 Text en © 2022 by the authors. https://creativecommons.org/licenses/by/4.0/Licensee MDPI, Basel, Switzerland. This article is an open access article distributed under the terms and conditions of the Creative Commons Attribution (CC BY) license (https://creativecommons.org/licenses/by/4.0/).
spellingShingle Article
Sitoe, Nádia
Sambo, Júlia
Nguenha, Neuza
Chilaule, Jorfelia
Chelene, Imelda
Loquiha, Osvaldo
Mudenyanga, Chishamiso
Viegas, Sofia
Cunningham, Jane
Jani, Ilesh
Performance Evaluation of the STANDARD(TM) Q COVID-19 and Panbio(TM) COVID-19 Antigen Tests in Detecting SARS-CoV-2 during High Transmission Period in Mozambique
title Performance Evaluation of the STANDARD(TM) Q COVID-19 and Panbio(TM) COVID-19 Antigen Tests in Detecting SARS-CoV-2 during High Transmission Period in Mozambique
title_full Performance Evaluation of the STANDARD(TM) Q COVID-19 and Panbio(TM) COVID-19 Antigen Tests in Detecting SARS-CoV-2 during High Transmission Period in Mozambique
title_fullStr Performance Evaluation of the STANDARD(TM) Q COVID-19 and Panbio(TM) COVID-19 Antigen Tests in Detecting SARS-CoV-2 during High Transmission Period in Mozambique
title_full_unstemmed Performance Evaluation of the STANDARD(TM) Q COVID-19 and Panbio(TM) COVID-19 Antigen Tests in Detecting SARS-CoV-2 during High Transmission Period in Mozambique
title_short Performance Evaluation of the STANDARD(TM) Q COVID-19 and Panbio(TM) COVID-19 Antigen Tests in Detecting SARS-CoV-2 during High Transmission Period in Mozambique
title_sort performance evaluation of the standard(tm) q covid-19 and panbio(tm) covid-19 antigen tests in detecting sars-cov-2 during high transmission period in mozambique
topic Article
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8871422/
https://www.ncbi.nlm.nih.gov/pubmed/35204566
http://dx.doi.org/10.3390/diagnostics12020475
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