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Considerations for the selection of tests for SARS-CoV-2 molecular diagnostics

During the course of 2020, the outbreak of Severe Acute Respiratory Syndrome Coronavirus-2 (SARS‐CoV‐2) spread rapidly across the world. Clinical diagnostic testing for SARS-Cov-2 infection has relied on the real‐time Reverse Transcriptase Polymerase Chain Reaction and is considered the gold standar...

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Autores principales: Erbak Yılmaz, Huriye, Iscan, Evin, Oz, Ozden, Batur, Tuğçe, Erdoğan, Aybike, Kılıç, Seval, Mutlu, Zeynep, Yılmaz, Murat, Spring, Kevin J.
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Springer Netherlands 2022
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9019540/
https://www.ncbi.nlm.nih.gov/pubmed/35441938
http://dx.doi.org/10.1007/s11033-022-07455-5
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author Erbak Yılmaz, Huriye
Iscan, Evin
Oz, Ozden
Batur, Tuğçe
Erdoğan, Aybike
Kılıç, Seval
Mutlu, Zeynep
Yılmaz, Murat
Spring, Kevin J.
author_facet Erbak Yılmaz, Huriye
Iscan, Evin
Oz, Ozden
Batur, Tuğçe
Erdoğan, Aybike
Kılıç, Seval
Mutlu, Zeynep
Yılmaz, Murat
Spring, Kevin J.
author_sort Erbak Yılmaz, Huriye
collection PubMed
description During the course of 2020, the outbreak of Severe Acute Respiratory Syndrome Coronavirus-2 (SARS‐CoV‐2) spread rapidly across the world. Clinical diagnostic testing for SARS-Cov-2 infection has relied on the real‐time Reverse Transcriptase Polymerase Chain Reaction and is considered the gold standard assay. Commercial vendors and laboratories quickly mobilised to develop diagnostic tests to detect the novel coronavirus, which was fundamentally important in the pandemic response. These SARS-Cov-2 assays were developed in line with the Food Drug Administration-Emergency Use Authorization guidance. Although new tests are continuously being developed, information about SARS-CoV-2 diagnostic molecular test accuracy has been limited and at times controversial. Therefore, the analytical and clinical performance of SARS-CoV-2 test kits should be carefully considered by the appropriate regulatory authorities and evaluated by independent laboratory validation. This would provide improved end-user confidence in selecting the most reliable and accurate diagnostic test. Moreover, it is unclear whether some of these rapidly developed tests have been subjected to rigorous quality control and assurance required under good manufacturing practice. Variable target gene regions selected for currently available tests, potential mutation in target gene regions, non-standardized pre-analytic phase, a lack of manufacturer independent validation data all create difficulties in selecting tests appropriate for different countries and laboratories. Here we provide information on test criteria which are important in the assessment and selection of SARS-CoV-2 molecular diagnostic tests and outline the potential issues associated with a proportion of the tests on the market. SUPPLEMENTARY INFORMATION: The online version contains supplementary material available at 10.1007/s11033-022-07455-5.
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spelling pubmed-90195402022-04-20 Considerations for the selection of tests for SARS-CoV-2 molecular diagnostics Erbak Yılmaz, Huriye Iscan, Evin Oz, Ozden Batur, Tuğçe Erdoğan, Aybike Kılıç, Seval Mutlu, Zeynep Yılmaz, Murat Spring, Kevin J. Mol Biol Rep Review During the course of 2020, the outbreak of Severe Acute Respiratory Syndrome Coronavirus-2 (SARS‐CoV‐2) spread rapidly across the world. Clinical diagnostic testing for SARS-Cov-2 infection has relied on the real‐time Reverse Transcriptase Polymerase Chain Reaction and is considered the gold standard assay. Commercial vendors and laboratories quickly mobilised to develop diagnostic tests to detect the novel coronavirus, which was fundamentally important in the pandemic response. These SARS-Cov-2 assays were developed in line with the Food Drug Administration-Emergency Use Authorization guidance. Although new tests are continuously being developed, information about SARS-CoV-2 diagnostic molecular test accuracy has been limited and at times controversial. Therefore, the analytical and clinical performance of SARS-CoV-2 test kits should be carefully considered by the appropriate regulatory authorities and evaluated by independent laboratory validation. This would provide improved end-user confidence in selecting the most reliable and accurate diagnostic test. Moreover, it is unclear whether some of these rapidly developed tests have been subjected to rigorous quality control and assurance required under good manufacturing practice. Variable target gene regions selected for currently available tests, potential mutation in target gene regions, non-standardized pre-analytic phase, a lack of manufacturer independent validation data all create difficulties in selecting tests appropriate for different countries and laboratories. Here we provide information on test criteria which are important in the assessment and selection of SARS-CoV-2 molecular diagnostic tests and outline the potential issues associated with a proportion of the tests on the market. SUPPLEMENTARY INFORMATION: The online version contains supplementary material available at 10.1007/s11033-022-07455-5. Springer Netherlands 2022-04-20 2022 /pmc/articles/PMC9019540/ /pubmed/35441938 http://dx.doi.org/10.1007/s11033-022-07455-5 Text en © The Author(s), under exclusive licence to Springer Nature B.V. 2022 This article is made available via the PMC Open Access Subset for unrestricted research re-use and secondary analysis in any form or by any means with acknowledgement of the original source. These permissions are granted for the duration of the World Health Organization (WHO) declaration of COVID-19 as a global pandemic.
spellingShingle Review
Erbak Yılmaz, Huriye
Iscan, Evin
Oz, Ozden
Batur, Tuğçe
Erdoğan, Aybike
Kılıç, Seval
Mutlu, Zeynep
Yılmaz, Murat
Spring, Kevin J.
Considerations for the selection of tests for SARS-CoV-2 molecular diagnostics
title Considerations for the selection of tests for SARS-CoV-2 molecular diagnostics
title_full Considerations for the selection of tests for SARS-CoV-2 molecular diagnostics
title_fullStr Considerations for the selection of tests for SARS-CoV-2 molecular diagnostics
title_full_unstemmed Considerations for the selection of tests for SARS-CoV-2 molecular diagnostics
title_short Considerations for the selection of tests for SARS-CoV-2 molecular diagnostics
title_sort considerations for the selection of tests for sars-cov-2 molecular diagnostics
topic Review
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9019540/
https://www.ncbi.nlm.nih.gov/pubmed/35441938
http://dx.doi.org/10.1007/s11033-022-07455-5
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