Comparative analysis of the diagnostic performance of five commercial COVID-19 qRT PCR kits used in India

Abstract To meet the unprecedented requirement of diagnostic testing for SARS-CoV-2, a large number of diagnostic kits were authorized by concerned authorities for diagnostic use within a short period of time during the initial phases of the ongoing pandemic. We undertook this study to evaluate the...

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Autores principales:	J. Singh, A. K. Yadav, A. Pakhare, P. Kulkarni, L. Lokhande, P. Soni, M. Dadheech, P. Gupta, N. Masarkar, A. K. Maurya, S. Nema, D. Biswas, S. Singh
Formato:	article
Lenguaje:	EN
Publicado:	Nature Portfolio 2021
Materias:	Medicine R Science Q
Acceso en línea:	https://doaj.org/article/1345b3225188482fb9ea0b3092f0b6dd
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spelling	oai:doaj.org-article:1345b3225188482fb9ea0b3092f0b6dd2021-11-14T12:19:55ZComparative analysis of the diagnostic performance of five commercial COVID-19 qRT PCR kits used in India10.1038/s41598-021-00852-z2045-2322https://doaj.org/article/1345b3225188482fb9ea0b3092f0b6dd2021-11-01T00:00:00Zhttps://doi.org/10.1038/s41598-021-00852-zhttps://doaj.org/toc/2045-2322Abstract To meet the unprecedented requirement of diagnostic testing for SARS-CoV-2, a large number of diagnostic kits were authorized by concerned authorities for diagnostic use within a short period of time during the initial phases of the ongoing pandemic. We undertook this study to evaluate the inter-test agreement and other key operational features of 5 such commercial kits that have been extensively used in India for routine diagnostic testing for COVID-19. The five commercial kits were evaluated, using a panel of positive and negative respiratory samples, considering the kit provided by National Institute of Virology, Indian Council of Medical Research (2019-nCoV Kit) as the reference. The positive panel comprised of individuals who fulfilled the 3 criteria of being clinically symptomatic, having history of contact with diagnosed cases and testing positive in the reference kit. The negative panel included both healthy and disease controls, the latter being drawn from individuals diagnosed with other respiratory viral infections. The same protocol of sample collection, same RNA extraction kit and same RT-PCR instrument were used for all the kits. Clinical samples were collected from a panel of 92 cases and 60 control patients, who fulfilled our inclusion criteria. The control group included equal number of healthy individuals and patients infected with other respiratory viruses (n = 30, in each group). We observed varying sensitivity and specificity among the evaluated kits, with LabGun COVID-19 RT-PCR kit showing the highest sensitivity and specificity (94% and 100% respectively), followed by TaqPath COVID-19 Combo and Allplex 2019-nCoV assays. The extent of inter-test agreement was not associated with viral loads of the samples. Poor correlation was observed between Ct values of the same genes amplified using different kits. Our findings reveal the presence of wide heterogeneity and sub-optimal inter-test agreement in the diagnostic performance of the evaluated kits and hint at the need of adopting stringent standards for fulfilling the quality assurance requirements of the COVID-19 diagnostic process.J. SinghA. K. YadavA. PakhareP. KulkarniL. LokhandeP. SoniM. DadheechP. GuptaN. MasarkarA. K. MauryaS. NemaD. BiswasS. SinghNature PortfolioarticleMedicineRScienceQENScientific Reports, Vol 11, Iss 1, Pp 1-8 (2021)
institution	DOAJ
collection	DOAJ
language	EN
topic	Medicine R Science Q
spellingShingle	Medicine R Science Q J. Singh A. K. Yadav A. Pakhare P. Kulkarni L. Lokhande P. Soni M. Dadheech P. Gupta N. Masarkar A. K. Maurya S. Nema D. Biswas S. Singh Comparative analysis of the diagnostic performance of five commercial COVID-19 qRT PCR kits used in India
description	Abstract To meet the unprecedented requirement of diagnostic testing for SARS-CoV-2, a large number of diagnostic kits were authorized by concerned authorities for diagnostic use within a short period of time during the initial phases of the ongoing pandemic. We undertook this study to evaluate the inter-test agreement and other key operational features of 5 such commercial kits that have been extensively used in India for routine diagnostic testing for COVID-19. The five commercial kits were evaluated, using a panel of positive and negative respiratory samples, considering the kit provided by National Institute of Virology, Indian Council of Medical Research (2019-nCoV Kit) as the reference. The positive panel comprised of individuals who fulfilled the 3 criteria of being clinically symptomatic, having history of contact with diagnosed cases and testing positive in the reference kit. The negative panel included both healthy and disease controls, the latter being drawn from individuals diagnosed with other respiratory viral infections. The same protocol of sample collection, same RNA extraction kit and same RT-PCR instrument were used for all the kits. Clinical samples were collected from a panel of 92 cases and 60 control patients, who fulfilled our inclusion criteria. The control group included equal number of healthy individuals and patients infected with other respiratory viruses (n = 30, in each group). We observed varying sensitivity and specificity among the evaluated kits, with LabGun COVID-19 RT-PCR kit showing the highest sensitivity and specificity (94% and 100% respectively), followed by TaqPath COVID-19 Combo and Allplex 2019-nCoV assays. The extent of inter-test agreement was not associated with viral loads of the samples. Poor correlation was observed between Ct values of the same genes amplified using different kits. Our findings reveal the presence of wide heterogeneity and sub-optimal inter-test agreement in the diagnostic performance of the evaluated kits and hint at the need of adopting stringent standards for fulfilling the quality assurance requirements of the COVID-19 diagnostic process.
format	article
author	J. Singh A. K. Yadav A. Pakhare P. Kulkarni L. Lokhande P. Soni M. Dadheech P. Gupta N. Masarkar A. K. Maurya S. Nema D. Biswas S. Singh
author_facet	J. Singh A. K. Yadav A. Pakhare P. Kulkarni L. Lokhande P. Soni M. Dadheech P. Gupta N. Masarkar A. K. Maurya S. Nema D. Biswas S. Singh
author_sort	J. Singh
title	Comparative analysis of the diagnostic performance of five commercial COVID-19 qRT PCR kits used in India
title_short	Comparative analysis of the diagnostic performance of five commercial COVID-19 qRT PCR kits used in India
title_full	Comparative analysis of the diagnostic performance of five commercial COVID-19 qRT PCR kits used in India
title_fullStr	Comparative analysis of the diagnostic performance of five commercial COVID-19 qRT PCR kits used in India
title_full_unstemmed	Comparative analysis of the diagnostic performance of five commercial COVID-19 qRT PCR kits used in India
title_sort	comparative analysis of the diagnostic performance of five commercial covid-19 qrt pcr kits used in india
publisher	Nature Portfolio
publishDate	2021
url	https://doaj.org/article/1345b3225188482fb9ea0b3092f0b6dd
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Comparative analysis of the diagnostic performance of five commercial COVID-19 qRT PCR kits used in India

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