Usefulness of TrueNat: A Chip-based Real-time PCR Test for COVID-19

Introduction: For the containment of growing Coronavirus Disease (COVID-19) pandemic, rapid diagnostic facilities are need of today. Indigenously developed TrueNat assay is a point-of-care assay developed for early diagnosis of Severe Acute Respiratory Syndrome-Coronavirus-2 (SARS-CoV-2). It is...

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Autores principales:	Swarnim Swarn, Indu Prasad, Amit Kumar Anand, Binod Shankar Singh
Formato:	article
Lenguaje:	EN
Publicado:	JCDR Research and Publications Private Limited 2021
Materias:	coronavirus disease-19 molecular diagnostic test polymerase chain reaction point-of-care assay rapid test Medicine R
Acceso en línea:	https://doaj.org/article/2347be7e2421458eb1d3bf521f690eec
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spelling	oai:doaj.org-article:2347be7e2421458eb1d3bf521f690eec2021-11-07T06:49:17ZUsefulness of TrueNat: A Chip-based Real-time PCR Test for COVID-1910.7860/JCDR/2021/48193.153482249-782X0973-709Xhttps://doaj.org/article/2347be7e2421458eb1d3bf521f690eec2021-09-01T00:00:00Zhttps://www.jcdr.net/articles/PDF/15348/48193_CE[Ra2]_F(SL)_PF1(JY_RK_KM)_PFA(JY_KM)_PN(KM).pdfhttps://doaj.org/toc/2249-782Xhttps://doaj.org/toc/0973-709XIntroduction: For the containment of growing Coronavirus Disease (COVID-19) pandemic, rapid diagnostic facilities are need of today. Indigenously developed TrueNat assay is a point-of-care assay developed for early diagnosis of Severe Acute Respiratory Syndrome-Coronavirus-2 (SARS-CoV-2). It is a portable, fully automated, chip-based, real-time quantitative polymerase chain reaction system with a turnaround time of 1.5-2 hours. Aim: To assess the practical utility and diagnostic accuracy of TrueNat testing for COVID-19 in a pandemic situation. Materials and Methods: A cohort selection cross-sectional study was conducted from July to September 2020 at Department of Biochemistry, Vardhaman Institute of Medical Sciences, Pawapuri, Bihar, India, after obtaining Institutional Ethics Committee (IEC) approval. A total of 296 cases with symptoms of COVID-19 were selected for the study. Assuming real-time Reverse TranscriptionPolymerase Chain Reaction (rRT-PCR) to be the gold standard, we collected oropharyngeal swabs from symptomatic COVID-19 suspected cases and tested by both TrueNat and standard RT-PCR. Agreement between both the assays were assessed by overall, Positive Percent Agreement (PPA) and Negative Percent Agreement (NPA) and Cohen’s kappa coefficient using Epitools (Ausvet 2020). Results: Out of 296 oropharyngeal swabs taken from suspected COVID-19 patients, 19 were read as “invalid” and discarded; hence only 277 samples were tested by TrueNat and RT-PCR both. Assuming RT-PCR as standard, TrueNat assay demonstrated an overall percent agreement of 99.64%, PPA of 95.65%, NPA 99.81%. The kappa coefficient was 0.9546. Conclusion: TrueNat assay offers a rapid, accurate and affordable technique for COVID-19. It may be deployed for mass screening and confirmation of COVID-19 cases in hospitals and remote areas.Swarnim SwarnIndu PrasadAmit Kumar AnandBinod Shankar SinghJCDR Research and Publications Private Limitedarticlecoronavirus disease-19molecular diagnostic testpolymerase chain reactionpoint-of-care assayrapid testMedicineRENJournal of Clinical and Diagnostic Research, Vol 15, Iss 9, Pp BC01-BC02 (2021)
institution	DOAJ
collection	DOAJ
language	EN
topic	coronavirus disease-19 molecular diagnostic test polymerase chain reaction point-of-care assay rapid test Medicine R
spellingShingle	coronavirus disease-19 molecular diagnostic test polymerase chain reaction point-of-care assay rapid test Medicine R Swarnim Swarn Indu Prasad Amit Kumar Anand Binod Shankar Singh Usefulness of TrueNat: A Chip-based Real-time PCR Test for COVID-19
description	Introduction: For the containment of growing Coronavirus Disease (COVID-19) pandemic, rapid diagnostic facilities are need of today. Indigenously developed TrueNat assay is a point-of-care assay developed for early diagnosis of Severe Acute Respiratory Syndrome-Coronavirus-2 (SARS-CoV-2). It is a portable, fully automated, chip-based, real-time quantitative polymerase chain reaction system with a turnaround time of 1.5-2 hours. Aim: To assess the practical utility and diagnostic accuracy of TrueNat testing for COVID-19 in a pandemic situation. Materials and Methods: A cohort selection cross-sectional study was conducted from July to September 2020 at Department of Biochemistry, Vardhaman Institute of Medical Sciences, Pawapuri, Bihar, India, after obtaining Institutional Ethics Committee (IEC) approval. A total of 296 cases with symptoms of COVID-19 were selected for the study. Assuming real-time Reverse TranscriptionPolymerase Chain Reaction (rRT-PCR) to be the gold standard, we collected oropharyngeal swabs from symptomatic COVID-19 suspected cases and tested by both TrueNat and standard RT-PCR. Agreement between both the assays were assessed by overall, Positive Percent Agreement (PPA) and Negative Percent Agreement (NPA) and Cohen’s kappa coefficient using Epitools (Ausvet 2020). Results: Out of 296 oropharyngeal swabs taken from suspected COVID-19 patients, 19 were read as “invalid” and discarded; hence only 277 samples were tested by TrueNat and RT-PCR both. Assuming RT-PCR as standard, TrueNat assay demonstrated an overall percent agreement of 99.64%, PPA of 95.65%, NPA 99.81%. The kappa coefficient was 0.9546. Conclusion: TrueNat assay offers a rapid, accurate and affordable technique for COVID-19. It may be deployed for mass screening and confirmation of COVID-19 cases in hospitals and remote areas.
format	article
author	Swarnim Swarn Indu Prasad Amit Kumar Anand Binod Shankar Singh
author_facet	Swarnim Swarn Indu Prasad Amit Kumar Anand Binod Shankar Singh
author_sort	Swarnim Swarn
title	Usefulness of TrueNat: A Chip-based Real-time PCR Test for COVID-19
title_short	Usefulness of TrueNat: A Chip-based Real-time PCR Test for COVID-19
title_full	Usefulness of TrueNat: A Chip-based Real-time PCR Test for COVID-19
title_fullStr	Usefulness of TrueNat: A Chip-based Real-time PCR Test for COVID-19
title_full_unstemmed	Usefulness of TrueNat: A Chip-based Real-time PCR Test for COVID-19
title_sort	usefulness of truenat: a chip-based real-time pcr test for covid-19
publisher	JCDR Research and Publications Private Limited
publishDate	2021
url	https://doaj.org/article/2347be7e2421458eb1d3bf521f690eec
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Usefulness of TrueNat: A Chip-based Real-time PCR Test for COVID-19

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