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: | , , , |
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| Formato: | article |
| Lenguaje: | EN |
| Publicado: |
JCDR Research and Publications Private Limited
2021
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| Materias: | |
| Acceso en línea: | https://doaj.org/article/2347be7e2421458eb1d3bf521f690eec |
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| Sumario: | 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. |
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