Rapid chromatographic immunoassay-based evaluation of COVID-19: A cross-sectional, diagnostic test accuracy study & its implications for COVID-19 management in India

Autor: Akhil Kant Singh, Manish Soneja, Randeep Guleria, Anjan Trikha, Richa Aggarwal, Ravindra Mohan Pandey, Ankesh Gupta, Bharthi Arunan, Rojaleen Das, Shivam Goel, Anivita Aggarwal, Surbhi Khurana, Ankit Mittal, Praveen Kumar Trilangi, Kapil Dev Soni, Lalit Dar, Suneeta Meena, Amit Lathwal, Diksha Patidar, Arvind Kumar, Purva Mathur, Parul Singh, Naveet Wig, Komal Singh, Deepankar Srigyan, Netto George, Vandana V. Kiro, Amit Singh, Devashish Desai, Harshith B Kadnur, Adil Rashid Khan, Neha Sharad, Rajesh Malhotra, Shivdas Naik
Jazyk: angličtina
Rok vydání: 2021
Předmět:
Zdroj: The Indian Journal of Medical Research
Indian Journal of Medical Research, Vol 153, Iss 1, Pp 126-131 (2021)
ISSN: 0975-9174
0971-5916
Popis: Background & objectives: Coronavirus disease 2019 (COVID-19) has so far affected over 41 million people globally. The limited supply of real-time reverse transcription-polymerase chain reaction (rRT-PCR) kits and reagents has made meeting the rising demand for increased testing incompetent, worldwide. A highly sensitive and specific antigen-based rapid diagnostic test (RDT) is the need of the hour. The objective of this study was to evaluate the performance of a rapid chromatographic immunoassay-based test (index test) compared with a clinical reference standard (rRT-PCR). Methods: A cross-sectional, single-blinded study was conducted at a tertiary care teaching hospital in north India. Paired samples were taken for RDT and rRT-PCR (reference standard) from consecutive participants screened for COVID-19 to calculate the sensitivity and specificity of the RDT. Further subgroup analysis was done based on the duration of illness and cycle threshold values. Cohen's kappa coefficient was used to measure the level of agreement between the two tests. Results: Of the 330 participants, 77 were rRT-PCR positive for SARS-CoV-2. Sixty four of these patients also tested positive for SARS-CoV-2 by RDT. The overall sensitivity and specificity were 81.8 and 99.6 per cent, respectively. The sensitivity of RDT was higher (85.9%) in participants with a duration of illness ≤5 days. Interpretation & conclusions: With an excellent specificity and moderate sensitivity, this RDT may be used to rule in COVID-19 in patients with a duration of illness ≤5 days. Large-scale testing based on this RDT across the country would result in quick detection, isolation and treatment of COVID-19 patients.
Databáze: OpenAIRE
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