• Ankesh Gupta, Surbhi Khurana, Rojaleen Das, Deepankar Srigyan, Amit Singh, Ankit Mittal, Parul Singh, Manish Soneja, Arvind Kumar, Akhil Kant Singh, Kapil Dev Soni, Suneeta Meena, Richa Aggarwal, Neha Sharad, Anivita Aggarwal, Harshith Kadnur, Netto George, Komal Singh, Devashish Desai, Praveen Trilangi, Adil Rashid Khan, Vandana V Kiro, Shivdas Naik, Bharthi Arunan, Shivam Goel, Diksha Patidar, Amit Lathwal, Lalit Dar, Anjan Trikha, Ravindra Mohan Pandey, Rajesh Malhotra, Randeep Guleria, Purva Mathur, and Naveet Wig.
• Department of Medicine, Pain Medicine & Critical Care, Centre, All India Institute of Medical Sciences, New Delhi, India.
• Indian J Med Res. 2021 Jan 1; 153 (1 & 2): 126-131.

Background & ObjectivesCoronavirus 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).MethodsA 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.ResultsOf 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 & ConclusionsWith 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.

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