Rapid chromatographic immunoassay-based evaluation of COVID-19: A cross-sectional, diagnostic test accuracy study & its implications for COVID-19 management in India Gupta A, Khurana S, Das R, Srigyan D, Singh A, Mittal A, Singh P, Soneja M, Kumar A, Singh AK, Soni KD, Meena S, Aggarwal R, Sharad N, Aggarwal A, Kadnur H, George N, Singh K, Desai D, Trilangi P, Khan AR, Kiro VV, Naik S, Arunan B, Goel S, Patidar D, Lathwal A, Dar L, Trikha A, Pandey RM, Malhotra R, Guleria R, Mathur P, Wig N,

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Rapid chromatographic immunoassay-based evaluation of COVID-19: A cross-sectional, diagnostic test accuracy study & its implications for COVID-19 management in India Ankesh Gupta¹, Surbhi Khurana², Rojaleen Das³, Deepankar Srigyan³, Amit Singh⁴, Ankit Mittal¹, Parul Singh², Manish Soneja¹, Arvind Kumar¹, Akhil Kant Singh⁵, Kapil Dev Soni⁶, Suneeta Meena⁷, Richa Aggarwal⁶, Neha Sharad², Anivita Aggarwal¹, Harshith Kadnur¹, Netto George¹, Komal Singh¹, Devashish Desai¹, Praveen Trilangi¹, Adil Rashid Khan¹, Vandana V Kiro², Shivdas Naik¹, Bharthi Arunan¹, Shivam Goel¹, Diksha Patidar¹, Amit Lathwal⁸, Lalit Dar³, Anjan Trikha⁵, Ravindra Mohan Pandey⁹, Rajesh Malhotra¹⁰, Randeep Guleria¹¹, Purva Mathur¹⁰, Naveet Wig¹ ¹ Department of Medicine, All India Institute of Medical Sciences, New Delhi, India ² Department of Laboratory Medicine, JPNA Trauma Centre, All India Institute of Medical Sciences, New Delhi, India ³ Department of Microbiology, All India Institute of Medical Sciences, New Delhi, India ⁴ Centralized Core Research Facility, All India Institute of Medical Sciences, New Delhi, India ⁵ Department of Anaesthesiology, Pain Medicine & Critical Care, All India Institute of Medical Sciences, New Delhi, India ⁶ Department of Critical & Intensive Care, JPNA Trauma Centre, All India Institute of Medical Sciences, New Delhi, India ⁷ Department of Laboratory Medicine, All India Institute of Medical Sciences, New Delhi, India ⁸ Department of Hospital Administration, JPNA Trauma Centre, All India Institute of Medical Sciences, New Delhi, India ⁹ Department of Biostatistics, All India Institute of Medical Sciences, New Delhi, India ¹⁰ Department of Orthopedics, JPNA Trauma Centre, All India Institute of Medical Sciences, New Delhi, India ¹¹ Department of Pulmonology & Sleep Disorder, All India Institute of Medical Sciences, New Delhi, India Correspondence Address: Purva Mathur, Department of Laboratory Medicine, JPNA Trauma Center, All India Institute of Medical Sciences, New Delhi 110 029 India Source of Support: None, Conflict of Interest: None DOI: 10.4103/ijmr.IJMR_3305_20 PMID: 33146157

*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.

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