Abstract

Purpose: To assess and compare the diagnostic accuracy of the GenBody COVID-19 Antigen kit (GenBody Inc., Cheonan, South Korea) available in the market with the gold standard reverse transcription-polymerase chain reaction (RT-PCR) assay to detect severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2).Methods: Nasopharyngeal and oropharyngeal swabs were collected from suspected coronavirus disease 2019 (COVID-19) patients and tested by RT-PCR and GenBody Rapid antigen kit. Performance characteristic of the antigen kit was calculated.Results: We tested nasopharyngeal swabs and oropharyngeal swabs (n=240). Amongst the 102 positive RT-PCR samples, the rapid antigen test detected 36 as positive, showing an overall sensitivity of 35.3%. All the samples detected positive with the antigen rapid test were also detected positive by RT-PCR.Conclusion: The performance of the rapid antigen kit was good with respect to high viral load samples, whereas those with lower levels were missed. Unfortunately, the overall low sensitivity of the antigen kit does not allow using it alone as the frontline testing kit for COVID-19 diagnosis.

Highlights

  • The coronavirus disease 2019 (COVID-19) pandemic has created havoc worldwide since it was first recorded in Wuhan, the capital city of Hubei province, China, in December 2019 [1]

  • The severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) is a single-stranded RNA virus that belongs to the genus β of Family Coronaviridae

  • Samples were collected and mixed in viral transport media (VTM) and immediately transported to the virology laboratory maintaining the cold chain where these samples were tested with reverse transcription-polymerase chain reaction (RT-PCR) and rapid antigen test kits simultaneously

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Summary

Introduction

The coronavirus disease 2019 (COVID-19) pandemic has created havoc worldwide since it was first recorded in Wuhan, the capital city of Hubei province, China, in December 2019 [1]. The severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) is a single-stranded RNA virus that belongs to the genus β of Family Coronaviridae. Being highly transmissible, this novel coronavirus disease (COVID-19) has spread fast worldwide [2]. The gold standard tests to diagnose SARS-CoV-2 infections are viral culture and reverse transcription-polymerase chain reaction (RT-PCR) assays [4]. It takes a few hours for RT-PCR to detect the nucleic acid and isolation of the virus from samples takes some days, but these tests need a specialized instrument and trained people in that particular field. Rapid tests for SARS-CoV2 might play an important role in mass screening to facilitate prevention and control of disease and screening before any surgical procedure [1]

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