Validation of 12 Rapid Antigen Tests for the Detection of SARS-CoV-2

Minghang Yu^1,2,3,4,#, Yang Xiong^1,2,#, Pu Liang^1,2,3,4,#, Danying Chen^1,2,3,4, Yuting Zhang^1,2,3,4, Huan Liu^1,2,3,4, Yuanyuan Zhang^1,2,3,4,*, Xuesen Zhao^1,2,3,4,*, Ronghua Jin^1,2,3,4,*, Xi Wang^1,2,3,4,*

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¹ Beijing Key Laboratory of Emerging Infectious Diseases, Institute of Infectious Diseases, Beijing Ditan Hospital, Capital Medical University, Beijing 100015, P.R.China.

² Beijing Institute of Infectious Diseases，Beijing, 100015, P.R.China.

³ National Center for Infectious Diseases, Beijing Ditan Hospital, Capital Medical University, Beijing 100015, P.R. China.

⁴ National Key Laboratory of Intelligent Tracking and Forecasting for Infectious Diseases, Beijing,100015, P.R.China.

JBM 2024 , 11(1), 1;

© 2024 by the author. Licensee POL Scientific, USA. This article is an open access article distributed under the terms and conditions of the Creative Commons Attribution 4.0 International License ( https://creativecommons.org/licenses/by/4.0/ )

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Abstract

The rapid identification SARS-CoV-2 virus has become the basis for the control of the COVID-19 outbreak. The rapid antigen tests for SARS-CoV-2 are quick, widely available, and inexpensive. Rapid antigen tests have gradually replaced the time-consuming and costly RT-PCR. Currently, although several RAT kits have been extensively used for the diagnosis of COVID-19, validity data are limited due to the inconsistent sensitivity and poor reproducibility. Meanwhile, WHO does not recommend specific commercial RAT kits. Therefore, it is crucial to establish a method to evaluate the effectiveness of different rapid antigen tests kits. This study aimed to develop an evaluation system for rapid antigen tests to provide an efficient and accurate technique for screening SARS-CoV-2 antigen detection kits. Given large number of rapid antigen tests kits available, this study only focused on those that are representative and commonely used in China. By minimzing biases through randomization, concealment, and blinding, we eventually found that the Test 1 had the lowest sensitivity and the Test VI had the highest sensitivity. This study provided an evaluation platform that can potentially serve as a reference for COVID-19 diagnostic strategies.

Keywords

antigen

COVID-19

rapid antigen test

SARS-CoV-2

sensitivity

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