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

Main Article Content

Minghang Yu
Yang Xiong
Pu Liang
Danying Chen
Yuting Zhang
Huan Liu
Yuanyuan Zhang
Xuesen Zhao
Ronghua Jin
Xi Wang

Keywords

antigen, COVID-19, rapid antigen test, SARS-CoV-2, sensitivity

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.

Downloads

Download data is not yet available.

Metrics

Metrics Loading ...
Abstract 17 | HTML Downloads 25 PDF Downloads 47

References

1. World Health Organization [Internet]. COVID-19 Epidemiological Update - 24 November 2023. Available from: https://www.who.int/publications/m/item/covid-19-epidemiological-update---24-november-2023.
2. Summer S, Schmidt R, Herdina AN, Krickl I, Madner J, Greiner G, et al. Detection of SARS-CoV-2 by real-time PCR under challenging pre-analytical conditions reveals independence of swab media and cooling chain. Sci Rep. 2021;11(1):13592. doi: 10.1038/s41598-021-93028-8. PMID: 34193912.
3. Lee H, Kang H, Cho Y, Oh J, Lim TH, Ko BS, et al. Diagnostic Performance of the Rapid Antigen Test as a Screening Tool for SARS-CoV-2 Infection in the Emergency Department. J Pers Med. 2022;12(7). doi: 10.3390/jpm12071172. PMID: 35887669.
4. Szekely J, Mongkolprasert J, Jeayodae N, Senorit C, Chaimuti P, Swangphon P, et al. Development, Analytical, and Clinical Evaluation of Rapid Immunochromatographic Antigen Test for SARS-CoV-2 Variants Detection. Diagnostics (Basel). 2022;12(2). doi: 10.3390/diagnostics12020381. PMID: 35204473.
5. Bekliz M, Adea K, Puhach O, Perez-Rodriguez F, Marques Melancia S, Baggio S, et al. Analytical Sensitivity of Eight Different SARS-CoV-2 Antigen-Detecting Rapid Tests for Omicron-BA.1 Variant. Microbiol Spectr. 2022;10(4):e0085322. doi: 10.1128/spectrum.00853-22. PMID: 35938792.
6. Gomes JC, Masood AI, Silva LHS, da Cruz Ferreira JRB, Freire Júnior AA, Rocha A, et al. Covid-19 diagnosis by combining RT-PCR and pseudo-convolutional machines to characterize virus sequences. Sci Rep. 2021;11(1):11545. doi: 10.1038/s41598-021-90766-7. PMID: 34078924.
7. Yu M, Chen D, Tang X, Zhang Y, Liang P, Xiong Y, et al. Evaluation of a high-sensitivity SARS-CoV-2 antigen test on the fully automated light-initiated chemiluminescent immunoassay platform. Clin Chem Lab Med. 2023. Epub 2023/01/20. doi: 10.1515/cclm-2022-1039. PMID: 36656975.
8. Dinnes J, Deeks JJ, Adriano A, Berhane S, Davenport C, Dittrich S, et al. Rapid, point-of-care antigen and molecular-based tests for diagnosis of SARS-CoV-2 infection. Cochrane Database Syst Rev. 2020;8(8):Cd013705. doi: 10.1002/14651858.Cd013705. PMID: 32845525.
9. CLSI. Evaluation of precision of quantitative measurement procedures; approved guideline-3rd edition. CLSI document EP5-A3. Wayne, PA: Clinical and Laboratory Standards Institute. 2014.
10. CLSI. User protocol for evaluation of qualitative test performance; approved guideline-second edition. CLSI document EP12-A2. Wayne, PA: Clinical and Laboratory Standards Institute. 2008.
11. Padoan A, Cosma C, Sciacovelli L, Faggian D, Plebani M. Analytical performances of a chemiluminescence immunoassay for SARS-CoV-2 IgM/IgG and antibody kinetics. Clin Chem Lab Med. 2020;58(7):1081-8. doi: 10.1515/cclm-2020-0443. PMID: 32301749.
12. Schneider UV, Forsberg MW, Leineweber TD, Jensen CB, Ghathian K, Agergaard CN, et al. A nationwide analytical and clinical evaluation of 44 rapid antigen tests for SARS-CoV-2 compared to RT-qPCR. J Clin Virol. 2022;153:105214. doi: 10.1016/j.jcv.2022.105214. PMID: 35738151.
13. Sakai-Tagawa Y, Yamayoshi S, Halfmann PJ, Kawaoka Y. Comparative Sensitivity of Rapid Antigen Tests for the Delta Variant (B.1.617.2) of SARS-CoV-2. Viruses. 2021;13(11). doi: 10.3390/v13112183. PMID: 34834991.

Most read articles by the same author(s)