Clinical assessment of SARS-CoV-2 antigen rapid detection compared with RT-PCR assay for emerging variants at a high-throughput community testing site in Taiwan

• Published in: International journal of infectious diseases Vol. 115; pp. 30 - 34
• Main Authors: Jian, Ming-Jr, Perng, Cherng-Lih, Chung, Hsing-Yi, Chang, Chih-Kai, Lin, Jung-Chung, Yeh, Kuo-Ming, Chen, Chien-Wen, Hsieh, Shan-Shan, Pan, Pin-Ching, Chang, Hao-Ting, Chang, Feng-Yee, Ho, Ching-Liang, Shang, Hung-Sheng
• Format: Journal Article
• Language: English
• Published: Canada Elsevier Ltd 01.02.2022; The Author(s). Published by Elsevier Ltd on behalf of International Society for Infectious Diseases; Elsevier
• Subjects: Antigens, Viral; B.1.1.7 lineage; Community transmission; COVID-19; Humans; Rapid antigen test; Reverse Transcriptase Polymerase Chain Reaction; Reverse transcription polymerase chain reaction; SARS-CoV-2; Sensitivity and Specificity; Taiwan - epidemiology; Taiwan; COVID-19; SARS-CoV-2; B.1.1.7 lineage; Rapid antigen test; Reverse transcription polymerase chain reaction; Community transmission
• ISSN: 1201-9712; 1878-3511; 1878-3511
• DOI: 10.1016/j.ijid.2021.11.034

•The severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2) B1.1.7 lineage was prevalent in April 2021 and spread into Taiwan.•The coronavirus disease 2019 (COVID-19) Antigen Rapid Test Kit (ART) can detect SARS-CoV-2 B.1.1.7 variants.•ART can be used in densely populated areas for symptomatic or asymptomatic subjects.•ART and RT-PCR combined can improve COVID-19 diagnosis and curb community transmission. With the emergence of the severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2) B.1.1.7 lineage in the ongoing coronavirus disease 2019 (COVID-19) pandemic, Taiwan confronted a COVID-19 flare up in May 2021. Large-scale, accurate, affordable and rapid diagnostic tests such as the lateral flow assay can help to prevent community transmission, but their performance characteristics in real-world conditions and relevant subpopulations remain unclear. The COVID-19 Antigen Rapid Test Kit (Eternal Materials, New Taipei City, Taiwan) was used in a high-throughput community testing site; the paired reverse transcription polymerase chain reaction (RT-PCR) results served as a reference for sensitivity and specificity calculations. Of 2096 specimens tested using the rapid antigen test, 70 (3.33%) were positive and 2026 (96.7%) were negative. This clinical performance was compared with the RT-PCR results. The sensitivity and specificity of the rapid antigen test were 76.39% [95% confidence interval (CI) 64.91–85.60%] and 99.26% (95% CI 98.78–99.58%), respectively, with high sensitivity in subjects with cycle threshold values ≤24. Further, the rapid antigen test detected the SARS-CoV-2 B.1.1.7 lineage effectively. Considering the short turnaround times and lower costs, this simple SARS-CoV-2 antigen detection test for rapid screening combined with RT-PCR as a double confirmatory screening tool can facilitate the prevention of community transmission during COVID-19 emergencies.