Clinical validation of an automated reverse transcription-insulated isothermal PCR assay for the detection of severe acute respiratory syndrome coronavirus 2

Pai-Ling Chang; Chia-Yi Lin; Cheng-Pin Chen; Yi-Chun Lin; Hui-Chun Hu; Shu-Hsing Cheng; Chien-Yu Cheng

Journal of Microbiology, Immunology and Infection (Jun 2021)

Clinical validation of an automated reverse transcription-insulated isothermal PCR assay for the detection of severe acute respiratory syndrome coronavirus 2

Pai-Ling Chang,
Chia-Yi Lin,
Cheng-Pin Chen,
Yi-Chun Lin,
Hui-Chun Hu,
Shu-Hsing Cheng,
Chien-Yu Cheng

Affiliations

Pai-Ling Chang: Department of Laboratory Medicine, Taoyuan General Hospital, Ministry of Health and Welfare, Taoyuan, Taiwan; Corresponding author. Fax: +886 3 3789127
Chia-Yi Lin: Department of Laboratory Medicine, Taoyuan General Hospital, Ministry of Health and Welfare, Taoyuan, Taiwan
Cheng-Pin Chen: Department of Infectious Diseases, Taoyuan General Hospital, Ministry of Health and Welfare, Taoyuan, Taiwan; School of Clinical Medicine, National Yang-Ming University, Taipei, Taiwan
Yi-Chun Lin: Department of Infectious Diseases, Taoyuan General Hospital, Ministry of Health and Welfare, Taoyuan, Taiwan
Hui-Chun Hu: Department of Nursing, Taoyuan General Hospital, Ministry of Health and Welfare, Taoyuan, Taiwan
Shu-Hsing Cheng: Department of Infectious Diseases, Taoyuan General Hospital, Ministry of Health and Welfare, Taoyuan, Taiwan; School of Public Health, Taipei Medical University, Taipei, Taiwan
Chien-Yu Cheng: Department of Infectious Diseases, Taoyuan General Hospital, Ministry of Health and Welfare, Taoyuan, Taiwan; School of Public Health, National Yang-Ming University, Taipei, Taiwan; Corresponding author. Division of Infectious Diseases, Department of Internal Medicine, Taoyuan General Hospital, Ministry of Health and Welfare, Taoyuan, Taiwan. Fax: +886 3 3789127

Journal volume & issue: Vol. 54, no. 3
pp. 522 – 526

Abstract

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To determine clinical performance of the single-target SARS-CoV-2 orf 1 ab reverse transcription-insulated isothermal PCR (RT-iiPCR) assay, the positive percentage agreement between this assay and a laboratory real-time RT-PCR assay was 96.8% (30 of 31; 95% confidence interval [CI], 90.5%–100%) and the negative percentage agreement was 97.1% (67 of 69; 95% CI, 93.1%–100%).

Published in Journal of Microbiology, Immunology and Infection

ISSN: 1684-1182 (Print)
Publisher: Elsevier
Country of publisher: Hong Kong
LCC subjects: Science: Microbiology
Website: https://www.sciencedirect.com/journal/journal-of-microbiology-immunology-and-infection

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