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

doi:10.1016/j.jmii.2021.01.005

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

J Microbiol Immunol Infect. 2021 Jun;54(3):522-526. doi: 10.1016/j.jmii.2021.01.005. Epub 2021 Feb 1.

Authors

Pai-Ling Chang¹, Chia-Yi Lin², Cheng-Pin Chen³, Yi-Chun Lin⁴, Hui-Chun Hu⁵, Shu-Hsing Cheng⁶, Chien-Yu Cheng⁷

Affiliations

¹ Department of Laboratory Medicine, Taoyuan General Hospital, Ministry of Health and Welfare, Taoyuan, Taiwan. Electronic address: [email protected].
² Department of Laboratory Medicine, Taoyuan General Hospital, Ministry of Health and Welfare, Taoyuan, Taiwan.
³ Department of Infectious Diseases, Taoyuan General Hospital, Ministry of Health and Welfare, Taoyuan, Taiwan; School of Clinical Medicine, National Yang-Ming University, Taipei, Taiwan.
⁴ Department of Infectious Diseases, Taoyuan General Hospital, Ministry of Health and Welfare, Taoyuan, Taiwan.
⁵ Department of Nursing, Taoyuan General Hospital, Ministry of Health and Welfare, Taoyuan, Taiwan.
⁶ Department of Infectious Diseases, Taoyuan General Hospital, Ministry of Health and Welfare, Taoyuan, Taiwan; School of Public Health, Taipei Medical University, Taipei, Taiwan.
⁷ Department of Infectious Diseases, Taoyuan General Hospital, Ministry of Health and Welfare, Taoyuan, Taiwan; School of Public Health, National Yang-Ming University, Taipei, Taiwan. Electronic address: [email protected].

Abstract

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%).

Keywords: COVID-19; Insulated isothermal PCR; SARS-CoV-2.

MeSH terms

Adult
Aged
COVID-19 / diagnosis*
COVID-19 Nucleic Acid Testing / methods*
Female
Humans
Male
Middle Aged
RNA, Viral / isolation & purification
Reverse Transcriptase Polymerase Chain Reaction
SARS-CoV-2 / isolation & purification*
Sensitivity and Specificity
Young Adult

Substances

RNA, Viral