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

[tetano]

J Microbiol Immunol Infect


. 2021 Feb 1;S1684-1182(21)00019-0.
doi: 10.1016/j.jmii.2021.01.005. Online ahead of print.
Clinical validation of an automated reverse transcription-insulated isothermal PCR assay for the detection of severe acute respiratory syndrome coronavirus 2


Pai-Ling Chang ¹ , Chia-Yi Lin ² , Cheng-Pin Chen ³ , Yi-Chun Lin ⁴ , Hui-Chun Hu ⁵ , Shu-Hsing Cheng ⁶ , Chien-Yu Cheng ⁷



Affiliations

• PMID: 33582073
• DOI: 10.1016/j.jmii.2021.01.005

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.