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


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%).

SUBMITTER: Chang PL 

PROVIDER: S-EPMC7849545 | biostudies-literature | 2021 Jun

REPOSITORIES: biostudies-literature

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

Chang Pai-Ling PL   Lin Chia-Yi CY   Chen Cheng-Pin CP   Lin Yi-Chun YC   Hu Hui-Chun HC   Cheng Shu-Hsing SH   Cheng Chien-Yu CY  

Journal of microbiology, immunology, and infection = Wei mian yu gan ran za zhi 20210201 3


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%). ...[more]

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