Harmonization of SARS-CoV-2 reverse transcription quantitative PCR tests to the first WHO international standard for SARS-CoV-2 RNA.

ABSTRACT:

Background

Cycle threshold (Ct) values from SARS-CoV-2 reverse transcription quantitative PCR (RT-qPCR) tests are used to measure viral burden. Calibration to the First WHO International Standard for SARS-CoV-2 RNA may improve quantitative inter-assay agreement.

Methods

WHO standard was tested using four emergency use authorized RT-qPCRs to generate calibration curves and evaluate Ct value differences. Harmonization of two assays, Cepheid Xpert Xpress SARS-CoV-2 targeting E and nucleocapsid (N2) [Xpert (E) and Xpert (N2)] and a laboratory-developed test targeting E [LDT (E)], was assessed using 93 positive upper respiratory samples. Platform (target) pairs were compared via Bland-Altman analysis and Passing-Bablok regression.

Results

Ct values with the WHO standard we

SUBMITTER: Sahoo MK 

PROVIDER: S-EPMC9287539 | biostudies-literature | 2022 Sep

REPOSITORIES: biostudies-literature