Analytical Performance Evaluation of Three Commercial Rapid Nucleic Acid Assays for SARS-CoV-2.

ABSTRACT:

Purpose

To cope with the SARS-CoV-2 epidemic, several rapid nucleic acid assays have been approved for use, but the analytical performance has not been well evaluated. In this report, two key performance parameters, analytical sensitivity (limit of detection) and reproducibility, of three approved rapid nucleic acid assays were assessed using heat-inactivated SARS-CoV-2 culture supernatants quantified by digital PCR.

Methods

The LOD (limit of detection) and reproducibility of three approved rapid nucleic acid assays using their own instruments were assessed, while the LOD and reproducibility of two assays on a 7500 Real-Time instrument were assessed at the same time.

Results

Using their own instruments, 100% of samples with 1150 copies/mL viral RNA could be detected b

SUBMITTER: Yi J 

PROVIDER: S-EPMC8374845 | biostudies-literature | 2021

REPOSITORIES: biostudies-literature