Performance evaluation of the DAAN HCV assay for quantification of hepatitis C virus RNA and its comparison with COBAS AmpliPrep/COBAS TaqMan HCV Quantitative Test, v2.0.

ABSTRACT:

Background

The Daan HCV RNA quantitative assay was a recently developed kit with high sensitivity for the detection of HCV RNA. We aimed to evaluate the analytical performance of the Daan HCV RNA quantitative assay and compare it with the COBAS AmpliPrep/COBAS TaqMan HCV Quantitative Test, v2.0.

Method

WHO HCV RNA standard, NIBSC 06/102 standard, and CLSI EP documents were used to evaluate the precision, accuracy, linearity, anti-interference ability, and cross-reactivity of the Daan HCV RNA quantitative assay. Overall 198 clinical serum specimens were used to make comparison between the Daan HCV RNA quantitative assay and the Roche Cobas test.

Results

The within-run precision (S_within ), and total precision (S_total ) for 6.11 log IU/mL, 4.22 log

SUBMITTER: He Y 

PROVIDER: S-EPMC7370725 | biostudies-literature | 2020 Jul

REPOSITORIES: biostudies-literature