Abstract
HBV RNA is used as a marker of cccDNA transcription and is applicable in the setting of nucleos(t)ide analogue (NA) treatment, which suppresses HBV DNA. Traditional assays for quantification of HBV RNA rely on labour-intensive 3'RACE assays targeting the polyA tail. In this study, the high-throughput Roche cobas®HBV RNA investigational assay was assessed on the Roche cobas® 6800 automated platform. Of 969 samples collected for a NA treatment cessation trial, and tested on the cobas assay, 249 were analysed for sensitivity, reproducibility, sample type applicability, and results were compared to a RACE-based assay.
Results of ninety-seven paired serum and plasma samples demonstrated an excellent correlation of 0.98. However, 14.5% plasma samples yielded detectable (below the limit of quantification) results, when the paired serum was undetectable, and plasma was shown to yield a statistically significant (P<0.001) greater mean 0.119 log10copies/mL.
Quantification of 152 samples showed good correlation (0.91) between the cobas and RACE assays. The cobas assay demonstrated superior lower limit of quantification, 10 copies/mL, which resulted in detection of 13.2% more samples than the RACE assay. Reproducibility and linear range of the automated assay were also confirmed.
The Roche cobas assay for HBV RNA is sensitive and highly recommended.
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