Clinical establishment of a laboratory developed quantitative HDV PCR assay on the cobas6800 high-throughput system.

ABSTRACT:

Background & aims

Currently available HDV PCR assays are characterized by considerable run-to-run and inter-laboratory variability. Hence, we established a quantitative reverse transcription real-time PCR (RT-qPCR) assay on the open channel of a fully automated PCR platform (cobas6800, Roche) offering improved consistency and reliability.

Methods

A primer/probe-set targeting a highly conserved region upstream of the HDV antigen was adapted for use on the cobas6800. The lower limit of detection (LLOD) was determined using a dilution panel of the HDV WHO standard (n = 21/dilution). Linearity and inclusivity were tested by preparing 10-fold dilution series of cell culture-derived virus (genotype [GT]1-8; n = 5/dilution). Patient samples containing a variety of bloodborne viral

SUBMITTER: Pfluger LS 

PROVIDER: S-EPMC8531665 | biostudies-literature | 2021 Dec

REPOSITORIES: biostudies-literature