Aptima HBV Quant evaluation
Research type
Research Study
Full title
Performance Evaluation of the Aptima HBV Quant Assay for the Detection and Quantitation of Hepatitis B Virus (HBV) in Plasma and Serum Samples
IRAS ID
211020
Contact name
Peter Muir
Contact email
Sponsor organisation
Hologic Ltd.
Duration of Study in the UK
0 years, 5 months, 15 days
Research summary
The Aptima HBV Quant assay is a real-time transcription mediated amplification test for the quantitation of hepatitis B virus (HBV) DNA in fresh and frozen human serum, and EDTA, ACD and PPT plasma from chronically HBV-infected individuals, using the Panther System for automated specimen processing, amplification, and detection. The aim of this study is to assess the clinical performance of the APTIMA HBV Quant real-time TMA assay for HBV DNA quantification in clinical specimens from patients chronically infected with HBV genotypes A to H from Hepatitis B treatment centres served by PHL Bristol Performance data such as specificity, analytical sensitivity, precision, reproducibility, linearity, accuracy and influence of the HBV genotype will be generated. The results will subsequently be compared to those obtained with the Abbott Real Time HBV assay, currently the reference method for HBV DNA quantification at PHL Bristol.
REC name
HSC REC A
REC reference
16/NI/0248
Date of REC Opinion
9 Dec 2016
REC opinion
Further Information Favourable Opinion