Aptima HCV Quant Dx evaluation
Research type
Research Study
Full title
Performance Evaluation of the Aptima HCV Quant Dx Assay for the Detection and Quantitation of Hepatitis C Virus in Plasma and Serum Samples
IRAS ID
203213
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 HCV Quant Dx assay is an in vitro nucleic acid amplification test (NAAT) for the detection and quantitation of Hepatitic C Virus (HCV) nucleic acid in patient serum or plasma samples using the fully automated Panther system. It is intended for use as an aid in the diagnosis or confirmation of HCV infection, and for assessment of treatment response in patients on antiviral therapy. This performance evaluation study will compare the performance of the Aptima HCV Quant Dx assay with that of the Abbott real time HCV PCR assay, which is our currently used assay for quantification of HCV in patient samples. In particular we will evaluate performance using samples with varying amounts of HCV, samples with different genetic strains of HCV, and samples from patients who have been treated with different antiviral drugs.
REC name
HSC REC A
REC reference
16/NI/0249
Date of REC Opinion
9 Dec 2016
REC opinion
Further Information Favourable Opinion