Hologic HIV viral load real time TMA evaluation
Research type
Research Study
Full title
Performance Evaluation of the Aptima HIV-1 Quant Dx Assay for the Detection of HIV-1 in Plasma Samples
IRAS ID
154193
Contact name
Peter Muir
Contact email
Duration of Study in the UK
0 years, 4 months, 29 days
Research summary
The Aptima HIV-1 Quant Dx assay is an in vitro nucleic acid amplification test (NAAT) for the detection and quantitation of human immunodeficiency virus type 1 (HIV-1) 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 HIV-1 infection, and for assessment of treatment response in patients on antiviral therapy. This performance evaluation study will compare the performance of the Aptima HIV-1 Quant Dx assay with that of the Abbott real time PCR assay, which is our currently used assay for quantification of HIV-1 in patient samples. In particular we will evaluate performance using samples with varying amounts of HIV-1, samples with different genetic strains of HIV-1, and samples from patients who have been treated with different antiviral drugs.
REC name
South West - Cornwall & Plymouth Research Ethics Committee
REC reference
15/SW/0218
Date of REC Opinion
23 Sep 2015
REC opinion
Further Information Favourable Opinion