Clinical Performance Evaluation of artus HCV v2 QS-RGQ Kit
Research type
Research Study
Full title
A non-interventional, retrospective, performance evaluation of the artus HCV v2 QS-RGQ Kit to evaluate clinical accuracy compared to a predicate CE-marked In Vitro Diagnostic medical device, in representative Hepatitis C Virus positive and negative samples.
IRAS ID
229707
Contact name
Kate Templeton
Contact email
Duration of Study in the UK
0 years, 3 months, 30 days
Research summary
This is a clinical performance evaluation of an in vitro diagnostic device: the artus HCV v2 QS-RGQ Kit, used for the quantification of Hepatitis C Virus (HCV) in RNA extracted from human plasma. The HCV v2 QS-RGQ Kit is designed to be used in conjunction with clinical information and other laboratory results for disease prognosis, to aid assessment of response to HCV treatment, as measured by changes in plasma levels of HCV.
This non-interventional, retrospective study has been designed to evaluate the clinical accuracy of the artus HCV v2 QS-RGQ Kit compared to a CE marked in vitro diagnostic medical device, using positive and negative clinical samples from tissue banks at 4 UK hospitals.
REC name
East of Scotland Research Ethics Service REC 1
REC reference
17/ES/0078
Date of REC Opinion
22 Jun 2017
REC opinion
Favourable Opinion