Alere HBsAg Rapid Test version 001
Research type
Research Study
Full title
Evaluation of the Clinical Performance of the Alere HBsAg Rapid Test
IRAS ID
210799
Contact name
Patrick Kennedy
Contact email
Sponsor organisation
Alere Medical Co., Ltd. Japan
Duration of Study in the UK
0 years, 5 months, 29 days
Research summary
Evaluation of the Clinical Performance of the Alere HBsAg Rapid Test:\nHepatitis B is a major global health problem. More than 780 000 people die every year due to complications of Hepatitis B virus (HBV), including cirrhosis and liver cancer. However, Hepatitis B can be prevented through a currently available safe and effective vaccine. Hepatitis B surface antigen (HBsAg) is the earliest indicator of acute infection and may be present before symptoms appear. HBsAg is also present in patients with chronic infection, and is used to screen for and detect HBV infection.\nThis is a study that will evaluate the clinical test performance (sensitivity and specificity) of a new HBsAg rapid test; the Alere HBsAg test. The Alere HBsAg test is intended as an aid to detect HBsAg in HBV infected individuals. It is a visually read, qualitative test which can be read 15-30 minutes after the sample has been applied to the specimen pad in the test. In this study, the Alere HBsAg test will be evaluated using serum, plasma and whole blood samples collected by venipuncture (all sample types) and fingerstick (whole blood only). The performance of the Alere HBsAg test will be evaluated against the quantitative Abbott Architect HBsAg QT laboratory assay. \nThis study will recruit 350 patients in the UK and Spain, of which at least 150 will be HBsAg-positive. Up to 250 patients will be recruited at sites in the UK. Patients of all ages presenting to participating clinical sites for HBsAg screening (high risk population), or routine follow-up of confirmed HBsAg infection (confirmed positive population) will be approached for enrolment into this study. Additional control populations may also be included. The patients’ participation in the study will consist of one visit only. \nThe study is funded by Alere Inc.\n
REC name
London - Brent Research Ethics Committee
REC reference
16/LO/1511
Date of REC Opinion
4 Oct 2016
REC opinion
Further Information Favourable Opinion