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Infectious Diseases clinical trial

Evaluation of the Clinical Performance of the Alere HBsAg Rapid Test

Summary:
Evaluation of the Clinical Performance of the Alere HBsAg Rapid Test:
Hepatitis 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.
This 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.
This 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.
The study is funded by Alere Inc.

Inclusion criteria:
1. Written informed consent given by the Subject or the Subject’s legal guardian.
2. Written assent given wherever possible.
3. The Subject, or the Subject’s Legal Guardian, agrees that all aspects of the study will be completed.
4. The Subject presents to a participating centre for HBsAg screening or Hepatitis B follow-up care.

Exclusion criteria:
1. The Subject has already participated in this study at a previous date.
2. The Subject is currently enrolled in a study to evaluate an investigational new drug and has started taking the
investigational drug.
3. Vulnerable populations as deemed inappropriate for the study by the study Investigator(s).

Principal Investigator for this trial: Dr Stephen D Ryder

Research Ethics Committee Reference: 16/LO/1511

Contact us about participating in this study by emailing R&IActiveStudyEnquiries@nuh.nhs.uk or telephoning 0115 924 9924 Ext. 70076

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