Preliminary Validation of an in Vitro Diagnosis-medical Device for Hepatitis B Screening

The diagnosis of hepatitis B in precarious populations is often difficult. The use of a in vitro diagnosis-medical device in point of care could alleviate this difficulty. It would identify whether or not the subjects are infected with the virus, whether they are immunized or not. Then, depending on the results, the subjects could be directly vaccinated or referred to a laboratory of medical biology for confirmation / invalidation of the diagnosis.

Inclusion criteria

• Group 1: HBsAg negative, Anti HBc negative, Anti HBs negative, during a laboratory assay on serum
• Group 2: HBsAg negative, Anti HBc negative, Anti HBs positive, during a laboratory assay on serum
• Group 3: HBsAg negative, Anti HBc positive, Ab anti HBs positive or negative, during a laboratory assay on serum
• Group 4: HBsAg positive, Anti HBc positive, Anti HBs negative, during a laboratory assay on serum
• all: affiliated to social security or beneficiary of such a scheme

Exclusion criteria

• Infection by a confounding factor: HIV, HCV and / or HDV
• Protected person: Pregnant woman, parturient, mother who is breastfeeding, person deprived of liberty by judicial or administrative decision, person subject to a legal protection measure
• Exclusion period for other research studies involving the human person
• Annual threshold of allowances for participation in research involving the affected human person.