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HBV infection status determined by enzyme-linked immuno-assay (ELISA)

HBV infection status determined initially by a rapid test, then confirmed by enzyme-linked immuno-assay (ELISA).

Enzyme-linked immuno-assay (ELISA) will be used to determine hepatitis B surface antigen (HBsAg) and anti-HBsAg antibody (anti-HBs Ab) status. Results will be given after test results are available (8-10 days).

ELISA testing

A rapid test will be performed to determine the subjects' hepatitis B surface antigen (HBsAg, using VIKIA®) and anti-HBs antibody status (anti-HBs Ab, using Quick ProfileTM). Results will be given the same day.

Rapid testing

Julie Bottero, MD

With over 280 000 chronic carriers, 2,500 new annual cases and 1,300 deaths each year, hepatitis B is currently a frequent and potentially severe disease in France, despite efforts towards prevention and effective care.

In terms of prevention, France has very low immunization coverage (27.7%) and a high percentage of people ignoring HBV status (55%), leading to a delay in care. This is partly explained by poor knowledge of hepatitis B infection in the general population and an underestimation of the health impact of hepatitis B by doctors and health officials. Until recently, there have been no national guidelines governing its implementation (which is variable depending on the structures where screening is performed) and an insufficient evaluation of screening practices. Thus, data on the severity of liver disease, indications for treatment of HBV-infected patients and data on the use of vaccination for nonimmunized people are scarce. Furthermore, while HIV rapid tests are beginning to be used more widely, particularly to address the issue of people who do not come back and collect their results and to better adapt "counselling", their usefulness to detect of hepatitis B virus has not been evaluated to date.

The main objective of the Optiscreen B Study is to determine the benefit, if any, of using rapid tests as a screening tool to improve diagnosis, care and prevention of hepatitis B. Individuals risk of HBV-infection will be randomized into 2 groups, one group for which screening will be performed by usual serological test and a second group for which screening will be based on rapid tests. Centers will be selected to represent a diverse range of health centers whose aims include screening, prevention and/or vaccination.

Application of HBV Rapid Tests as a Tool for Wide-Use Screening

Is the Combination of Screening Algorithms and Use of Hepatitis B Rapid Tests Useful in Optimizing the Screening and Prevention of Hepatitis B?

Data will be shared upon official request by interested parties. All requests are subject to approval by the Scientific Committee.

Subjects who are considered required to seek further care are as follows:

* those who need HBV vaccination (non-immunized)
* those who are infected with hepatitis B virus (infected)

Of these patients, subjects who have achieved appropriate care are considered as follows:

* non immunized subjects who have initiated HBV vaccination sequence (vaccinated)
* infected subjects who seek health care at a specialized center, allowing to quantify the severity of liver-related disease (infected with care)

The percentage of patients appropriately seeking care will be then calculated by the following formula:

((nb Vaccinated + nb infected with care) / (nb non-immunized + nb infected))\*100

ANRS, Emerging Infectious Diseases

Gilead Sciences

Roche Pharma AG

Mairie de Paris

BioMérieux

Institut de Médecine et d'Epidémiologie Appliquée - Fondation Internationale Léon M'Ba

Any event possibly related to physical HBV test.

HBV infection status determined by enzyme-linked immuno-assay (ELISA)

ELISA testing: Enzyme-linked immuno-assay (ELISA) will be used to determine hepatitis B surface antigen (HBsAg) and anti-HBsAg antibody (anti-HBs Ab) status. Results will be given after test results are available (8-10 days).

ELISA Testing

HBV infection status determined initially by a rapid test, then confirmed by enzyme-linked immuno-assay (ELISA).

ELISA testing: Enzyme-linked immuno-assay (ELISA) will be used to determine hepatitis B surface antigen (HBsAg) and anti-HBsAg antibody (anti-HBs Ab) status. Results will be given after test results are available (8-10 days).

Rapid testing: A rapid test will be performed to determine the subjects' hepatitis B surface antigen (HBsAg, using VIKIA®) and anti-HBs antibody status (anti-HBs Ab, using Quick ProfileTM). Results will be given the same day.

Rapid Testing

Total

Age, Continuous

Sex: Female, Male

Low (<2.0%)

Intermediate (2.0-8.0%)

High (>8.0%)

HBV prevalence of birth country

Social security

Health insurance plan

All participants completing their intervention.

Low prevalence of HBV infection; individuals with barriers to healthcare were underrepresented; Quick Profile anti-HBsAb rapid test unable to confirm nonimmunized status; intervention had same-day blood draws, which is not done in routine practice.

Dr. Julie Bottero

Power calculations were performed to detect \>15% difference in immediate linkage-to-care and vaccination. We hypothesized from discussions with an expert panel that \~30% of participants would have appropriate care with standard HBV serology. Assuming type 1 error=0.05 and power=80%, 152 participants per arm would be needed. As \~40% of the population would be nonimmunized or HBsAg-positive from previous data, a minimum 375 participants per arm would be required.

Only participants needing further medical intervention were included in analysis: non-immunized (HBsAg negative, anti-HBc antibody negative, anti-HBs antibody negative) or infected (HBsAg positive).

Percentage of Patients Appropriately Seeking Care

Overall Study

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Application of HBV Rapid Tests as a Tool for Wide-Use Screening	NCT01767597	Hepatitis B Liver Cirrhosis Carcinoma, Hepa...	ELISA testing Rapid testing	18 Years -	Institut de Médecine et d'Epidémiologie Appliquée - Fondation Internationale Léon M'Ba
Application of HBV Rapid Tests as a Tool for Wide-Use Screening	NCT01767597	Hepatitis B Liver Cirrhosis Carcinoma, Hepa...	ELISA testing Rapid testing	18 Years -	Institut de Médecine et d'Epidémiologie Appliquée - Fondation Internationale Léon M'Ba

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