Place of Point-of-Care Tests (POCTs) in hepatitis B screening strategy
In response to a demand from the Ministry of Health, HAS establishes guidelines on the place of Point-of-Care Tests (POCTs) in hepatitis B screening strategy.
In France, the hepatitis B screening strategy is focused on high risk populations for HBV and is currently based on detection of the three HBV infection markers (HBsAg, anti-HBs Ab, anti-HBc Ab) by an Elisa test performed on a venous sample.
The majority of existing HBV POCTs detects HBsAg only, allowing identification of individuals who are chronic carriers only and not the identification of high risk persons who have never been in contact with hepatitis B and susceptible to receive a hepatitis B vaccination.
If the performances of the single test detecting HBsAg marketed in France are deemed satisfactory in whole blood, they are lesser in capillary blood and require a laboratory screening confirmation in case of positivity.
HAS highlights that these point-of-care tests do not replace serological screening, which remains the standard.
Therefore, HAS recommends the use of HBV POCTs as a complementary screening tool to conventional laboratory screening since it may be more appropriate for high risk populations not or insufficiently screened and distant from common access structures such as: Persons from high and medium endemic areas, drug users, persons already infected by HIV or HCV and who are not under medical monitoring, detainees, sex workers, the most isolated and vulnerable persons who are in a precarious situation, and who frequent centres such as Continuous Access to Health Care (PASS) centres, Care and Support Centres for Reduction of Risks for Drug Users (CAARUD), Centres for Care, Support and Prevention in Addition (CSAPA), community associations, places for medico-social assistance, resocialisation, or marginalised populations hard-to-reach outside of specific nonclinical settings.
Within these high risk populations, HAS recommends the development of a combined screening offer for sexually transmitted infections, including by HIV, HCV and HBV POCTs.
Screening by POCTs must also be part of a more global objective of health education and reduction of risks and harm and constitutes, for the populations distant from care, a contact opportunity with the health system, allowing dissemination of general prevention messages related to these infections and a reminder about the opportunity for screened people or their friends and family members to receive a hepatitis B vaccination.
Besides regulatory and quality requirements, HAS recommends that conditions of the HIV/HCV/HBV POCTs use would allow optimization of the efficiency of POCTs testing and considers that better targeting of actions and linking upstream of the screening settings, healthcare networks and medico-psycho-social structures are essential to achieve.
HAS also recommends a spread of the POCTs testing to a larger number of volunteer associations and actors in addition to the implementation of a sustainable and equitable funding system regardless of the actors.
Finally, HAS recommends continuing monitoring the implementation of the offer of combined screening by HIV/HCV/HBV POCTs and assessment of its impact on access to care and to the medico-social system. HAS also deems it necessary to implement studies to document the impact of POC screening on the prognosis of infections and the efficiency of the POC testing.