VP124 The End Of A French Medical Dogma For Hepatitis B And C Diagnosis

Abstract

INTRODUCTION:

Since the 1990s in France, based on contemporary French consensus conferences, for Hepatitis B (HBV) or Hepatitis C (HCV), diagnosis is acknowledged when detection of Hepatitis B surface antigen or anti-HCV antibody is positive on a 1^st test line and further replicated on an independent blood sample.

The replication was introduced to alleviate the low performance of immunoassay and avoid false positive results.

Currently, the Haute Autorité de santé (HAS) is managing an update of diagnostic tests reimbursed for HBV and HCV to fully cover diagnostic needs.

Our aim is to assess the clinical relevance of this repetition.

METHODS:

The assessment involves a critical analysis of national and international guidelines identified by a systematic literature search, and stakeholders’ views (professionals and public authorities).

RESULTS:

Since the 1990s, new tools were introduced (that is, polymerase chain reaction (PCR) for diagnosis and follow-up), and performances were improved for both enzyme immunoassay tests and PCR. Despite those change, replications are still performed nowadays in France.

Neither guidelines nor stakeholders’ contributions mentioned any replication tests’ clinical relevance.The Ministry of Health confirms that replications have not any legal basis contrary to HIV diagnosis procedures. Also the French National agency for health products safety confirms there are neither technological pitfalls nor reagent vigilance signals involving HBV or HCV in vitro diagnostic tests. Furthermore, after 1^st line positive results, a second blood sample is always collected to test other markers such as HBV DNA or HCV RNA which represent the best 2^nd proof of infection.

CONCLUSIONS:

This work has enlightened a lack of clinical relevance for the replication of the same serological makers’ detection. It may obliterate soon this French medical dogma. This work has illustrated that short assessment based on critical guideline analysis linked with stakeholders’ views allows a rapid answer without assessment quality reduction. This HAS work will contribute to medical practice rationalization and cost reduction.