Viral hepatitis causes inflammation of the liver that leads to severe disease and liver cancer. World Hepatitis Day is observed each year on the 28th of July to raise awareness, and reduce deaths and new infections – World Health Organisation (WHO) aims to eliminate hepatitis by 2030.

In the WHO European Region, an estimated 13.3 million people live with chronic hepatitis B (1.8% of adults) and an estimated 15 million people with hepatitis C (2.0% of adults); these numbers don’t include people who are not diagnosed yet. Hepatitis B causes about 36,000 deaths and hepatitis C about 86, 000 deaths per year in WHO European Member States.

In France, the health system around medical examination is organized as follows:

  • Hepatitis vaccine policy is defined by the Ministry of Health;
  • HAS (Haute Autorité de Santé or French National Authority for Health) is making the recommendation for good practices;
  • Laboratories are performing the medical examinations; and
  • Cofrac (the French National Accreditation Body) is coordinating the action of all the interested parties, under the supervision of the French authorities.

Viral hepatitis diagnostics – from the detection to the confirmation of the diagnostic for patients and for the examination of labile blood products and organs donation – have to be conducted in France by accredited laboratories, as all laboratories performing medical examinations have to be accredited according to EN ISO 15189, the international standard defining the requirements for quality and competence of medical laboratories. Some determined hepatitis has to be declared to Santé Publique France (Public Health France).

Accreditation covers biological diagnostics of hepatitis and builds a mutual trust between national authorities, health organizations, laboratories, nursing staff, etc.

When accreditation is not mandatory, non-conformities can’t be identified so there is no control by any authorities whatsoever. Accreditation ensures that the assessment is neutral, and performed by professionals who are qualified to evaluate the conformity and quality. The distinction between each role gives strength and impartiality to the whole process.

In that sense, accreditation and mandatory accredited laboratories are important in reducing and preventing hepatitis cases as it helps to detect pathology, accelerate the start of the treatment in the patient’s best interest, and increase the chances of recovery.