Blood Donation: Our Work

Epidemiological surveillance of blood donors makes it possible to track the prevalence and incidence of bloodborne infections in this population, to obtain epidemiological information on donors who test positive (gender, age, donor type (first-time/repeat), geographic origin, probable mode of transmission, other markers of infection, etc.), as well as demographic information on the entire donor population.

Epidemiological surveillance covers pathogens systematically screened for in blood donations, namely:

• HIV (anti-HIV antibodies and/or HIV RNA)

• HCV (anti-HCV antibodies and/or HCV RNA)

• HBV (HBsAg and/or HBV DNA)

• syphilis (TPHA, ELISA, and immunoblot)

• HTLV* (anti-HTLV antibodies)

• EHV (EHV RNA)**

*Since April 2019, in mainland France and Réunion, anti-HTLV antibody testing is performed only on first-time donors.
** Screening performed on all donations since March 20, 2023.

Another important objective of this surveillance is to estimate the residual risk of transmission of these infections through transfusion. Despite the laboratory tests performed on every blood donation, there is a so-called “residual” risk of transmitting a viral infection, linked to the window period—the time between when a person becomes infected and when markers of the infection become detectable by laboratory tests. Surveillance thus contributes to the evaluation of blood donor selection, which is governed by a decree of the Minister of Health (the most recent decree is that of January 11, 2022, amending the decree of December 17, 2019, establishing the criteria for blood donor selection).

This surveillance also makes it possible to assess the impact of viral genomic testing (VGT) on the screening for HIV, HCV, and HBV.

Surveillance launched in 1985 with HIV screening

Epidemiological surveillance of blood donors began in 1985 with the introduction of HIV screening. Over the years, this epidemiological surveillance has continued to evolve. As early as 1986, it was expanded to include all infectious agents screened for as part of routine blood donation screening, namely Treponema pallidum, the causative agent of syphilis (screened since 1945), and the hepatitis B virus (screened since 1971 using the HBsAg marker, to which anti-HBc antibodies were added in 1988). In 1990, epidemiological surveillance was expanded to include hepatitis C virus infection through screening for anti-HCV antibodies, and then, starting in July 1991, to include HTLV infection through screening for anti-HTLV antibodies. Since April 2019 (decree of December 24, 2018), HTLV screening has been restricted to first-time donors, with the exception of Guadeloupe and Martinique, where it remains in place for all blood donations. In 2023, surveillance was expanded to include screening for hepatitis E virus (HEV) RNA in all blood donations (since 2012, only a fraction of donations had been screened; these “HEV-free” donations were reserved for recipients at risk of developing chronic infections).

Since 1993, Santé publique France has coordinated the epidemiological surveillance of blood donors, in partnership with the French Blood Establishment (EFS), the Armed Forces Blood Transfusion Center (CTSA), the National Reference Center for Transfusion-Related Infectious Risks (CNR RIT), and the National Agency for Medicines and Health Products Safety (ANSM).
The role of Santé publique France in this surveillance is currently defined by Decree No. 2006-99 of February 1, 2006. This decree specifies in particular that:

• Each blood transfusion center must provide Santé publique France with the data necessary for the epidemiological surveillance of blood donors

• Santé publique France is part of the "national hemovigilance system" and, as such, data from this surveillance must be transmitted to the ANSM.

Furthermore, the order of January 11, 2022, amending the order of December 17, 2019, establishing the criteria for the selection of blood donors, specifies that the implementation of the selection criteria is subject to an annual review of the epidemiological monitoring of blood donors conducted by Santé publique France and presented to the blood donor selection monitoring committee. This review is conducted based on data provided by the French Blood Establishment and the Armed Forces Blood Transfusion Center and is submitted to the Minister of Health.

COMPLIDON Survey

A study conducted in 2017–2018 to assess compliance with blood donor selection criteria.