Don de sang

Blood donation

Santé publique France coordinates the epidemiological surveillance of blood donors and helps assess the risk that a blood donation may be infected with a pathogen transmissible through transfusion.

Our missions

  • Epidemiological surveillance of blood donors

  • Estimating the residual risk of viral infection transmission (HIV, HCV, HBV, HTLV) through transfusion

  • Evaluation of blood donor selection

Data

In 2024, more than 2.6 million donations were made to the French Blood Establishment (EFS) and the Armed Forces Blood Transfusion Center (CTSA) by 1.5 million donors. Of these donations:

  • 23 tested positive for HIV (a rate of 0.08 positive donations per 10,000 donations), all of which were HIV-1

  • 15 were positive for HTLV (0.06 per 10,000), of which 1 was HTLV-2

  • 66 tested positive for HCV (0.25 per 10,000)

  • 218 for HBV (0.82 per 10,000)

  • 443 for syphilis (1.66 per 10,000)

Prevalence rates among new donors

Prevalence rates for HIV, HTLV, HCV, HBV, and syphilis are calculated among new donors.

In 2024, out of a total of 256,480 new donors, 7 tested positive for HIV, 15 for HTLV, 60 for HCV, 213 for HBV, and 267 for syphilis.

Prevalence rates have been relatively stable since the 2010s for HIV, HCV, and HTLV (0.27, 2.3, and 0.58 per 10,000 new donors in 2024, respectively). In contrast, prevalence rates for HBV and syphilis have been increasing since 2020 (8.3 and 10.4 per 10,000 new donors in 2024, respectively, compared to 3.9 and 6.7 in 2020).

A trend analysis over a 32-year period (1992–2024) shows that prevalence rates have decreased by a factor of 19 for HCV, 6 for HIV, 4 for HBV, and 1.3 for HTLV. The decreases observed for HIV and hepatitis B and C viruses are primarily linked to stricter screening of blood donors over time, but also to changes in epidemiology and improved understanding of the virological status of each of these infections. The prevalence rate of syphilis has increased by a factor of 1.7 since 2007, the date since which the definition of a syphilis-positive donation has remained unchanged.

Incidence rates among regular donors

The incidence rates of HIV, HCV, HBV, and syphilis are calculated among donors who have donated at least twice over a three-year period.

During the latest study period (2022–2024), 11 new cases of HIV, 1 case of HCV, 105 cases of syphilis, and an estimated 15 cases of HBV were observed. Based on 2,421,931 person-years (PY) over the 2022–2024 period, incidence rates were estimated at 0.45 per 100,000 PY (95% confidence interval: 0.24–0.84) for HIV, 0.04 (0.00–0.27) for HCV, 0.63 (0.37–1.06) for HBV, and 4.41 (3.63–5.36) for syphilis.

Between the 2019–2021 and 2022–2024 periods, the incidence rate of HCV was reduced by a factor of 4 (non-significant decrease), while the incidence rates of HBV, syphilis, and HIV increased non-significantly. The increases in HBV and syphilis rates could be due to the EFS’s gradual rollout of new, more sensitive screening tests since 2021, as well as an increase in incidence in the general population.

Residual Risks of Pathogen Transmission via Transfusion

Over the past thirty years, considerable progress has been made in terms of the viral safety of blood products thanks to improved donor screening and the development of effective screening tools. Despite these advances, there remains a residual risk of transmission via transfusion of infections that are routinely screened for in every blood donation. This risk is linked to the “window period,” defined as the time between when an individual becomes infected and when available laboratory tests can detect the infection.

For the 2022–2024 period, residual risks have been estimated at 1 in 8,900,000 donations for HIV, 1 in 2,600,000 for HBV, and 1 in 126,300,000 for HCV, which corresponds to one potentially infected and undetected donation every 3 years for HIV, every year for HBV, and every 48 years for HCV. These risks are estimates, not observed values. The last reported case of HIV transmission through blood transfusion was in 2002, so the actual risk is likely lower.

Overview of Viral Genomic Testing (VGT) in France for HIV, HCV, and HBV

Viral genomic screening (VGS) is a screening technique that reduces the duration of silent windows by identifying new infections before seroconversion (positive antibodies for HIV and HCV and positive HBs antigen for HBV). VGS for HIV and HCV has been performed on all blood donations since 2001, and VGS for HBV was rolled out nationwide in 2010.

For the 2022–2024 period, DGV helped exclude 1 donation infected with HIV, 0 donations for HCV, and 6 donations for HBV that would not have been detected by antibody testing for HIV and HCV or HBs antigen testing for HBV alone. Based on the 8 million donations collected in France during this period, the benefit of DGV is 0.13 donations detected solely through DGV per million donations for HIV, and 0.75 for HBV. In total, since the widespread implementation of DGV on all donations, 29 HIV-positive donations have been screened out, 16 HCV-positive donations, and 33 HBV-positive donations.

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Change in 2016 to the selection criteria for MSM

The selection criteria, in effect until July 10, 2016, had been established by the order of January 12, 2009. This order specifically stipulated that men who have sex with men (MSM) were permanently deferred from donating blood. This exclusion actually dated back more than 30 years, as a circular dated June 20, 1983, regarding “the prevention of potential AIDS transmission through blood transfusion” recommended that blood transfusion centers exclude from blood donation individuals belonging to populations at risk for the AIDS virus, which included homosexuals. Starting August 1, 1985, HIV screening became mandatory for every blood donation, but the circular of October 20, 1985, establishing this screening noted that it was not intended “in any way to replace the donor exclusion measures that remain in effect.”

In the 2000s, against a backdrop of significant control over the residual risk of HIV transmission through transfusion (fewer than one potentially undetectable infected donation per year in France, out of approximately 3 million donations), several organizations fighting AIDS and homophobia had been calling for several years to allow MSM to donate blood, considering that their lifelong exclusion was a “discriminatory measure” against them. This is why, in 2015, the Ministry of Health organized a broad consultation with all stakeholders to establish a deferral policy for MSM that was proportionate to the risk. This consultation also led to a review of all blood donor selection criteria.

After several months of debate, the Ministry of Social Affairs, Health, and Women’s Rights announced on November 4, 2015, a modification to the deferral policy for MSM, which was formalized in the decree of April 5, 2016, establishing the criteria for selecting blood donors: As of July 10, 2016, men who have not had sex with other men in the past 12 months may donate whole blood, and MSM who have had no more than one sexual partner in the past 4 months may donate plasma that has been made safe through quarantine. The measure regarding whole blood donation is presented as a first step, leaving open the possibility, in a second phase, of further shortening the deferral period (6 or 4 months without sexual relations with a man) or of establishing a deferral period identical to that for heterosexual donors, namely having had no more than one sexual partner in the 4 months prior to donation.

The modification of the measure concerning MSM was based on epidemiological data observed in the blood donor population in France and on an analysis of the risk of HIV transmission via transfusion in this population, which showed that the 12-month deferral for MSM did not appear to increase the residual transfusion-related HIV risk in France. Furthermore, the experience of countries that had modified the deferral policy for MSM in recent years, notably Australia and the United Kingdom, showed that this change had not impacted the risk of HIV transmission through transfusion.

Evaluation of the change in selection criteria implemented in July 2016 regarding MSM

A comparison of surveillance indicators between the two 18-month periods, before and after July 10, 2016, shows that opening blood donation to MSM had no impact on the rates of HIV-positive donations, on the distribution of donors found to be HIV-positive based on their likely mode of infection, or on the residual risk of HIV transmission through transfusion.

Since the change in the selection criteria regarding MSM had no impact on epidemiological surveillance indicators, the Minister of Health then considered further expanding blood donation eligibility to include MSM. To guide her decision, she asked Santé publique France to conduct analyses of residual HIV risk for the following two scenarios:

  1. deferral of men who have had sex with men in the 4 months prior to donation;

  2. deferring MSM who had more than one sexual partner in the 4 months prior to donation.

Regardless of the scenario studied, the residual HIV risk remained very low. In the first scenario, it was identical to that observed for a 12-month deferral of MSM, and in the second, it was significantly higher and less robust to variations in the model parameters. This risk associated with the window period was then estimated at approximately 1 HIV-infected blood donation that tested negative, every two years in France. This was an estimate and not an observation. Indeed, since 2002, no HIV transmission via blood transfusion has been reported, so the actual risk is likely lower.

Modification in 2020 of the selection criteria for MSM

In 2019, following up on the work undertaken in 2015, the monitoring committee for the blood donor selection decree worked with all stakeholders on the two scenarios under consideration, based in particular on epidemiological data and risk analyses.

In light of the available data and the opinions expressed by stakeholders, the Ministry of Solidarity and Health decided to proceed in stages. The first stage, confirmed in the decree of December 17, 2019, and implemented on April 2, 2020, allows MSM to donate blood, provided they have not had sex with another man in the past four months.

The Ministry stated that "this broader opening of blood donation to MSM will be evaluated with full transparency to enable consideration, by 2022, of the adoption of selection criteria independent of sexual orientation and identical for all donors, namely a single partner over the past four months. This final step can only be implemented provided that optimal transfusion safety is maintained."

Modification, in 2022, of the selection criteria regarding MSM

The objective of this third change was to implement selection criteria not based on the gender of the individual or their partner, while maintaining maximum transfusion safety (Article 12 of the Bioethics Bill), that is, to ask all potential donors the same questions regarding their sexual risks or those of their partner. In practical terms, this meant eliminating the 4-month deferral period for MSM and for women whose partners have had sexual relations with a man.

In the favorable context of an extremely low residual HIV risk, based on the opinion of the High Council of Public Health regarding the conditions necessary for updating selection criteria, and following discussions by the Blood Donor Selection Monitoring Committee, in which all stakeholders participated, the Minister of Solidarity and Health announced the lifting of the deferral for men who have sex with men effective March 16, 2022. As of that date, donor selection criteria will therefore be identical regardless of the donor’s sexual orientation. Thus, the deferral criterion of “having had sexual intercourse with more than one partner in the four months prior to donation” now also applies to MSM.

There is not yet sufficient hindsight to assess the impact of the removal of the MSM deferral criterion in March 2022; however, the evaluation of the April 2020 change showed that reducing the deferral period for MSM from 12 to 4 months had no negative impact on blood donor surveillance indicators. The residual risk of HIV transmission through transfusion, which was 1 in 7.8 million donations over the 2.5-year period prior to the second amendment (October 1, 2017 – April 1, 2020), was estimated at 1 in 10.5 million donations over the 2.5-year period following the second amendment (April 2, 2020 to September 30, 2022), or one donation potentially infected with HIV every 4 years.

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For other infectious agents, particularly those that can cause acute infections not routinely screened for—such as hepatitis A, parvovirus B19, toxoplasmosis, dengue, leptospirosis, chikungunya, or West Nile virus, the transfusion risk had not been documented until about fifteen years ago. A project aimed at providing a priori quantitative estimates of the risk of blood donation contamination by infectious agents for various scenarios, in terms of incidence and spatiotemporal distribution, was conducted between 2005 and 2007 by a working group comprising the French Health Products Safety Agency (Afssaps), the French Blood Establishment (EFS), the National Institute of Blood Transfusion (INTS), and Santé publique France. This study made it possible to compile all the available data necessary to estimate the probability of contamination of a donation during epidemic periods, to identify methods for estimating this risk, and to test these methods. This study also made it possible to anticipate epidemic situations and facilitate risk assessment during emergencies, such as during the 2005 chikungunya epidemic or the 2016 Zika epidemic.

Estimating the risk of contamination in a blood donation for certain infectious agents

Zika virus

The Zika virus, transmitted primarily by mosquitoes, can also be transmitted—albeit much more rarely—through sexual contact, from mother to fetus, and most likely through blood transfusion. Measures have been implemented to prevent this transfusion-related transmission. During the 2016 epidemic in Latin America, blood donations collected in Guadeloupe and Martinique were systematically screened for this virus (RNA testing). In mainland France, potential donors returning from an epidemic area are excluded for a period of 28 days after their return. However, this exclusion measure does not cover the risk associated with a donor who has not traveled to a region where the epidemic is raging but who may have contracted the virus through sexual contact with a male partner returning from an affected area.

In May 2016, in the context of the Zika epidemic, Santé publique France conducted a risk assessment, which showed that the risk of a blood donation being infected with the Zika virus in mainland France, following sexual transmission linked to travelers returning from an area affected by the virus (South America, Central America, and the Caribbean), was very low. Furthermore, the risk that such a donation would be used for a transfusion in a pregnant woman would be even lower. If we limit the analysis to blood donations used for transfusions during pregnancy outside the period of childbirth, this risk would be one donation infected with the Zika virus every 90 to 2,100 years.

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Chikungunya

The risk estimation method was applied in real time during the epidemic that occurred in Réunion in 2005–2006. Estimates of the risk of a blood donation being contaminated with the chikungunya virus were thus carried out as early as late January 2006, coinciding with the suspension of whole blood collection by the EFS in Réunion, at a time when the epidemic was peaking with an estimated weekly incidence of between 15,000 and 45,000 cases. These estimates were subsequently refined using consolidated incidence data and new insights into parameters acquired during the epidemic. At the epidemic peak in February 2006, the risk of contamination in a donation was estimated at 1,500 per 100,000 donations. Thus, the suspension of collection prevented 40 potentially contaminated donations. These estimates were supported by the results of viral genomic screening on platelet donations, which continued during the outbreak.

For other agents, the parameters necessary for risk estimation and incidence scenarios were documented based on available data. However, data on the frequency and duration of asymptomatic viremia are, to date, insufficient to allow for estimates.

West Nile Virus

During the cluster of cases that occurred in the Var region in 2003, the average risk of a donation being contaminated with West Nile virus was estimated at 6 per 100,000 donations. This estimation method was validated for this virus in the United States by comparing the estimates with direct measurements of viral genomes in blood donations.

Parvovirus B19

The risk of a blood donation being contaminated with Parvovirus B19 could be estimated directly based on viral genomic screening of plasma intended for fractionation. Over a 10-year period, this risk was 12 viremic donations per 100,000 donations. During an epidemic period from February to September 2005, this risk reached 23 viremic donations per 100,000 donations.

Hepatitis A

The risk of a blood donation being contaminated with the hepatitis A virus was estimated based on an outbreak of acute hepatitis A that occurred between December 1996 and July 1997 in the Midi-Pyrénées region. It was estimated at approximately 5 per 100,000 donations. However, this risk is likely underestimated due to the incomplete case identification during the investigation of the outbreak.

Leptospirosis

The risk of contamination of a donation by leptospirosis is low in both endemic and epidemic situations; depending on the epidemic episodes considered, it is estimated to be between 0.02 and 0.08 per 100,000 donations or between 0.1 and 0.9 per 100,000 donations.

Chagas disease

In French Guiana, the risk of a donation being contaminated with T. cruzi, the parasite responsible for Chagas disease, was estimated at 250 per 100,000 donations. Due to this risk, blood collections have been suspended in French Guiana since April 2005. In mainland France and the French West Indies, the risk was estimated based on the prevalence of this infection among people born in or who have lived in Latin America, or whose mother was born in Latin America, and on estimates of the number of blood donors belonging to these groups at risk of infection. The risk of T. cruzi contamination in a donation was estimated at 0.68 per 100,000 donations in mainland France and 3.28 per 100,000 donations in the French West Indies, corresponding to 17 donations and fewer than one at-risk donation per year, respectively. Since 2005, individuals who have spent more than three months in Latin America have been temporarily excluded from donating, which has reduced this risk. Additionally, serological screening of at-risk groups was implemented in November 2006 for blood drives in the French West Indies and in May 2007 for blood drives in mainland France.

Dengue

During the 2001 epidemic in Martinique, the risk of a blood donation being contaminated with dengue increased 24-fold compared to the pre-epidemic period. The absolute risk during this epidemic episode was estimated at between 58 and 649 contaminated donations per 100,000 donations, based on assumptions regarding the proportion of asymptomatic cases. These very high estimates must be weighed against the absence of documented cases of transfusion-transmitted dengue to date by hemovigilance in France and the small number of post-transfusion cases described in the literature. This underscores the importance of studying transmission efficiency, which is a very important parameter of transfusion risk.

Learn more:

  • Pillonel J, Gallian P, Sommen C, Couturier E, Piquet Y, Djoudi R, Laperche S for the steering committee on epidemiological surveillance of blood donors. Estimation of an emerging transfusion risk: the example of HEV. Transfus Clin Biol. 2014 Nov;21(4-5):162-6.

  • Brouard C, de Valk H, Pillonel J for the Afssaps, EFS, INTS, InVS working group. Quantitative estimation of the risk of contamination of a blood donation by infectious agents. Saint-Maurice: Institut de veille sanitaire, 2007, 79 p.

  • Gallian P, Corbi C, Coste J, Pouchol E, Legrand D, Courbil R, Tiberghien P. Risks associated with transmissible agents not subject to systematic screening in blood transfusion. Bull Epidémiol Hebd. 2012;(39-40):452-55.

  • Pillonel J, Brouard C, Laperche S, Barin F, Bernillon P, De Valk H, and the Afssaps, EFS, INTS, and InVS working group. Quantitative estimation of the risk of blood donation contamination by infectious agents. Transfus Clin Biol. 2009 May;16:138-45.

  • El Ghouzzi MH, Boiret E, Wind F, Brochard C, Fittere S, Paris L, Mazier D, Sansonetti N, Bierling P. Testing blood donors for Chagas disease in the Paris area, France: first results after 18 months of screening. Transfusion. 2010 Mar;50(3):575-83.

  • Assal A, Corbi C. Chagas disease and blood transfusion: an emerging parasitic problem in non-endemic countries. Transf Clin Biol. 2011;18:286-91.

  • Jeannel D, Noireau F, Chaud P. Emergence of Chagas disease in French Guiana. Assessment in 2005 and outlook. Saint-Maurice: Institute for Health Surveillance, 2007, 79 p.

  • Brouard C, Bernillon P, Quatresous I, Pillonel J, Assal A, De Valk H, Desenclos JC; workgroup "Quantitative Estimation of the Risk of Blood Donation Contamination by Infectious Agents". Estimated risk of Chikungunya viremic blood donation during an epidemic on Reunion Island in the Indian Ocean, 2005 to 2007. Transfusion. July 2008;48(7):1333-41.

  • Brouard C, Bernillon P, Quatresous I, Pillonel J, Assal A, De Valk H, Desenclos JC for the working group "Quantitative Estimation of the Risk of Blood Donation Contamination by Infectious Agents". Quantitative estimation of the risk of Chikungunya contamination of a blood donation during the epidemic that occurred in Réunion, France, in 2005–2007. Bull Epidémiol Hebd. 2008;(18):149–52.

In relation to

VIH/sida

HIV/AIDS

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HIV, or Human Immunodeficiency Virus, is a sexually transmitted human retrovirus. It weakens the immune system, and if left untreated, leads to AIDS.

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Hepatitis B and D

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Hépatite C

Hepatitis C

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