The COMPLIDON Study
Survey of Blood Donors
Following the revision of blood donor selection criteria on July 10, 2016, the Directorate General for Health sought to implement enhanced monitoring: in addition to epidemiological surveillance of blood donors, Santé publique France was commissioned to conduct a survey of donors.
Background
The viral safety of blood products relies primarily on the systematic screening of each blood donation for biological markers of several infections related to HIV, HCV, HTLV, and syphilis. However, there is a delay of several days between infection and the point at which markers of the infection become detectable by available biological tests. This “silent window” constitutes the primary component of residual transfusion risk.
The selection of blood donors is therefore a critical component of blood product safety. This is why, before donating blood, prospective donors must complete a questionnaire and then undergo a pre-donation interview. These two steps determine whether or not candidates are eligible to donate blood, based on criteria defined in a ministerial decree.
The decree of April 5, 2016, which took effect on July 10, 2016, revised the criteria for selecting blood donors. In particular, it allowed men who have sex with men (MSM) to donate blood under certain conditions: for whole blood donation, not having had sex with another man in the past 12 months; for quarantined plasma donation, not having had more than one sexual partner in the past 4 months.
Who participated and how?
The Complidon survey was conducted by Santé publique France, in partnership with the French Blood Establishment (EFS) and the Armed Forces Blood Transfusion Center (CTSA).
Anyone who donated blood, platelets, or plasma to the EFS or the CTSA between September and December 2017, who made a therapeutic donation that tested negative for all infectious markers (HIV, HCV, HBV, HTLV, syphilis), and who had an email address was invited via email to participate in the study.
The questionnaire, available online, was anonymous and consisted of approximately fifty questions covering the respondents’ profiles, the circumstances of their last donation, their perceptions of the questionnaire and the pre-donation interview, their health status, drug use, sexual behavior, travel history, and their knowledge of the selection criteria and screening tests performed on each blood donation.
To produce results representative of all donors who donated between July 10, 2016 (the date the order took effect) and December 2017, the data collected in the survey were adjusted to reflect the characteristics of blood donors who donated during this period: gender, age group, region of residence, donor type (first-time/repeat), and collection type (fixed/mobile).
Study Results
A total of 420,190 donors who donated blood, plasma, or platelets between September and December 2017 were contacted by email; of these, 108,386 completed the questionnaire, representing a response rate of 26%.
Exclusion criteria not reported at the time of the last blood donation
Among all blood donors, 3.6% did not report, at the time of their last blood donation, at least one exclusion criterion related to a risk of transmission of an infectious agent through sexual contact, drug use, or tattooing/piercing:
during the 4 months prior to the donation:
having had more than one sexual partner,
having had a partner who themselves had more than one sexual partner,
having had a sexually transmitted infection (STI),
having had a tattoo or piercing;
in the 12 months prior to donation:
having had a partner who has injected drugs or performance-enhancing substances without a prescription,
having had sex in exchange for money or drugs,
having had a partner who has had sex in exchange for money or drugs,
having had a partner who is HIV-positive,
for men: having had sex with other men,
for women: having had a partner who has had sex with men;
at some point in life: having injected drugs or performance-enhancing substances without a prescription.
Regarding travel-related criteria, 1.2% of donors reported meeting one of the following:
having stayed in the United Kingdom for a cumulative total of more than one year between January 1980 and December 1996;
having a confirmed history of malaria within the past 3 years;
having traveled in the past 4 months:
to a country requiring preventive treatment against malaria
to Central or South America.
In addition, 0.69% of donors reported having received a blood transfusion at some point in their lives, a criterion that results in permanent exclusion.
Among all these situations associated with a risk of transmitting an infectious agent, the most frequently reported involved the donor having multiple sexual partners in the 4 months prior to donation (in 1.9% of cases) or their partner having multiple sexual partners (1.0%). Next were reporting a blood transfusion at some point in their lives (0.69%), travel to a malaria-risk country in the past 4 months (0.64%), a tattoo or piercing in the past 4 months (0.44%), injecting drug use in their lifetime (0.29%), and an STI in the past 4 months (0.15%).
Among men, 0.73% reported having had sex with men in the 12 months prior to donation.
REFERENCES:
Decree of April 5, 2016 establishing the selection criteria for blood donors
Learn more
Sauvage C, Spinardi R, Pelat C, Pouget T, Danic B, Woimant G, Lot F, Gross S, Laperche S, Pillonel J; Steering Committee. Noncompliance with blood donor selection criteria - Complidon 2017, France. Transfusion. 2020 Jan;60(1):73-83.
Sauvage C, Spinardi R, Pelat C, Pouget T, Danic B, Woimant G, Lot F, Gross S, Laperche S, Pillonel J; Steering Committee. Non-compliance with blood donor selection criteria – Complidon 2017, France. Bull Epidémiol Hebd 2020 No. 8-9