Plasma donation, a process called plasmapheresis, is a medical procedure where blood is drawn, the plasma is separated, and the remaining blood components are returned to the donor. This collected plasma is then used to create life-saving therapies, such as immunoglobulins and clotting factors. Individuals with an active Hepatitis C virus (HCV) infection are permanently ineligible to donate plasma due to strict safety regulations.
Eligibility Rules for Hepatitis C Status
Regulatory bodies, including the U.S. Food and Drug Administration (FDA), impose rigorous requirements for donor suitability to protect the blood supply. The regulations specify that any individual with clinical evidence of a relevant transfusion-transmitted infection, which includes HCV, must be indefinitely deferred from donating source plasma. This permanent deferral applies not only to those with an active infection but also to those with a history of HCV infection.
Even if an individual has been successfully treated and achieved a sustained virologic response (SVR)—meaning the virus is undetectable in their blood—they are still typically deferred from donating source plasma. This policy exists because the body may still carry Hepatitis C antibodies, which indicate past exposure, and the presence of these antibodies is generally sufficient for permanent deferral under current source plasma rules.
Why HCV Transmission is a Major Concern
The strict deferral rules are rooted in the nature of the Hepatitis C virus, which is a bloodborne pathogen capable of surviving in plasma. HCV infection can lead to chronic liver disease, cirrhosis, and liver cancer, making its transmission a serious public health risk. Plasma donations are frequently pooled from many donors to create large batches for the manufacturing of medicinal products, which intensifies the need for absolute safety.
If a single unit of infected plasma were to enter this manufacturing process, it could potentially contaminate a large volume of the final therapeutic product. Although the manufacturing process includes steps for viral inactivation and removal, the initial safety layer is preventing HCV-positive plasma from entering the supply chain at all. The concern is heightened by the existence of a “window period” early in an infection where the virus is present in the bloodstream.
During this window period, a donor could unknowingly transmit the virus, and the standard antibody tests may return a false negative result. Even a very low residual risk of transmission is unacceptable, especially for products given to immunocompromised patients who rely on these therapies. The extreme caution exercised by plasma centers ensures the global supply of plasma-derived medicines remains safe from viral contamination.
Donor Screening and Deferral Process
Plasma collection centers implement a multi-layered screening process to identify and exclude donors who may pose a risk of infection. Before every donation, prospective donors must complete a detailed health and medical history questionnaire that specifically asks about past and present infections, including Hepatitis C. This initial step is designed to identify and exclude high-risk individuals and those with a known history of the virus.
The physical screening is followed by mandatory laboratory testing on every donation using sophisticated techniques like Nucleic Acid Testing (NAT) to detect the presence of the Hepatitis C viral RNA directly. NAT is highly sensitive and helps to close the previously mentioned “window period” significantly by detecting the virus just days after infection. If any of the screening tests for HCV return a reactive result, the donor is immediately entered into a permanent donor deferral registry.
Any collected plasma unit that tests positive is quarantined and destroyed to prevent its use in manufacturing. The donor is also notified of the reactive test result, advised that they are permanently deferred from future donations, and encouraged to seek medical follow-up for a formal diagnosis. This comprehensive process of medical history review, advanced laboratory testing, and permanent deferral ensures that the plasma supply remains protected from the risks associated with transfusion-transmitted infections.