Plasma donation involves collecting blood, separating the plasma component, and returning the remaining blood cells to the donor. This collected plasma is used to manufacture life-saving therapies for various complex diseases, such as immune deficiencies and bleeding disorders. Because these medications treat vulnerable patients, the donation process is subject to stringent safety standards. Hepatitis C Virus (HCV) is a bloodborne pathogen that causes liver inflammation, and its presence poses a direct risk to the public health supply.
Hepatitis C and Permanent Donor Deferral
Individuals who have ever tested positive for Hepatitis C (HCV) are subject to permanent donor deferral for both plasma and whole blood in the United States and most other highly regulated countries. This lifetime deferral is mandated regardless of the donor’s current health status or if they received successful treatment. This policy makes no exception for individuals who have achieved a sustained virologic response (SVR), often described as a “cure” for the infection. The regulatory standard requires this indefinite deferral to maintain the safety and integrity of the source plasma supply.
Why HCV Infection Leads to Exclusion
The strict exclusionary rule exists because HCV is highly transmissible through blood-to-blood contact. Plasma is often pooled from thousands of individual donors to create a single batch of medicine, meaning a contaminated donation could potentially affect numerous patients. This pooling necessitates a zero-tolerance policy for known carriers of bloodborne viruses.
A primary biological reason for permanent exclusion is the persistence of antibodies in the blood long after the virus has been cleared. Even a successfully treated person remains positive for the Hepatitis C antibody (anti-HCV) for the rest of their life. Since antibody testing is a standard screening measure, a positive result permanently flags the donor, making their plasma unusable. The deferral also safeguards against the risk of a false-negative test result during the “window period,” which is the time between initial infection and reliable detection by screening tests.
Donor Screening and Testing Protocols
To enforce safety standards, plasma centers employ a two-part screening process for every potential donor. The first step involves a comprehensive health history questionnaire and interview. Individuals must self-report any past diagnosis of Hepatitis C or high-risk behaviors that could lead to infection.
The second step is mandatory laboratory testing on a sample collected at every donation visit. This testing includes a serological assay, which looks for the presence of antibodies to HCV (anti-HCV), indicating past or current exposure. The sample also undergoes Nucleic Acid Testing (NAT), a highly sensitive molecular method that directly detects the genetic material (RNA) of the Hepatitis C virus itself. Any positive result from either the antibody or NAT screening triggers a permanent deferral, and the donor is notified of the finding.