Magazine article Drug Topics

New Screening Ensures Safety of Blood Products

Magazine article Drug Topics

New Screening Ensures Safety of Blood Products

Article excerpt

Each year, approximately 14 million units of whole blood are collected from about eight million volunteer donors. This blood is used to make components that are transfused directly into the more than 3.5 million Americans whose health depends on plasmaderived products.

In the 1980s, the discovery of viral transmission by these plasmaderived products sent panic through the blood-recipient public, as well as through the pharmaceutical industry. In 1987, for instance, an estimated 12,000 patients were infected with HIV through transfusion of contaminated blood products. In San Francisco alone, an estimated 2,135 transfusion recipients were infected with HIV during the seven years before HIV antibody testing of blood donations began in 1985.

While the fear persists today, new measures recently introduced to screen blood products for HIV and other key viruses may dilute some of the concern. In March, the Food & Drug Administration heard testimony from Aventis Behring, King of Prussia, Pa., about polymerase chain reaction (PCR) screening, one of the latest advancements to help ensure blood product safety. The first U.S. company to screen plasma for the five most feared viruses (HIV, hepatitis A, hepatitis B, hepatitis C, and parvovirus B29), Aventis Behring was asked by the FDA to present data about its use of investigational PCR screening. PCR screening tests blood for the actual presence of virus as opposed to traditional screening methods, which test merely for the body's response to virus.

PCR screening is a form of nucleic acid testing (NAT) designed to detect extremely low levels of viruses by testing for the presence of viral genetic material (DNA and RNA). It is believed to enable detection of viruses at an earlier stage than traditional screening methods (e.g., serology). Serology screening detects either virus proteins or antibodies to virus proteins (the body's response to viral presence). The data presented by Aventis Behring indicate that PCR screening may be valuable irt identifying the presence of hepatitis B (HBV) virus in plasma that had already cleared serology tests that screen for HBV surface antigen.

Knowledge of the techniques used to determine the safety of plasma products is important for pharmacists who dispense these therapies to patients. "Anything we can do to ensure the safety of the products we provide our patients is something we want to pursue," said Jeff Binkley, Pharm. …

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