Plasma Testing

Samples from each unit of plasma collected are shipped to one of CSL Plasma’s state-of-the-art testing laboratories. CSL Plasma uses highly sensitive laboratory tests to check each sample for suitability and for the presence of viruses and other pathogens prior to use in manufacturing. Any unit that fails testing is appropriately destroyed, and the donor is permanently deferred.

Each plasma donation is tested for viral markers before being approved for manufacturing. These tests include:

• Serology Tests
• Nucleic Acid Amplification Technology and Polymerase Chain Reaction Tests (NAT/PCR)
• Licensed tests, proficiency tests and validated NAT/PCR assays ensure accuracy

Serology Testing

* For these antigens, a positive test is desired in order to manufacture high quality immunoglobulins / hyperimmunoglobulins

NAT/PCR Testing

Nucleic acid Amplification Technology (NAT) testing allows certain viruses to be detected even before a donor displays any symptoms or develops antibiodies. This very sensitive screening has the ability to detect viruses far earlier than serological testing, vastly reducing the chance that a window period donation can enter the manufacturing pool. NAT detects the genetic material of a transfusion-transmitted virus like HIV without waiting for the body to form antibodies, potentially offering an important time advantage over current techniques.

Polymerase chain reaction (PCR) is a type of NAT. It is a technique used to amplify specific regions of a DNA or RNA strand via enzymatic replication, without using a living organism (such as E. coli or yeast).

CSL Behring was the first company to conduct NAT/PCR testing of source plasma for these five viruses. Inventory hold ensures that units testing positive during the window period are destroyed.