Plasma Nucleic Acid Testing Deemed Suitable for Hepatitis C Screening


A recent FDA study determined that current nucleic acid testing (NAT) of the plasma of donated blood is adequate for the detection of the hepatitis C virus (HCV).

Testing the plasma alone of potential blood donors using a NAT test was found to be an adequate method of screening for HCV, according to a recent study conducted by the FDA.

NAT, also known as a nucleic acid amplification test, is a biochemical technique that detects the genetic material of an infectious organism or virus in an assay. These tests were developed to shorten the time between when a patient has been infected and when they show up as positive by antibody tests. The NAT test detects the HCV virus within about a week after infection, whereas the test that detects antibodies against HCV takes about 7 weeks.

The FDA study compared the detectable HCV genetic material in whole blood, plasma, and red blood cells to evaluate whether testing the plasma alone would be sufficient to detect HCV in infected donations. Plasma is currently used by the FDA as a testing source for genetic evidence of HCV infection.

According to a press release from the regulatory agency, “The FDA study shows that testing cellular components of blood does not increase sensitivity of HCV detection in infected donors.” Based on this evidence, FDA researches determined that it is not necessary to test whole blood or blood components when using NAT.

Gene-based testing of individual donations has the potential to improve blood safety significantly and decrease the window of transmission of hepatitis C.

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