KING OF PRUSSIA, PA-Aventis Behring recently presented information to the Food and Drug Administration (FDA) about its ongoing investigation regarding the use of proprietary polymerase chain reaction (PCR) technology to screen for the presence of certain viruses in plasma. PCR screening, a form of nucleic acid testing (NAT), can detect very low levels of a material and, therefore, may enable the detection of viruses at an earlier stage than traditional screening methods such as serology tests. Aventis Behring's data indicates PCR screening may be effective in identifying the hepatitis B virus in plasma that has passed undetected in previous serology tests that screen for hepatitis B surface antigen. In an analysis of 3,250,000 plasma samples that received negative results for hepatitis B surface antigen, researchers used their PCR technology and found that 62 samples from 42 donors contained the virus.
Many manufacturers of plasma products are using NAT as a part of their screening process. Though still investigational, the process is considered another step in an ongoing safety conscious field. Aventis Behring is committed to PCR screening and only manufactures products from plasma that has been screened for HIV-1; hepatitis A, B, and C; and parvovirus B19.