Food and Drug Administration - November 12, 2004
Richard Klein

The Food and Drug Administration (FDA) has issued final guidance on the "Use of Nucleic Acid Tests on Pooled and Individual Samples from Donors of Whole Blood and Blood Components (including Source Plasma and Source Leukocytes) to Adequately and Appropriately Reduce the Risk of Transmission of HIV-1 and HCV."

FDA's blood testing rules require establishments that collect blood and blood components (e.g. Whole Blood and Blood Components, including Source Plasma and Source Leukocytes), to test each donation of human blood or blood component intended for use in preparing a blood product for evidence of infection due to specific communicable disease agents. The purpose is to reduce the risk of transfusion-transmitted transmission of communicable disease.

The purpose of this guidance is to inform blood collecting and processing establishments that:

1. FDA has licensed nucleic acid tests (NAT) as tests to screen blood donors for HIV-1 ribonucleic acid (RNA), and HCV RNA; and

2. These licensed tests can detect evidence of infection at a significantly earlier stage than is possible under previously approved tests using antibody or antigen detection technology; including the HIV-1 p24 antigen test.

Nucleic Acid Testing, or NAT, is a nucleic acid amplification technology that includes polymer chain reaction, or PCR, to detect certain viral components. NAT enables the earliest and most sensitive detection of disease-causing human viruses in blood and plasma donations.

A recently infected person would have virus particles in the blood stream. Although the blood or plasma could be infectious, the infection may not be detected using current antibody tests because the person may not yet have developed antibodies. This time frame before measurable antibody production is called the "window period." Over time, the person would make enough antibodies for the antibody test to be effective. However, because NAT can detect RNA or DNA from a very small number of virus particles, it can reduce the window period by detecting the infection earlier.

This guidance combines and finalizes the draft guidance "Use of Nucleic Acid Tests on Pooled Samples from Source Plasma Donors to Adequately and Appropriately Reduce the Risk of Transmission of HIV-1 and HCV" ( /files/fda/2004/1102_gdl0001[1].pdf )dated December 2001 (January 31, 2002, 67 FR 4719) and the draft guidance "Use of Nucleic Acid Tests on Pooled and Individual Samples from Donors of Whole Blood and Blood Components for Transfusion to Adequately and Appropriately Reduce the Risk of Transmission of HIV-1 and HCV" ( /files/fda/2004/1102_040902c[1].pdf )dated March 2002 (April 9, 2002, 67 FR 17077).

The complete final guidance document can be found on the FDA website at http://www.fda.gov/cber/gdlns/hivhcvnatbld.htm

Richard Klein

HIV/AIDS Program Director

Office of Special Health Issues

Food and Drug Administration
041112
FD041102

SOURCE: Food and Drug Administration (FDA).

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