FDA Draft Guidance on NAT tests to reduce the risks of HBV transmission from cells and tissues

In January 2016 the Food and Drug Administration, Center for Biologics Evaluation and Research (CBER) published a Draft Guidance for Industry with the title "Use of Nucleic Acid Tests to Reduce the Risk of Transmission of Hepatitis B Virus from Donors of Human Cells, Tissues, and Cellular and Tissue-Based Products".

Related to 21 CFR 1271, screening and testing of HBV is required to adequately and appropriately reduce the risk of transmission of Hepatitis B Virus by Human Cells, Tissues, and Cellular and Tissue-Based Products. Since 2007 the  "Donor Eligibility Guidance" recommends that HCT/P donors be tested for HBsAg and total anti-HBc (IgG and IgM) (Ref. 1). The guidance also indicated that the FDA recommendations on specific tests may change in the future due to technological advances or evolving scientific knowledge.

The present draft provides establishments that make donor eligibility determinations for donors of human cells, tissues, and cellular and tissue-based products (HCT/Ps), with recommendations concerning the use of FDA-licensed nucleic acid tests (NAT) in donor testing for hepatitis B virus (HBV) desoxyribonucleic acid (DNA). Related to the potency of NAT test to detect an infection at an earlier stage than the hepatitis B surface antigen (HBsAg) and total antibody to hepatitis B core antigen (anti-HBc tests), the FDA recommends the use of FDA-licensed HBV NAT for testing donors of HCT/Ps for evidence of infection with HBV. In addition licensed HBsAg and total anti-HBc Immunoglobulin G (IgG) and Immunoglobulin M (IgM) should be used.

The guideline has the following table of contents:

  • Introduction
  • Background
    A. HBV Epidemiology and Public Health Impact
    B. Rationale for HCT/P Donor Testing Using HBV NAT
  • Recommendations
  • Implementation
  • References

The draft guidance, when finalized, will supplement previous recommendations from FDA to HCT/P establishments concerning donor testing for HBsAg and total anti-HBc, in the document entitled “Guidance for Industry: Eligibility Determination for Donors of Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps)” dated August 2007 (2007 Donor Eligibility Guidance).

For more details pelase read the complete draft guidance "Use of Nucleic Acid Tests to Reduce the Risk of Transmission of Hepatitis B Virus from Donors of Human Cells, Tissues, and Cellular and Tissue-Based Products"

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