HTLV Testing - Changes to Standards
AATB News Release
November 11, 2009
The Board of Governors has approved changes to AATB's Standards for Tissue Banking to remove the requirement to test tissue donors for antibodies to human T-lymphotropic virus type I and type II (anti-HTLV-I and anti-HTLV-II).
These changes were recommended by the Physicians' Council and by the Standards Committee. These groups evaluated relevant, scientific literature as well as current state, federal, and international requirements for screening and testing tissue donors for HTLV-I and HTLV-II.
Because of administrative and operational considerations, there is no requirement to implement these changes by a specific date. They can be made at the discretion of the Tissue Bank at any time.
The changes are summarized as follows:
- Standard D4.354 Required Infectious Disease Tests is modified to delete the requirement to test all tissue donors for antibodies to human T-lymphotropic virus type I and type II (anti-HTLV-I and anti-HTLV-II). However, donors of viable leukocyte-rich tissue (e.g., semen) must continue to be tested and found to be negative for anti-HTLV-I and anti-HTLV-II to be considered suitable for release for transplantation. Note: HTLV testing of donors of other tissue types may be required by law and/or regulation, including, where applicable, foreign laws and/or regulations.
- Standard D4.355 Interpretation of Infectious Disease Test Results no longer requires that human tissue shall be determined not suitable for transplantation if from a donor whose specimen has tested repeatedly reactive on an FDA-licensed, approved, or cleared donor screening test for anti-HTLV-I or anti-HTLV-II. However, viable leukocyte-rich tissue (e.g., semen) will continue to be determined not to be suitable for transplantation if from a donor whose specimen has tested repeatedly reactive (RR) on an FDA-licensed, approved, or cleared donor screening test for anti-HTLV-I or anti-HTLV-II. The suitability of other human tissue for transplantation from donors whose specimens test RR for anti-HTLV-I or anti-HTLV-II shall be determined by the Medical Director. Note: Law and/or regulation, including, where applicable, foreign laws and/or regulations, may differ with regard to a RR HTLV antibody test result and how this impacts the suitability of the donor's tissues for transplantation.
- Standard G3.210 Summary of Records Content is amended to require that if a test for anti-HTLV I and/or anti-HTLV II was performed it must be reported.
- An addition to a separate part of Standard D4.355 Interpretation of Infectious Disease Test Results clarifies intent (this is not specific to HTLV testing). If a laboratory that performs organ donor testing performs the initial testing in duplicate or triplicate, the Tissue Bank must obtain and review the results of all individual tests performed. If any one of those initial tests is reactive or positive, the tissue is determined not suitable for transplantation.
When implementing these changes, operational issues to consider can include but are not limited to:
- Some tissue in released/distributable inventory will be from donors who have been tested for anti-HTLV-I and anti-HTLV-II, and some will not. The appropriate package insert/summary of records must accompany distributed tissue.
- Some tissue in released/distributable inventory will be from donors who have been tested for anti-HTLV-I and anti-HTLV-II, and the test results may be RR. If an HTLV test was performed, the result is required to be reported in the summary of records.
- Tissue Bank policies and/or procedures should characterize tissue handled or processed by describing them as "viable, leukocyte-rich" or not.
- State and foreign requirements related to HTLV testing and test results differ and can affect selection of tissue for distribution. Refer to regulatory review documents (regulatory comparison table) at these links:
HTLV Requirement Comparison Table
HTLV Testing - Regulatory Review Document
Note: The AATB Executive Office will soon be contacting state and foreign authorities to inform them of these changes to AATB's Standards and to promote harmonization with the Food and Drug Administration's requirements for human cells, tissues, and cellular and tissue-based products at: § 1271.3( r)(ii); § 1271.75(b); § 1271.85(b)(1)(i)(ii); and appropriate parts of the Final Guidance for Industry: Eligibility Determination for Donors of Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps), dated August 2007.
If you have any questions, please contact Scott Brubaker at the Executive Office.