Printable Update for Insertion Into Standards D4.354

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CHANGES TO AATB STANDARDS FOR TISSUE BANKING

SECTION D - ACQUISITION OF TISSUE: CONSENT, DONOR SCREENING, AND TISSUE RECOVERY AND COLLECTION

D4.000 DONOR SUITABILITY

D4.300 Disease Screening

D4.354 Required Infectious Disease Tests

Excluding autologous tissue, oocytes and embryos, all human tissue intended for transplantation shall be from donors who are tested and found to be negative for:
1) antibodies to the human immunodeficiency virus, type 1 and type 2 (anti-HIV-1 and anti-HIV-2);

2) nucleic acid test (NAT) for HIV-1;

3) hepatitis B surface antigen (HBsAg);

4) total antibodies to hepatitis B core antigen (anti-HBc—total, meaning IgG and IgM);

5) antibodies to the hepatitis C virus (anti-HCV);

6) nucleic acid test (NAT) for HCV; and

7) antibodies to human T-lymphotropic virus type I and type II (anti-HTLV-I and anti-HTLV-II); and

87) syphilis (a non-treponemal or treponemal-specific assay may be performed).

Donors of viable leukocyte-rich tissue (e.g., semen) shall also be tested and found to be negative for antibodies to human T-lymphotropic virus type I and type II (anti-HTLV-I and anti-HTLV-II).  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.

All test results shall be documented in the donor’s record.

(R) In addition to the infectious disease tests listed above, all anonymous and directed Semen and Oocyte Donors shall undergo testing for Neisseria gonorrhea and Chlamydia trachomatis. The manufacturer’s requirements for specimens must be met. If the reproductive tissue is procured by a method that ensures freedom from contamination of the tissue by infectious disease organisms that may be present in the genitourinary tract, then these tests are not required.

All anonymous and directed Semen Donors shall also be tested for total antibody to cytomegalovirus (anti-CMV—total, meaning IgG and IgM).

All anonymous and directed Oocyte Donors shall be tested for all above listed tests, excluding antibodies to human T-lymphotropic virus type I and type II (anti-HTLV-I and anti-HTLV-II) and total antibody to cytomegalovirus (anti-CMV).

Required tests for anonymous and directed embryo donors are listed in D4.360 Repeat Testing of Living Donors.

Client Depositors who deposit Semen, testicular fluid or tissues, oocytes, or ovarian tissue, or embryos, shall be tested prior to use for:

1) antibodies to the human immunodeficiency virus, type 1 and type 2 (anti-HIV-1 and anti-HIV-2);

2) hepatitis B surface antigen (HBsAg); and

3) antibodies to hepatitis C virus (anti-HCV).

All Oocyte Donors must undergo required testing within 30 days prior to egg retrieval, or within 7 days post donation. Samples for infectious disease testing of anonymous and directed Semen Donors must be obtained within 7 days of initial Semen Collection.

Published date: November 11, 2009 (AATB News Release)
Effective date: At the discretion of the Tissue Bank