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Standards for Histocompatibility Testing
(4/98) Copyright © 1995 - 2002 American Society for Histocompatibility and Immunogenetics. All rights reserved.

Section I - Renal Transplantation

I1.000 If cadaver donor transplants are done, personnel for the required histocompatibility testing must be available 24 hours a day, seven days a week.

I2.100 Laboratories must have a documented policy in place to evaluate the extent of sensitization of each patient at the time of their initial evaluation. (This could include testing for autoantibody, DTT reducible antibody, etc.)

I2.110 Laboratories must have a program to periodically screen serum samples from each patient for antibody to HLA antigens. Samples must be collected monthly. The laboratory must have a documented policy establishing the frequency of screening serum samples and must have data to support this policy.

I2.120 Laboratories should maintain a record of potentially sensitizing events for each patient. Serum samples should be collected and stored after each of these events for possible subsequent screening for antibody to HLA antigens and/or use in crossmatch tests.

I2.200 Antibodies of defined HLA specificity should be identified and reported.

I2.300 Studies should be performed to distinguish antibodies to HLA antigens from antibodies with other specificities.

I3.000 Crossmatching.

I3.100 Crossmatching must be performed prospectively.

I3.200 Techniques

I3.210 Crossmatching must use techniques documented to have increased sensitivity in comparison with the standard complement-dependent, basic microlymphocytotoxicity test.

I3.220 Lymphocytotoxic or flow cytometry crossmatches must be performed with potential donor T lymphocytes and should be performed with B lymphocytes.

I3.300 Samples

I3.310 Sera must be tested at a dilution that is optimal for each assay. For lymphocytotoxicity crossmatches, sera must be tested undiluted and should be tested at one or more dilutions.

I3.320 Sera obtained 14 days after a potentially sensitizing event should be included in a final crossmatch.

I3.400 Serum samples used for crossmatching should be retained in the frozen state for at least 12 months following transplantation.

I4.000 HLA Typing

I4.100 Prospective typing of donor and recipient for HLA-A, B, and DR antigens is mandatory.

I4.200 Typing donor and recipient for HLA-C, DQ, DP and D antigens is optional

I5.000 Family donors.

I5.100 All available members of the immediate family should be typed for accurate haplotype assignment.

I5.200 An MLC test may be advisable before use of a family donor. Either a one-way or a two-way MLC can be used.

I5.300 Final crossmatches performed prior to transplantation should utilize a recipient serum sample collected within the past 48 hours before transplant if the recipient has class I lymphocytotoxic antibodies (reactivity with more than 15% panel cells) or has had a recent sensitizing event (see H3.120). Otherwise, a serum collected within seven days should be used.

I5.400 A reverse lymphocytotoxicity and granulocytotoxicity crossmatch (donor serum, patient cells) is advisable in mother to child pretransplant donor specific blood transfusions.

I6.000 Cadaver donors.

I6.100 Donors may be typed using lymphocytes from lymph nodes, spleen or peripheral blood.

I7.000 Tests to monitor the immune responsiveness of a recipient are an appropriate function for a histocompatibility laboratory. These may include, but are not limited to, the following:

I7.100 Enumeration of T lymphocytes (and subsets), B cells, NK cells and monocytes.

I7.200 Evaluation of function of T cells (cytotoxic, helper and suppressor activity), B cells (antibody production), and NK cells (cytotoxicity).

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Standards

Minimal criteria which all accredited histocompatibility laboratories must meet

A - General Policies
B - Personnel Qualifications
C - General Comments and Quality Assurance
D - HLA Antigens
E - Serologic Typing - HLA Class I
F - Serologic Typing - HLA Class II
G - Mixed Leukocyte Culture Tests
H - Antibody Screening
I - Renal Transplantation
J - Non-Renal Transplantation
K - Marrow Transplantation
L - Plat & Gran Transfusion
M - Disease Association
N - Parentage Testing
P - Nucleic Acid Analysis
Q - Flow Cytometry
R - ELISA


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