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Jun 9, 2016

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Clinical Hub,Tools & Resources,UWHC Lab Test Directory,Histocompatibility

HLA Class 2 Donor Specific Ab by Luminex, Post-Tx

HLA Class 2 Donor Specific Ab by Luminex, Post-Tx (HCDSA2B) Histocompatibility Lab Test

Name: HLA Class 2 Donor Specific Ab by Luminex, Post-Tx

Test Name: HLA Class 2 Donor Specific Ab by Luminex, Post-Tx

Health Link Test Code: HCDSA2B

LIS Test Code: DSA2B

CPT Code(s): 86833

Methodology: Luminex xMAP (Multi-Analyte Profiling)

Clinical Information:

Test is used for the detection and identification of antibodies directed to donor-specific HLA class II antigens.

Days Performed: Mon-Fri.

In-Lab Turnaround Time: 2 - 4 days.

Stat In-Lab Turnaround Time: Not available stat.

Patient Preparation:

If patient is on dialysis, draw specimen pre-anticoagulation.

Specimen: Blood

Collection Container: Red top

Also Acceptable: Lavender top, Red cap with yellow ring (SST)

Collection Instructions:

Tests may be analyzed on serum or EDTA plasma specimens already in the UWHC HLA Laboratory. Indicate on order to use most recent sample in lab.

Collection Volume: 4 mL

Pediatric Collection Volume: 1 mL

Stability Ambient:

8 days unseparated; 10 days serum or EDTA plasma separated

Stability Refridgerated:

8 days unseparated; 10 days serum or EDTA plasma separated

Stability Frozen:

Indefinitely

Sample Analyzed: Serum or EDTA Plasma

Testing Volume: 0.5 mL

Pediatric Testing Volume: 0.1 mL

Specimen Transport:

Transport specimen to UWHC Hospital Laboratory. Separate serum or EDTA plasma from clot/cells if potential for hemolysis exists. Transport at room temperature.

Unacceptable Criteria:

Grossly hemolyzed samples are not acceptable.

Separated serum or EDTA plasma greater than 10 days old are not acceptable. 

Unseparated specimens greater than 8 days old are not acceptable.

Interpretation:

The laboratory will report normalized mean fluorescent intensity (MFI) of those beads bearing HLA antigen specific to the broad HLA-DR, -DQ, or -DP antigens mismatched to the transplant organ donor. This may be useful in tracking and trending sensitization (or desensitization) to donor HLA antigens.

Test Limitations:

Per agreement with the UWHC Abdominal Transplant group, testing will be limited to one specimen per week per patient, unless otherwise arranged on a patient-by-patient basis.

Additional Information:

This test utilizes flow cytometry-based detection of HLA class II antibodies by HLA single antigen-bound beads (Luminex). This test has high sensitivity and high specificity to identify antibodies in highly-sensitized patients. Target beads are bound with individual HLA-DR, HLA-DQ, or HLA-DP antigens on each bead. Note that antibodies may be allele specific, and while the bead may match the antigen of relevance, the allele represented on the bead reported may not represent the allele of the donor, which may result in bead luminescence unrelated to donor-specific antibodies.

 

This test was developed and its performance characteristics determined by this laboratory.  It has not been cleared or approved by the US Food and Drug Administration.  The FDA has determined that such clearance or approval is not necessary.  This test is used for clinical purposes.  It should not be regarded as investigational or for research.  This laboratory is certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA-88) as qualified to perform high complexity clinical laboratory testing