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UW Health SMPH
American Family Children's Hospital

UW Hospital and Clinics Lab Test Directory

Test Name: HLA Class 1 Donor Specific HLA Ab by Luminex

Test Code(s): DSA1S / HCDSA1S (if Pre-Tx)

CPT Code(s): 86832

Methodology: Luminex xMAP (Multi-Analyte Profiling)

Clinical Significance: Test is used for the detection and identification of antibodies directed to donor-specific HLA class I antigens by single-antigen bead-based flow cytometry.

Days Performed: Mon-Fri.

Turnaround Time: Stat: Not available stat.
Routine: 1 week.


Specimen Requirements

Specimen: Blood

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

Collection Instructions: Test may be analyzed on serum specimens already in the UWHC HLA/Molecular Diagnostics Laboratory. Indicate on order to use most recent sample in lab.

Collection Container: Preferred: Red top
Also Acceptable: Lavender top

Collection Volume: Preferred: 9 mL
Pediatrics: 1 mL

Sample Analyzed: Serum

Volume Required: Preferred: 0.5 mL
Pediatrics: 0.1 mL

Specimen Transport: Transport specimen to UWHC Core Laboratory (B4/220) immediately.  Separate serum from clot if potential for hemolysis exists.  Transport at room temperature or on coolant pack if coming from outreach location.

Unacceptable Criteria: Specimens greater than 7 days old and grossly hemolyzed samples are not acceptable.

Stability: Ambient: 7 days
Refrigerated: 7 days
Frozen: 14 days (serum)


Interpretation

The laboratory will report mean fluorescence intensity (MFI) of those beads bearing HLA antigen specific to the broad HLA-A or -B 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 I 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-A or HLA-B 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.

DSA, Luminex

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