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Jun 9, 2016

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

HLA Class I Antibody ID by Luminex

HLA Class I Antibody ID by Luminex (HCLUC1S (if Pre-Tx), HCLUC1B (if Post-Tx, stem cell patient, or billed i.e. VA)) Histocompatibility Lab Test

Name: HLA Class I Antibody ID by Luminex

Test Name: HLA Class I Antibody ID by Luminex

Health Link Test Code: HCLUC1S (if Pre-Tx), HCLUC1B (if Post-Tx, stem cell patient, or billed i.e. VA)

LIS Test Code: LUC1S (if Pre-Tx), LUC1B (if Post-Tx, stem cell patient, or billed i.e. VA)

CPT Code(s): 86832

Methodology: Luminex xMAP (Multi-Analyte Profiling)

Clinical Information:

Test used for the detection and identification of antibodies to HLA class I (A-, B-, C-loci) antigens by single-antigen bead-based flow cytometry.

Days Performed: Mon-Fri, dayshift.

In-Lab Turnaround Time: 12 days.

Patient Preparation:

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

Specimen: Blood

Collection Container: Red top

Also Acceptable: Lavender top (if not for solid organ pre-transplant)

Collection Instructions:

Test may be analyzed on serum specimens (or EDTA plasma for Post-Tx, stem cell patient, or billed i.e. VA) 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 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:

Results will list calculated PRA (percent reactive antibody) of class I (HLA-A, -B, or -C locus) antibodies detected, and list HLA specificities identified.

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 and can identify antibody specificities in highly-sensitized patients. Target beads are bound with individual HLA-A, HLA-B, or HLA-C locus antigens on each bead. Panel Reactive Antibody (PRA) result is expressed as a calculated PRA based on UWHC donor population HLA frequencies.

 

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.