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HLA B57 Screen for Abacavir Sensitivity

HLA-B*5701 Screening for Abacavir Hypersensitivity

Test Codes

EPIC: LAB6425, SOFT: CIB57

Department

HLA

Specimen Collection Criteria

Collect: One Yellow-top ACD tube OR one Lavender-top EDTA tube. Invert several times to mix well. 

Physician Office/Draw Specimen Preparation

Do not refrigerate or freeze specimen. Maintain whole blood at room temperature (20-26°C or 68-78.8°F) prior to transport. Transport to the Laboratory within 24 hours of collection.

Preparation for Courier Transport

Transport: Whole blood at room temperature (20-26°C or 68-78.8°F).

Rejection Criteria

• Unlabeled specimens.
• Specimens drawn in clot, SST, or Heparin tubes.
• This test will only be performed once in a lifetime for a patient.

In-Lab Processing

1. Harvest lymphocytes from whole blood by density centrifugation.
2. Extract DNA from lymphocytes.
3. Perform PCR for HLA Class I gene products using commercially available Sequence Specific Priming (SSP) kits.
4. Perform gel electrophoresis followed by gel interpretation to determine HLA Class I genotype.
5. Perform reflex testing, if necessary (see below).

Storage

Specimen Stability for Testing:

Room Temperature (20-26°C or 68-78.8°F): 24 hours
Refrigerated (2-8°C or 36-46°F): Unacceptable
Frozen (-20°C/-4°F or below): Unacceptable

Specimen Storage in Department Prior to Disposal:

Frozen (-80°C): 5 years (DNA)

Laboratory

Royal Oak HLA Laboratory

Performed

Monday – Friday, 7:00 am – 5:00 pm.
Results available within 7 days.

Reference Range

Negative or positive for HLA-B*57:01.

Test Methodology

Sequence Specific Priming (SSP) for HLA Class I Genotyping.

Clinical Utility

The FDA recommends that genetic testing for HLA-B*5701 be performed prior to prescribing the reverse transcriptase inhibitor, Abacavir, to HIV patients. The presence of HLA-B*5701 is associated with a drug-induced hypersensitivity reaction to Abacavir that can be prevented with prior genetic screening.

Clinical Disease

Human Immunodeficiency Virus (HIV).

Reference

1. Mallal et al. HLA-B*5701 Screening for Hypersensitivity to Abacavir. The New England Journal of Medicine, 358 (6): 568-579, 2008.

CPT Codes

81381
LOINC: 50956-2

Contacts

Last Updated

12/30/2022