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Epic Code LAB6425 HLA B57 Screen for Abacavir Sensitivity

Additional Test Codes

EPIC: LAB6425, SOFT: CIB57

Clinical Information

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.

Specimen Type

Blood

Collection Instructions

Specimen Collection Criteria

 

Collect: One Yellow-top ACD tube OR one Pink-top 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 72 hours of collection.

 

Preparation for Courier Transport

 

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

Lab Staff Instructions

  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).

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.

Specimen Stability

Specimen Stability for Testing:

Room Temperature (20-26°C or 68-78.8°F): 72 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): 2 years (DNA)

Test Frequency

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

Reference Range

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

Performing Department

HLA

Performing Department Laboratory Location

Royal Oak HLA Laboratory

Methodology

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

CPT

81381

CDM Code

CDM

Epic Test ID

#

LOINC

LOINC: 50956-2

Reviewed Date

Under Review 10/29/2024