Ordering Recommendation

Standard of care prior to abacavir therapy per FDA. Predicts risk of abacavir hypersensitivity syndrome. Relevant to most populations.

Mnemonic
HLA-B5701
Methodology

Polymerase Chain Reaction/Fluorescence Monitoring

Performed

Tue-Sat

Reported

5-10 days

New York DOH Approval Status
This test is New York DOH approved.
Specimen Required
Patient Preparation
Collect

Lavender (EDTA), pink (K2EDTA), or yellow (ACD Solution A or B).

Specimen Preparation

Transport 3 mL whole blood. (Min: 1 mL)

Storage/Transport Temperature

Refrigerated.

Unacceptable Conditions

Plasma or serum. Heparinized specimens.

Remarks
Stability

Ambient: 72 hours; Refrigerated: 2 weeks; Frozen: 1 month.

Reference Interval

By report

Interpretive Data

Background Information for HLA-B*57:01 for Abacavir Sensitivity:
Characteristics:
Abacavir sulfate is a nucleoside reverse transcriptase inhibitor (NRTI) used for the treatment of HIV.
Abacavir hypersensitivity reaction is characterized by fever, rash, malaise, gastrointestinal, and respiratory symptoms.
Symptoms typically appear within the first six weeks of treatment, worsen with each subsequent abacavir dose, and may be severe or fatal.
Inheritance:
Autosomal dominant.
Cause:
Abacavir hypersensitivity is strongly associated with the HLA-B*57:01 allele. The mechanism is related to drug-specific activation of T lymphocyte killer cells.
Allele Tested:
Presence or absence of the HLA-B*57:01 allele.
Allele Frequency: Southwest Asian 11 percent, Other Asian 0-6.7 percent, European 6.8 percent, South American 2.6 percent, Middle Eastern 2.5 percent, Mexican 2.2 percent, African 1 percent.
Clinical Sensitivity: 100 percent for immunologically confirmed hypersensitivity reaction.
Methodology:
Polymerase Chain Reaction (PCR) and Fluorescence Monitoring.
Analytical Sensitivity and Specificity:
Greater than 99 percent.
Limitations:
Alleles other than HLA-B*57:01 will not be evaluated. This test does not distinguish between heterozygote and homozygote carriers. Diagnostic errors can occur due to rare sequence variations. Risk of therapeutic failure or adverse reactions with abacavir may be affected by genetic and non-genetic factors that are not detected by this test. This result does not replace the need for therapeutic drug or clinical monitoring.

Compliance Category

Laboratory Developed Test (LDT)

Note
Hotline History
N/A
CPT Codes

81381

Components
Component Test Code* Component Chart Name LOINC
2002431 HLA-B*57:01 Specimen 31208-2
2002432 HLA-B*57:01 Allele 50956-2
* Component test codes cannot be used to order tests. The information provided here is not sufficient for interface builds; for a complete test mix, please click the sidebar link to access the Interface Map.
Aliases
  • Abacavir hypersensitivity genotyping
  • Abacavir Sensitivity
  • HLA-B 5701 Genotype, Abacavir Hypersensitivity, Saliva
HLA-B*57:01 for Abacavir Sensitivity