HLA-B*57:01 for Abacavir Sensitivity
Ordering Recommendation
Standard of care prior to abacavir therapy per FDA. Screening test to determine susceptibility to abacavir hypersensitivity syndrome.
Polymerase Chain Reaction/Fluorescence Monitoring
4-8 days  
New York DOH Approval Status
This test is New York DOH approved.
Submit With Order
Specimen Required
Patient Preparation
Lavender (EDTA), pink (K2EDTA), or yellow (ACD Solution A or B).  
Specimen Preparation
Transport 3 mL whole blood. (Min: 1 mL)  
Storage/Transport Temperature
Unacceptable Conditions
Plasma or serum. Heparinized specimens.  
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:
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.
Autosomal dominant.
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.
Polymerase Chain Reaction (PCR) and Fluorescence Monitoring.
Analytical Sensitivity and Specificity:
Greater than 99 percent.
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 Statement C: The performance characteristics of this test were validated by ARUP Laboratories. The U.S. Food and Drug Administration (FDA) has not approved or cleared this test; however, FDA approval or clearance is currently not required for clinical use of this test. The results are not intended to be used as the sole means for clinical diagnosis or patient management decisions. ARUP is authorized under Clinical Laboratory Improvement Amendments (CLIA) and by all states to perform high-complexity testing.

Counseling and informed consent are recommended for genetic testing. Consent forms are available online.
CPT Code(s)
Component Test Code*Component Chart NameLOINC
2002431HLA-B*57:01 Specimen31208-2
2002432HLA-B*57:01 Allele50956-2
* 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.
  • Abacavir hypersensitivity genotyping
  • Abacavir Sensitivity
  • HLA-B 5701 Genotype, Abacavir Hypersensitivity, Saliva