HLA-B*5701 Associated Variant Genotyping 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/High Resolution Melt Analysis
Tue, Fri
4-10 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
Ambient: 72 hours; Refrigerated: 1 week; Frozen: Unacceptable  
Reference Interval
By report  
Interpretive Data
Background Information for HLA-B*5701 Associated Variant Genotyping 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.
HLA-B*5701 allele frequency varies by ethnicity: Indian 0.20, Thai 0.11, Caucasian 0.08, African American 0.02, Asian (rare).
Autosomal dominant.
98 percent.
Abacavir hypersensitivity is strongly associated with the HLA-B*5701 allele. The mechanism is related to drug-specific activation of T lymphocyte killer cells.
Variant Tested:
Single nucleotide polymorphism (SNP) rs2395029 in the HCP5 gene which is in linkage disequilibrium with HLA-B*5701.
Clinical Sensitivity and Specificity:
98 and 99 percent respectively, for immunologically confirmed hypersensitivity reaction.
Polymerase Chain Reaction/High Resolution Melt Analysis.
Analytical Sensitivity and Specificity:
99 percent for prediction of HLA-B*5701 carrier status by SNP rs2395029 genotyping.
Diagnostic errors can occur due to rare sequence variations. Rare recombination events between HCP5 SNP
rs2395029 and HLA-B*5701 may occur. Alleles other than HLA-B*5701 will not be evaluated. Non-genetic factors that may affect drug sensitivity are not identified.

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*5701 Specimen31208-2
2002432HLA-B*5701 Genotyping50956-2
* 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