HLA-B*57:01 for Abacavir Sensitivity
Also known as: HLA-B5701
Use
The HLA-B*57:01 test is used to predict the risk of abacavir hypersensitivity syndrome, which is an important standard of care prior to abacavir therapy per FDA recommendations. This allele is strongly associated with the occurrence of a hypersensitivity reaction to abacavir, which may manifest as fever, rash, malaise, and gastrointestinal and respiratory symptoms. These hypersensitivity reactions can be severe or fatal, making this test relevant to most populations considering or currently on abacavir therapy.
Special Instructions
Counseling and informed consent are recommended for genetic testing, and specific consent forms are required for patients in New York. The test is classified as a Laboratory Developed Test (LDT).
Limitations
This test only evaluates for the presence or absence of the HLA-B*57:01 allele and does not test for other alleles. It cannot distinguish between heterozygote and homozygote carriers, and diagnostic errors can occur due to rare sequence variations. Genetic and non-genetic factors not detected by this test may influence therapeutic failure or adverse reactions with abacavir. This test does not eliminate the need for therapeutic drug monitoring or clinical observation.
New York Approved
Methodology
PCR-based
Biomarkers
LOINC Codes
- 31208-2
- 50956-2
Result Turnaround Time
5-10 days
Related Documents
For more information, please review the documents below
Specimen
Whole Blood
Volume
3 mL
Minimum Volume
1 mL
Container
Lavender (EDTA), pink (K2EDTA), or yellow (ACD Solution A or B)
Storage Instructions
Refrigerated.
Causes for Rejection
Plasma or serum, heparinized specimens, frozen specimens in glass collection tubes.
Stability Requirements
| Temperature | Period |
|---|---|
| Room Temperature | 72 hours |
| Refrigerated | 1 week |
| Frozen | 1 month |