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HLA-B*5701 Typing

Test Summary

Abacavir therapy for HIV treatment is associated with significant drug hypersensitivity in approximately 8% of recipients, with retrospective studies indicating a strong association with the HLA-B*5701 Allele. HLA-B*5701 typing can be used for genetic risk stratification prior to initiation of Abacavir therapy.

Aliases

  • N/A

Specimen Collection

Special Instructions

N/A

Preferred Specimen

5 mL whole blood collected in an EDTA (lavender-top) tube

Minimum Volume

3 mL

Instructions

A separate EDTA (lavender-top) tube must be submitted for all HLA testing. If submitted with any other test requiring an EDTA tube, please submit a separate tube for this test. Do not open tube.

Patient Preparation

N/A

Storage

N/A

Transport Temperature

Room temperature

Specimen Stability

  • Room temperature: 7 days
  • Refrigerated: 7 days
  • Frozen: Unacceptable

Limitations

A negative result does not rule out the risk for ABC HSR and clinical vigilance should be maintained regardless of the result. The frequency of HLA/-B5701 is approximately 8% in Caucasians and 2% in African Americans.

Other Acceptable Specimens

Whole blood collected in: sodium heparin (green-top) tube, EDTA (pink-top), EDTA (royal blue-top), or sodium citrate (light blue-top) tube

Unacceptable Specimens

Received frozen • Clotted

Order Code

HLATYP

EPIC (Premier) Code

LAB3312

Includes

Additional testing by Sequence Based Typing (SBT) may be performed when necessary.

CPT Code

  • 81381

Billing Code

  • 670053

CPT Statement

Methodology

Polymerase Chain Reaction (PCR) • Sequence Specific Oligonucleotide Probes (SSO)

FDA Status

Typing performed by using AS-PCR with reflex to the FDA-cleared LABType® SSO Kit. The AS-PCR portion of the test was developed and its performance characteristics have been determined by Quest Diagnostics.

Physician Attestation of Informed Consent

This germline genetic test requires physician attestation that patient consent has been received if ordering medical facility is located in AK, DE, FL, GA, IA, MA, MN, NV, NJ, NY, OR, SD or VT or test is performed in MA.

Testing Laboratory

Quest Diagnostics Nichols Institute
14225 Newbrook Drive
Chantilly VA, 20153

Department

Reference Testing

Reference Range

See Laboratory Report

Setup Schedule / Expected Turnaround Time

Daily; Report available: 6 days

Specimen Collection

Special Instructions

N/A

Preferred Specimen

5 mL whole blood collected in an EDTA (lavender-top) tube

Minimum Volume

3 mL

Instructions

A separate EDTA (lavender-top) tube must be submitted for all HLA testing. If submitted with any other test requiring an EDTA tube, please submit a separate tube for this test. Do not open tube.

Patient Preparation

N/A

Storage

N/A

Transport Temperature

Room temperature

Specimen Stability

  • Room temperature: 7 days
  • Refrigerated: 7 days
  • Frozen: Unacceptable

Limitations

A negative result does not rule out the risk for ABC HSR and clinical vigilance should be maintained regardless of the result. The frequency of HLA/-B5701 is approximately 8% in Caucasians and 2% in African Americans.

Other Acceptable Specimens

Whole blood collected in: sodium heparin (green-top) tube, EDTA (pink-top), EDTA (royal blue-top), or sodium citrate (light blue-top) tube

Unacceptable Specimens

Received frozen • Clotted

Billing

CPT Code

  • 81381

Billing Code

  • 670053

CPT Statement

Result Information

Methodology

Polymerase Chain Reaction (PCR) • Sequence Specific Oligonucleotide Probes (SSO)

Testing Laboratory

N/A

Reference Range

See Laboratory Report

Setup Schedule / Expected Turnaround Time

Daily; Report available: 6 days