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Test Directory

HIV-1 Genotype

Test Summary

This test is intended for use in conjunction with clinical presentation and other laboratory markers of disease progress for the clinical management of HIV-1 infected patients. The test identifies drug resistance-associated mutations in the HIV-1 protease and reverse transcriptase genes. It can be used to predict antiretroviral drug resistance before initiation of therapy and in patients experiencing virologic failure while on therapy.

Aliases

  • N/A

Specimen Collection

Special Instructions

N/A

Preferred Specimen

2 mL plasma collected in an EDTA (lavender-top), or potassium PPT (white-top) tube

Minimum Volume

0.6 mL
(Please note: This volume does not allow for repeat testing)

Instructions

Do not freeze whole blood or any samples stored in primary tube. Freshly drawn specimens (whole blood) may be stored at 2-25°C for up to 24 hours prior to centrifugation. Separate plasma from cells within 24 hours of collection by centrifugation. If shipping frozen, transfer plasma to a leakproof transport tube, then freeze prior to shipment. Follow manufacturer's instructions for collection tube handling.

Patient Preparation

N/A

Storage

N/A

Transport Temperature

Frozen

Specimen Stability

  • Room temperature: 24 hours
  • Refrigerated: 6 days
  • Frozen: 42 days

Limitations

An infection is often composed of a variety of strains of the virus. The test may identify only the predominant type of virus thus leaving the minority viruses to thrive once the predominant type is treated. Lack of resistance may not confer susceptibilities.

Other Acceptable Specimens

2 mL CSF collected in a sterile leak-proof container

Unacceptable Specimens

Plasma received frozen in the plasma preparation tube (PPT) • Serum • Whole blood greater than 24 hours old • Frozen whole blood

Order Code

HIV1GN

EPIC (Premier) Code

LAB608

Includes

N/A

CPT Code

  • 87900
  • 87901

Billing Code

  • 670002
  • 670001

CPT Statement

Methodology

DNA Sequencing • Reverse Transcriptase Polymerase Chain Reaction (RT-PCR)

FDA Status

This test was developed and its analytical performance characteristics have been determined by Quest Infectious Disease Diagnostics. It has not been cleared or approved by the U.S. Food and Drug Administration. This assay has been validated pursuant to the CLIA regulations and is used for clinical purposes.

Physician Attestation of Informed Consent

N/A

Testing Laboratory

Quest Diagnostics Nichols Institute
33608 Ortega Highway
San Juan Capistrano CA, 92675

Department

Reference Testing

Reference Range

See Laboratory Report

Setup Schedule / Expected Turnaround Time

Daily; Report available: 5 - 10 days

Specimen Collection

Special Instructions

N/A

Preferred Specimen

2 mL plasma collected in an EDTA (lavender-top), or potassium PPT (white-top) tube

Minimum Volume

0.6 mL
(Please note: This volume does not allow for repeat testing)

Instructions

Do not freeze whole blood or any samples stored in primary tube. Freshly drawn specimens (whole blood) may be stored at 2-25°C for up to 24 hours prior to centrifugation. Separate plasma from cells within 24 hours of collection by centrifugation. If shipping frozen, transfer plasma to a leakproof transport tube, then freeze prior to shipment. Follow manufacturer's instructions for collection tube handling.

Patient Preparation

N/A

Storage

N/A

Transport Temperature

Frozen

Specimen Stability

  • Room temperature: 24 hours
  • Refrigerated: 6 days
  • Frozen: 42 days

Limitations

An infection is often composed of a variety of strains of the virus. The test may identify only the predominant type of virus thus leaving the minority viruses to thrive once the predominant type is treated. Lack of resistance may not confer susceptibilities.

Other Acceptable Specimens

2 mL CSF collected in a sterile leak-proof container

Unacceptable Specimens

Plasma received frozen in the plasma preparation tube (PPT) • Serum • Whole blood greater than 24 hours old • Frozen whole blood

Billing

CPT Code

  • 87900
  • 87901

Billing Code

  • 670002
  • 670001

CPT Statement

Result Information

Methodology

DNA Sequencing • Reverse Transcriptase Polymerase Chain Reaction (RT-PCR)

Testing Laboratory

N/A

Reference Range

See Laboratory Report

Setup Schedule / Expected Turnaround Time

Daily; Report available: 5 - 10 days