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Test Directory » HIV 1 RNA, Quantitative PCR, W/Reflex To Integrase Genotype

Test Directory HIV 1 RNA, Quantitative PCR, W/Reflex To Integrase Genotype

HIV 1 RNA, Quantitative PCR, W/Reflex To Integrase Genotype

Order Code: HV1INT

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 can be used to assess patient prognosis by measuring the baseline HIV-1 RNA level or to monitor the effects of antiretroviral therapy by measuring changes in EDTA plasma HIV-1 RNA levels during the course of antiretroviral treatment. The emergence of integrase drug resistance mutations has been observed in vitro and in patients experiencing virologic failure on Raltegravir in clinical trials. Twenty three percent of patients receiving Raltegravir in a clinical trial experience virologic failure at 48 weeks and genotypic analysis detected raltegravir associated resistance mutations in 68% of virologic failures. This assay amplifies and sequences the HIV-1 integrase gene and reports mutations at positions associated with integrase inhibitor drug resistance.

Aliases

Specimen Collection

Special Instructions

N/A

Preferred Specimen

3 mL plasma collected in an EDTA (lavender-top) tube

Minimum Volume

2.5 mL

Instructions

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 and immediately transfer to a transport tube. Follow manufacturer's instructions for collection tube handling.

Patient Preparation

N/A

Storage

N/A

Transport Temperature

Frozen

Specimen Stability

Room temperature: Unacceptable
Refrigerated: 6 days
Frozen: 42 days

Limitations

N/A

Other Acceptable Specimens

Plasma collected in: PPT potassium EDTA (white-top) tube

Unacceptable Specimens

Samples received in primary collection tube • Gross hemolysis • Lipemia

Order Code

HV1INT

EPIC (Premier) Code

LAB5229

Includes

If HIV-1 viral load is >400 copies/mL, then HIV-1 Integrase will be performed at an additional charge (CPT Code(s): 87906).

CPT Code

87536

Billing Code

670075

CPT Statement

Methodology

Real-Time Polymerase Chain Reaction (RT-PCR)

FDA Status

This test was developed and its analytical performance characteristics have been determined by Quest Diagnostics Infectious Disease. 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

HIV-1 RNA, QN, PCR Not detected copies/mL HIV-1 RNA, QN, PCR Not detected Log copies/Ml

Setup Schedule / Expected Turnaround Time

Monday - Saturday; Report available: 3 - 5 days