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Quest Diagnostics

Contacts
To order tests or for more information:
Quest Client Services
(800) 642-4657


Quest Diagnostics is a commercial laboratory that currently provides a non-kit-based genotypic assay** and the Virco and ViroLogic phenotypic resistance tests.


GENERAL INFORMATION

Assay Names Genotype HIV-1 Genotyping for Drug Resistance to Protease Inhibitors and Reverse Transcriptase Inhibitors - 83600N [3946]

HIV-1 RNA quantitative PCR with Reflex to HIV-1 Genotyping
for Drug Resistance to Protease Inhibitors and Reverse
Transcriptase Inhibitors - 12377N [3374]

VirtualPhenotype™ (Virco) - 10039N [12474]
Phenotype Antivirogram® (Virco) - 10040N [12475], PhenoSense™ HIV (ViroLogic) - 10421N [12300]
Collaborators/Distributors Virco, ViroLogic
Availability Commercially available for research use only.
Regulatory Status
CLIA certified laboratory. All test offerings are non-kit-based assays.** The FDA does not currently regulate non-kit-based tests through published regulations or site inspections.
Proficiency Testing Programs Content in development.
Clinical Trials No
Financial Assistance Approved Provider, California Department of Health, Office of AIDS HIV Resistance Testing Program.

** Proprietary/Non-kit-based assays are sometimes referred to as "home brew" assays. See the background article regarding FDA regulation of kit- vs. non-kit-based assays.


ASSAY INFORMATION

Genotype Phenotype Codons Interrogated
HIV-1 Genotyping Antivirogram™ PhenoSense™ RT PI
Full sequence assay See Virco
See ViroLogic 1–240 1–99

Turnaround Time Sensitivity
HIV-1 Genotyping Antivirogram™ PhenoSense™ HIV-1 Genotyping Antivirogram™ PhenoSense™
? ? ? ? 1,000 RNA copies/mL 500 RNA copies/mL


METHODOLOGY

Genotype
Viral RNA is extracted from plasma and amplified through RT-PCR. The products undergo automated dye terminator sequencing of the entire protease gene and the amino-terminal 240 amino acids of the reverse transcriptase gene (1.3Kb). Commercial software is then used to compare the sequences with wild type viral sequences to determine the resistance mutations.

Phenotype
Antivirogram®: See Virco page.

PhenoSense™ HIV: See ViroLogic page.


REPORT INFORMATION

Report Drug Resistance
Interpretation
Genotype Yes Two optional interpretations are available. The standard interpretation algorithm for the genotypic assay is constructed and updated in collaboration with Dr. Thomas Merigan at Stanford University. As new information is validated by peer review publications, modifications are made to the "GART Chart" which tracks mutations associated with resistance.
VirtualPhenotype™ Yes Alternate interpretation: See Virco page.
Phenotype Yes Antivirogram®: See Virco page.

PhenoSense™ HIV: See ViroLogic page.


Return to Test Information Table - Genotypic

Return to Test Information Table - Phenotypic


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