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]
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.
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.
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.
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.