ARUP Laboratories offers HIV-1 drug resistance testing using a non-kit-based genotypic assay and the VirtualPhenotype™ system (Virco).
GENERAL INFORMATION
Assay Names
Genotype
RT-PCR and DNA Sequencing of HIV-1 protease and RT
VirtualPhenotype™ (Virco): quantitative prediction of resistance from genotype
Collaborators/Distributors
Virco (VirtualPhenotype™ only)
Availability
Commercially available for research use only.
Regulatory Status
CLIA certified laboratory. Genotypic assay is 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
No
**
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
Genotypic
Codons Interrogated
Turnaround time
Sensitivity
RT
PI
Full sequence assay
1–320
1–99
14 days
1,000 RNA copies/mL
METHODOLOGY
Genotype
Viral RNA is extracted from plasma and amplified through RT-PCR. Using an ABI PRISM 3100 Genetic Analyzer, a fluorescent-based DNA analysis system that uses capillary electrophoresis, the products undergo automated dye terminator sequencing of the entire protease and up to codon 320 of the reverse transcriptase genes.
1,000 RNA copies/mL