Contacts To order tests, or for more information: (800) 421-7110
Specialty Laboratories is a commercial laboratory that provides a non-kit-based genotyping assay** and the ViroLogic phenotypic resistance test.
GENERAL INFORMATION
Assay Names
Genotype
HIV-1 GenotypR PLUS™ 2001
Phenotype
PhenoSense HIV™ (ViroLogic)
Collaborators/Distributors
ViroLogic
Availability
Commercially available for research use only.
Regulatory Status
CLIA certified laboratory. The assays are non-kit-based. ** 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.
ASSAY INFORMATION
Genotypic
Phenotypic
Codons Interrogated
Turnaround time
Sensitivity
HIV-1 GenotypR PLUS™ 2001
PhenoSense™ HIV
RT
PI
HIV-1 GenotypR PLUS™ 2001
PhenoSense™ HIV
HIV-1 GenotypR PLUS™ 2001
PhenoSense™ HIV
Full sequence assay
Recombinant
1–400
1–99
7 days
14 days
200 copies/mL
500 copies/mL
METHODOLOGY
Genotype
Viral RNA is extracted from plasma and amplified through RT-PCR. The products undergo automated dye terminator sequencing of the full protease gene and up to codon 400 of the reverse transcriptase gene. Commercial software is then used to compare the sequences with wild type viral sequences to determine the resistance mutations.
The report includes a listing of detected primary and secondary mutations and a final interpretation that reports three levels of resistance (sensitive, low resistance, resistant). Reports are updated as new mutations are identified and deemed clinically relevant. The interpretation is based on an algorithm derived from literature, expert consultation and a database of more than 40, 000 test results. It is based in part on the consensus statement of the International AIDS Society-USA (Antiretroviral Drug Resistance Testing in Adult HIV-1 Infection: Recommendations of an International AIDS Society-USA Panel. JAMA. 2000 May 10;283(18):2417-26), as well as peer-reviewed literature from large studies and information provided by pharmaceutical companies.
200 copies/mL