BC Centre for Excellence 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™ quantitative analysis of drug 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 assay.** The FDA does not currently regulate non-kit-based tests through published regulations or site inspections. |
| Proficiency Testing Programs |
Virco |
| Clinical Trials |
Yes |
| Financial Assistance |
N/A |
| ** |
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 |
? |
1–99 |
|
METHODOLOGY
Genotype
[EXAMPLE] 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
VirtualPhenotype™
See Virco page.
REPORT INFORMATION
| Report |
Drug Resistance Interpretation |
| Genotype |
Yes |
VirtualPhenotype™: See Virco page
|
Return to Test Information Table - Genotypic
Return to Test Information Table - Phenotypic
|
