LabCorp is a commercial clinical reference laboratory that currently provides and performs (in whole or in part) genotypic and phenotypic resistance tests using genotyping methods performed with an in-house assay and phenotyping offered through two manufacturers (Virco and ViroLogic).
GENERAL INFORMATION
| Assay Names |
Genotype |
HIV GenoSure™: HIV Genotype
HIV GenoSure Plus™: HIV Genotype With VirtualPhenotype™ |
| Phenotype |
Antivirogram™ (Virco): HIV Phenotype
PhenoSense™ HIV (ViroLogic): HIV Phenotype
|
| Collaborators/Distributors |
Virco, ViroLogic |
| Availability |
Commercially available for research use only. |
| Regulatory Status |
All laboratories and all methodologies are CLIA certified, CAP accredited, and New York state accredited. These products are non-kit-based assays.** The FDA does not currently regulate non-kit-based assays through published regulations or site inspections. |
| Proficiency Testing Programs |
Virco Program, ENVA, CAP. |
| 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
| Genotype |
Phenotype |
Codons Interrogated |
| HIV GenoSure™* |
Antivirogram™ |
PhenoSense™ |
RT |
PI |
| Full sequence assay |
See Virco
|
See ViroLogic |
1–400 |
1–99 |
| Turnaround Time |
Sensitivity |
| HIV GenoSure™ |
Antivirogram™ |
PhenoSense™ |
HIV GenoSure™ |
Antivirogram™ |
PhenoSense™ |
| 9 days |
21–28 days |
14 days |
 1,000 RNA copies/mL |
1,000 RNA copies/mL |
500 RNA copies/mL |
METHODOLOGY
Genotype
HIV GenoSure™: Viral RNA is extracted from plasma and amplified through RT-PCR. The products undergo sequencing of the entire protease gene and up to codon 400 of the reverse transcriptase gene. Proprietary software is then used to compare the sequences with wild type viral sequences to determine the presence of any mutations and provide a phenotypic interpretation for each antiviral (susceptible, resistance possible, resistant).
| * |
HIV GenoSure Plus™: Sequencing is conducted as described above. Genotypic sequence is interpreted using Virco’s proprietary VirtualPhenotype™ software system (see Virco page). |
Phenotype
Antivirogram®: See Virco page.
PhenoSense™ HIV: See ViroLogic page.
REPORT INFORMATION
| Report |
Drug Resistance Interpretation |
| Genotype |
Yes |
The interpretation for the HIV GenoSureTM assay uses a rules-based algorithm and provides both a listing of mutations and a drug-specific interpretation: sensitive, resistance possible or resistant. Partial information is provided at no cost if the laboratory is unable to process the full sequence data.
Sample Report:
GenoSureinterpretation.pdf
|
| VirtualPhenotype™ |
Yes |
VirtualPhenotype™: 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
|
