There are two general methods to test for the presence of drug-resistant HIV: genotypic tests and phenotypic tests .
Genotypic Tests Point mutations may occur in the virus of patients who take antiretroviral agents. Many of these mutations have been linked to the phenotypic expression of drug resistance. Genotypic testing detects the presence of mutations in a patient's virus population by identifying codon changes that differ from the standard, or "wild-type," genetic sequence of HIV. Many of these companies also supply phenotypic testing. See phenotype table .
Genotypic: Kit Based (Sold by Manufacturer for Use in Independent Laboratories)
For further information about companies or collaborators, click on the company name.
Affymetrix Product withdrawn from development
American Medical Laboratories TRUGENE™ Visible Genetics See Visible Genetics
Applied Biosystems (formerly PE Biosystems) ViroSeq™ HIV-1 Genotyping System RDL, Contra Costa County Public Health Laboratory Full sequence FDA approved under an IDE4 in CLIA5 certified labs Commercially6 No See Contra Costa, RDL (CA only)
Applied Sciences TRUGENE™ A subsidiary of Visible Genetics See Visible Genetics
Bayer Diagnostics INNO-LiPA HIV-1 RT, INNO-LiPA Protease Innogenetics See Innogenetics Content in development
Contra Costa County ViroSeq™ Applied Biosystems See Applied Biosystems Yes3
Gladstone-UCSF TRUGENE™ Visible Genetics See Visible Genetics Yes3
Innogenetics INNO-LiPA HIV-1 RT, INNO-LiPA Protease Bayer Diagnostics Line probe assay/point mutations FDA approved under an IDE4 in CLIA5 certified labs Commercially6 Content in development Content in development
LA County TRUGENE™ Visible Genetics See Visible Genetics Yes3
RDL TRUGENE™ Visible Genetics, Applied Biosystems See Visible Genetics Applied Biosystems Yes3
USC Pathology Reference Library TRUGENE™ Visible Genetics See Visible Genetics Yes3
Visible Genetics TRUGENE™ HIV-1 Genotyping Kit American Medical Laboratories, Applied Sciences, Gladstone-UCSF, LA County, RDL, USC Full sequence FDA approved for marketing Commercially6 Yes Yes
1 See HIVresistanceWeb article regarding regulatory status .
2 Some companies provide assistance with reimbursement. This category refers to those companies that provide some free or reduced price tests.
3 State of California only (California Department of Health, Office of AIDS HIV Resistance Testing Program)
4 IDE = Investigational Device Exemption [see http://www.fda.gov/cdrh/devadvice/ide/ ]; see Dr. Michelle Roland's article regarding regulatory status .
5 CLIA = Clinical Laboratory Improvement Amendments; see Dr. Michelle Roland's article regarding regulatory status .
6 Commercially available for research use only.
Many of these companies also supply phenotypic testing. See phenotype table .
Genotypic: Proprietary/Non-Kit-Based 7 (Performed by Individual Commercial or Academic Laboratories)
For further information about companies or collaborators, click on the company name.
ARUP Laboratory HIV-1 Genotyping for Drug Resistance, Virtual Phenotype ™ Virco (VP only)
Full sequencing assay
CLIA certified5 Commercially6 No No
BC Centre HIV RT and Protease Genotype, Virtual Phenotype™ Virco (VP only) See Virco
Chelsea & Westminster Hospital GENChec ™ Virco (VP only) See Virco
LabCorp HIV GenoSure ™, HIV GenoSure Plus ™ , Virtual Phenotype ™ Virco Full sequencing assay CLIA certified5 Commercially6 No No
Mayo Medical Laboratories Not available/lab declines to provide information at this time.
Quest Diagnostics HIV-1 Genotyping for Drug Resistance, Virtual Phenotype™ Virco (VP only) Full sequencing assay CLIA certified5 Commercially6 No Yes 3
Specialty Laboratories HIV-1 GenotypR Plus™ 2001 None Full sequencing assay CLIA certified5 Commercially6 No Yes
SRL See Virco Virco See Virco
Stanford University HIV RT and Protease Genotype None Full sequencing assay CLIA certified5 Commercially6 No Yes 3
Unilab Content in development.
Virco GENChec ™ ARUP VP , Gilead, LabCorpVP , QuestVP , BC Centre (Vancouver)VP , Chelsea and Westminster Hospital (London), SRL (Japan) Full sequencing assay CLIA certified5 Commercially6 No No
ViroLogic GenSeq™ HIV American Medical Laboratories, ARUP, Mayo Medical Laboratories, Quest Diagnostics, Specialty Laboratories Full sequencing assay CLIA certified5 Commercially6 No Yes 3
1 See HIVresistanceWeb article regarding regulatory status .
2 Some companies provide assistance with reimbursement. This category refers to those companies that provide some free or reduced price tests.
3 State of California only (California Department of Health, Office of AIDS HIV Resistance Testing Program)
4 IDE = Investigational Device Exemption [see http://www.fda.gov/cdrh/devadvice/ide/ ]; see Dr. Michelle Roland's article regarding regulatory status .
5 CLIA = Clinical Laboratory Improvement Amendments; see Dr. Michelle Roland's article regarding regulatory status .
6 Commercially available for research use only.
7 Proprietary/Non-kit-based assays are sometimes referred to as "home brew" assays. See the background article regarding this issue.
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