Gladstone/UCSF Information Page

Gladstone/UCSF Laboratory of Clinical Virology

Contacts
To order tests or for more information:
Teri Liegler, Associate Director
(415) 695-3832

The Gladstone-UCSF Laboratory of Clinical Virology is a university-based laboratory that provides non-kit-based** and kit-based (Visible Genetics) genotypic testing.

GENERAL INFORMATION

Assay Name	TRUGENE™ (Visible Genetics)
Collaborators/Distributors	Visible Genetics
Availability	Commercially available for research use only
Regulatory Status	TruGene™ HIV is available for "Investigational Use Only" under an FDA-approved IDE in CLIA certified labs. Gladstone Laboratory is a CLIA-approved laboratory.
Proficiency Testing Programs	Content in development.
Clinical Trials	Yes
Financial Assistance	Approved Provider, California Department of Health, Office of AIDS HIV Resistance Testing Program.

**	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
TRUGENE™ HIV (Visible Genetics)	RT	PI	TRUGENE™	TRUGENE™
Full sequence	40–247	1–99	7–14 days	1,000 RNA copies/mL

METHODOLOGY

TRUGENE™ HIV-1: See Visible Genetics page.

REPORT INFORMATION

Report	Drug Resistance Interpretation
Genotype	Yes	The report is a modified form (in format only) of Visible Genetics' TRUGENE™ HIV report. See Visible Genetics page.

Return to Test Information Table - Genotypic

Return to Test Information Table - Phenotypic