Contacts For clinical information:
Dr. Suzanne Coberly Clinical Affairs, Applied Biosystems (650) 638-2263 coberlsk@appliedbiosystems.com
To order tests or for other information:
Leila Smith
Product Manager, Applied Biosystems
(650) 638-6443 smithlg@appliedbiosystems.com
Applied Biosystems Group, formerly PE Biosystems Group, changed its name when its parent company, PE Corporation, became Applera Corporation. This new name is a combination of the names of the company’s two operating businesses, the Applied Biosystems Group and the Celera Genomics Group.
Applied Biosystems is a manufacturer of a kit-based sequencing assay. This kit is currently commercialized as a Research Use Only assay.
GENERAL INFORMATION
Assay Names
ViroSeq™ HIV-1 Genotyping System
Collaborators/Distributors
RDL, Contra Costa County Public Health Laboratory
Availability
Commercially available for research use only.
Regulatory Status
For "Investigational Use Only" under an FDA-approved IDE in CLIA certified labs. Applied Biosystems is a CLIA certified laboratory.
Proficiency Testing Programs
Content in development.
Clinical Trials
Content in development.
Financial Assistance
No
ASSAY INFORMATION
Genotypic
Codons Interrogated
Turnaround time
Sensitivity
RT
PI
Full sequencing assay
1–320
1–99
Variable
500 RNA copies/mL
METHODOLOGY
Viral RNA is extracted from plasma and amplified through RT-PCR. The products undergo dye terminator sequencing. ViroSeq HIV-1 Genotyping System uses DNA Sequencing technology: the entire protease gene and the first 320 codons of the reverse transcriptase gene are sequenced to identify the HIV-1 mutations. ViroSeq system software is then used to compare the sequences with wild type viral sequences (HXB2) and against a database of known resistance mutations to determine the resistance mutations.
REPORT INFORMATION
Report
Drug Resistance Interpretation
Genotype
Yes
Currently, the report and interpretation are based on HIV-1 mutations that are known to be associated to drug resistance. Additional content in development.
500 RNA copies/mL