Profile:

COBAS^® TaqMan^® HIV-1 Test, v2.0 For Use With The High Pure System

State-of-the-art dual target technology now available for all COBAS^® TaqMan^® HIV customers

An advanced and reliable HIV-1 viral load detection with a dual-target approach.

A viral load test* used to quantify the amount of Human Immunodeficiency Virus Type 1 (HIV-1) in human plasma of HIV infected individuals. The test is used as an aid in the management of HIV infected patients undergoing anti-viral therapy. It also increases the probability of detection and expands coverage by targeting two highly conserved regions of the HIV-1 genome to compensate for the possibility of mutations or mismatches.

Features and benefits

Features

All COBAS^® TaqMan^® HIV-1 Assays are fully traceable to WHO International Standards
The test uses the High Pure System Viral Nucleic Acid Kit for manual specimen preparation and the COBAS^® TaqMan^® 48 Analyser for automated amplification and detection
The test can quantitate HIV-1 RNA over the range of 34 to 10,000,000 copies/mL

Benefits

Enhanced reliability and greater security of test results in the increasing presence of mutations
Dual target approach expands coverage and provides additional security in the event of a mutation in one of the primer/probe regions
Global Surveillance Program ensures current and future products remain state of the art
There are over 26,000 HIV-1 sequences in the database

Intended use

The COBAS^® TaqMan^® HIV-1 Test, version 2.0 (v2.0) For Use With The High Pure System is an in vitro nucleic acid amplification test for the quantitation of Human Immunodeficiency Virus Type 1 (HIV-1) RNA in human plasma, using the High Pure System Viral Nucleic Acid Kit for manual specimen preparation and the COBAS^® TaqMan^® 48 Analyser for automated amplification and detection. The test can quantitate HIV-1 RNA over the range of 34 to 10,000,000 copies/mL. One copy of HIV-1 RNA is equivalent to 1.7 ± 0.1 International Units (IU) based on the World Health Organisation 1st International Standard for HIV-1 RNA (NIBSC code 97/656).

The test is intended for use in conjunction with clinical presentation and other laboratory markers of disease progress for the clinical management of HIV-1 infected patients. The test can be used to assess patient prognosis by measuring the baseline HIV-1 RNA level or to monitor the effects of antiretroviral therapy by measuring changes in EDTA plasma HIV-1 RNA levels during the course of antiretroviral treatment.

The COBAS^® TaqMan^® HIV-1 Test, v2.0 is not intended to be used as a screening test for the presence of HIV-1 in blood or blood products or as a diagnostic test to confirm the presence of HIV-1 infection.

*The COBAS^® TaqMan^® HIV-1 Test, v2.0 For Use With The High Pure System is not available in the United States.

Registration status

CE-IVD

Package inserts

Access package inserts through your country’s Roche Diagnostics Website.

COBAS® TaqMan® HIV-1 Test, v2.0 For Use With The High Pure System

State-of-the-art dual target technology now available for all COBAS® TaqMan® HIV customers