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cobas® HIV-1 for use on the cobas® 6800/8800 System

Confidently and effectively quantify HIV-1

Stay one step ahead, with a dual-target HIV-1 approach

As the challenges you face evolve, stay one step ahead with cobas® HIV-1 for use on the cobas® 6800/8800 Systems, a next-generation, dual-target quantitative HIV-1 assay.

The rapidly mutating HIV-1 virus can evade quantification with a single target viral load assay.1,2 cobas® HIV-1 quantitative nucleic acid test for use on the cobas® 6800/8800 Systems targets two unique regions of the HIV-1 genome to improve genotype inclusivity, detects HIV-1 variants and potentially avoids under quantification.

Get improved sensitivity, coverage and security

Roche dual-target assays provide reliable results to confidently and effectively quantify HIV-1 with improved test sensitivity, coverage and security.

  • Target two unique regions of the HIV-1 genome, gag and LTR, which are not subject to selective drug pressure.
  • Confidently detect HIV-1 variants and potentially avoid under quantification.
  • Accurately quantify HIV-1 RNA with a dual-target assay and contribute to optimal treatment decisions for patient management.

 

Intended use

US-IVD:

cobas® HIV-1 is an in vitro nucleic acid amplification test for the quantitation of human immunodeficiency virus type 1 (HIV-1) in EDTA plasma of HIV-1-infected individuals using the automated cobas® 6800/8800 Systems for specimen processing, amplification and detection. The test can quantitate HIV-1 RNA over the range of 20-10,000,000 copies/mL (33 to 1.67 x 107 International Units/mL).

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

cobas® HIV-1 is not intended for use as a screening test for the presence of HIV-1 in donated blood or plasma or as a diagnostic test to confirm the presence of HIV-1 infection.

CE-IVD:

cobas® HIV-1 is an in vitro nucleic acid amplification test for the quantitation of human immunodeficiency virus type 1 (HIV-1) in EDTA plasma of HIV-1-infected individuals.

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

Parameters Performances
Sample type  EDTA Plasma, Serum
 Sample processing volume  500 μL or 200 μL
 Analytical sensitivity (LoD by hit rate of ≥ 95%) 500 μL: 13.2 copies/mL
200 μL: 35.5 copies/mL*
 Linear range 500 μL: 20 copies/mL – 1 x 107 copies/mL
200 μL: 50 copies/mL – 1 x 107 copies/mL*
 Specificity 100.0% (one-sided 95% confidence interval; 99.5%)
 Genotypes detected  HIV-1M (A-D, F-H, CRF01_AE, CRF02_AG), HIV-1O, HIV-1N

* 200μL volume not commercially available in the United States

Accurately quantify and detect HIV-1

The innovative cobas® HIV-1 dual-target assay enables accurate detection and quantification even in the presence of drug-induced mutations, driving better decisions for a positive impact on patients’ lives.

References:

  1. Sire JM, et al. Comparative RNA quantification of HIV-1 Group M and non-M with the Roche Cobas AmpliPrep/Cobas TaqMan HIV-1 v2.0 and Abbott Real-Time HIV-1 PCR assays. J Acquir Immune Defic Syndr. 2001;56: 239-243.
  1. Damond F, et al. Evaluation of an upgraded version of the HIV-1 test for HIV-1 viral load quantification. J Clin Microbiol. 2010;48:1413-1416.