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cobas® HIV-1 for use on the cobas® 4800 System

Reliable HIV genome detection

Targets two unique regions of the HIV-1 genome

It takes more than a single target

Trust in a reliable HIV-1 viral load monitoring test built upon the dual-target assay design, only from Roche.

The cobas® HIV-1 quantitative nucleic acid test for use on the cobas® 4800 Systems targets two unique regions of the HIV-1 genome to improve genotype inclusivity, detect HIV-1 variants and potentially avoid under quantification. The rapidly mutating HIV-1 virus can evade quantification with a single-target, viral-load assay.1,2

Get dual-target reliability for HIV-1 quantification

This dual-target approach improves test sensitivity, coverage and security in the event of mutation in one primer/probe region.

  • 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

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 of disease progression 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.

Performance

Parameters Performances
Sample type EDTA plasma
Sample processing volume 400 or 200 µL
Analytical sensitivity (LoD by hit rate of ≥ 95%) 400 µL: 14.2 copies/mL
200 µL: 43.9 copies/mL
Linear range 400 µL: 20 copies/mL – 1.0 x 107 /mL
200 µL: 60 copies/mL – 1.0 x 107 /mL
Specificity 100% (one-sided confidence inverval: 99.5%)
Genotypes detected HIV-1 Group M (A-D, F-H, CRF01_AE, CRF02_AG), Group O, Group N

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.