cobas^® HIV-1 Test

Targets two unique regions of the HIV-1 genome on cobas^® 6800/8800 Systems

It takes more than a single target

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, only from Roche.

The 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, 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

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

Contact

Roche Dual Target HIV 1

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Intended use

cobas^® HIV-1 for the 6800/8800 Systems

US-IVD

The 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.

The 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.

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.

Registration status

cobas^® HIV-1 for 6800/8800 Systems: US-IVD

Package inserts

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

References

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.
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.

cobas^® 6800/8800 Systems* Performance

Sample type

EDTA plasma
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 - 1.0 x 10⁷/mL
200 µL: 50 copies/mL - 1.0 x 10⁷/mL**
Specificity

100% (one-sided 95% confidence interval; 99.5%)
Genotypes detected

HIV - 1M (A - D, F - H, CRF01_AE, CRF02_AG), HIV - 1O, HIV - 1N

*200 μL volume not commercially available in the United States.

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cobas^® 6800 System

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cobas^® 8800 System

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cobas® HIV-1 Test

Targets two unique regions of the HIV-1 genome on cobas® 6800/8800 Systems

It takes more than a single target

Intended use

Accurately quantify and detect HIV-1

Registration status

Package inserts

Related diseases

cobas® 6800/8800 Systems* Performance

Related assays