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cobas® HIV-1 Test

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Targets two unique regions of the HIV-1 genome on cobas® 4800 and cobas® 5800/6800/8800 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® 4800 and cobas® 5800/6800/8800 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® 4800 and cobas® 5800/6800/8800 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
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Intended use

Intended use

CE-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.

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.

CE-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® 5800/6800/8800 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 4800 System: CE-IVD 

cobas® HIV-1 for 5800/6800/8800 Systems: CE-IVD

Package inserts

Access package inserts through Roche DiaLog.

Related diseases

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.
  2. 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® 4800 System Performance

  • Sample type

    EDTA plasma

  • Sample processing volume

    400 µL 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 interval: 99.5%)

  • Genotypes detected

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

cobas® 5800/6800/8800 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

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