cobas^® HIV-1 Test

Roche Dual Target HIV 1

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Intended use

cobas^® HIV-1 for the 4800/6800/8800 Systems

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.

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.

References

^{1. Loeb LA et al. Lethal mutagenesis of HIV with mutagenic nucleoside analogs. Proc Natl Acad Sci U S A. 1999; 96: 1492–1497.}

^{2. [15] Wainberg MA et al. The development of novel HIV integrase inhibitors and the problem of drug resistance. Curr Opin Virol. 2012; 2: 656-662.}

^{3. Data on File with Roche Diagnostics, September 2015.}

^{4. Reference Drug Manufacturer Package Inserts.}

^{5. DHHS Guidelines for the Use of Antiretroviral Agents in HIV-1-Infected Adults and Adolescents. Last Updated July 14, 2016. https://aidsinfo.nih.gov/contentfiles/lvguidelines/adultandadolescentgl.pdf. Accessed 2/1/2017.}

^{6 .J. Clin, Microbology. Damond F et al. (2010).}

^{7. J Clin Microbiol. Wojewoda CM et al. (2013).}

^{8. HIV in the United States: At A Glance. https://www.cdc.gov/hiv/statistics/overview/ataglance.html accessed on 1-26-2018.}

cobas^® 6800/8800 Systems Performance

Sample type

EDTA plasma
Sample processing volume

200 µL⁹
Analytical sensitivity (LoD by hit rate of ≥ 95%)

500 µL: 13.2 copies/mL
Linear range

500 µL: 20 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

^References:

^{9. Roche cobas HIV-1 Package Insert (w/ Low Volume) (v3.0, pg. 13)}

Intended use

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

US-IVD

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.