cobas^® HIV-1 Test

Viruses evolve, so have we

HIV-1, either from polymorphic¹ or drug pressure², continues to mutate; yet you can test with confidence, knowing that Roche will continue to improve testing and keep you a step ahead of this highly mutagenic virus.

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Right Targets, Right Reasons

All tests are not created equal

Selective drug pressure on a drug target can cause underquantification for any single target assay. Potentially compromising treatment efficacy
Targeting two non-drug target regions improves genotype inclusivity, detects HIV-1 variants and potentially avoids under quantification
Amplification of a less ideal target region(s) might explain discrepancies observed in the literature
The Aptima HIV-1 Quant Assay has dual-target amplification and detection systems, targeting pol and LTR independently. The result reported by the system will be based on the primary system, pol, unless pol is not amplified. In these cases, the system will report the result from the secondary system, LTR.

HIV: Still Prevalent and Spreading

More than 1.2 million people in the US are living with HIV⁸

Roche Dual Target HIV 1

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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 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.

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cobas® HIV-1 Test

Viruses evolve, so have we

Right Targets, Right Reasons

All tests are not created equal

HIV: Still Prevalent and Spreading

More than 1.2 million people in the US are living with HIV8

Related information

Accurately quantify and detect HIV-1

cobas® 6800/8800 Systems Performance