Molecular cobas HIV-1 Test

Human Immunodeficiency Virus: (HIV)

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Overview
Virology Human Immunodeficiency Virus HIV

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.

8TH GENERATION HIV TEST

With the experience of 52 million viral loads3 and 40 clinical drug trials4, Roche launched its 8th generation HIV test on the cobas® 6800/8800 analyzer, still the most clinically validated test available.

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.

Specific drug target reqions are shown for protease inhibitors (PI), reverse transcriptase inhibitors (NRTI/NNRTI), and integrase inhibitors. The Roche cobas HIV-1 test targets both the LTR (long terminal repeat) and gag (group specific antigen) genes for a dual target approach to HIV detection and quantification.5,6,7

 

HIV: Still Prevalent and Spreading

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

6,721 deaths were attributed
directly to HIV in 20148

We are committed to continuous global surveillance with mutating viruses and the latest innovation in assay design

In 1998 Roche introduced the Global Surveillance Program to monitor and stay ahead of changes in HIV-1 sequences and isolates. Through this program, Roche collaborates with laboratories around the world monitoring changes in genomic sequences and isolates of multiple viruses.

With our more than 80% market share worldwide, Roche is provided access to rare clinical lab specimens along with sequences in the public domain. As HIV-1 diversity and complexity increases, our database records and tracks these changes.

Currently the Global Surveillance database contains over 26,000 sequences. This program ensures that current and future Roche assays accurately quantify HIV-1 RNA providing our customers with confidence in each HIV-1 viral load result for every patient regardless of subtype or treatment regime.

The HIV Test is based upon
Real-Time PCR Gold Standard Technology

The #1 choice that patients depend on

Receive the unmatched reliance of Roche PCR tests with 82% of US virology market share9 and 52 million HIV tests performed3.

Trends in HIV Care & Viral Load Monitoring

Opportunities and Challenges

HIV Viral Load Monitoring

An Open Letter to the Clinical Lab William M. Valenti, MD

Consistent performance, regardless of platform3

Seamless transition — consistent performance

 
  COBAS® AmpliPrep / COBAS® TaqMan System10 COBAS® 6800 System / COBAS® 8800 System11
Specificity 100%
Primer and probe design Dual target designed to increase flexibility and avoid misquantification
Linear range 20 - 1.0E+07 cp/mL
Contamination control with AmpErase Yes
  Analytical sensitivity (LOD by probit analysis)
EDTA plasma (IU/mL) 16.5 cp/mL 13.2 cp/mL

Get additional Performance data and learn more about the innovation with cobas® 6800/8800 Systems

Evolutionary virology assay development program

Continuous innovation and menu expansion

cobas® HCV Test

Redefining HCV Viral Load Monitoring

The cobas® HCV test is the first and only FDA-approved HCV RNA viral load test for use as an aid in the diagnosis of active HCV infections.

cobas® HBV Test

Quantitate HBV viral loads with Confidence

The cobas® HBV test is a real-time PCR test that provides quantitative HBV DNA results that have an impact on the workflow in your laboratory without compromising the results you rely on.

COBAS®
AmpliPrep/COBAS®
TaqMan® CMV Test

Standardization for patients. Simplification for laboratories.

The COBAS® AmpliPrep/COBAS® TaqMan® CMV test is a fully automated FDA-approved CMV test that delivers the benefits of standardization for clinical decision making, while providing improved efficiencies the laboratory truly needs.

COBAS, AMPLIPREP, and TAQMAN are trademarks of Roche.

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 Virol Methods. Damond F et al. (2010).
  7. J Clin Microbiol. Wojewoda CM et al. (2013).
  8. HIV in the United States: At A Glance. Accessed on 2/1/2017 http://www.cdc.gov/hiv/statistics/overview/ataglance.html.
  9. Independent market research validated through secondary sources.
  10. cobas AmpliPrep/ cobas TaqMan HIV test, v2.0 package insert 05328276001-04EN ver. 4.0.
  11. cobas HIV-1 package insert 07175493001-01EN, ver. 1.0.
Explore

cobas® HIV Test Intended Use1

COBAS® 6800/8800 Systems

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.

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.


Method correlation1

Excellent correlation to COBAS® AmpliPrep/COBAS® TaqMan HIV Test



cobas® HIV Test Innovation Review

Key improvements in simplicity and functionality

 

 

  COBAS® AmpliPrep / COBAS® TaqMan System3 COBAS® 6800 System / COBAS® 8800 System1

Benefits

Sample type EDTA plasma EDTA and PPT plasma Increases flexibility of specimen types
Sample size 1250 uL 650 uL Reduces need for extra blood draws
CLIA complexity categorization High Moderate Increases flexibility of personnel
Coverage HIV-1 Group M (A-D, F-H, CRF01_AE, CRF02_AG), Group O HIV-1 Group M (A-D, F-H, CRF01_AE, CRF02_AG), Group O, Group N Increases genotypes covered
Tests per package 48 96 Reduces waste
Control packaging Included in kit Packaged separately
Onboard open reagent stability 64 hours 30 days or 10 runs

References:

  1. cobas® HIV-1 package insert 07175493001-01EN, ver. 1.0.
  2. cobas® AmpliPrep/cobas® TaqMan HIV test, v2.0 package insert 05328276001-04EN ver. 4.0.
Performance

cobas® HIV Test Performance Summary

Gold Standard Performance with additional benefits

 
  COBAS® AmpliPrep / COBAS® TaqMan System1 COBAS® 6800 System / COBAS® 8800 System2
Specificity 100%
Primer and probe design Dual target designed to increase flexibility and avoid misquantification
Linear range 20 – 1.0E+07 cp/mL
Contamination control with AmpErase Yes
  Analytical sensitivity (LOD by probit analysis)
EDTA plasma 16.5 cp/mL 13.2 cp/mL

Need additional performance data?

References:

  1. cobas® AmpliPrep/ cobas® TaqMan HIV test, v2.0 package insert 05328276001-04EN ver. 4.0.
  2. cobas® HIV-1 package insert 07175493001-01EN, ver. 1.0.
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