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Advanced and reliable detection with a dual-target approach

Get the bigger picture with dual targeting – the new standard for accurate quantification

Now you can ensure enhanced reliability of test results and more confidence in assessing viral loads with the COBAS® AmpliPrep/COBAS® TaqMan® HIV-1 Test, v2.0 (Cat. No. 05212294190)*. Increase the probability of detection and expand your coverage by targeting two highly conserved regions of the HIV-1 genome to compensate for the possibility of mutations or mismatches. Because it is impossible to predict when these mutations will occur, Roche designed this test to detect all HIV-1 strains (Group M, Subtypes A-H and Group O).

It is critical for viral load monitoring tests to be able to quantify very low and high levels of virus, an indicator of the need for more or less aggressive treatment. The test is highly sensitive and can detect the World Health Organization HIV-1 RNA Standard in EDTA plasma as low as 20 copies per millilitre of patient sample. The test can also accurately quantify the amount of HIV-1 in a patient sample up to 10 million copies/mL representing a broader dynamic range than previous generation tests.

The test uses Roche's proprietary fully automated real-time PCR technology to quantify the amount of HIV-1 RNA in a patient's blood. It provides reliable results for laboratories and physicians to more confidently and efficiently treat HIV-1 patients undergoing therapy.

The COBAS® AmpliPrep/COBAS® TaqMan® HIV-1 Test, v2.0 is the first dual-target test to be offered on the COBAS® AmpliPrep/COBAS® TaqMan® System. The COBAS® AmpliPrep/COBAS® TaqMan® System is flexible and customizable to meet the space and workflow needs of any laboratory.

The COBAS® AmpliPrep/COBAS® TaqMan® HIV-1 Test, v2.0 is intended for use in conjunction with clinical presentation and other laboratory markers of disease progress for the clinical management of HIV-1 group M and HIV-1 group O infected patients. The test can be used to assess patient prognosis by measuring the baseline HIV-1 RNA level or to monitor the effects of antiretroviral therapy by measuring changes in EDTA plasma HIV-1 RNA levels during the course of antiretroviral treatment.

About HIV-1

According to estimates by the World Health Organization (WHO) and UNAIDS, 33.2 million people were living with HIV at the end of 2007. That same year, some 2.5 million people became newly infected, and 2.1 million died of AIDS, including 330,000 children.

The human immunodeficiency virus (HIV) is a retrovirus that infects cells of the human immune system, destroying or impairing their function. In the early stages of infection, the person has no symptoms. Within 10-15 years an HIV infection will develop into acquired immunodeficiency syndrome (AIDS); antiretroviral drugs can slow down this process even further. HIV is transmitted through unprotected sexual intercourse (anal or vaginal), transfusion of contaminated blood, sharing of contaminated needles, and between a mother and her infant during pregnancy, childbirth and breastfeeding.

Keep a step ahead of HIV-1’s history of rapid mutation

HIV-1 mutations are a serious problem. The innovative dual target approach provides reliable test results even when mutations are present. The COBAS® AmpliPrep/COBAS® TaqMan® HIV-1 Test, v2.0, targets two highly conserved regions of the HIV-1 genome – gag and Long Terminal Repeat (LTR) – increasing the probability of detection. The LTR primers have broad genotype inclusivity and are well conserved phylogenetically. The dual target approach expands your coverage and security in the event of mutation in one primer/probe region. It provides diagnostic accuracy of test results even when mutations should occur in one of the two regions.

In the face of the rapidly growing genetic diversity of HIV-1 and its implications for the efficacy of antiretroviral therapy, the new dual-target approach

  • provides diagnostic accuracy of test results even if mutations occur in one of the 2 regions
  • compensates for the possibility of mismatch occurring with a primer/probe region – and increases the probability of detection
  • ensures enhanced reliability of test results and more confidence in assessing viral loads
  • offers greater security of test results against the growing number of unexpected mutations

Furthermore, by targeting gag and LTR the COBAS® AmpliPrep/COBAS® TaqMan® HIV-1 Test, v2.0 avoids sequence regions that are targets of antiviral drug selection – in contrast to other molecular diagnostic tests which target the pol or int region of the HIV-1 genome.

It is well known that the HIV-1 genome is rapidly mutating and that drug resistance is the inevitable consequence of incomplete suppression of HIV-1 replication. The rapid replication rate of HIV and its inherent genetic variation (caused by using reverse transcription as replication mechanism) have led to the identification of many HIV-1 variants that exhibit altered drug susceptibility. The ability of HIV to mutate itself in the presence of antiretroviral drugs can lead to treatment failure, increased direct and indirect health costs associated with the need to start more costly second-line treatment for patients, the spread of resistant strains of HIV and the need to develop new anti-HIV drugs.

Although the complete HIV-1 genome is prone to acquiring mutations, the application of antiretroviral drug classes – such as Reverse Transcriptase and Integrase inhibitors – is exerting an even more increased selective pressure on HIV-1, causing new (resistance) mutations at an enhanced rate especially in those genes coding for the target enzymes of these drugs. International data show that e.g. raltegravir (an Integrase inhibitor) failure was associated with major and minor Integrase mutations in two genetic pathways. Mutations in the primer/probe regions of the HIV-1 genome can make HIV-1 tests less reliable; by targeting only one region, it is possible that the HIV-1 test may not work if patients develop resistance to the drug due to mutations in that region. The dual-target approach of the COBAS® AmpliPrep/COBAS® TaqMan® HIV-1 Test, v2.0, compensates for the possibility of a mismatch occurring within a primer/probe target region and increases the probability of detection.

Robust test performance delivers more confident results

The COBAS® AmpliPrep/COBAS® TaqMan® HIV-1 Test, v2.0:

  • Provides diagnostic accuracy of test results even if mutations occur in one of the two regions.
  • Compensates for the possibility of mismatch occurring with a primer/probe region.
  • Ensures enhanced reliability of test results and more confidence in assessing viral loads.
  • Offers primers and probes that are used to amplify the gag and LTR regions
  • Provides LTR primers that have broad genotype inclusivity and are well conserved phylogenetically.
  • Quantifies the clinically significant HIV-1 groups and subtypes with full subtype coverage and quantification of HIV-1 groups O and M.
  • Offers increased sensitivity and linear range for accurate measurement of viral suppression.
  • Has a lower limit of detection (LOD) and 100% specificity at 20 copies/mL than previously available HIV-1 tests.
  • Is fully traceable to WHO international standards.

See the product information brochure and flyer for more detailed performance data.

*To be able to run the COBAS® AmpliPrep/COBAS® TaqMan® HIV-1 Test, v2.0 a new Test Definition File has to be installed into AMPLILINK Software on the COBAS® AmpliPrep/COBAS® TaqMan® System. There are two different TDFs available:

  • COBAS® AmpliPrep/COBAS® TaqMan® HIV-1 Test, v2.0 TDF for COBAS® TaqMan® 48 Analyser (Cat. No. 05332508190)
  • COBAS® AmpliPrep/COBAS® TaqMan® HIV-1 Test, v2.0 TDF for the COBAS® TaqMan® Analyser (Cat. No. 05332559190)
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