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AMPLICOR HIV-1 Monitor Test, v1.5 |  | | General Information |  |
| Vendor |  | Roche Diagnostics | | Item |  | AMPLICOR HIV-1 Monitor Test, v1.5 | | Catalog Number |  | Inquire | | Features |  | - High levels of sensitivity for an accurate measurement of viral suppression in patients on anti-retroviral therapy
- 100% specificity
- A domain of linearity from 50 to 750,000 copies/mL1
- Proven performance in major pharmaceutical studies
- The only FDA-approved test which can measure HIV-1 RNA down to 50 copies/mL
- Quantification of HIV-1 Group M subtypes A-G
| | Approval |  | US FDA | | Analysis Time |  | Inquire | | Analyte |  | HIV-1 RNA Detection by PCR | | Sample Material |  | human plasma | | Sensitivity and Specificity |  | 50 RNA copies/mL | | Test Duration |  | Inquire | | CLIA waved |  | No | | Number of Tests |  | Inquire | | Pricing |  | Inquire |
 | | Product Description |  |
| The AMPLICOR HIV-1 MONITOR Test, v1.5, an FDA-approved HIV-1 RNA assay, is utilized for HIV-1 viral load testing, has been used in the regulatory approval for HIV-1 therapies, and is now found in eight out of 10 clinical laboratories worldwide.
The AMPLICOR HIV-1 MONITOR® Test, v1.5 is an in vitro nucleic acid amplification test for the quantification of Human Immunodeficiency Virus Type 1 (HIV-1) RNA in human plasma. The test can be used to assess patient prognosis by measuring the baseline HIV-1 RNA level and to monitor the effects of anti-retroviral therapy by measuring changes in plasma HIV-1 RNA levels during the course of anti-retroviral treatment. The Gold Standard in Viral Load Assessment
The AMPLICOR HIV-1 MONITOR® Test was the first commercial FDA-approved test to quantify the amount of HIV-1 RNA. This test has been used for FDA approval of most of the currently approved anti-retroviral drugs. With a limited number of treatment regimens available to HIV-1 patients, the accurate monitoring of viral load levels is essential to establish and monitor the effectiveness of therapeutic regimens, assess the potential of drug resistance and identify treatment failure.
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| Roche Diagnostics | Call Roche Diagnostics to buy products (US and Canada only; other locations use number below) 1-866-415-6694 |
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