AMPLICOR HIV-1 Monitor Test, v1.5

• 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

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.