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> > > AMPLICOR HIV-1 Monitor Test, v1.5

AMPLICOR HIV-1 Monitor Test, v1.5

AMPLICOR HIV-1 Monitor Test, v1.5
General Information
VendorRoche Diagnostics
ItemAMPLICOR HIV-1 Monitor Test, v1.5
Catalog NumberInquire
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
ApprovalUS FDA
Analysis TimeInquire
AnalyteHIV-1 RNA Detection by PCR
Sample Materialhuman plasma
Sensitivity and Specificity50 RNA copies/mL
Test DurationInquire
CLIA wavedNo
Number of TestsInquire
PricingInquire
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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