Automated Test for Measuring Viral Load in HIV Patients

The test has been cleared by the US Food and Drug Administration (FDA).

The assay amplifies and detects genetic material, allowing for accurate quantification of even small amounts of viral RNA in the blood. In fact, the test can measure viral loads as low as 50 copies of HIV-1 RNA per milliliter of plasma. This level of sensitivity is needed for optimizing treatment strategies, since maintaining an infected patient's viral load below 50 copies/ml (undetectable) has been associated with a more complete and durable viral suppression.

The new assay also has the ability to quantify HIV-1 Group M subtypes A-G. While HIV-1 subtype B continues to predominate in Western countries, studies now confirm that the incidence of HIV-1 non-B subtypes is increasing all over the world. A test's ability to detect a broader range of these genetically diverse viruses will therefore be crucial to HIV patient care on a global basis. Called Cobas Amplicor HIV-1 Monitor Test (version 1.5), the assay is the automated version of the Amplicor HIV-1 Monitor Test introduced earlier. The test is the product of Roche (Basel, Switzerland).

"The Cobas Amplicor HIV-1 Monitor Test (version 1.5) will allow laboratories to deliver quality HIV viral load results in a shorter time, thanks to cutting edge automation,” noted Heino von Prondzynski, head of Roche Diagnostics.




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