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news.Roche has announced that its new dual-target HIV-1 test has received CE Mark certification, allowing it to be sold for clinical use in the European Union.
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The Cobas AmpliPrep/Cobas TaqMan HIV-1 Test, v2.0 utilizes a unique design to simultaneously amplify and detect two separate regions of the HIV-1 genome, the company said. This approach reportedly provides reliable test results even when mutations are present. 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.
According to the company, 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 milliliter of patient sample. The test can also accurately quantify the amount of HIV in a patient sample up to 10 million copies/mL representing a broader dynamic range than previous generation tests, the company added.
Daniel O’Day, president and CEO of Roche Molecular Diagnostics, said: HIV mutations are a serious problem. Because it is impossible to predict when these mutations will occur, we have designed this test to detect all HIV-1 (Group M and O) strains. This innovative fully automated solution will provide reliable results for laboratories and physicians to more confidently and efficiently treat HIV-1 patients undergoing therapy.