FDA Issues Urgent Recall For Roche Cobas Amplicor HIV-1 Monitor Test
The United States Food and Drug Administration (FDA) issued an urgent recall this month for Roche Diagnostics’ Cobas Amplicor HIV-1 Monitor Test, v1.5, due to invalid test results from faulty standardizing solutions.
The test is used by doctors to measure HIV viral loads, or the amount of virus present in the bloodstream. The FDA states that the problem causes an error that prevents the test from giving results.
The FDA advised customers to discontinue use of lot M02635, with an expiration date of June 30, and to contact Roche Molecular Diagnostics Technical Support. The catalog number for the affected lot is 03155935018.
The Cobas Amplicor HIV-1 Monitor Test, cleared by the FDA in 2003, is a type of polymerase chain reaction (PCR) test used to measure viral load. It works by amplifying and measuring the amount of HIV RNA (HIV genetic material) in blood samples.
Together with CD4 cell counts, the test provides a baseline measurement that shows how actively the HIV virus is replicating.
A low test result indicates that the HIV virus is not actively multiplying, meaning that the risk of disease progression is low. A high result indicates that the virus is replicating and the disease is likely to progress faster.
Measuring viral loads and CD4 counts allow doctors to determine when patients should start antiretroviral treatment, and to monitor how well antiretrovirals are working for people already taking them.
Although different PCR tests are available, the different test methods often give different results for the same patient blood sample. Therefore, patients should use the same kind of test to measure viral load over time.
For more information, please see the press release on the FDA website.
I received a new batch of Cobas Amplicor HIV-1 Monitor kit with Lot No M15605 Expiry date 2011/04 two days ago. 70-80% of the results have invalid quantitation standards (QS). Could this be related to this problem?
Mr. Achidri,
At this time there is no information on the lot number you purchased, M15605. However, given the recent recall, you may wish to contact Roche Diagnostics about your problems to see if they can help. The California facility can be reached at 1-925-730-8000, or you can contact Roche through their website here:
http://molecular.roche.com/servicebox/contact/index.php
Hope that helps!
Courtney McQueen
Managing Editor
The AIDS Beacon
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