>>The Food and Drug Administration is considering changes to its blood-donor guidelines including increasing the time that people suspected of having or diagnosed with West Nile virus should be prohibited from giving blood.<<
Considering that anyone in many parts of the U.S. who has been bitten by a mosquito could be "suspected" of having West Nile virus, this could be a tricky ruling to enforce.
(And could substantially decrease the blood donor pool.)
>>Those who test positive for the mosquito-borne illness are also deferred for 28 days.<<
>> There have been two probable cases of human-to-human vCJD transmission via blood transfusions reported in the past year. Since there are no clinical signs or symptoms of the disease for many years, and the only reliable tests to determine who has the disease are performed post-mortem, there is no way of knowing how many people may be harboring vCJD and donating blood.
These events have spurred increasing concern about the possibility of a second and bigger wave of mad cow disease in humans. Public health officials and risk assessment experts believe that the problem is not limited to the UK, where a majority of the early cases of vCJD have been identified, or to Europe, but is a potential global threat that includes the U.S. and Canada. They urge that in addition to maintaining existing precautionary measures, additional risk assessments should be conducted for blood products in the U.S. <<
>> FDA Accepts for Review New Roche Diagnostics Blood Screening Test
Automated test is designed to detect broader range of HIV and hepatitis in a single multiplex assay.
PLEASANTON, Calif., March 7 /PRNewswire/ -- Roche Diagnostics announced today that the United States (U.S.) Food & Drug Administration has accepted for review its application for a new test designed to detect a broad range of human immunodeficiency virus (HIV) and viral hepatitis infections in donated blood and plasma. The test, called the cobas TaqScreen MPX Test, uses real- time PCR to detect HIV type 1 (Groups M & O), HIV type 2, hepatitis C virus (HCV), and hepatitis B virus (HBV) in a single multiplex assay. The test is designed for use on Roche's newly automated, modular cobas s 201 platform. Nucleic acid amplification technologies such as PCR allow earlier and more specific detection of active infections in donated blood than earlier generation serology tests, helping to ensure a safer blood supply and retention of donors who would otherwise be deferred.
"We are pleased to have reached this important milestone in bringing multiplex testing and full automation to the U.S. blood-screening market," said Daniel O'Day, head of Roche Molecular Diagnostics, a business area of Roche Diagnostics that developed the test. "We believe this automated test, with detection of HIV-1 Group O and HIV-2, may help blood banks and laboratories improve blood safety, workflow efficiency, and donor retention. In addition, the system's modular design and optional built in back-ups are designed to minimize downtime in this highly time-sensitive industry."
The U.S. Centers for Disease Control estimates that there are more than a million people in the U.S. living with HIV/AIDS, with an additional 40,000 people being infected each year. It is estimated that 300,000 infected persons are unaware of their HIV status. More than 4 million people in the U.S. have been infected with HCV, 3.2 million of whom are chronically infected. HCV is the leading cause of liver cancer in the U.S. and is the leading diagnosis in patients undergoing liver transplantation. More than 1,200,000 people are chronically infected with HBV and about 5,000 people die of complications of HBV every year. Many individuals with HBV and HCV show no symptoms of disease and do not know that they are infected. These individuals may attempt to donate blood. The cobas TaqScreen MPX assay is designed to identify infected blood from these potential donors, before they inadvertently transmit infection to others. <<
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