FDA Approves Comprehensive System to Test Donated Blood for HIV, Hepatitis B and Hepatitis C

[Guest guest]

http://www.infectioncontroltoday.com/hotnews/testing-donated-blood.html

FDA Approves Comprehensive System to Test Donated Blood for HIV, Hepatitis B and

Hepatitis C

01/02/2009

The Food & Drug Administration (FDA) today approved a new nucleic acid test from

Roche to screen donated blood for HIV-1 Group M RNA, hepatitis C RNA and

hepatitis B DNA in a single, automated assay. The test, called the cobas

TaqScreen MPX Test for use on the cobas s 201 system, is a qualitative in vitro

test for comprehensive single-assay detection of HIV-1 Group M RNA, HIV-1 Group

O RNA, HIV-2 RNA, hepatitis C virus RNA and hepatitis B virus DNA in human

plasma. The test, which is not intended for use as an aid in diagnosis, is

designed to further increase the safety of blood supplies by identifying

infections earlier than traditional serology tests.

" Roche is committed to meeting the needs of blood centers with tests and systems

that ensure the highest blood safety, " said O'Day, head of Roche

Molecular Diagnostics, the business area of Roche Diagnostics that developed the

test. " Our multiplex test has been widely adopted and has demonstrated excellent

performance in blood centers worldwide. We are pleased to introduce it in the

U.S. as we continue to further invest in solutions for this critical industry. "

The test runs on the fully automated, real-time PCR cobas s 201 system, designed

to increase processing efficiency with a unique modular design and ready to use

reagents.

" The Roche MPX test raises the blood industry to a higher level with regard to

overall blood safety, process simplification and process control, " said Louis M.

Katz, MD, executive vice president of medical affairs at Mississippi Valley

Regional Blood Center, one of the TaqScreen MPX clinical trials sites. " Our

organization looks forward to using the MPX test. "

Countries that have implemented NAT testing have demonstrated a reduction in

transfusion-related HIV, HBV, and HCV infections. In the U.S. alone, the Centers

for Disease Control and Prevention (CDC) estimates that there are more than 1

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. More than 1,200,000 people are

chronically infected with HBV and about 5,000 people die of complications of HBV

every year in the U.S. Many individuals with HBV and HCV show no symptoms of

disease, and do not know that they are infected.

Source: Roche

[Guest guest]

http://www.infectioncontroltoday.com/hotnews/testing-donated-blood.html

FDA Approves Comprehensive System to Test Donated Blood for HIV, Hepatitis B and

Hepatitis C

01/02/2009

The Food & Drug Administration (FDA) today approved a new nucleic acid test from

Roche to screen donated blood for HIV-1 Group M RNA, hepatitis C RNA and

hepatitis B DNA in a single, automated assay. The test, called the cobas

TaqScreen MPX Test for use on the cobas s 201 system, is a qualitative in vitro

test for comprehensive single-assay detection of HIV-1 Group M RNA, HIV-1 Group

O RNA, HIV-2 RNA, hepatitis C virus RNA and hepatitis B virus DNA in human

plasma. The test, which is not intended for use as an aid in diagnosis, is

designed to further increase the safety of blood supplies by identifying

infections earlier than traditional serology tests.

" Roche is committed to meeting the needs of blood centers with tests and systems

that ensure the highest blood safety, " said O'Day, head of Roche

Molecular Diagnostics, the business area of Roche Diagnostics that developed the

test. " Our multiplex test has been widely adopted and has demonstrated excellent

performance in blood centers worldwide. We are pleased to introduce it in the

U.S. as we continue to further invest in solutions for this critical industry. "

The test runs on the fully automated, real-time PCR cobas s 201 system, designed

to increase processing efficiency with a unique modular design and ready to use

reagents.

" The Roche MPX test raises the blood industry to a higher level with regard to

overall blood safety, process simplification and process control, " said Louis M.

Katz, MD, executive vice president of medical affairs at Mississippi Valley

Regional Blood Center, one of the TaqScreen MPX clinical trials sites. " Our

organization looks forward to using the MPX test. "

Countries that have implemented NAT testing have demonstrated a reduction in

transfusion-related HIV, HBV, and HCV infections. In the U.S. alone, the Centers

for Disease Control and Prevention (CDC) estimates that there are more than 1

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. More than 1,200,000 people are

chronically infected with HBV and about 5,000 people die of complications of HBV

every year in the U.S. Many individuals with HBV and HCV show no symptoms of

disease, and do not know that they are infected.

Source: Roche