Medical Device Daily

Recognizing the importance of enabling blood banks to quickly screen for a broad range of human immunodeficiency virus (HIV) and viral hepatitis infections in donated blood, Roche Molecular Diagnostics (Pleasanton, California), a business unit of Roche Diagnostics (Basel, Switzerland), has developed an automated test to detect a variety of HIV and hepatitis infections in a single multiplex assay.

Roche yesterday reported that the FDA has accepted for review its application for the test, called the cobas TaqScreen MPX Test, which uses real-time PCR to detect HIV type 1 (Groups M & O), HIV type 2, hepatitis C virus (HCV), and hepatitis B virus (HBV).

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, Roche said.

Rick Roose, a spokesman for Roche Molecular Diagnostics, told Medical Device Daily that the new test responds to the primary focus of blood banks and labs, which is to “deliver the safest possible supply of blood as quickly as possible because blood supply has a limited shelf life.”

The fact that this is an automated test is what distinguishes the cobas TaqScreen MPX from earlier generation serology tests, Roose said.

“The more automation you have the easier it is to have different lab technicians with a variety of skills perform the screening. If the test isn’t automated, it requires a lab technician with a higher skill level,” Roose said.

The Centers for Disease Control and Prevention (Atlanta) 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. and is the leading diagnosis in patients undergoing liver transplantation. More than 1.2 million 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.

Because these individuals may try to donate blood, according to Roche, the Cobas TaqScreen MPX assay is designed to identify infected blood from these potential donors before they inadvertently transmit the infection to others.

HIV-1 was discovered in 1984, three years after the first reports of a disease that was to become known as AIDS. In 1986, a second type of HIV — less common in the U.S. — was discovered, called HIV-2. The most common form of HIV-1 is called HIV-1 Group M. In 1994, the first report confirming the identification of a different form of HIV-1, called HIV-1 Group O, was published, with the first case in the U.S. being reported in 1996.

“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. “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.”