• Whole Blood Test for Donor Screening Receives FDA Approval

Laboratory Products

Whole Blood Test for Donor Screening Receives FDA Approval

Sep 23 2019

Roche have announced that it has received approval from the US Food and Drug Administration (FDA) for the cobas® Babesia test for use on the cobas® 6800/8800 Systems for individual blood donation testing. This is Roche's first commercially available whole blood test to screen donations and follows May 2019 FDA updated industry guidance recommending screening and testing for Babesia, to reduce the risk of transmitting the parasite through transfusions.
 
cobas® Babesia detects parasites that live in red blood cells. This test is an important advancement because the Babesia parasite cannot be detected in traditional plasma or serum samples. The test is able to detect the four common species of Babesia and employs the new whole blood collection tube, which simplifies Babesia sample preparation by consolidating steps within the tube itself to provide an efficient solution for testing laboratories.
 
In most cases, the Babesia parasite is transmitted to humans through the bite of an infected tick; however, the parasite can also be transmitted through blood transfusions or from mother to foetus during pregnancy. The parasite infects and destroys red blood cells which can lead to anaemia and related life-threatening complications, particularly in the elderly or otherwise immunocompromised patients. In healthy people, the infection can be asymptomatic, or cause a range of mild flu-like symptoms.

"We are dedicated to helping save patients' lives by providing advanced solutions to enable the protection of the global blood supply from infectious diseases. With the approval of Roche's first whole blood test used in blood screening we can help healthcare professionals further diminish potential risks of infection from transfused blood products," said Thomas Schinecker, Head of Roche Diagnostics. "In addition, we hope to help customers improve their lab efficiency by simplifying sample prep while ensuring maximum detection of infectious pathogens in the blood and the safety of the blood supply for the patients we serve."


Digital Edition

International Labmate Buyers' Guide 2024/25

June 2024

Buyers' Guide featuring: Product Listings & Manufacturers Directory Chromatography Articles - Enhancing HPLC Field Service with fast-response, non-invasive flowmeters - Digital transformatio...

View all digital editions

Events

HPLC 2024

Jul 20 2024 Denver, CO, USA

ICMGP 2024

Jul 21 2024 Cape Town, South Africa

ADLM 2024

Jul 28 2024 San Diego, CA USA

InaLab 2024

Jul 30 2024 Jakarta, Indonesia

Miconex

Jul 31 2024 Chengdu, China

View all events