FDA Approves Cobas Malaria the first molecular test to Help Reduce Risks Infections From Transfused Blood Products
The FDA approved cobas Malaria (Roche) for use on the cobas 6800/8800 systems to assist health care professionals in reducing the potential risks of patient infection from transfused blood products. The test can provide a very sensitive, specific solution to help ensure infected blood is removed from the supply.
The cobas Malaria test is a qualitative, in vitro nucleic acid screening test that scans whole blood samples from individual human donors for the 5 parasite species that cause malaria in humans, allowing for the direct detection of both Plasmodium RNA and DNA. The test is designed for use on the cobas 6800/8800 Systems in the US and can be performed alongside other routine blood donor screening tests; however, it is not intended to be used for the diagnosis of Plasmodium infection, for use on cord blood samples, or for use on cadaveric blood specimens. For increased workflow efficiency, the test allowed for direct draw from the donor and is loaded directly into the cobas 6800/8800 Systems.
Malaria is a serious and sometimes fatal disease that is caused by a parasite that infects mosquitoes that feed on humans, but it can also be transmitted through blood transfusion, organ transplant, or the shared use of needles or syringes contaminated with blood. Symptoms of malaria include high fever, shaking chills, and flu-like symptoms.
A lot of potential donors are excluded from giving blood due to recent travel to or from malaria-endemic areas. Although existing microscopy and serological tests are not sensitive enough to reliably detect malaria transfusion risk, the cobas Malaria screening test has the potential to help improve both blood safety and availability, and is intended to be used when screening blood, organ, and tissue donors.
Currently, the cobas 6800 and cobas 8800 Systems have been established as the new standard for routine molecular testing. Since 2014, the Systems have delivered fully integrated, automated solutions that screen donors for infectious diseases, sexual health, transplant, respiratory, and antimicrobial stewardship.
Approximately half of the world’s population was at risk of malaria in 2022, with sub-Saharan Africa carrying a much higher burden compared with other regions. According to the World Health Organization, there was an estimated 249 million cases of malaria in 2022, of which 608,000 were fatal. In addition, Africa had approximately 94% and 95% of malaria cases and deaths, respectively. According to the FDA, the cobas Malaria test is predicted to be available in the summer of 2024, with approval in other countries later this year.
“As the first FDA-approved blood screening test for malaria, this represents an important step forward in safeguarding the global supply of donated blood," said Matt Sause, CEO of Roche Diagnostics, in a press release. “The approval of cobas Malaria represents a significant advancement in malaria detection, offering health care professionals a reliable tool for donor screening and improving the safety of patients worldwide.”
April 1, 2024
