Grifols, Barcelona, recently announced that the American Red Cross laboratory in Charlotte, NC, is now screening blood samples collected in the states of New Hampshire, New Jersey, Maine, Maryland, Pennsylvania, and Vermont, using the company’s Procleix Babesia assay under an investigational new drug (IND) study.
The Procleix Babesia assay is a qualitative in vitro nucleic acid screening test for the direct detection of the Babesia parasite in whole blood specimens from human blood donors, performed on the fully automated Procleix Panther system platform.
The Babesia parasite is transmitted to humans primarily through tick bites, but can be transmitted through blood, which underscores the importance of this screening. Data collected during the study will be used to seek FDA approval for the Procleix Babesia assay, which is designed to be used for routine screening by US blood banks.
“The Red Cross is excited to participate in this timely critical trial,” says Susan Stramer, PhD, vice president of scientific affairs at the Red Cross. “The availability of a sensitive and specific nucleic acid test to decrease the incidence of transfusion-transmitted Babesia throughout the endemic areas of the United States will be an important accomplishment.”
“We are very pleased that the Red Cross joins Grifols’ efforts and strong commitment to blood safety,” says Carsten Schroeder, president of diagnostic commercial operations at Grifols. “This collection of clinical data will be used to register the assay for use in the US market.”
Although widespread, the main concentrations of Babesia are found in the northeastern and midwestern portions of the United States, according to the US Centers for Disease Control and Prevention (CDC).1 The latest data from CDC show more than 1,700 people were affected by Babesia in 2014, with highest concentrations in Connecticut, Maine, Massachusetts, Minnesota, New Hampshire, New Jersey, New York, Rhode Island, and Wisconsin.
The Procleix Panther system automates all aspects of nucleic acid-based blood screening on a single, integrated platform. It eliminates the need for batch processing and combines walkaway freedom with intuitive design for ease of use. The system has received regulatory approvals in countries around the world, and is in development for the US market.
For more information, visit Grifols.
- Parasites—Babesiosis [online]. Atlanta: Centers for Disease Control and Prevention, 2016. Available at: www.cdc.gov/parasites/babesiosis/index.html. Accessed September 15, 2017.