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BD Max Enteric Parasite Panel Gets FDA OK

NEW YORK (GenomeWeb) – Becton Dickinson's BD Life Sciences segment said today that its BD Max Enteric Parasite Panel for use on the BD Max system has received US Food and Drug Administration clearance.

The BD Max Enteric Panel is the latest in the BD Max suite of assays that aid in the diagnosis of infectious gastroenteritis. It is a qualitative in vitro test that detects DNA from Giardia lamblia, Cryptosporidium (C. hominis and C. parvum), and Entamoeba histolytica in both unpreserved and 10 percent formalin-fixed stool specimens.

The BD Max system automates sample preparation, extraction, nucleic acid amplification, and detection. The new panel, combined with the BD Max Enteric Bacteria Panel for BD Max, can detect the pathogens that are responsible for up to 95 percent of the bacteria that cause gastroenteritis, BD said.

"The BD Max Enteric Parasite Panel addition to the menu will further streamline our workflow, improve turnaround time and free up staff that were previously running [enzyme-linked immunoassay] testing manually," Annette Monterrubio, microbiology and molecular biology system technical coordinator at St. Luke's Health System in Boise, Idaho, said in a statement. "I believe this will greatly benefit patient care."

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