Enteric Bacterial Panel Detects Common Causes of Bacterial Gastroenteritis

An enteric bacterial panel is a qualitative in vitro diagnostic (IVD) test detecting DNA from Campylobacter spp. (C. jejuni and C. coli), Salmonella spp., Shigella spp. / Enteroinvasive E. coli (EIEC) as well as stx 1 and stx 2 genes in stool specimens.

The global medical technology company Becton, Dickinson and Company (BD; Sparks, MD, USA), announced the availability of the FDA-cleared BD MAX Enteric Bacterial Panel for use on the BD MAX System. The pathogens it detects are responsible for up to 95% of the bacteria causing gastroenteritis, accounting for millions of deaths annually.

The BD MAX Enteric Bacterial Panel is designed to detect bacterial pathogens in line with widely recommended clinical algorithms for testing. These algorithms utilize patient history and clinical presentation in selecting diagnostic tests. The use of focused panels enables the implementation of enteric molecular testing in a cost effective manner. Additionally, the use of the BD MAX Enteric Bacterial Panel allows laboratories to implement [US] Centers for Disease Control and Prevention (CDC; Atlanta, GA, USA) recommended and Joint Commission required STEC screening. Specimen types include unpreserved and Cary-Blair preserved stool specimens from symptomatic patients with suspected acute gastroenteritis, enteritis, or colitis, adding to the flexibility of use for the laboratory. The assay was CE-marked in March 2013 and has demonstrated excellent performance in Europe.

Doug White, vice president and general manager, Molecular Diagnostics & Women's Health, BD Diagnostics, said, "The BD MAX Enteric Bacterial Panel will provide clinicians with fast, accurate results that will enable more rapid diagnosis compared with conventional culture methods and will help improve standard of care and clinical efficiencies. The BD MAX Enteric Bacterial Panel is the first FDA-cleared assay in the BD MAX Enteric portfolio and we plan to add additional panels that include viral, parasite and extended bacterial detection."

The BD MAX Enteric Parasite Panel was CE marked for the qualitative detection of the parasitic enteric pathogens Giardia lamblia, Cryptosporidium spp. (C. hominis and C. parvum), and Entamoeba histolytica directly from stool specimens.

Infectious gastroenteritis accounts for approximately 1.7 billion cases of diarrhea globally and more than 2 million deaths annually. These infections may be caused by viruses, bacteria, or parasites and often take two to four days or more to identify in the clinical laboratory using conventional methods. In the laboratory a high level of expertise and labor are associated with traditional stool culture. Multiple methods, materials and environments are required to detect the pathogens included in the BD MAX Enteric Bacterial Panel. Using the BD MAX Enteric Bacterial panel can result in the reduction of labor and 60% of material and environments typically required for stool cultures. Additionally, results are available in approximately 3 hours with minimal technologist intervention. The improved availability of results may positively impact the clinical management of these patients.

The BD MAX System offers a highly efficient path to improved clinical outcomes through flexible molecular solutions. The BD MAX System automates sample preparation, extraction, amplification, and detection on a single system, saving time and improving lab efficiency. Molecular testing on the BD MAX System is simplified and standardized, minimizing variability in results.

The BD MAX Enteric Parasite Panel is not yet approved for sale or use in the US.

Related Links:
Becton, Dickinson and Company
Centers for Disease Control and Prevention