BD MAX™ Extended Enteric Bacterial Panel

Description

• The BD MAX™ Extended Enteric Bacterial Panel performed on the BD MAX System, is an automated in vitro diagnostic test for the direct qualitative detection and differentiation of enteric bacterial pathogens
• It is used in conjunction with the BD MAX™ Enteric Bacterial Panel as an optional Master Mix addition to the 4 snap Unitized Reagent Strip
• The BD MAX Extended Enteric Bacterial Panel detects nucleic acids from: Plesiomonas shigelloides, Vibrio (V
• vulnificus, V
• parahaemolyticus, and V
• cholerae), Enterotoxigenic Escherichia coli (ETEC) heat-labile enterotoxin (LT)/ heat-stable enterotoxin (ST) genes, Yersina enterocolitica
• Testing is performed on unpreserved soft to diarrheal stool specimens or Cary-Blair preserved stool specimens from symptomatic patients with suspected acute gastroenteritis, enteritis or colitis
• The test is performed directly on the specimen, utilizing real-time polymerase chain reaction (PCR) for the amplification of relevant gene target DNA
• The test utilizes fluorogenic gene-specific hybridization probes for the detection of the amplified DNA.  This test is intended for use, in conjunction with clinical presentation, laboratory findings, and epidemiological information, as an aid in the differential diagnosis of Plesiomonas shigelloides, Vibrio (V
• vulnificus, V
• parahaemolyticus, and V
• cholerae) Enterotoxigenic Escherichia coli (ETEC) LT/ST and Yersinia enterocolitica infections
• Results of this test should not be used as the sole basis for diagnosis, treatment, or other patient management decisions
• Positive results do not rule out co-infection with other organisms that are not detected by this test, and may not be the sole or definitive cause of patient illness
• Negative results in the setting of clinical illness compatible with gastroenteritis may be due to infection by pathogens that are not detected by this test or non-infectious causes such as ulcerative colitis, irritable bowel syndrome, or Crohn's disease.