BD MAX™ Enteric Bacterial Panel

Description

• The BD MAX™ 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
• The BD MAX Enteric Bacterial Panel detects nucleic acids from: Salmonella spp., Campylobacter spp.(jejuni and coli), Shigella spp./ Enteroinvasive E
• coli (EIEC), Shiga toxin 1 (stx1)/Shiga toxin 2 (stx2) genes (found in Shiga toxin-producing E.coli (STEC) as well as Shigella dysenteriae, which can possess a Shiga toxin gene (stx) that is identical to the stx1 gene of STEC
• 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 spaO, a Campylobacter specific tuf gene sequence, ipaH and stx1/stx2
• The test utilizes fluorgenic sequence-specific hybridization probes for detection of the amplified DNA
• This test is intended for use, in conjunction with the clinical presentation, laboratory findings, and epidemiological information, as an aid in the differential diagnosis of Salmonella, Shigella/EIEC, Campylobacter and Shiga-toxin producing E
• coli (STEC) 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.