BD MAX™ Enteric Bacterial Panel

The BD MAX™ Enteric Bacterial Panel detects bacteria causing infectious gastroenteritis, including Salmonella spp., Shigella spp./enteroinvasive Escherichia coli (EIEC), Campylobacter spp. (jejuni and coli) and Shiga toxin producing organisms (STEC, Shigella dysenteriae).

Supplier:  BD 442963

Catalog No. B442963

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.

Specifications

• Includes: BD MAX™ Enteric Bacterial Panel Extraction Tubes (24), BD MAX™ Enteric Bacterial Panel Sample Buffer Tubes (24), BD MAX™ Septum Caps (25), BD MAX™ Enteric Bacterial Panel Reagent Strips (24), BD MAX™ Enteric Bacterial Panel Master Mix (24)
• Test Time: ≈3 hr.