BD™ MAX™ Enteric Parasite Panel

The BD MAX™ Enteric Parasite Panel detects three commonly isolated and highly pathogenic parasites that cause gastroenteritis – Giardia lamblia, Cryptosporidium spp. (C. parvum and C. hominis) and Entamoeba histolytica – from one specimen.

Supplier:  BD™ 442960

Catalog No. B442960

Description

The BD MAX™ Enteric Parasite Panel performed on the BD MAX System is an automated in vitro diagnostic test for the direct qualitative detection of enteric parasitic pathogens. The BD MAX Enteric Parasite Panel detects nucleic acids from Giardia lamblia, Cryptosporidium(C. hominis and C. parvum only), and Entamoeba histolytica. Testing is performed on unpreserved or 10% formalin-fixed stool specimens from symptomatic patients with suspected gastroenteritis, enteritis or colitis. The assay is intended to aid in the diagnosis of gastrointestinal infection when used in conjunction with clinical evaluation and other laboratory findings. The test is performed directly on the specimen, utilizing real-time polymerase chain reaction (PCR) for the amplification of specific targets. The test utilizes fluorogenic gene-specific hybridization probes for 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 Giardia lamblia, Cryptosporidium hominis and C. parvum, as well as Entamoeba histolytica infections. Results of this test should not be used as the sole basis for diagnosis, treatment, or other patient management decision. 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 and/or colitis 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 Parasite Panel Extraction Tubes (24), BD MAX™ Enteric Parasite Panel Sample Buffer Tubes (24), BD MAX™ Septum Caps (25), BD MAX™ Enteric Parasite Panel Reagent Strips (24), BD MAX™ Enteric Parasite Panel Master Mix (24)
• Test Time: ≈4 hr.