BD MAX™ Enteric Parasite Panel

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.