Gastrointestinal Pathogen Panel

The GI pathogen panel tests for 17 gastrointestinal parasites, including:

• Bacteria: E. coli O157, Vibrio spp., Campylobacter, Salmonella spp., enterotoxigenic E. coli LT/ST, Shiga-like toxin-producing E. coli stx1/stx2, Vibrio parahemolyticus, Clostridium difficile toxins A and B, Yersinia enterocolitica, enteroaggregative E. coli, shigella/enteroinvasive E. coli
• Viruses: Rotavirus A, Norovirus GI/GII, Adenovirus 40/41
• Parasites: Giardia lamblia, Cryptosporidium, Entamoeba histolytica

Our gastrointestinal pathogen panel is FDA 510(k) cleared in the United States. This clearance means that the assay is substantially equivalent to a previously cleared and commercially distributed FDA device. This panel is equivalent to similar tests on the market — it has undergone parallel testing with other BioCode^® assays that have been FDA-cleared.

The BioCode^® GI panel test is compatible with these extraction systems: 

• NUCLISENS^® easyMag^®: This IVD-labeled automated system from bioMérieux is used for total nucleic acid extraction from biological samples for molecular infectious disease assays.
• MagNA Pure 96: This system from Roche delivers fully automated and high-throughput nucleic acid purification for consistent and reproducible yields.
• KingFisher Flex: Thermo Scientific KingFisher Flex is an automated extraction and purification system for proteins, cells, RNA, and DNA. The medium- to high-throughput extraction processes 24 or 96 samples per run.

Data masking allows pathogen targets to be masked and unmasked based on the clinician’s orders. This option enables you to:

• Customize reports for the full pathogen panel or defined subpanel.
• Adjust to changing demands in the laboratory.
• Reduce reimbursement and liability concerns with insurance coverage for GI pathogen panel testing.

The BioCode^® Gastrointestinal Pathogen Panel has optional data masking to enable select target reporting.

Barcoded Magnetic Bead technology allows oligonucleotides and proteins, such as antigens and antibodies, on the surface of barcoded magnetic beads to be immobilized for multiplex analyte detection. This technology combines microparticles and digital barcodes to enhance accurate molecular detection and identification.