NxTAG® Gastrointestinal Pathogen Panel

NxTAG® Gastrointestinal Pathogen Panel

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The NxTAG® Gastrointestinal Pathogen Panel (NxTAG GPP) is a multiplex nucleic acid test intended for the simultaneous qualitative detection and identification of multiple bacterial, viral, and parasitic nucleic acids in human stool specimens or human stool in Cary-Blair media from individuals with signs and symptoms of infectious colitis or gastroenteritis.

Description

The NxTAG® Gastrointestinal Pathogen Panel (NxTAG GPP) is a multiplex nucleic acid test intended for the simultaneous qualitative detection and identification of multiple bacterial, viral, and parasitic nucleic acids in human stool specimens or human stool in Cary-Blair media from individuals with signs and symptoms of infectious colitis or gastroenteritis.

The detection and identification of specific microbial nucleic acid from individuals exhibiting signs and symptoms of gastrointestinal infection aids in the diagnosis of gastrointestinal infection when used in conjunction with clinical evaluation, laboratory findings, and epidemiological information. A multiplex nucleic acid-based assay identifying gastrointestinal microorganisms also aids in the detection and identification of acute gastroenteritis in the context of outbreaks.

The results of this test should not be used as the sole basis for diagnosis, treatment, or other patient management decisions. Confirmed 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 NxTAG GPP 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.

The NxTAG GPP test is indicated for use with the MAGPIX® System with xPONENT® and SYNCT™ software.

Comprehensive and scalable GI testing with an improved workflow in a closed‑tube system

The NxTAG® Gastrointestinal Pathogen Panel (GPP) is a multiplex PCR CE-IVD test that detects 16 bacterial, viral, and parasitic targets directly from human stool specimens alone or in Cary-Blair media from individuals with signs and symptoms of infectious colitis or gastroenteriti on an easy-to-use, single well, closed-tube system.

As opposed to traditional workflows (which can take multiple days), NxTAG GPP delivers same-day results—including extraction and processing.

The NxTAG Gastrointestinal Pathogen Panel (CE-IVD) offers:

A streamlined workflow: The NxTAG workflow makes GI testing much easier, providing results in 3 hours post-extraction.
Minimal hands-on time: Simplify your workflow with pre-plated lyophilized reagents.
Comprehensive coverage of GI pathogens: Detect a broad range of bacterial, viral, and parasite targets in a single tube.
Scalable throughput: Run 1–96 samples at a time based on your needs.
NxTAG® Gastrointestinal Pathogen Panel Targets
Bacterial Targets:

Campylobacter Group
C. difficile (Toxin A/B)
ETEC (LT/ST)
STEC (stx1/stx2)
Shigella spp./EIEC
Salmonella spp.
Vibrio cholerae
Yersinia enterocolitica
Viral Targets:

Adenovirus F40/41
Astrovirus
Norovirus GI/GII
Rotavirus A
Sapovirus I/II/IV/V
Parasite Targets:

Cryptosporidium Group
Entamoeba histolytica
Giardia lamblia