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The Xpert GI Panel, performed on the GeneXpert® Instrument Systems, is a qualitative multiplexed in vitro diagnostic test that is capable of the simultaneous detection and identification of DNA and RNA from multiple bacteria, parasites and/or virus directly from stool samples in Cary Blair transport media obtained from individuals with signs and symptoms of gastrointestinal infection. The test utilizes automated, qualitative real time polymerase chain reaction (PCR). The following bacteria (including several diarrheagenic E. coli/Shigella pathotypes), parasites, and virus are identified using the Xpert GI Panel:

Pathogens Detected:

• Bacteria: Campylobacter (C. jejuni/C. coli), Shiga toxin-producing Escherichia coli (STEC) stx1/stx2, Salmonella, Shigella/Enteroinvasive Escherichia coli, Yersinia enterocolitica, Vibrio parahaemolyticus, Vibrio cholerae
• Parasites: Giardia (also known as G. intestinalis, G. duodenalis & G. lamblia), Cryptosporidium
• Virus: Norovirus GI/GII

Pathogens Reported:

• Bacteria: Campylobacter, STEC stx1, STEC stx2, Salmonella, Shigella EIEC, Yersinia, V. parahaemolyticus, V. cholerae
• Parasites: Giardia, Cryptosporidium
• Virus: Norovirus

Results are meant to be used in conjunction with other clinical, laboratory and epidemiological data and 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 pathogens not included in the Xpert GI Panel. The pathogen detected may not be the definite cause of the disease. 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.

The Xpert Gastrointestinal (GI) Panel test, performed on Cepheid GeneXpert® Instrument Systems equipped with 10-color modules, is an automated in vitro diagnostic test for qualitative detection and differentiation of eleven (11) pathogens in stool in Cary Blair specimens collected from individuals suspected of gastrointestinal infection (GI). The results from the Xpert GI Panel test will be available in approximately 74 minutes.

The Xpert GI Panel is performed on the Cepheid GeneXpert® Instrument Systems equipped with GeneXpert 10-color modules running software version 6.4 and higher (GeneXpert Dx), software version Xpertise 7.1 or higher (GeneXpert Infinity) or software version COS 2.1 or higher (GeneXpert with Touchscreen). The GeneXpert® Instrument Systems automate and integrate sample purification, nucleic acid amplification, and detection of the target sequences from clinical specimens using reverse transcription (conversion of RNA template into DNA) followed by real-time polymerase chain reaction (real-time PCR) and melt curve analysis. The systems consist of an instrument, computer, and preloaded software for running tests and viewing the results. Each test requires the use of a single-use disposable GeneXpert cartridge that contains target-specific reagents and carries out the reverse transcription and PCR processes.

The Xpert GI Panel test includes reagents needed: (i) for sample preparation and (ii) to detect the different bacteria, parasites, and virus. A Sample Processing Control (SPC), an Internal Control (IC) and a Probe Check Control (PCC) are also included in the cartridge. The PCC verifies reagent rehydration, PCR tube filling in the cartridge, probe integrity, and dye stability. The IC is present to ensure adequate processing of RNA targets and monitor the presence of inhibitor(s) in the PCR reaction. The SPC is present to control for adequate extraction and processing of the target sequences in the PCR reaction. The SPC also acts as a control for functionality of melt curve analysis.

The Xpert GI Panel test results are interpreted by GeneXpert Instrument Systems from measured fluorescent signals and embedded calculation algorithms and will be reported as positive or negative for each of the targets.

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