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QIAstat-Dx Gastrointestinal Panel 2:

The QIAstat-Dx Gastrointestinal Panel 2 is a multiplexed nucleic acid test intended for use with the QIAstat-Dx Analyzer 2.0 and QIAstat-Dx Rise for the simultaneous in vitro qualitative detection and identification of nucleic acids from multiple viruses, bacteria, and parasites directly from preserved stool samples (Para-Pak C&S or FecalSwab) obtained from individuals with signs and/or symptoms of gastrointestinal infection. The following viruses, bacteria (including several diarrheagenic E. coli/ Shigella pathotypes), and parasites are identified with the QIAstat-Dx Gastrointestinal Panel 2:

• Adenovirus F40/F41
• Astrovirus
• Norovirus GI/GII
• Rotavirus A
• Campylobacter (C. jejuni, C. coli and C. upsaliensis)
• Shigella/Enteroinvasive Escherichia coli (EIEC)
• Enteropathogenic Escherichia coli (EPEC)
• Enterotoxigenic Escherichia coli (ETEC) lt/st
• Shiga-like toxin-producing Escherichia coli (STEC) stx1/stx2 (including specific identification of E. coli O157 serogroup within STEC)
• Salmonella
• Plesiomonas shigelloides
• Yersinia enterocolitica
• Cryptosporidium
• Cyclospora cayetanensis
• Entamoeba histolytica
• Giardia lamblia*

*Also known as Giardia intestinalis and Giardia duodenalis

Concomitant culture is necessary for organism recovery and further typing of bacterial agents. The QIAstat-Dx Gastrointestinal Panel 2 is indicated as an aid in the diagnosis of specific agents of gastrointestinal illness, in conjunction with other clinical, laboratory, and epidemiological data. Positive results do not rule-out co-infection with organisms not detected by the QIAstat-Dx Gastrointestinal Panel 2. The organisms detected may not be the sole or definitive cause of the disease.

Negative QIAstat-Dx Gastrointestinal Panel 2 results in the setting of clinical illness compatible with gastroenteritis may be due to infection by pathogens that are not detected by this assay test or non-infectious causes such as ulcerative colitis, irritable bowel syndrome, or Crohn's disease.

QIAstat-Dx GI Panel 2 Mini B&V:

The QIAstat-Dx GI Panel 2 Mini B&V is a multiplexed nucleic acid test intended for use with the QIAstat-Dx Analyzer 2.0 and QIAstat-Dx Rise for the simultaneous in vitro qualitative detection and identification of nucleic acids from multiple bacteria and one virus directly from preserved stool samples (Para-Pak C&S or FecalSwab) obtained from individuals with signs and/or symptoms of gastrointestinal infection. The following virus and bacteria (including several diarrheagenic E. coli/ Shigella pathotypes) are identified with the QIAstat-Dx GI Panel 2 Mini B&V:

• Norovirus
• Campylobacter
• Shigella
• Shiga-like toxin E. coli (STEC)
• Salmonella

Concomitant culture is necessary for organism recovery and further typing of bacterial agents.The QIAstat-Dx GI Panel 2 Mini B&V is indicated as an aid in the diagnosis of specific agents of gastrointestinal illness, in conjunction with other clinical, laboratory, and epidemiological data. Positive results do not rule-out co-infection with organisms not detected by the QIAstat-Dx GI Panel 2 Mini B&V. The organisms detected may not be the sole or definitive cause of the disease.

Negative QIAstat-Dx GI Panel 2 Mini B&V results in the setting of clinical illness compatible with gastroenteritis may be due to infection by pathogens that are not detected by this assay test or non-infectious causes such as ulcerative colitis, irritable bowel syndrome, or Crohn's disease.

QIAstat-Dx GI Panel 2 Mini B:

The QIAstat-Dx GI Panel 2 Mini B is a multiplexed nucleic acid test intended for use with the QIAstat-Dx Analyzer 2.0 and QIAstat-Dx Rise for the simultaneous in vitro qualitative detection and identification of nucleic acids from multiple bacteria directly from preserved stool samples (Para-Pak C&S or FecalSwab) obtained from individuals with signs and/or symptoms of gastrointestinal infection. The following bacteria (including several diarrheagenic E. coli/ Shigella pathotypes) are identified with the QIAstat-Dx GI Panel 2 Mini B:

• Campylobacter
• Shigella
• Shiga-like toxin Escherichia coli (STEC)
• Salmonella
• Yersinia enterocolitica

Concomitant culture is necessary for organism recovery and further typing of bacterial agents. The QIAstat-Dx GI Panel 2 Mini B is indicated as an aid in the diagnosis of specific agents of gastrointestinal illness, in conjunction with other clinical, laboratory, and epidemiological data. Positive results do not rule-out co-infection with organisms not detected by the QIAstat-Dx GI Panel 2 Mini B. The organisms detected may not be the sole or definitive cause of the disease.

Negative QIAstat-Dx GI Panel 2 Mini B results in the setting of clinical illness compatible with gastroenteritis may be due to infection by pathogens that are not detected by this assay test or non-infectious causes such as ulcerative colitis, irritable bowel syndrome, or Crohn's disease.

The QIAstat-Dx Gastrointestinal Panel 2, the QIAstat-Dx GI Panel 2 Mini B&V, and the QIAstat-Dx GI Panel 2 Mini B ("QIAstat-Dx Gastrointestinal Panels") are multiplexed nucleic acid tests which are designed for use with the QIAstat-Dx Analyzer 2.0. The device modification is to add the QIAstat-Dx Rise as an additional instrument for use with the QIAstat-Dx Gastrointestinal Panels. The QIAstat-Dx Rise is a higher throughput platform, incorporating up to eight QIAstat-Dx Analytical Modules (AM) on a small footprint. The instrument allows queuing up to 18 cartridges, with processing being limited up to 16 cartridges for the QIAstat-Dx Gastrointestinal Panels. The cartridges are scheduled for processing and delivered to the appropriate AM by an integrated robotic handler. The AM used with the QIAstat-Dx Rise is the same AM that can be used with the QIAstat-Dx Analyzer 2.0.

The modified QIAstat-Dx Gastrointestinal Panel 2, the QIAstat-Dx GI Panel 2 Mini B&V, and the QIAstat-Dx GI Panel 2 Mini B are identical to the QIAstat-Dx Gastrointestinal Panel 2, the QIAstat-Dx GI Panel 2 Mini B&V, and the QIAstat-Dx GI Panel 2 Mini B (K252329), respectively, with the exception of the Instructions for Use which were updated to include the assay-specific procedure for use with the QIAstat-Dx Rise.

The QIAstat-Dx Gastrointestinal Panels are intended for the simultaneous in vitro qualitative detection and identification of nucleic acids from multiple targets directly from preserved stool samples (Para-Pak C&S or FecalSwab) obtained from individuals with signs and/or symptoms of gastrointestinal infection.

All the reagents required for the complete execution of the test are pre-loaded and self-contained in the QIAstat-Dx Gastrointestinal Panels. The user does not need to manipulate any reagents. During the test, reagents are handled by pneumatically operated microfluidics without any direct contact with the user or the analyzer actuators. This eliminates any possibility of exposure of the user or the analyzer to chemicals contained in the cartridge during the test and up to the disposal of used cartridges.

Within the cartridge, multiple steps are automatically performed in sequence by using pneumatic pressure and a multiport valve to transfer sample and fluids via the Transfer Chamber to their intended destinations. Following the introduction of the sample from a disposable transfer pipette, the following assay steps occur automatically and sequentially:

• Sample pre-treatment for PCR Inhibitors removal
• Resuspension of Internal Control and Proteinase K
• Cell lysis using mechanical and/or chemical means
• Membrane-based nucleic acid purification
• Rehydration of Master Mix
• Transfer of defined aliquots of eluate/master mix to different reaction chambers
• Performance of multiplex real-time RT-PCR testing within each reaction chamber.

The QIAstat-Dx Gastrointestinal Panels Assay Definition File (ADF) automatically interprets test results and displays a summary on the instrument display screen. The detected analytes are displayed in red. All other tested but not detected analytes are listed in green. The instrument will report if an error occurs during processing, in which case the test will fail and no results will be provided (screen will show "FAIL").

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