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The Micronics PanNAT STEC Test is a qualitative, in vitro nucleic acid amplification-based tor the simultaneous detection and identification of the stx1 and stx2 Shiga toxin genes and the O-antigen gene cluster of E.coli O157 (fc/). Testing is performed in a unitized cartridge on the PanNAT System on soft to diarrheal unpreserved or Cary-Blair preserved stool specimens from individuals with signs and symptoms of gastrointestinal infection. The PanNAT STEC Test is intended for use, in conjunction with clinical presentation, laboratory findings and epidemiological risk factors, as an aid in detection of specific Shiga-toxin expressing strains of E. coli ("STEC") from patients with diarrhea. The results of this test should not be used as the sole basis for diagnosis, treatment or other patient management decisions. Positive PanNAT STEC Test results do not rule out the potential for coinfection with other pathogens that are not detected by this device and may not be indicative of the sole or definitive cause of patient illness. Negative PanNAT STEC Test results in the context 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 PanNAT System consists of the instrument with onboard software and 9-inch touchscreen used to process PanNAT STEC Test cartridges. The instrument automates all steps of the assay after sample addition to the test cartridge and insertion into the instrument; including DNA purification, nucleic acid amplification and detection of the target nucleic acid sequences using qualitative real-time PCR. The system is a portable device that is powered by an external mains supply with a voltage range of 100-240VAC and a frequency range of 50-60 Hz. An onboard battery is included to provide power to the instrument for up to one hour in the event that mains power supply is interrupted. The instrument includes a pneumatic subsystem, a thermal control unit, fluorescent optical detectors, and software needed to process a test cartridge, The PanNAT STEC Test cartridge is a unique, single use, disposable device in which all test reagents and controls are incorporated and all steps of the assay are performed. The PanNAT STEC Test cartridge uses a PanNAT Sample Transfer Pack accessory that contains a flocked swab, a prefilled Sample Buffer Tube and an Adaptor Cap. There are three integrated controls for the PanNAT STEC Test: an endogenous human DNA internal process control that is coextracted and coamplified with the target nucleic acids, a negative control, and a positive control. These controls are performed automatically and do not require any action from the operator. External quality controls for the PanNAT STEC Test are also commercially available. Alternatively, laboratories may prepare their own controls.