Laboratory test that uses molecular techniques to simultaneously detect and identify multiple different types of microorganisms present in a stool sample, allowing for rapid diagnosis of gastrointestinal infections by analyzing their genetic material (nucleic acids) all at once; essentially, a single test that can identify various bacteria, viruses, or parasites causing gastrointestinal issues in a patient.

Intended Use of Gastrointestinal Microorganism Multiplex Nucleic Acid-Based Assay

A Gastrointestinal Microorganism Multiplex Nucleic Acid-Based Assay is a qualitative in vitro diagnostic device intended to simultaneously detect and identify multiple gastrointestinal microbial nucleic acids extracted from human stool specimens. The device detects specific nucleic acid sequences for organism identification as well as for determining the presence of toxin genes. The detection and identification of a specific gastrointestinal 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 and other laboratory findings. A gastrointestinal microorganism multiplex nucleic acid-based assay also aids in the detection and identification of acute gastroenteritis in the context of outbreaks.

Intended Use.

It is a nucleic acid test designed for in vitro detection and identification of nucleic acids from multiple bacteria and one virus from preserved stool samples obtained from individuals with signs of gastrointestinal infection. It identifies several pathotypes of E. coli/Shigella, including Norovirus, Campylobacter, Shigella, Shiga-like toxin Escherichia coli, and Salmonella. The test is used to aid in diagnosing specific agents of gastrointestinal illness, in conjunction with other clinical, laboratory, and epidemiological data.

Device description:

The assay cartridge is a single-test system that uses pre-packaged reagents for sample preparation and detection of selected analytes using PCR technology. The test is automated and self-contained, requiring no manipulation of reagents. The system uses pneumatically operated microfluidics to handle reagents, and multiple steps are performed sequentially using pneumatic pressure and a multiport valve. The assay includes sample pre-treatment, resuspension, cell lysis, membrane-based nucleic acid purification, rehydration of Master Mix, and multiplex real-time RT-PCR testing within each reaction chamber.

Performance Testing (Analytical-Nonclinical) for Gastrointestinal Microorganism Multiplex Nucleic Acid-Based Assay

• Stability Studies
• Precision/Reproducibility
• Detection studies
• Linearity/assay reportable range
• Detection limit
• Analytical specificity
• Traceability (controls, calibrators, or method)
• Analytical Sensitivity
• Analytical Specificity (Cross Reactivity/Inclusivity)
• Interfering Substances

Clinical Testing:  Required for 510k submission.