• Size/weight requirements/restrictions: Instrument must be able to fit onto a benchtop/desk and not take up more than six (6) square feet of bench space. Instrument must be able to run off of standard 110 voltage. • The test system (e.g., instrumentation, associated reagents, consumables, and kits) must be capable of simultaneously testing a minimum of fifteen (15) targets per panel, not including assay controls, using nucleic acid amplification in clinical samples. • The test system must include, at a minimum, both a respiratory and gastrointestinal disease panel. The respiratory panel must, at a minimum, be able to detect and differentiate Bordetella pertussis, Mycoplasma pneumoniae, Severe Acute Respiratory Syndrome Coronavirus (SARS-CoV-2), Influenza A, Influenza B, Influenza A H1, Influenza A H1N1 pdm09, Influenza A H3, Adenovirus, Respiratory syncytial virus, Human metapneumovirus, Human Rhinovirus/Enterovirus, Parainfluenza virus 1, Parainfluenza virus 2, Parainfluenza virus 3, Parainfluenza virus 4, Human Coronavirus 229E, Human Coronavirus HKU1, Human Coronavirus NL63, Human Coronavirus OC43 and Chlamydophila pneumoniae from nasopharyngeal swabs. The gastrointestinal panel must, at a minimum, be able to detect and differentiate Campylobacter spp., Shigella spp./Enteroinvasive Escherichia coli (EIEC), Enteropathogenic Escherichia coli (EPEC), Enterotoxigenic Escherichia coli (ETEC), Shiga-like toxin producing Escherichia coli (STEC), Salmonella spp., Yersinia enterocolitica, Adenovirus F40/41, Astrovirus, Norovirus, Rotavirus A, Cryptosporidium, Cyclospora cayetanensis, Entamoeba histolytica, and Giardia lamblia (also known as Giardia intestinalis or Giardia duodenalis) from preserved stool samples in modified Carey-Blair (e.g., Para-Pak C&S). • Total expected test volume for both panels is expected to be no more than two hundred (200) tests per year. Additionally, the test system reagents, consumables, and kits must be capable of room temperature storage. To avoid unnecessary waste due to expired supplies, individual tests must not be bundled/packaged more than ten (10) tests per unit (i.e. “kit”) purchased. • Test system must be modular with the capability to expand testing capacity if needed. • Test system must be capable of directly testing and reporting results from clinical specimens with minimal intervention, or processing, (i.e., fully automated) by laboratory staff. • The testing panels must have full FDA approval (i.e., 510k or Pre-Market Approval (PMA)) for IVD testing. • To maximize efficiency and minimize the types of specimen collection supplies stocked at IBL, test systems must be compatible with specific specimen types. Acceptable specimens for the respiratory panel must include, at a minimum, nasopharyngeal, or nasal swabs transported in either Viral Transport Medium (VTM) or Universal Transport Medium (UTM). Test systems with a gastrointestinal panel must accept, at a minimum, stool samples preserved in modified Cary-Blair Medium, or equivalent. • The estimated annual quantity for the Respiratory panel is one-hundred fifty (150) each tests. • The estimated annual quantity for the Gastrointestinal panel is fifty (50) each tests
