I. Molecular Based Medical Testing Equipment A. Shall have reagent bottles designed to help minimize human error when loading. B. Shall not require off-board reagent reconstitution. C. Shall have operator and QC lockout. D. Shall have a built-in barcode scanner, built-in or included computer with touchscreen and a printer. E. Shall have the ability to change waste while processing. F. Shall not require daily maintenance. G. Shall accommodate multiple tube types, widths, and heights all in the same sample rack. H. Shall have documentation detailing cross contamination checks and aerosol safety within the processing room. II. Testing Supplies A. General 1. Pricing shall include Multiplex Test Kits for COVID-19, FLU-A, FLU-B, and, if included RSV 2. Assay shall have an internal (specimen quality) QC and external (assay quality) QC 3. Shall be able to provide first results in 115 minutes or less 4. Shall be FDA approved or emergency use authorized for diagnostic result reporting 5. Shall be able to detect Influenza A, including avian and swine variants 6. Shall be able to detect SARS-CoV-2, including emerging variants 7. Shall be able to differentiate FLU-A, FLU-B, RSV (if applicable), and SARS-CoV-2 and potential co-infections 8. Shall not require removing swab and cap from tube for testing such as utilizing pierceable caps 9. Shall have SARS-CoV sensitivity and specificity comparable to current in house methods, Thermo TaqPath with Kingfisher extraction and Hologic SARS-CoV-2 on Panther. 10. Shall have Influenza A and Influenza B sensitivity and specificity comparable to current in house methods, BioFire RP 2.1 and CDC Influenza A/B Screen.
