PCR System Unit price must include cost to furnish, setup, and provide training. No pricing to be submitted on this page. Prices are to be submitted on Attachment B - Price Sheet. * Unit price must include PC and all required accessories for running the provided software and system. * No electrical work is required for installation * Literature should be included with bid response. * Brand: ThermoFisher or Equal * Model: QuantStudio 5 Dx Real-Time PCR System or Equal * SKU: A56200 or Equal * System to include the following: SKU: A47326 - QuantStudio 5 Dx Real-Time PCR System with laptop or Equal SKU: ZGP1SCQ - One Year Warranty with One PM/OQ or Equal SKU: A34911 - IQ/OQPQ, QS5 DX IVD, 96W Kit or Equal SKU: TRN00301 - Smartstart QS5 Certified training for six staff members or Equal SKU: A58195 - Diomni ENT IVD One Year License or Equal SKU: A58880 - Diomni Smartstart 0.5D or Equal SKU: A58881 - Diomni Install Consultation or Equal * Specifications: * Must appear on CDC’s list of Group I platforms indicating it is best suited for broad public health applications. * Must be an in vitro diagnostic device intended to perform fluorescence-based PCR to provide detection of nucleic acid sequences in human-derived specimens. * Instrument system must include the instrument, software, user documentation, and either a desktop or laptop computer. * Instrument must include a heated lid assembly that heats the top half of the sample plates and provides an effective seal to minimize evaporation of the reaction mixture. * Instrument must support reaction volumes of 10–100 μL on the 0.2 mL 96-well block. * Instrument must be factory calibrated with FAM™, SYBR™ Green I, VIC™, ABY™, NED™, TAMRA™, JUN™, ROX™, Mustang Purple™, and Cy®5 dyes. * Instrument must be designed to complete a 40-cycle real-time PCR run using a fluorogenic 5ʹ nuclease assay and Fast chemistry in under 30 minutes and the instrument must also run in standard ramping mode with standard chemistry. * Instrument must have real-time quantitative PCR installation specifications to demonstrate the ability to distinguish 5,000 template copies from 10,000 copies at greater than or equal to 99.7% confidence level. * Software must allow for locked, IVD use for cleared or approved assays. * Software must enable users to operate the instrument in either In Vitro Diagnostic (IVD) Mode or Test Development (DEV) Mode. * Software must include the ability to assign sample IDs and controls to individual wells. * Instrument purchase must include orientation session for approximately eight staff members by eLearning module or a trained technical scientist. * Vendor must supply all the necessary consumables to perform instrument qualification (IQ), operational qualification (OQ), and instrument performance verification (IPV).
