Specifications include, but are not limited to: 2.1 To acquire a reagent rental program that is inclusive of reagent kit and consumables purchase, testing instrument (including associated software), preventative maintenance, and any other service or products available for testing of Mucopolysarcharidosis Type I (MPS I) and Glycogen Storage Disease Type II (Pompe Disease); and 2.2 The instrument and reagent kit shall evaluate and determine Food and Drug Administration (FDA) cleared or approved testing methodologies for MPS I and Pompe Disease. 3.1 Provide testing methodologies (i.e. reagent kit and testing instrument) that are FDA cleared or approved; and 3.2 Provide documentation(s) of FDA clearance on the testing methodologies (i.e. a reagent kit’s package insert with in vitro diagnostic mark); 3.3 Provide reagent rental program including: 3.3.1 Discounted price for the reagent kit, 3.3.2 The number of samples that can be tested per reagent kit, 3.3.3 Discounted price per sample, 3.3.4 Number of testing instrument(s) and the preventative maintenance provided to ADHS at no cost, 3.3.5 Discounted price on consumables needed for the testing that are not included in the kit, 3.3.6 Discounted price on first (1st) tier testing for MPS I and Pompe Disease at the Contractor’s facility if ADHS does not implement testing of MPS I and Pompe Disease by May 1st, 2023, and 3.3.7 Discounted price on second (2nd) tier testing for MPS I and Pompe Disease at the Contractor’s facility,
