Assays and Consumables
Added: May 02, 2017 7:07 am The Naval Medical Logistics Command (NMLC) intends to negotiate on a sole source basis (IAW FAR 13.501(a), Sole Source Acquisitions). The proposed source is Nanosphere, 4088 Commercial Avenue Northbrook, IL, 60062-1829.The Naval Medical Center San Diego has a requirement for an IDIQ of assays and consumables to be used by the microbiology department for multiplex detection of respiratory viruses. The assays and consumables shall be compatible with the Nanosphere Verigene system that NMC San Diego currently owns.Testing for respiratory viruses is an important part of Influenza preparedness and diagnosis of respiratory viral disease. Identification of gram-positive and gram-negative bacteria in positive blood cultures within a few hours greatly improves a patient's prognosis. These assays are the only tests compatible with the government owned Nanosphere Verigene system and capable of performing multiple tests on an individual patient specimen simultaneously in a fully-automated random-access capacity that allows for an increased toughput while decreasing the demands on staff workload. The use of nucleic acid amplification and multiplex detection increased accuracy and precision not provided by other testing methodologies.The assays shall provide for multiplex detection of respiratory viruses from human nasopharyngeal swabs to detect at a minimum Influenza A, Influenza A subtypes H1 and H3, Influenza B, Respiratory Syncytial Virus, Adenovirus, Rhinovirus, Parainfluenza Viruses 1, 2, 3 and 4, Metapneumovirus and Bordetella pertussis. Specificity and differentiation of target detection is essential to avoid cross-reactivity and false reporting of results with a demonstrated specificity of ≥ 95% for each individual target included in the panel. Assay sensitivity should be sufficient to detect a range of viral titers that corresponds to very early infection, fulminant infection, and convalescing infections. Also provide testing for the identification of gram-positive and gram-negative bacteria in positive blood cultures. The reagents shall have a shelf-life of no less than 6 months after receipt.The unit shall be compliant with the Food and Drug Administration (FDA) requirements to market and deliver medical products for use in the United States of America, even should delivery be requested outside of the United States. The claims made for the product shall comply with the regulations of the FDA, with respect to products for marketing and delivery of a medical product for use in the United States of America, even should delivery be requested outside of the United States. The system shall be installed in compliance with OSHA requirements.Contractor shall be an Original Equipment Manufacturer (OEM) authorized dealer, authorized distributor or authorized reseller for the proposed equipment/system, such that OEM warranty and service are provided and maintained by the OEM. All software licensing, warranty and service associated with the equipment/system shall be in accordance with the OEM terms and conditions.Upon delivery, the contractor shall be responsible for uncrating the unit/system, transporting it tough the facility to the location of intended use for installation, and removing of all trash created in this process. If interim storage is required, the vendor shall make arrangements for the storage.There are not set-aside restrictions for this requirement. The intended procurement will be classified under North America Industry Classification System (NAICS) 325413. This notice of intent is not a request for competitive proposals and no solicitation document exists for this requirement. However, parties interested in responding to this notice will need to submit technical data sufficient to determine capability in providing the same product. All capability statements received by the closing date of this synopsis will be considered by the Government. A determination by the Government not to compete based on responses to this notice is solely within the discretion of the Government. Information received will be considered solely for the purpose of determining whether to conduct a competitive procurement.If a vendor challenges the basis of this requirement, please email product capability statements (formats for submission: PDF, MS Word, or MS Excel) to Derek Bell at derek.j.bell.civ@mail.mil. Closing date for challenges is no later than 9:00 AM ET on 17 May 17. No phone calls will be accepted. N0025918RCE0001 Department of the Navy Bureau of Medicine and Surgery
5/2/17, 7:07 AM Assays and Consumables
Added: Oct 11, 2017 7:06 am N0025918RCE0001 Department of the Navy Bureau of Medicine and Surgery
10/11/17, 7:06 AM