The requirement is for a molecular assay laboratory analyzer that is capable of analyzing blood samples for infectious microorganisms. The unit shall be a fully automated Nucleic Acid Testing (NAT) platform for blood screening to ensure accurate tests shortly after infection. The term fully automated meaning that no human interaction is required while the instrument processes the samples. The output that is obtained through a fully automated system could not be met without additional staff. The system shall allow individual sample testing and pooled samples testing. The system shall have barcode identification method for sample tubes and reagents and the testing process shall be traceable. The system shall have a load and walk away capability allowing the users to load samples and reagents hence letting the system perform all the necessary tests in a fully automated mode. The system shall be capable of testing for West Nile Virus (WNV) RNA, Hepatitis B Virus (HBV) DNA, Hepatitis C Virus (HCV) RNA, and Human Immunodeficiency Virus (HIV-1) RNA. The system shall allow the user to create a work list, manage fluid inventory and perform daily maintenances. The system shall allow the user to enclose control brackets of samples within a single run and shall be able to release results without the need to complete the entire run. The system shall have Biological License Application (BLA) approved by the FDA. The electrical requirements are 120VAC and 60Hz.
Vendor 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. The maintenance shall be provided by original equipment manufacturer (OEM)-certified technicians and shall use only OEM-approved replacement parts and proprietary software.

Regulatory Requirements: The system and all its components 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.
This acquisition is being conducted under simplified acquisition procedures IAW FAR 13. There are no set-aside restrictions for this requirement. The intended procurement will be classified under North America Industry Classification System (NAICS) 334516 with a small business size standard of 500. 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.

Submit capability statements via email (using PDF, MS Word, Excel attachments) to Christina Boyd-Brown at [email protected]. Statements are due not later than 4:00 P.M. ET on 24 July 2013. No phone calls accepted.