Lab Services Leptospira spp.

Added: Aug 12, 2015 11:36 am

NOTICE OF INTENT TO SOLE SOURCE. The Centers for Disease Control and Prevention intends to award a sole source firm fixed price contract to Silverlake Research Corporation. The Centers for Disease Control and Prevention (DCD), National Center for Emerging and Zoonotic Infectious Diseases (NCEZID) is seeking this technical assistance for the development of monoclonal antibodies and lateral flow assay for Leptospirosis spp. detection. This is an approach to using whole genome sequence to select small peptides that are specific to their pathogen and use an immunization approach that produces high affinity and specific antibodies to small peptides. These antibodies need to be able to distinguish between proteins that may only differ by one (1) or two (2) amino acids. This approach allows for a more controlled and specific selection of antibody generation compared to traditional approaches where immunization is done with whole pathogens or proteins. The primary objective is to develop a panel of hyper-specific monoclonal antibodies for Leptospira spp., which can subsequently be used in antigen detection assays for diagnosis of leptospirosis in a variety of formats. This contract action is for services for which the Government intends to solicit and negotiate with only one source under the authority of FAR 6.302-1, Only one responsible source and no other supplies or services will satisfy agency requirements. The applicable NAICS code is 541711, Research and Development in Biotechnology.

Early diagnosis of leptospirosis is critical to initiate appropriate antibiotic treatment, particularly because the illness mimics many viral illnesses. However, detection of antibodies occurs after about four (4) days of symptoms, therefore, missing those who present acutely. Polymerase chain reaction (PCR) is able to detect Leptospira in acute samples, but this is costly and not available at the primary health clinics in endemic areas. A monoclonal antibody can be used in a variety of diagnostic tests to detect antigen in patients presenting acutely, before an immunological response can be detected, hence enabling early detection and appropriate treatment of leptospirosis.

This notice of intent is not a request for competitive proposals; however, all responses received by August 24, 2015 will be considered by the Government. A determination by the Government not to compete this requirement 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. Responses should be emailed to the Contract Specialist, Pat Billins, at PBillins@cdc.gov by 2:00pm Eastern Time, Monday, August 24, 2015.