Laser-Induced Fluoresence (LIF) Detector

MARKET RESEARCH PURPOSES ONLY NOT A REQUEST FOR PROPOSAL OR SOLICITATION The U.S. Food and Drug Administration, is conducting market research to support the Center for Biologics Evaluation and Research requirement for one (1) Laser-Induced Fluorescence (LIF) Detector Module to include installation and post?warranty maintenance. This is a sources sought to determine the availability and capability of small business manufacturers or small businesses capable of supplying a U.S. made product of a small business manufacturer or producer. The associated North American Industry Classification System (NAICS) Code is? 334516 ? Analytical Laboratory Instrument Manufacturing; Small Business Size Standard is 500 employees. Part I: General Information A. Introduction Characterization of bio-conjugated nanoparticles and detection/quantification of oligonucleotides/proteins/peptides are crucial for development of ultrasensitive viral pathogen diagnostic methods for and the research of blood borne pathogens and emerging diseases. Recently the Food & Drug Administration (FDA), Center for Biologics Evaluation and Research (CBER) acquired an Agilent 7100A Capillary Electrophoresis (CE) instrument equipped with an Agilent Ultraviolet-Diode Array Detector (UV-DAD) for use in this research work. The sensitivity of the UV-DAD detector is insufficient for identifying picomolar/femtomolar levels of samples. To further enhance the capability of the CE system, the FDA/CBER requires a Laser-Induced Fluorescence (LIF) Detector. B. Background The CE technique provides ultrahigh resolution and great separation speed for a broad range of complex biological samples found in life sciences such as nucleic acids, peptides, proteins, lipids, carbohydrates, pharmaceutical compounds, nanoparticles, viruses and cells. However, the sensitivity of the standard CE detector, UV-DAD, is insufficient for identifying samples with concentrations at or below picomolar levels, which greatly hinders efforts on the study of HIV, influenza and viruses from other emerging diseases, discovery of related biomarkers, and development of ultrasensitive diagnostic tools against the pathogens. A typical LIF detector, however, is up to 100,000 times more sensitive than UV detection. The significantly higher sensitivity of the LIF detector makes it highly desirable for sensitively and selectively detecting low-abundance analytes in complex biological matrixes, and thus greatly benefits the CE method development/validation, nanoparticle bio-conjugate characterization and general clinical research. C. Scope An ultrasensitive LIF detector is important to the CE study of pathogens and rapid identification of oligonucleotides, proteins, small compounds and nano/micrometer-sized particles. The LIF detector together with the existing Agilent 7100A CE system will be employed in the characterization of bio-conjugated nanoparticles, analysis of Polymerase Chain Reaction (PCR) products and peptides/proteins/antibodies from HIV/influenza or other viruses, as well as the discovery of nucleic acid/peptide/protein biomarkers for diagnosis of blood borne pathogens in existing and emerging diseases. Part II: Work Requirements A. Technical requirements: - Capabilities: ultrasensitive fluorescence detection and quantification of fluorescent-dye-labeled or natively fluorescent proteins, nucleic acids (DNA/RNA), polysacchoarides, small compounds, virus/bacterial particles and nanomaterials. Detection limit shall be achieved at picomolar to femtomolar levels. - Must be able to excite wavelength from 280-620 nm - Must be able to detect emission from 450-700 nm - Must be able to accept multiple laser sources in the detector - Must include 355 nm and 488 nm laser sources and necessary accessories (e.g. filter block, detection cell, power sources, etc.) - Adaptable to different capillary columns (Inner Dimension (ID)/Outer Dimension (OD): 50-200 - m /360-400 - m) - Ability to interface through dual-detector mode with downstream mass spectrometer required (for CE-LIF-MS setup). - Must be compatible with Agilent 7100A CE instrument - Inside delivery (to end-users laboratory) is required. - Equipment shall be furnished with all software, drivers, adapters, cassettes, converters, etc., required to seamlessly integrate with the existing Agilent 7100A CE instrument and Chemstation software (data acquisition and analysis); Contractor is responsible for turnkey solution. - Installation and testing are required to verify all aspects of the system are operating within manufacture's recommended calibration parameters. At a minimum, this will be accomplished by running an operational test followed by a performance qualification test (measuring the signal to noise ratio of a test solution and comparing it against the specifications). - Comprehensive on-site post warranty annual preventative maintenance inclusive of all labor, parts, and travel. At a minimum, preventative maintenance shall include inspecting the detector, laser and power supply for defects and correct operation. The system and cell shall be cleaned, calibrated and operationally tested to ensure correct function. A quality performance qualification test shall be completed, requiring the measurement of the signal-to-noise ratio of a test solution to compare against the specifications. All maintenance and calibration of equipment must be conducted by factory certified technicians. - Unlimited Technical Support and Trouble Shooting Assistance by phone, email, live-chat Interface, etc. within 4 hours from initial contact. - Unlimited Software Updates and Firmware Updates. Part III: Supporting Information A. Security Delivery driver shall call Jikun Liu (301-827-0906) or Jiangqin Zhao (301-827-0797) from security guard desk for entry to B258 Nicholson Lane Research Center (NLRC) loading dock. B. Place of Performance Shall be delivered to, installed, tested and maintained at: B258, 5516 Nicholson Lane, Kensington, MD 20895 301-827-0906 C. Period of Performance Delivery expected within 10 weeks of award with up to 3 post-warranty annual preventative maintenance option periods. Responses to this sources sought shall unequivocally demonstrate that respondent is regularly engaged in the manufacture and/or sale of same or substantially similar items. Though the target audience is small business manufacturers or small businesses capable of supplying a U.S. made product of a small business manufacturer or producer all interested parties may respond. At a minimum, responses shall include the following: - Business name and bio, DUNS number, business address, business website, business size status (i.e., SB, VOSB, SDVOSB, HUBZone SB, 8(a), SDB, WOSB, EDWOSB, LB), point of contact name, mailing address (if different from business address), phone number and email address; [Provide this same information again for the manufacturer/producer if responding to provide a product manufactured by another firm.] - Three (3) years of past performance information for the manufacture and/or sale of same or substantially similar items, which are or have been used with same or similar equipment for same or similar purposes, to include date of sale, description (should also include technical literature and specifications), dollar value, client name, client address, client point of contact name, client point of contact mailing address (if different from that provided for client), client point of contact phone number, client point of contact email address, and name of the manufacturer (to include DUNS number and size status) if not the respondent; - Descriptive literature, brochures, specifications, marketing material, etc. detailing the nature of the items the responding firm is regularly engaged in manufacturing and/or selling; - If applicable, identification of the firm's GSA Schedule contract(s) by Schedule number and SINs that are applicable to this requirement; - If a large business, identify the subcontracting opportunities that would exist for small business concerns - Although this is not a request for quote, informational pricing is encouraged. - The Government encourages any comments and/or suggestions from any interested party, regarding the specifications. While the Government will not respond directly to your comments and/or suggestions; we will consider them as we finalize the specifications in preparation for the forthcoming solicitation. The Government is not responsible for locating or securing any information, not identified in the response. Interested Parties must respond with capability statements which are due in person, by postal mail or email to the point of contact listed below on or before January 23, 2013 by 1:00 PM (Central Time in Jefferson, Arkansas) at the Food and Drug Administration, OC/OA/OAGS, Attn: Crystal G. McCoskey, 3900 NCTR Road, Bldg 50/Room 426, HFT?320, Jefferson, AR 72079?9502 or email crystal.mccoskey@fda.hhs.gov. Reference #1113351 in all correspondence with the point of contact listed above. Notice of Intent Responses to this sources sought announcement will assist the Government in determining whether this requirement should be set aside for small business, made available to full and open competition or procured through other than full and open acquisition procedures. Disclaimer and Important Notes This notice does not obligate the Government to award a contract or otherwise pay for the information provided in response. The Government reserves the right to use information provided by respondents for any purpose deemed necessary and legally appropriate. Any organization responding to this notice should ensure that its response is complete and sufficiently detailed to allow the Government to determine the organization's qualifications to perform the work. Respondents are advised that the Government is under no obligation to acknowledge receipt of the information received or provide feedback to respondents with respect to any information submitted. After a review of the responses received, a combined synopsis/solicitation (No. 1113351) may be published via FedBizOpps. However, responses to this notice will not be considered adequate responses to a solicitation. Confidentiality No proprietary, classified, confidential, or sensitive information should be included in your response. The Government reserves the right to use any non-proprietary technical information in any resultant solicitation(s).