Upright fluorescence microscope with digital imaging and image analysis capabilities

MARKET RESEARCH PURPOSES ONLY NOT A REQUEST FOR PROPOSAL OR SOLICITATION The U.S. Food and Drug Administration (FDA), Office of Acquisitions and Grants Services (OAGS) is issuing this source sought announcement on behalf of the Center for Biologics Evaluation and Research (CBER), in order to determine if there are existing small business sources capable of providing a Upright Fluorescent Microscope. Other than small business concerns, especially vendors who may be able to offer domestic products are also encouraged to submit a capability statement that provides company information, as well as information demonstrating that it can meet all of the minimum requirements included below, to include the country of manufacture of products offered. If your firm is considered a small business source under North American Industry Classification System (NAICS) Code 334516 - Analytical Laboratory Instrument Manufacturing; with a Small Business Size Standard of 1,000 employees and you believe that your firm would be able to provide the FDA with the supplies/services described below, please submit an email to Warren.Dutter@fda.hhs.gov. Background: The U.S. Food and Drug Administration (FDA), Center for Biologics Evaluation and Research (CBER), Office of Vaccines Research and Review (OVRR), Division of Bacterial, Parasitic and Allergenic Products (DBPAP), requires the purchase of an upright microscope with fluorescent image acquisition and processing. An upright fluorescence microscope with digital imaging and image analysis capabilities is required to support research on malaria parasite biology and gene regulation. The system will be used to evaluate parasite morphology and determine the intracellular localization of proteins of interest through fluorescent protein tagging and immunofluorescence assays using fluorophore-conjugated antibodies. High-resolution image acquisition is required to accurately document protein localization patterns and morphological changes throughout the parasite life cycle. The microscope must include an integrated digital camera and image acquisition software capable of capturing, processing, and analyzing fluorescence images. Continuous access to the instrument is necessary to support live-cell imaging experiments and longitudinal observation of parasites throughout their approximately 48-hour intraerythrocytic life cycle. Dedicated access minimizes imaging artifacts associated with sample fixation, storage, and transport and enables the collection of reproducible data under physiologically relevant conditions. Minimum Technical Requirements: 1. Upright Configuration The proposed system shall be an upright microscope configuration suitable for slide-based brightfield, fluorescence, and differential interference contrast (DIC) imaging. 2. Mechanical Stage and Specimen Holder The system shall include a mechanical X-Y stage with a minimum travel range of 75 mm 50 mm. The stage shall include adjustable friction or torque control for specimen positioning. The system shall include a specimen holder capable of accommodating at least two standard microscope slides (76 mm 26 mm). 3. Focus Drive The system shall provide a minimum of 24 mm vertical (Z-axis) focus travel. Coarse and fine focus controls shall be accessible from both sides of the microscope stand. The system shall include an adjustable focus stop and a mechanical safety mechanism to prevent objective-to-specimen contact. 4. Multichannel Fluorescence Illumination The system shall include a solid-state LED fluorescence illumination source with a minimum of four independently controllable excitation channels covering ultraviolet, blue, green, and red excitation wavelengths. The illumination system shall support excitation of, at a minimum, UV-excitable nuclear stains, GFP/FITC-class fluorophores, TRITC/Cy3-class fluorophores, and Cy5-class fluorophores. The illumination system shall provide independent intensity adjustment for each excitation channel and retain user-defined illumination settings. The illumination source shall be LED-based and designed for extended operation without routine lamp replacement or alignment. 5. Fluorescence Filter Set and Reflector Turret The system shall include fluorescence filter sets supporting detection of at least four fluorescence channels corresponding to DAPI, FITC, TRITC, and Cy5 or equivalent fluorophores. The system shall include a reflector turret with a minimum of four filter positions. 6. Microscope Stand Controls The system shall permit image acquisition, fluorescence channel selection, and illumination intensity adjustment without requiring continuous operation through a dedicated PC. The system shall provide an interface for microscope configuration and illumination management through an integrated display, on-screen interface, or equivalent user-accessible control system. 7. Objectives The system shall include objectives with minimum magnifications of 5x, 10x, 20x, 40x, and 100x oil immersion. The system shall support DIC imaging at the required objective magnifications. Objectives shall be mounted on a nosepiece with a minimum capacity of six objective positions. 8. DIC Optical Capabilities The system shall support differential interference contrast (DIC) imaging. The condenser shall have a numerical aperture of at least 0.90 and shall support brightfield, darkfield, phase contrast, and DIC imaging techniques. The condenser shall include a minimum of five selectable imaging positions or equivalent functionality. 9. Monochrome Camera The system shall include a monochrome scientific camera with a minimum resolution of 3.0 megapixels. The camera shall support a minimum of 12-bit digitization. The camera shall have a spectral sensitivity range of approximately 350 nm to 850 nm. The camera shall support live image acquisition at a minimum frame rate of 30 frames per second. The camera shall include USB 3.0 and Ethernet connectivity. The camera shall support image acquisition in both standalone and PC-connected operating modes. The camera shall support storage of images in both lossless and standard image file formats. 10. Software The system shall include imaging software capable of multichannel fluorescence image acquisition, processing, measurement, and analysis. The software shall be compatible with current 64-bit Microsoft Windows operating systems. The software shall support image acquisition, visualization, processing, and analysis when connected to a PC. 11. Binocular Phototube The system shall include a binocular phototube with a minimum field number of 23 mm and a viewing angle of at least 30 degrees. The phototube shall provide a switchable optical path allowing full light transmission to either the eyepieces or the camera port. 12. Power Management and System Operation The system shall include an automatic standby, sleep, or power-saving mode. The system shall provide automated illumination management or equivalent functionality to maintain consistent imaging conditions during operation. The system shall include an integrated power supply compatible with 100 240 VAC, 50 60 Hz electrical service. Additional System Requirements: The components and equipment shall be newly manufactured, not used or refurbished, or previously used for demonstration. Offered systems shall be a turn-key solution i.e., the contractor shall be responsible for providing all hardware, components, instruments, computers, software, and that otherwise required to meet these specifications and the FDA s stated need. The systems shall be delivered with all necessary supplies and accessories required for installation and start-up. The system and associated accessories shall include operations and maintenance manuals covering proper operation, routine maintenance, and troubleshooting for the system and controlling software. All manuals and documentation shall be provided in hard copy and/or electronic format. The Contractor shall provide all labor, travel, and tools to install the equipment at the address provided below, to include shipping. The contractor shall demonstrate upon installation that the item meets or exceeds all performance specifications. Upon acceptance of the system, the contractor shall provide on-site operator training/familiarization. Such familiarization shall include system operations, calibration, optimization, troubleshooting and basic operational maintenance procedures. Systems shall be warranted for not less than one (1) year from FDA acceptance of the system(s). Warranty service shall include troubleshooting capabilities based on complete knowledge of the entire system, and immediate access to replacement parts. Phone and email technical support shall be included for a minimum of one (1) year. Delivery/Place of Performance: FOB Point Destination. All items shall include shipping, handling, inside delivery and installation to the destination identified herein. FDA/CBER 10903 New Hampshire Avenue WO Bldg. 52/72, Room…