Upright Fluorescence Microscope With Digital Imaging And Analysis Capabilities

A REQUEST FOR PROPOSAL OR SOLICITATION The U.S. Food and Drug Administration (FDA), (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 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 [email protected].

Background: The U.S. Food and Drug Administration (FDA), Center for Biologics Evaluation and Research (CBER), (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