Attachment 1 - Statement of Need 75N94025Q00178.pdf

STATEMENT OF NEED (SON)

1.0 TITLE

Flow Cytometer for NIDDK

2.0 BACKGROUND

Background: The mission of the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) is to conduct and support medical research and research training and to disseminate science-based information on diabetes and other endocrine and metabolic diseases; digestive diseases, nutritional disorders, and obesity; and kidney, urologic, and hematologic diseases, to improve people’s health and quality of life. The NIDDK Intramural Research Program (IRP) conducts biomedical research and training related to diabetes mellitus;

endocrine, bone, and metabolic diseases; digestive diseases, including liver diseases and nutritional disorders; and kidney, urologic, and hematologic diseases. Intramural research is conducted in the Institute's laboratories and clinical facilities in Bethesda, Maryland and in Phoenix, Arizona.

There are currently 17 Laboratories and Branches (i.e. 17 departments with different focus areas) in the NIDDK IRP. Most if not all these areas of research, either occasionally or on an ongoing basis, require advanced light microscopy methods to qualitatively complement other assays, or as the basis of a quantitative assay. A flow cytometer is a crucial instrument for immunology and studies related with human diseases. Our current flow cytometer was purchased in 2018 and is limited to roughly 10-14 color panels and now constrains the lab’s ability to dissect rare immune and parenchymal cell states in kidney, spleen, and tumor digests or to analyze irreplaceable patient samples. Modern immunology increasingly demands 40 plus parameters per cell to integrate flow data with single cell RNA seq, ATAC seq, and spatial transcriptomic pipelines already active in the lab. We need a new flow cytometer instrument that will shorten instrument queues, and serve as an open resource for neighboring groups that express interest, also broadening training opportunities for fellows across the institute. Without a new flow cytometer instrument, current and future research will be negatively affected because it will rely on an outdated instrument.

3.0 TYPE OF ORDER

Firm Fixed-Price type Purchase Order.

4.0 ORDER REQUIREMENTS

We require a flow cytometer instrument that is designed for high-speed, high-parameter analysis of cells, offering both spectral and conventional flow cytometry capabilities. We require it to leverage acoustic focusing technology for precise cell alignment and enable faster sample acquisition and clog-resistant fluidics. This is important to our lab research as it results in quicker, more accurate, and reliable data for researchers, particularly in fields like immunology and immuno-oncology.

We require the following ThermoFisher Scientific brand name items, or equal/comparable items:

1. ATTUNE XENITH FLOW CYTOMETER (A59358) or equal, EA, QTY 1

2. SMARTSTART XENITH 3D (TRN00390) or equal, EA, QTY 1

3. AB ASSURANCE 1PM-XENITH (ZG11SCXE NITH) or equal, EA, QTY 2

4. CYTKICK MAX SYSTEM AAS2, (A42973) or equal, EA, QTY 1

5. SMARTSTART CYTKICK MAX 1DAY CS TRAINING (TRN00306) or equal, EA, QTY 1

6. AB ASSURANCE 1PM CYTKICK MAX (ZG11SCCK M) or equal, EA, QTY 2

7. Shipping & Handling, EA, QTY 1

4.1 FEATURES/SALIENT CHARACTERISTICS/SPECIFICATIONS

Flow Cytometer Specifications:

Combine 6 spatially separated flat-top lasers, 51 fluorescence detectors, acoustic-focusing fluidics, and dual conventional/spectral unmixing.

Provide acoustic focusing that virtually eliminates clogs when running dense tissue digests (kidney, spleen, tumor).

Have sample-recovery mode, calibrated volume delivery, and 20 µL minimum uptake to protect limited specimens and enable absolute counts without the use of additional counting beads.

Have an optical train that is user-realign-free and uniquely allows plug-and-play dichroics/bandpass filters for rapid panel changes.

Process samples at sample flow rates between 12.5 µL and 500 µL per minute.

Come with 57 detectors: 51 for fluorescence detection and 6 for scatter detection and enable spectral unmixing of panels of up to 32 colors.

Have software enabled with both spectral and conventional compensation workflows.

Permit adjustment of the photomultiplier gain.

Analyze particles in the size range of 0.16 µm to 50 µm.

Have scatter detector array that shall enable the user to identify cells across a broad dynamic size range within a sample. This expanded range shall be accomplished using violet forward- scatter and side-scatter detectors for small particles and both available blue forward-scatter and side-scatter detectors.

Have advanced polarized scatter detection capabilities for detection of intracellular crystal structures.

Have lower coefficients of variation (<3%) than those of hydrodynamic instruments.

Allow the user to adjust the optical configuration without assistance from a service engineer.

Collect height, area, and width measurements in all scatter and fluorescence channels.

Easily identify appropriate reagents to use for a particular channel and annotate data plots.

Use flat-top lasers, and the optical alignment has been designed to be highly stable, so under normal operating conditions (without moving the instrument), the user is not required to align optics.

Have a laser light engine with 6 spatially separated flat-top lasers.

Provide at least 6 decades of resolution, and shall be capable of high data collection rates, capturing up to 35,000 events per second.

Have calibrated sample volume delivery with minimal draw variation.

Have positive- displacement fluidics.

Provide a fluidics cart with weight- based level sensing that carries fluid for approximately 16 hours of run time and the main fluids needed for automated maintenance functions.

Have a built-in touchscreen on the instrument that allows the user to run startup and shutdown operations without logging into the software and enables monitoring of fluid levels during acquisition of samples.

Have a minimum uptake volume of 20 µL when running plates.

Have acoustic focusing technology that enables the instrument to analyze blood samples without the need to lyse, wash, or concentrate samples.

Be compact enough to be placed either on a counter or in a laminar flow hood.

Instrument dimensions (H x W x D): 49.5 x 86.4 x 61 cm; 19.5 x 34 x 24 in or less.

Fluid cart dimensions (H x W x D): 65 x 76 x 60 cm; 26 x 30 x 24 or less.

Operate at temperatures of 15–30°C (59–86°F), with operating humidity 20–80% (noncondensing).

Have instrument tube lifter that accommodates 0.5, 1.5, and 2.0 mL microcentrifuge tubes and 2 and 5mL flow cytometry tubes.

Include workstation with Processor: Intel Core i9 processor, 64 GB RAM, solid state drive, 2 x 8 TB, 560

MB/s, NVIDIA RTX A2000 graphics card, 32-inch flat panel (4K resolution) or similar.

Compatibility with the CytKick Max Autosampler, our current plate-handling device.

Software Requirements

Have data from the instrument stored in industry-standard FCS 3.1 file formats.

Include software designed to collect and analyze flow cytometry data.

Have a simple user interface based on the Windows platform.

Support data acquisition, data analysis, and functional control of the instrument.

Be designed so that data analysis can be performed in real time during data acquisition or post acquisition.

Include multiple plot types, including dot plots, density plots, spectrum plots, dimensionality reduction plots, and histograms that include linear, logarithmic, hyperlog, and biexponential scaling.

Provide automated startup and shutdown capabilities from the desktop application and touchscreen.

Have maintenance functions, including: unclog, debubble, system decontamination, and flow cell clean, which can be fully automated from the instrument software.

Have spectral and conventional compensation unmixing modes.

Include a spectral energy plot, a cosine similarity score, and complexity scores.

Allow batch export of experiments and FCS files.

Include statistical analysis tools that allow analyses to be exported to a CSV file.

Statistical operations that can be performed shall include mean, median, percent robust coefficient of variation (RCV), standard deviation, percent parent, percent total, and concentration.

Have software that allows experiment annotation by import of CSV files.

Generate account usage logs for a user-defined time.

Allow graphical thresholding of up to two parameters simultaneously.

Have a sample recovery mode.

Allow the user to define a backup storage location for data files.

Service Requirements:

Customer training at the customer’s site or at an internal facility by a certified technical scientist, focusing on basic operation and maintenance.

Limited warranty for a period of one year, or longer, beginning on the date of installation.