Attachment_1_SON_RFQ_75N91024Q00080.pdf

STATEMENT OF NEED (SON)

National Cancer Institute | Statement of Need

1.0 TITLE

Brand Name or Equal Mabtech IRIS 2 Immunoassay Reader.

2.0 BACKGROUND

The Department of Health and Human Services (DHHS), National Institutes of Health (NIH), National Cancer Institute (NCI), Center for Cancer Research (CCR), Center for Immuno- Oncology (CIO), functions as a multidisciplinary and interdisciplinary translational research programmatic effort with the goal of developing novel immunotherapies for cancer.

The CIO requires the purchase of immunoassay reader to enumerate tumor-specific multifunctional T cells collected from either preclinical mouse studies or from human patients enrolled in clinical trials. These measurements will allow the CIO to correlate tumor-specific immunity to the responses seen following the administration of various immune-oncology agents currently being evaluated.

3.0 TYPE OF ORDER

This is a Firm Fixed-Price Purchase Order.

4.0 SPECIAL ORDER REQUIREMENTS

4.1 PRODUCT FEATURES/SALIENT CHARACTERISTICS

The following minimum product features/characteristics are required:

1. Footprint: due to space limitations, the instrument’s external dimensions shall not exceed 550 x 550 x 550 mm (H x W x D).

2. The immunoassay reader shall be capable of performing the following techniques:

a. ELISpot for the detection of secreted proteins (i.e., cytokines and growth factors).

b. FluoroSpot for the quantification of analyte-secreting cells.

c. FociSpot or equivalent assay for the detection of virus-infected cells. Assay must be capable of the following:

i. Automated counting of viral foci in a 96-well plate format.

ii. Capable of performing viral neutralization tests in a 96-well format. Using mouse or human sera.

iii. Capable of performing tissue culture infectious dose assays in a 96-well format.

iv. Capable of imaging and automated counting of Foci using specific immunostaining using virus-specific antibodies and/or antibodies specific for transgene(s) encoded by a viral vector.

v. Instrument shall detect spot centers for each FociSpot counted.

vi. Instrument shall extract volume information for each FociSpot counted.

3. Features and performance characteristics:

a. Capable of detecting spot centers for accurate spot counting.

b. Capable of extracting volume information for each spot corresponding to the amount of secreted analyte.

c. Be equipped with self-calibrating, automated XY table for a streamlined workflow.

d. Equipped with a camera sensor with a resolution of greater than 2,000 x 2,000 pixels for high-quality assay well imaging.

e. Be equipped with a white LED ring light for ELISpot assays.

f. Be equipped with four independent LED light sources capable of exciting the following fluorochromes: DAPI, FITC, Cy3 and Cy5.

g. Equipped with a telecentric lens to ensure consistent magnification across the imaging field.

h. Capable of scanning 96-well ELISPOT and 96-well FluoroSpot assay plates.

i. Capable of analyzing up to four analytes simultaneously.

j. Fast reading speed:

i. ELISpot and FociSpot or equivalent assays in less than 2 minutes per plate.

ii. FluoroSpot assays in less than 13 minutes per plate at 4 colors.

4. Allows qualification of performance and reproducibility through standardized test plates as needed,

5. Hardware shall include one (1) computer workstation (desktop and monitor) with Windows 10 (or higher) operating system to control the instrument and associated software.

6. Software shall have the following capabilities:

a. Accurately enumerates multifunctional T cells producing multiple cytokine analytes.

b. Counts single-color ELISPOT and 4 color FluoroSpot assays.

c. Provides a graphical user interface.

d. Standardized analysis to reduce user error and batch variability.

e. Export image data using both raw and jpg image formats.

f. Exports analyzed data as Microsoft Excel files and as GraphPad Prism files.

7. The immunoassay reader shall be compatible with the following well plates:

a. For ELISpot assays: MSIP (multiscreen-IP filter) plates (Millipore Sigma product

#MAIPSWU10).

b. For FluoroSpot assays: IPFL (inorganic particle filtration layer) plates (transparent, low autofluorescence, with polyvinylidene difluoride (PVDF) membrane).

c. For FociSpot or equivalent assays: Corning 96-well plates, Nunc plates.

8. Capable of being upgraded with robotic plate loader.

4.2 WARRANTY

In addition to the Implied warranty contained in FAR Clause 52.212-4, quoters are encouraged to provide express warranties. At a minimum, the Contractor shall provide a 12-month warranty from date of final installation on all equipment and associated items provided under, or as a part of this purchase order. The warranty shall include repair and or replacement of parts, including travel, labor, and materials, at no additional cost to the Government. The warranty shall not exclude or limit the Governments rights for an Implied warranty as established in the terms and conditions of clause 52.212-4.

4.3 TRAINING

The Contractor shall provide one (1) training session for a minimum of two (2) NCI staff.

Training may be virtual or on-site and shall take place within seven (7) days of equipment installation and shall be facilitated by a factory-trained product specialist. Training will include an overview of setup approaches, maintaining instrument settings, establishing operational voltages, and software usage for custom instrument configurations, as well as a demonstration of the performance. All training expenses, including materials and/or travel expenses, shall be included in the quoted price.

4.4 DELIVERY / INSTALLATION

Delivery shall be within thirty (30) calendar days of the purchase order award. All shipping/handling (including FOB) and delivery/installation fees shall be included in the quote.

Upon delivery, the Contractor shall notify the respective NCI Technical Point of Contact, TBD at award, to schedule installation dates and times. Installation shall occur within one (1) business day of delivery and shall be performed by, or under the direct supervision of, an

Original Equipment Manufacturer (OEM) certified technician. Equipment shall be delivered to and installed at the following address:

Address: T.B.D

Item No.:

Deliverable Due Date

1 Delivery and Installation of (1) Brand Name or Equal Mabtech IRIS 2 Immunoassay Reader.

30 Days After Receipt of Order (ARO)

2 One (1) training session for two (2) NCI staff members. 37 Days After Receipt of Order (ARO)

Note: Access to the NIH campus is restricted. As such all-Contractor personnel will be required to access campus via designated entrances where they are subject to security screening. Please refer to the NIH Security and Access site for more details: (www.nih.gov/about-nih/visitor-information/campus-access-security).

5.0 INSPECTION AND ACCEPTANCE

Pursuant to FAR Clause 52.212-4, all items, services, materials, or supplies to be provided by the Contractor in relation to this Purchase Order are subject to final inspection and acceptance by an authorized representative of the Government. The authorized representative of the Government is the Technical Point of Contact (TPOC).

6.0 TECHNICAL POINT OF CONTACT (TPOC)

The Technical Point of Contact (TPOC) is responsible for inspection and acceptance of all items/services in relation to this requirement and will serve as the Governments primary point of contact throughout the duration of the requirement. All efforts must be coordinated with this individual. The TPOC for this requirement is:

Technical Point of Contact:

Name: T.B.D Email:

Phone:

Note: The TPOC has limited authority as defined within this Statement of Need. They do not have the authority to commit or obligate Government funds or make changes to the terms and conditions of the purchase order. As such, any changes to the purchase order must be performed by a warranted Government Contracting Officer with appropriate delegated authority to do so.