Specifications_-_Flow_Cytometer.docx

FLOW CYTOMETER SPECIFICATIONS

I. BACKGROUND INFORMATION

The National Institute of Standards and Technology, and the Food and Drug Administration (FDA), are actively collaborating on projects that address regulatory, and measurement challenges for cell therapies and regenerative medicine products. Flow Cytometry is a laser based technology used to count and sort cells, detect biomarkers and engineer proteins, by suspending cells in stream of fluid and passing them by and electronic detection system. It is used in research and clinical laboratories for many applications to include chromosome analysis, cancer diagnosis, protein expression, DNA and RNA quantification, multi-drug resistance, and measuring enzyme activity.

To meet mission requirements, BMG must purchase a flow cytometer, with six laser excitations, 375 nm, 405 nm, 488 nm, 561 nm, 638 nm, and 808 nm, capable of performing highly sensitive measurements on a total of 21 fluorescence channels, plus two scattering channels. Th flow cytometer with proper acquisition software, can perform daily QA/QC, as well as, rare event and small bioparticle detection.

II. SCOPE OF WORK

The Contractor shall deliver one (1) Flow Cytometer meeting the specifications outlined below:

1. Includes 375 nm, 405 nm, 488 nm, 561 nm, 638 nm, and 808 nm solid diode lasers/LEDs and can acquire 23 parameters on a single sample, 21 color fluorescence data plus forward and side scatter.

2. Includes Avalanche Photo Diode detector arrays for fluorescence and side scatter light detections, and permits the detection of <100 nm nano-sized bioparticle with side scatter from either 405 nm or 375 nm laser.

3. Permits detector sensitivity (Q) and background (B) measurements in the unit of equivalent number of reference fluorophores that can be compared with cytometer platforms manufactured by different vendors. For example, <30 fluorescein molecules for Fluorescein channel and <10 phycoerythrin molecules for phycoerythrin channel.

4. Includes a complete compensation matrix that will allow end users to compensate the signal from every channel, out of every other channel.

5. Includes daily QC and performance tracking system.

6. Permits the adjustment of the optical configuration by the end user without the need for a service engineer by using plug and play dichroic mirrors and band-pass filters, providing greater flexibility in reagent selection.

7. Provides at least 6-7 decades of resolution enabling high data accuracy and can capture up to 30,000 events/second allowing high data collection rates.

8. Process samples at sample flow rates between 10 and 240 μL per minute in 1 μL increments and enables absolute cell counting with proper software.

9. Include both sample formats, tube and plate loader.

10. The instrument shall operate with 110V.

11. The instrument shall have an approximate footprint (H x W x D): 24 in x 30 in x 20 in, small enough to allow the unit to be placed either on a counter or in a laminar flow hood.

12. Includes acquisition software supporting data acquisition, data analysis, data exporting, and functional control of the instrument making the overall operation of the instrument simple and convenient.

13. The instrument shall be equipped with a computer inclusive of a Windows 10 professional operating system and monitor, allowing visualization of data acquisition and data analysis modules.

14. The instrument includes a license to software at no cost that is designed to collect and analyze the flow cytometry data in standard FCS 3.0 format.

15. The contractor shall provide the manufacturers instrument brochure.

16. Supply the necessary consumables to perform instrument performance tracking, daily operation, maintenance, and warranty repairs during the service contract period.

17. The contractor shall provide Telephone Technical Support and Field Applications/Sales/Service Support to answer technical questions, help review data, make recommendations on troubleshooting results encountered with flow cytometry experiments.

III. INSTALLATION AND TRAINING

The Contractor shall provide installation and training at NIST campus, Gaithersburg, MD. Training shall be conducted on NIST campus, for two days for no more than two people.

IV. WARRANTY

The Contractor shall provide, at minimum, a one (1) year warranty on the Cytometer.

V. PLACE OF PERFORMANCE

All work shall be accomplished at the Contractor’s facility except installation, training and warranty service.

VI. PERIOD OF PERFORMANCE

Delivery, installation, and training shall be completed within 45 days after award.

VII. PERFORMANCE REQUIREMENT SUMMARY

VIII. GENERAL INFORMATION

Safety: The Contractor employee shall be responsible for knowing and complying with all installation safety prevention regulations. Such regulations include, but are not limited to, general safety, fire prevention, and waste disposal.

Security: NIST is a restricted campus. An identification badge is required for access for entry into buildings and is shown to the armed Security Police when entering the campus.

Identification Badges: Contractor employees shall comply with NIST identification and access requirements. The Contractor employee is responsible for absences due to expired identification and access documents. Each Contractor employee shall wear a visible identification badge provided by the NIST Security Office. The badge must show the full name, title, and if required by NIST, the words “Contractor” in front. The Contractor employee shall turn in the NIST identification badge and vehicle pass to the TPOC, COR, or Contracting Officer (CO) upon termination of their services under this contract.

Vehicle Registration: All Contractor employees must register their vehicles with the NIST Security Office to gain access to the campus. A valid driver’s license, Government-furnished civilian ID, proof of insurance and current registration must be presented to the NIST Security Office, at which time a NIST vehicle pass must be issued. The pass shall be displayed on the vehicle’s rear-view mirror in accordance with instructions. The Contractor employee shall follow NIST procedures for removal and turn-in of the vehicle pass upon termination of services under this contract.