Statement of Requirements.docx

VIRUS COUNTER SPECIFICATIONS

I. BACKGROUND INFORMATION

A virus counter instrument is required by the Bioassay Methods Group to support numerous research projects including gene therapy viral vector characterization, cell reference material generation for viral vector cope number, CAR T cell generation and functionality evaluation. The instrument is intended for study of lentiviral vector and adeno-associated vector qualification through monitoring viral particle concentration, capsid content and aggregation.

To meet the mission, the Group requires a virus counter with an enclosed class 3B laser diode module and photomultiplier tube (PMT) plus a fluid system to provide rapid, direct, biologically relevant virus quantification. A key feature of the instrument must possess is command line control of software and export of the acquired quantification data.

II. SCOPE OF WORK

The Contractor shall deliver one (1) Virus counter meeting the specifications outlined below:

1. Includes an enclosed Class 3B laser diode module lasers, e.g. red and yellow lasers to enumerate fluorescently labeled virus sample using fluorescence thresholding;

2. Includes photomultiplier tubes (PMT) with high detection efficiency;

3. Permits detection of both large (Baculovirus, 30 to 60 x 250 to 300 nm) and small (AVV, 25 nm) viruses and discrimination of viruses with discrete sizes;

4. Permits linear dynamic range of 5x105 vp/ml – 1x109 vp/ml;

5. Permits enveloped and partial-enveloped virus detection;

6. Provides quantification of total virus particles in a fluidic stream;

7. Instrument shall have an integrated performance verification procedure, and is able to process samples in high-throughput matter and with sample volumes measured accurately through calibrated flow rates;

8. Includes both sample formats, tube and plate loader;

9. Includes compressed gas-clean dry air (CDA) or nitrogen: 15psi (103 kPa) and permits a sample flow rate of less than 1 microliter per minute;

10. The instrument shall operate with 100-240V;

11. The viral counter shall have an approximate size (H x W x D): 17 in x 16.5 in x 11 in, small enough to allow the unit to be placed in a biosafety hood;

12. Includes acquisition software supporting data acquisition, data analysis, data exporting, and functional control of the instrument, e.g. sample line cleaning and disinfection, making the overall operation of the instrument easy to learn;

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 shall include a non-expiring license to software that is designed to collect and analyze the data at no additional cost;

15. The weight of the instrument does not exceed 35 lbs;

III. INSTALLATION

The Contractor shall install the Virus Counter at NIST, Gaithersburg, MD. Installation, at minimum, shall include uncrating/unpacking of all equipment, set-up, and hook-up of all equipment, instrument start-up, demonstration of instrument performance with the specifications and removal of any trash. The Virus Counter shall operate to manufacturers specifications upon installation. Installation shall take place between 8:30 AM and 5:00 PM Monday through Friday, with the exception of holidays. Installation shall be coordinated with the NIST Technical Point of Contact (TPOC).

IV. WARRANTY

The Contractor shall include at minimum a one (1) year warranty to include all parts, labor, and travel for the Virus Counter and associated software. To keep the system operating to manufacturers specifications software updates and one (1) preventative maintenance visit shall be included and coordinated with the TPOC at least 10 days prior to the visit. The Contractor shall supply the necessary consumables, such as synthetic particles and/or bioparticles as reference controls, to conduct instrument performance tracking, maintenance and repairs. The contractor shall provide unlimited telephone/email support to answer technical questions, data review, and make recommendations on troubleshooting results encountered with experiments using the instrument. If the problem is not resolved, the contractor shall send a certified/trained service technical expert to repair the instrument with a response within 24 hours of NIST request during normal hours between Mon-Fri 8:30 – 5PM. The warranty shall commence upon NISTs acceptance of the instrument.

V. TRAINING

The Contractor shall provide training for one day for two personnel. The training shall provide at minimum, the basic use of the hardware, software, and a thorough demonstration of all system functions, maintenance data administration, and basic troubleshooting. Training shall be completed on-site at NIST, Gaithersburg, after installation.

VI. PLACE OF PERFORMANCE

All work shall be accomplished at the Contractor’s facility. Installation, and training shall take place at NIST Campus, Gaithersburg, MD.

VII. DELIVERY

Delivery, installation, and training shall be completed within 45 days after award. However, due to current access restrictions, delivery shall not take place until the contractor coordinates with the designated TPOC and the Contracting Officer (CO). Prior to shipment, the Contractor must ensure NISTs campus is open and accepting deliveries. If the restrictions of access to the campus impacts delivery schedules, a modification may be executed by the CO to establish an extended delivery timeframe.

VIII. PERFORMANCE REQUIREMENT SUMMARY

IX. 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.