Statement_of_Work_-_Digital_PCR.docx

STATEMENT OF WORK

TITLE: Procurement of a Digital PCR Instrument LAB REQUESTING SERVICE: Material Measurement Laboratory, Biosystems and Biomaterials Division

I. BACKGROUND INFORMATION

The Biosystems and Biomaterials Division develops and applies standards and methods for all analytical and bio-analytical measurements to ensure bioassay performance for identification and quantitation of molecular and biological species; works to improve the quality and reliability of measurements in the biological sciences; supports a broad range of health, defense, environmental, and energy research related activities and customers; and uses state-of-the-art techniques and methods to explore and resolve measurement issues in molecular biology, nano-biotechnology, immunology, biophysical chemistry, molecular spectrometry and surface chemistry.

II. SCOPE OF WORK

A digital PCR Instrument is used to determine the accurate and reproducible concentration of DNA samples. NIST requires a Digital PCR Instrument for use in certifying the concentration of Standard Reference Materials (SRM) that are produced in the Biosystems and Biomaterials Division. The instrument is required to produce high levels of data quality for the accurate measurement of the samples. In addition to high accuracy and reproducibility (precision) the instrument must also be able to measure large number of samples in a reasonable time (sample throughput) and at a reasonable cost per sample.

A Droplet Digital PCR instrument works on the principal that single DNA molecules can be partitioned into droplet (compartments) and then PCR (polymerase chain reaction) is applied to amplify the single DNA molecules to detectable amounts. The PCR step can be done on a separate device (a thermocycler, many are already available at NIST) or part of the instrument.

Each droplet that contains a single DNA molecule that is amplified by the PCR reaction and then detected by using a fluorescent dye molecule. The droplets that contain the amplified DNA are termed a positives and droplets that do not contain a DNA molecule are termed negatives. The fraction of negative droplets and the size of the droplets is used to calculate the concentration of DNA in the original sample.

The instrument must have provisions for multiple samples, dispersion of the samples into the droplets and detection of the positives by detection of fluorescent dyes and software for data manipulation for calculation of the concentration values.

III. SPECIFICATIONS

The Contractor shall provide one (1) digital PCR instrument system that meets the following minimum technical requirements. The Contractor shall install the instrument and provide training as described below.

Salient Characteristics:

· The droplet generator, the droplet reader, and the data analysis module must fit on a laboratory bench top size (each unit up to 48 inches in depth, 48 inches in width and 48 inches in height)

· The droplet generator must capable of generating at least 20,000 droplets using a sample size of 20 microliters, allowing for detection of samples that differ in concentration up to 5 orders of magnitude

· The instrument must be capable of detection of at least 2 fluorescent channels for at least 2 target sequences using common fluorescent dyes such as FAM, EvaGreen, HEX and VIC

· The droplet reader capacity must have capability of automated reading for as few as 1 sample and up to 96 samples

· The 96 samples must be analyzed by the droplet reader in less than 4 hours

· The sample to sample reproducibility shall be within 10% of the calculated concentration values (precision).

· The instrument shall include a data analysis module that is capable of collecting, storing and processing the data for at least 96 samples.

· The instrument shall include software that can calculate the concentration of the DNA in each droplet for at least two fluorescent dyes by fitting the fraction of negative droplet data to a Poisson calculation to determine the copy numbers of the DNA targets

· The software shall be able to display the fluorescent dye intensity for at least two dyes for each droplet.

· The software shall be able to allow the adjustment of the threshold settings for calling positive droplets in individual wells or up to 96 samples.

· The system shall include an operations and maintenance manual covering proper operation, routine maintenance, and troubleshooting for the instrument and controlling software

Installation:

The Contractor shall install the instrument in Building 227, Room A237, at NIST Gaithersburg, MD. Installation shall include, at a minimum, uncrating/unpacking of all equipment, set-up and hook-up of all equipment, start-up, demonstration of specifications, and removal of all trash. Instrument shall operate to manufacturer’s specifications upon installation. Installation will take place during normal business hours, between 8:30 am and 5:00 pm Eastern Time, Monday through Friday except Federal Holidays, and will be coordinated with the NIST Technical Point of Contact (TPOC). Installation is to occur within 90 days of award.

Warranty:

The Contractor shall provide, at a minimum, a one year warranty for the equipment. The warranty shall cover all parts, labor and travel. The warranty shall commence upon successful completion of delivery, installation, training, and demonstration of all required specifications.

Training:

Training at NIST for up to 2 NIST personnel covering normal operation, troubleshooting, and routine maintenance shall be included. Training shall be provided during normal business hours, between 8:30am and 5:00pm Eastern Time, Monday through Friday, except Federal Holidays, and will be coordinated with the NIST Technical Point of Contact (TPOC) to ensure maximum availability of NIST personnel. Training is to occur within 30 days of installation. The training may be completed on-site at NIST immediately after installation and demonstration of specifications.

IV. BRAND NAME OR EQUAL

This is a brand name or equal purchase. The Government considers the following instrument manufactured by Bio Rad Laboratories, 2000 Alfred Nobel Drive, Hercules, CA 94547as meeting the specifications cited above:

QX200 Droplet Digital PCR

Offerors may propose another item but shall include with their proposal documentation that demonstrates that it meets the specifications as outline above in Section III. Documentation must include drawings, diagrams, brochures or other literature that demonstrates these salient characteristics. Failure to provide such documentation will cause the proposal to be unacceptable.

V. PERIOD OF PERFORMANCE

Delivery, installation, and training shall be completed within 90 days after award.

VI. PLACE OF PERFORMANCE

The instrument shall be manufactured at the Contractor’s facility. Installation of the instrument and training shall be accomplished at NIST, 100 Bureau Drive, Gaithersburg, Maryland. Normal duty hours are Monday through Friday, 8:30 a.m. to 5:00 p.m. with the exception of Federal holidays.

VII. DELIVERABLES

VIII. ACCEPTANCE CRITERIA

After installation at NIST, the Contractor shall demonstrate performance specifications of the instrument are met.

IX. ACCEPTANCE AND PAYMENT

NIST personnel will verify equipment operation meets technical standards post installation via visual inspection, and training.

The contractor may invoice in one lump sum after all required items have been accepted by the Government. Partial payments are not authorized. Advance payment is not authorized.