Statement of Work.pdf

Version 11-30-2016-1 FAR Part 11—Describing Agency Needs

STATEMENT OF WORK (SOW)

GENERAL INFORMATION

Title of Project:

Single-plex NULISApcr Absolute Quantification Assay of HDGFL2 in Plasma Samples

Statement of Need and Purpose:

The purpose of this procurement is the development of HDGFL2 detection assay resulting from TDP-43 dysfunction.

Background Information and Objective:

Center for Alzheimer’s Disease and Related Dementias (CARD) is endeavoring on a large-scale phenotyping project to characterize patient samples afflicted with Alzheimer’s Disease and Related Dementias (ADRD). Analysis of TDP-43 protein has shown to be associated with amyotrophic lateral sclerosis (ALS), frontotemporal dementia (FTD), and Alzheimer’s disease (AD). TDP-43 is a splicing agent and dysfunction results in mispliced proteins, called cryptic exons. Previous work at CARD has identified proteins that are most affected in patients affected by ALS/FTD, and we are now working towards the development of antibodies for these candidate proteins. One protein of interest is HDGFL2, and the goal of this effort is to develop a biomarker assay for HDGFL2 cryptic peptides.

Period of Performance:

Twelve (12) months after award

SCOPE OF WORK

General Requirements:

Independently and not as an agent of the Government, the Contractor shall furnish all the necessary services, qualified personnel, material, equipment, and facilities, not otherwise provided by the Government as needed to perform the Statement of Work below.

Specific Requirements:

Vendor shall receive samples sent by the Government and provide receipt of shipment, including number of samples and condition of shipment.

Vendor shall develop the HDGFL2 asasy using NULISA platform.

Vendor shall provide antibody-oligo conjugation, antibodies not provided by the Government, all reagents required to perform NULISA, and commercially available healthy donor samples for initial screening.

Vendor shall perform the work in three phases, with a review of results and go/no-go decision and option to discontinue work after each phase.

Vendor shall perform a quantitative initial assessment as phase one. Phase one shall include three stages:

Sourcing and screening 14 antibodies to identify optimal pairs;

Using standard NULISA buffer system and analyte concentration to give adequate signal above background. Vendor shall minimize background and maintain signal intensity through the use of a 4-point calibration curve for each condition;

Testing prototype assay using 10 disease samples provided by the Government and 10 healthy donor samples provided by the Vendor to determine detectiability in matrix of interest

Vendor shall perform a quantitative assay characterization as phase two. Phase two shall include two stages:

Characterization of the assay through determination Hook effect, dilutional linearity, parallelism, and spike recovery;

Optimization of the assay with the intention of improving performace metric by evaluating modified buffer condition. Performance metrics include minimization of background and maintenance of singal intensity, which shall be monitered with each alteration using 3-point evaluation process

Vendor shall perform assay verification as phase three. Phase three shall include six stages:

Intra-assay precision determination to test repeatability of the assay under the same operating conditions over a short interval of time. Acceptance criteria is ≤ 20% CV on each sample and bias within ±20% expected (80% of samples run) or deviation accepted by the Government;

Inter-assay precision determination to test reproducibility of results across multiple days (minimum of 3 separate days). Acceptance criteria is ≤ 20% CV on each sample and bias within ±20% expected (80% of samples run) or deviation accepted by the Government;

Verification of assay range using the modified optimized conditions as determined in previous stages to determine quantifiability;

Verification of dilutional linearity and determination of minimum required dilution to determine the ability of the assay to reliably measure samples following dilution and determine if a minimum required dilution is required. Acceptance criteria is ≤ 20% CV on each sample and bias within ±20% expected (75% of samples run) or deviation accepted by the Government;

Verification of the selectivity of the assay and the appropriateness of using the selected standard to quantify the biomarker of interest by testing a series of five endogenous samples across 4 levels of dilution. Acceptance criteria: ≤ 20% CV on each sample and bias within ±20% expected (75% of samples run) or deviation accepted by the Government. If acceptance criteria are not met, assay will be reoptimized as needed;

Confirmation of the functionality of the assay for use in samples that will be used by the Government

Vendor shall allow the Government to include sample testing with the optimized assay in duplicate at any stage of development.

Vendor shall provide a dedicated project manager to the government as a contact point for the services.

GOVERNMENT RESPONSIBILITIES

Government will provide up to 20 disease matrix samples. Samples will be 150 µL human plasma.

Government will notify Vendor of sample shipment as it is prepared for departure.

Government will provide Vendor with an electronic shipping manifest.

Government will review results from each phase of the assay development and make a decision to move forward with the next phase or discontinue work.

DELIVERY OR DELIVERABLES

Vendor shall deliver a summary report of data and results using Vendor’s assay platform

REPORTING REQUIREMENTS

The Contractor shall submit the following reports as specified below. All reports shall be submitted electronically either as a Word document or PDF file or Excel file, as appropriate.

Contractor shall provide the results via reporting transfer through email.

Interim reports on sample tesing results via Excel, including standard curve and control sample replicates, mean, deviation and CV from signal as well as interpolated values;

slope and target LLOQ; sampe mean, deviation, and CV from signal as well as interpolated values; sample dilution corrected values; and note kit lot number, operator and day of testing, equipment used, and date of calibration

OTHER CONSIDERATIONS

Travel:

The principal place of performance is the Contractor’s work site. Travel for contractor employees will not be necessary.

Data Rights:

The Contractor shall be responsible for the transfer of de-identified raw data to the Government.

Data shall be transmitted electronically. The Contractor shall provide consultation on related features of manuscript preparation.

Section 508—Electronic and Information Technology Standards:

The contractor shall comply with Section 508 of the Rehabilitation Act (29 U.S.C. § 794d), as amended by the Workforce Investment Act of 1998 (P.L. 105-220), August 7, 1998.