B_SOW.pdf

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

STATEMENT OF WORK (SERVICES)

(SOW)

GENERAL INFORMATION

Title of Project:

Inflammatory and neurodegeneration markers in the Baltimore Longitudinal Study of Aging

(BLSA).

Statement of Need and Purpose:

The National Institute on Aging (NIA) has purchased state-of-art assay kits for quantification of serum/plasma of N4PE, STREM2, and pTau 181 from Quanterix. These biomarkers will be assayed using stored specimens from participants in the BLSA. This procurement is for the services of a senior technician to run the assays on the Quanterix Simoa HD-1 or HD-X analyzer.

Background Information and Objective:

Evidence from autosomal dominant Alzheimer’s disease (AD) research suggests that soluble forms of phosphorylated tau (including p-tau181) may have downstream effects on neurodegenerative processes and cognitive decline. However, this has not yet been systematically examined in late-life/sporadic AD. Investigators in the Laboratory of Behavioral Neuroscience, Translational Gerontology Branch, and Laboratory of Clinical Investigation propose three research aims that apply new ultra-sensitive plasma tau assays and leverage the wealth of available neuroimaging, cognitive, and clinical data in the BLSA to further understand the causes and consequences of pathological tau in the preclinical (asymptomatic) phase of AD.

Specifically, the proposed research will examine the degree to which p-tau181, N4PE, and sTREM2 measured in plasma of cognitively normal individuals relates to MRI-defined neurodegeneration, cognitive decline, and incident dementia over a 10-year follow-up period.

This project requires the use of high throughput equipment and sensitive assays for the identification of biomarkers in serum/plasma of sTREM2, pTau 181, N4PE. These biomarkers will provide important insights into the biological underpinnings of cognitive impairment years before any symptoms would be apparent. New insights may lead to novel treatments to help prevent or delay AD.

Period of Performance:

May 1, 2022 to April 30, 2023

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:

Contractor shall analyze pTau 181, N4PE, and sTREM2 in 5594 samples from the BLSA study participants. The contractor will use a senior technician to run the assays on the Quanterix Simoa HD-1 or HD-X analyzer.

LEVEL OF EFFORT:

Senior Technician at 70% effort

GOVERNMENT RESPONSIBILITIES

The government will provide the serum/plasma samples to be assayed and the necessary kits and materials to perform the Quanterix assays.

DELIVERY OR DELIVERABLES

The contractor shall deliver an electronic copy of the results of the analysis within one (1) year from the date of receipt of the contract.

REPORTING REQUIREMENTS

The contractor is required to provide a written progress report once the samples have been analyzed that will cover measurements for each sample, problems encountered, problem resolution, and unresolved problems.

OTHER CONSIDERATIONS

Travel:

N/A

Key Personnel:

Senior technician with experience running assays on the Quanterix HD-1 or HD-X

Information System Security Plan:

N/A

Data Rights:

The National Institute on Aging shall have unlimited rights to and ownership of all deliverables provided under this contract including reports, recommendations, briefings, work plans and all other deliverables. This includes the deliverables provided under the basic contract and any optional task deliverables exercised by the contracting officer. In addition, it includes any additional deliverables required by contract change. The definition of “unlimited rights” is contained in Federal Acquisition Regulation (FAR) 27.401, “Definitions.” FAR clause 52.227-14, “Rights in Data-General, ” is hereby incorporated by reference and made a part of this contract/order.

Section 508—Electronic and Information Technology Standards:

N/A

Publications and Publicity:

The contractor will work with the National Institute on Aging on publications. Any publications are required to follow the National Institute on Aging and Women’s Health Initiative (WHI) publication procedures.

Confidentiality of Information:

N/A