RFQ Attachment 1_Purchase Description.pdf

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Assay Kits for Lumipulse instrument
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75N95025Q00005-RFQ
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This is a Purchase Description detailing the National Institute on Aging's (NIA) requirement for state-of-art assay kits to quantify serum/plasma of abeta42, abeta40, and pTau 217 using Lumipulse assays on their Lumipulse G1200 instrument manufactured by Fujirebio. The assays will be used to study biomarkers of Alzheimer's Disease in specimens from participants in the Baltimore Longitudinal Study of Aging (BLSA).

The requirement includes specific quantities of IRC Plasma kits (103 each of BA1-42, BA1-40, and pTau217 3x14), Calibration kits (4 each of BA1-42, BA1-40, and pTau217 1x5), and Control kits (6 each of BA1-42/1-40 1x2 and pTau217 2x2). The total quantity is 4,410 units, split into two deliveries: Part A of 1,500 units to be shipped after award and Part B of 2,910 units to be shipped within 6 months of award. All items must be manufactured by Fujirebio and delivered to Baltimore, Maryland.

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FAR Part 11—Describing Agency Needs

PURCHASE DESCRIPTION

1. Statement of Need and Purpose: National Institute on Aging (NIA) requires state-of-art assay kits for quantification of serum/plasma of abeta42, abeta40, and pTau 217 using Lumipulse assays on the NIA owned Lumipulse G1200 instrument manufactured by Fujirebio. These biomarkers will be assayed using stored specimens from participants in the Baltimore Longitudinal Study of Aging

(BLSA).

2. Background Information and Objective: Evidence from autosomal dominant Alzheimer’s disease (AD) research suggests that soluble forms of phosphorylated tau may have downstream effects on neurodegenerative processes and cognitive decline. Recent data suggest that pTau217 may be particularly sensitive to the development of brain amyloid. The purpose of the study is to perform assays for biomarkers of Alzheimer’s Disease-AD (ABeta, pTau) in longitudinal data from participants in the BLSA who have scores on the phenotypic metric of aging index or proteomics data. These data will be used by investigators in the Laboratory of Behavioral Neuroscience and Translational Gerontology Branch to leverage the wealth of available neuroimaging, cognitive, and clinical data in the BLSA. Specifically measures of ABeta and pTau217 will be used to stratify participants to determine the likelihood that participants are in a preclinical phase of AD. These measures will also be used continuously alone and in combination with biomarkers of inflammation and neuronal injury to further understand the causes of cognitive and brain changes in healthy individuals and those with a variety of comorbidities.

3. Generic Name of Product: abeta42, abeta40, and pTau 217 Lumipulse assays

4. Purchase Description: Manufacturer’s Name: Fujirebio

5. Salient characteristics:

Contractor shall provide the NIA/LBN with abeta42, abeta40, and pTau 217 Lumipulse assay kits, as well as controls:

IRCs

• IRC Plasma BA1-42 3x14

• IRC Plasma BA1-40 3x14

• IRC Plasma pTau217 3x14

Cals

• Plasma BA1-42 1x5

• Plasma BA1-40 1x5

• Plasma pTau217 1x5

Controls

• Plasma BA1-42 &1-40 1x2

• Plasma pTau217 2x2

FAR Part 11—Describing Agency Needs

6. Quantity: 4,410 (Part A =1500 and Part B =2910)

IRCs Product Code # Quantity

• IRC Plasma BA1-42 3x14 81301 103

• IRC Plasma BA1-40 3x14 81298 103

• IRC Plasma pTau217 3x14 81472 103

Cals

• Plasma BA1-42 1x5 81303 4

• Plasma BA1-40 1x5 81299 4

• Plasma pTau217 1x5 81471 4

Controls

• Plasma BA1-42 &1-40 1x2 81300 6

• Plasma pTau217 2x2 81473 6

7. Delivery Date: Multiple deliveries: Part A =1500 shipped after award, Part B =2910 shipped within 6 months of award.

File details come from the government source that posted it. Updated .