This notice is issued to help determine the availability of qualified companies technically capable of meeting the Government requirement and to determine the method of acquisition. It is not to be construed as a commitment by the Government to issue a solicitation or ultimately award a contract. Responses will not be considered as proposals or quotes. No award will be made because of this notice. The Government will NOT be responsible for any costs incurred by the respondents to this notice. This notice is strictly for research and information purposes only.

Background / Purpose / Objective: The National Institute of Aging (NIA) Intramural Research Program (IRP) requires state-of-art Simoa 96-well plate assay kits for quantification of serum/plasma of AB40, AB42, Total Tau, IL-6 and NF-Light. These biomarkers will be assayed using baseline biospecimens from women followed for many years through the Women's Health Initiative (WHI). The Women's Health Initiative Memory Study (WHIMS) is an ancillary study to WHI randomized clinical trial of the effects of postmenopausal hormone therapy on health outcomes. The current project will investigate the biology of cognitive resilience in women who carry the Apolipoprotein E e4 risk allele for Alzheimer disease (AD) as well as risk factors for cognitive impairment in women who have developed cognitive impairment. The current project makes use of stored biospecimens from WHI baseline assessment to investigate potential biomarkers of cognitive resilience as well as development of probable dementia. This project requires the use of high throughput equipment and sensitive assays for the identification biomarkers in serum/plasma of AB40, AB42, Total Tau, IL-6 and NF-Light. These biomarkers will provide important insights into the biological underpinnings of cognitive resilience and cognitive impairment years before any symptoms would be apparent. New insights may lead to novel treatments to help prevent or delay AD.

Specifications: The NIA required the Simoa 96-well plate assays and all necessary reagents to include: (1) Complete kit for running one 96-well plate of a Simoa 3-plex assay for human AB40, AB42, total Tau Advanced Quadrupole Technology combines high selectivity and efficiency of transfer for selected ions symmetrically across the isolation window; (2) Complete kit for 96-well plate of a Simoa assay for IL-6; (3) Complete kit for 96-well plate of a Simoa assay for NF-light; and (4) Complete assay kit for running one 96 well plate (or 96 tubes) of target analyte. Includes calibrator concentrate, calibrator diluent, beads detector, SBG, RGP, and sample diluent. Novel ETD HD-high dynamic range ETD provides significantly increased fragment ion coverage.

The Simoa 96-well plate assays should be brand-name or equivalent to: (1) Product code: 101995, Product name: Neurology 3-Plex A (AB40, AB42, Tau)*, Product Description: Complete kit for running one 96-well plate of a Simoa 3-plex assay for human AB40, AB42, total Tau, Quantity: 48-each; (2) Product code: 101622, Product name: IL-6 Simoa 2.0 Assay Kit*, Product Description: Complete assay kit for running one 96 well plate (or 96 tubes) of target analyte. Includes calibrator concentrate, calibrator diluent, beads, detector, SBG, RGP, and sample diluent, Quantity: 48-each; (3) Product code: 103186, Product name: NF-light Simoa Assay Advantage Kit (Ref Cal)*, Product Description: NF-light Simoa Assay Advantage Kit (Ref Cal)*, Product Description: Complete assay kit for running one 96 well plate (or 96 tubes) of target analyte. Includes reference calibrators, beads, detector, SBG, RGP, and sample diluent, Quantity: 48-each; (4) Product code: 103347, Product name: Disc Kit for Simoa HD-1 (rev 2), Product Description: This kit includes a stack of 16 Simoa Discs, 500 Simoa cuvettes, 4 Simoa assay plates and lids, an 8-pack of 15 ml bottles, and 8 boxes of disposable Simoa pipettor tips (768). This kit includes enough materials to run 4 plates under customary operating circumstances, Quantity: 36-each; (5) Product code: 100206, Product name: Simoa Sealing Oil for HD-1, Product Description: One 500 mL bag of Simoa oil for sealing the microarrays onboard the Simoa HD-1 Analyzer during operation. This quantity is sufficient for running approximately 8000 tests, Quantity: 1-each; (6) Product code: 100486, Product name: System Buffer 1, (2 Pack), Product Description: 2x (5L) Wash Buffer 1 specifically formulated to optimize performance of assays on the Simoa HD-1 Analyzer, Quantity: 8-each; (7) Product code: 100487, Product name: System Buffer 2, (2 Pack), Product Description: 2x (3 L) Wash Buffer 2 specifically formulated to optimize performance of assays on the Simoa HD-1 Analyzer, Quantity: 1-each, manufactured by Quanterix, 113 Hartwell Avenue, Lexington, MA 02421, Telephone Number: (617) 301-9400, Representative: David Kulick, Email: [email protected] .

Anticipated period of performance / delivery date: The Government's anticipated delivery date is 90 calendar days after receipt of the duly executed purchase order.

Other important considerations: The response may cite any other information that is necessary for potential respondents to understand the nature of the potential requirement or proposed acquisition.

Capability statement /information sought. The respondents must submit clear and convincing evidence that their product is equivalent or superior to the brand-name specified in this notice. The response shall include: the unit price, list price, shipping and handling costs, delivery days after contract award, delivery terms, prompt payment discount terms, F.O.B. Point (Destination or Origin), product or catalog number(s); product description; and any other information or factors that may be considered to determine the method of acquisition. The information must address each of the minimum specifications and the equivalent elements of the brand-name parts stated herein. The response must also indicate the country of manufacturer.

The response must also include their DUNS number, organization name, address, point of contact, and size and type of business (e.g., 8(a), HubZone, etc., pursuant to the applicable NAICS code and any other information that may be helpful in developing or finalizing the acquisition requirements.

The response must include the respondents' technical and administrative points of contact, including names, titles, addresses, telephone and fax numbers, and e-mail addresses.

The response must be clear and concise in Microsoft Word or Adobe PDF format using 11-point or 12-point font, 8-1/2" x 11" paper size, with 1" top, bottom, left and right margins, with single or double spacing, and limited to ten (10) pages (exclusive of the cover page, executive summary, or references, if requested).

All responses to this notice must be submitted electronically to Debra C. Hawkins Contractor, Acquisition Policy Analyst II, at [email protected] on or before August 13, 2019, 12:00 PM. Facsimile responses are NOT accepted.

Disclaimer and Important Notes: This notice does not obligate the Government to award a contract or otherwise pay for the information provided in response. The Government reserves the right to use information provided by respondents for any purpose deemed necessary and legally appropriate. Any organization responding to this notice should ensure that its response is complete and sufficiently detailed to allow the Government to determine the organization's qualifications to provide the product or perform the services specified herein.

Respondents are advised that the Government is under no obligation to acknowledge receipt of the information received or provide feedback to respondents with respect to any information submitted. After a review of the responses received, a presolicitation synopsis and solicitation may be published in Federal Business Opportunities. However, responses to this notice will not be considered adequate responses to a solicitation.

Confidentiality: No proprietary, classified, confidential, or sensitive information should be included in your response. The Government reserves the right to use any non-proprietary technical information in any resultant solicitation(s)."