SOLICITATION NOTICE
66 -- Freezer Farm Q.C. Project
- Notice Date
- 4/15/2015
- Notice Type
- Combined Synopsis/Solicitation
- NAICS
- 334516
— Analytical Laboratory Instrument Manufacturing
- Contracting Office
- Department of Health and Human Services, National Institutes of Health, National Institute on Drug Abuse, 6001 Executive Boulevard, Room 4211 - MSC 9559, Bethesda, Maryland, 20892, United States
- ZIP Code
- 20892
- Solicitation Number
- HHS-NIH-NIDA(SSSA)-2015-CSS-199
- Archive Date
- 5/6/2015
- Point of Contact
- Rodney E. Brooks, Phone: 3014020751
- E-Mail Address
-
rodney.brooks@nih.gov
(rodney.brooks@nih.gov)
- Small Business Set-Aside
- N/A
- Description
- Combined Synopsis/Solicitation Introduction: This is a combined synopsis/solicitation for commercial items prepared in accordance with the format in Subpart 12.6 as supplemented with additional information included in this notice. This announcement constitutes the only solicitation; proposals are being requested and a written solicitation will not be issued. The solicitation number is HHS-NIH-NIDA(SSSA)-2015-CSS-199 and the solicitation is issued as an request for quotation (RFQ). North American Industry Classification System (NAICS) Code: The intended procurement classified under NAICS code 334516 with a Size Standard of 500 Employees. Acquisition Authority: This acquisition is for a commercial item or service and is conducted under the authority of the Federal Acquisition Regulation (FAR) Part 13-Simplified Acquisition Procedures; FAR Subpart 13.5-Test Program for Certain Commercial Items; and FAR Part 12-Acquisition of Commercial Items, and is expected to exceed the simplified acquisition threshold. The solicitation document and incorporated provisions and clauses are those in effect through Federal Acquisition Circular 2005-05-80, dated March 2, 2015. Description of Requirement: Background: The annual Freezer Farm Q.C. Project was previously performed by the Luminex 100 IS. The purpose of this project is to pull and test samples periodically to make sure the molecular integrity of proteins in the biospecimens is preserved during storage in the freezers located in the Biorepository - Freezer Farm. Temperature changes can take place infrequently or occur over a period of time that can potentially harm the biospecimens' integrity. The freezer quality control (Q.C.) process was designed to test control pools of human serum and plasma stored in every freezer for analytes that are relatively sensitive to temperature change (e.g., enzymes, cytokines, etc.). This will enable quantitative assessment of the quality of sample storage over time and help maintain the integrity of biospecimens over the course of data collection. Due to issues with the Luminex multiplex insensitivity below the assay curve, inconsistencies with sample reproducibility and inability to move beyond the current platform, it was decided to purchase an analyzer such as the Quanterix - Simoa HD-1 DX. The Simoa offers more stable assays without the use of multiple plates and decreased technical error. It has great potential for other projects such Homebrew kits within NIA and NIH wide. Purpose: The purpose of this requirement is to purchase a system like the Quanterix-Simoa HD-1-DX Analyzer that is a fully automated digital immunoassay instrument capable of analyzing samples using single-molecule array technology and delivering ultra-sensitive measurements of proteins of interest over a wide dynamic range and with low C.V.'s. The Freezer Farm Q.C. Project involves analyzing samples that have been kept in ultralow temperatures over time. In order to accurately assay these samples for cytokines, the use of an analyzer that offers efficiency and reproducibility of low C.V.s in needed in order to determine which freezers are keeping the samples at optimal temperatures. This in term will give an overall picture of stability in long-term sample storage. The Homebrew kits will be used to help develop cost-effective ultrasensitive assays by enhancing the laboratory's ability to address specific research applications within NIA. The analyzer is an open research platform, allowing the laboratory to design custom assay protocols and optimize calibration curve fitting for custom assays. This will allow for cutting edge digital immunoassay technology, full automation, and open access tools to maximize efficiency and productivity in ultra-high sensitivity immunoassay-enabled research. Project Requirements: The specific requirements are as follows: Product Code - 100438 Product - Simoa HD-1 DX Analyzer The Simoa HD-1 DX Analyzer, a fully automated digital immunoassay instrument capable of analyzing samples using the proprietary single-molecule array (Simoa) technology and delivering ultra-sensitive measurements of proteins of interest over a wide dynamic range and with low CV's. In addition to the features of the Simoa HD-1 analyzer, it includes an integrated barcode reader and a cooled reagent bay. This includes all hardware and software as well as two reagent racks. The system sought has the following characteristics: • The system has the ability to measure biomarkers (proteins/cytokines/metabolites) in biological samples at concentrations that are a 1,000 fold (femtogram/mL) improvement over current ELISA based methods allowing multiplexing assays of up to 10 low abundance proteins/biomarkers simultaneously. • The system is able to detect biomarkers, proteins and DNA in urine, blood, plasma, serum, stool, cell lysates, CSF and environmental water. It also has the ability to measure DNA in an automated fashion with little purification and no amplification. • The instrument is capable of analyzing biological samples using single-molecule digital ELISA array technology; assay technology is not plate-based. Utilizes magnetic beads to form immunocomplex's which allows the enzyme bound to the capture antibody to produce sufficient fluorescence in each well to be detectable, even when just a single molecule is present. • The instrument has an increased sensitivity which will allow for less sample to be used for sample processing (sample volumes 10-100 µL). It utilizes discs with twenty four channels used to load, seal, and image the proteins of interest containing approximately 216,000 wells for maximum sensitivity. • The system is an open platform (Homebrew Kit) which will allow for the adoption and development of markers that might be of commercial interest and not currently available. The open platform assay kits allow end users to modify and develop and adapt unique, lab specific biomarkers. • The workflow is totally automated and plates or tubes can be used for sample introduction. There is no need to manually process plates at the bench and then be introduced into a reader which increases technical error. The digital signal allows for greater sensitivity and reproducibility. • The instrument throughput is 68 tests per hour with results between 30 and 60 mins, run in batches or individually, with analytical precision and C.V. of less than 10% and a dynamic range of 4 to 5 logs. Anticipated Period of Performance: 90 days after receipt of Purchase Order. Place of Performance: National Institute on Aging Biomedical Research Center (BRC) 251 Bayview Blvd., Suite 100, Room 08B014A Baltimore, MD 21224 Other Important Considerations: Payment Terms: 30 Days Net. Pricing USD Shipping Terms: FOB Destination for instruments Shipping Terms: FOB Ship Point for all other products Estimated Ship Date for Instruments: 90 Days Contract Type: The Government intends to issue a firm fixed price Contract for this requirement. Applicable Clauses and Provisions: All Offerors MUST be actively registered in the System for Award Management (SAM) www.sam.gov The provision of FAR clause 52.212-1, Instructions to Offerors - Commercial Items applies to this acquisition. The provision of FAR clause 52.212-2, Evaluation - Commercial Items applies to this acquisition. A completed copy of the provision at FAR clause 52.212-3, Offeror Representations and Certifications - Commercial Items, is required with any offer submitted. The FAR clause is located at http://www.acquisition.gov/far/. This requirement may be met by completion of the provision in the System for Award Management. FAR clauses 52.212-4, Contract Terms and Conditions - Commercial Items and 52.212-5 Contract Terms and Conditions Required to Implement Statutes or Executive Orders - Commercial items apply to this acquisition. FAR clause at 52.212-5, Contract Terms and Conditions Required to Implement Statutes or Executive Orders-Commercial Items (September 2013), applies to this acquisition. The Defense Priorities and Allocations System (DPAS) are not applicable to this requirement. Evaluation Criteria: FAR clause 52.212-2, Evaluation - Commercial Items applies to this acquisition and the specific evaluation criteria to be included in paragraph (a) of that provision are as follows: The Government will award a contract resulting from this solicitation to the responsible offeror whose offer conforming to the solicitation will be most advantageous to the Government, technical, price and other factors considered. There are no additional contract requirement(s) or terms and conditions determined by the contracting officer to be necessary for this acquisition and consistent with customary commercial practices. Response Format: Responses to this solicitation must include sufficient information to establish the interested parties' bona-fide capabilities for fulfilling the requirement. The price quote shall include: unit price, list price, shipping and handling costs, the delivery period after contract award, delivery terms, the prompt payment discount terms, the F.O.B. Point (Destination or Origin), the Dun & Bradstreet Number (DUNS), the Taxpayer Identification Number (TIN), the certification of business size, product or catalog numbers, product description and other information or factors that may be considered in the award decision. Such factors may include: past performance; special features required for effective program performance; trade-in considerations; probable life of the item selected as compared with that of a comparable item; warranty considerations; maintenance availability; and environmental and energy efficiency considerations. Respondents that believe that they are manufacturers or authorized resellers of the brand-name product specified in this announcement must provide, as part of their response: (a) product, catalog, model, and/or part number(s); (b) product description; (c) all relevant information and documentation that the item(s) offered meets the salient physical, functional, or performance characteristics as specified in the purchase description; quantity; estimated price or cost; shipping, handling, and/or installation charges; and delivery date after receipt of order. In addition the Dun & Bradstreet Number (DUNS), the Taxpayer Identification Number (TIN), and the certification of business size must be included in the response. All offerors must have an active registration in the System for Award Management (SAM) www.sam.gov." All responses must be received by April 21, 2015 at 12:00pm EST and must reference number HHS-NIH-NIDA(SSSA)-2015-CSS-199. Responses may be submitted electronically to Rodney Brooks, Contract Specialist at rodney.brooks@nih.gov. "All responsible sources may submit a capability statement, proposal, or quotation, which shall be considered by the agency."
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