Microvolume Plate Reader for Analytical Chemistry

INTRODUCTION
This is a Small Business Sources Sought (SBSS) notice. This is NOT a solicitation for proposals, proposal abstracts, or quotations. The purpose of this notice is to obtain information regarding: (1) the availability and capability of qualified small business sources; (2) whether they are small businesses; HUBZone small businesses; service-disabled, veteran-owned small businesses; 8(a) small businesses; veteran-owned small businesses; woman-owned small businesses; or small disadvantaged businesses; and (3) their size classification relative to the North American Industry Classification System (NAICS) code for the proposed acquisition. Your responses to the information requested will assist the Government in determining the appropriate acquisition method, including whether a set-aside is possible. An organization that is not considered a small business under the applicable NAICS code should not submit a response to this notice.
This notice is issued to help determine the availability and type of qualified Small Business companies technically capable of meeting this potential 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 as a result of this notice. The Government will NOT be responsible for any costs incurred by the respondents to this notice. The notice is strictly for research and information purposes only.

The information requested will assist the Government in determining the appropriate acquisition method including small business socio-economic set-aside possibilities and to determine the availability of qualified Small Business companies technically capable of meeting the Government's potential requirement. All Small Business companies with the capability and availability to perform the requirement under the applicable NAICS code are invited to submit a response to this notice.

NORTH AMERICAN CLASSIFICATION SYSTEM (NAICS) CODE
The NAICS code applicable to this requirement is 339112 Surgical and Medical Instrument
Manufacturing with size standard 1000 employees.
BACKGROUND
The National Institutes of Health (NIH) is the nation's leading medical research agency and the primary Federal agency whose mission is to seek fundamental knowledge about the nature and behavior of living systems and the application of that knowledge to enhance health, lengthen life, and reduce illness and disability. The National Center for Advancing Translational Sciences (NCATS) is a translational science center whose mission is to catalyze the generation of innovative methods and technologies that will enhance the development, testing and implementation of diagnostics and therapeutics across a wide range of human diseases and conditions.

The Division of Pre-Clinical Innovation (DPI) at NCATS plans, conducts and uses both internal and contract resources to advance collaborative research projects across the pre-clinical phases of the translational science spectrum. Specifically, the analytical chemistry group at the DPI has a potential requirement for a microvolume plate reader to determine the protein concentration as a critical step prior to HPLC-MS analysis.

At analytical chemistry group, there has been an increasing number of project requests analyzing intact protein, peptide (digested from protein extraction), and antibody drug conjugation. In order to address these increasing demands from the data required from these products, the analytical chemistry group requires a microvolume plate reader, which is a powerful QC tool offering high-speed and automation friendly quantification of Protein, DNA and RNA.

Purpose and Objectives
This Small Business Sources Sought notice seeks to determine eligible sources capable of achieving the essential features of this potential requirement. The purpose of this potential requirement is to obtain quantity one (1) Micro Volume Plate Reader on a BRAND-NAME-OR-EQUAL basis to the Big Lunatic microvolume plate reader platform, part number (PN): 700-2000; 10 Lunatic plates, 0.03-40 OD, PN-701-2002; 30 Lunatic Plate Frame Strips, 0.03-40 OD, 16 sample per chip, PN-701-2005; and half-day installation and training, PN-704-2000, manufactured by Unchained Labs, located at 6870 Koll Ctr Pkwy, Pleasonton, CA 94566.

Project Requirements
Specifically, the following features are deemed essential that this potential requirement shall achieve:
Big Lunatic instrument
1. Compact and completely enclosed benchtop instrument
2. No manual sample loading or cleaning steps required on the instrument
3. High speed measurement of a Lunatic Plate (about 5 minutes for 96 samples)
4. Automation and robotics friendly design and optional API interface
5. GLP options for IQOQ and CFR 21 part 11 validation

Lunatic Plate and High Lunatic Plate
1. Microfluidic disposable combining multiple features for robust and convenient sample read-out
2. Up to 96 samples on a plate, multiple barcoded plates per run possible
3. Re-use of the Lunatic Plate on the positions not used in previous measurements
4. Only 2 μl sample loading, with automatic sample uptake by capillary channels
5. Compatible for sample loading using liquid handling robots
6. On-chip sample conservation for up to 2 hours. No spilling, evaporation or cross-contamination
7. On-chip sample retention after analysis
8. Path lengths built into the microfluidic structure
9. Linear measurement range from 0.03 up to 200 OD (10mm path converted)
10. Compatible with various biological samples (DNA, RNA and proteins) and many chemical substances (DMSO, ...)

Lunatic Client and Analysis software
1. Simple experiment design wizard with access to advanced functionalities like replicates handling and standard curves
2. Analytical software including two quantification methods: Standard UV/Vis apps and advanced Unmix apps
3. Customizable data import and export templates to MS Excel and pdf a.o.
4. Wide selection of Unmix applications for different sample sources and common extraction kits and methods for accurate bio-molecule (DNA, RNA or protein) quantification in a wide variety of biological samples, covering most common isolation techniques or kits used • Specific target molecule quantification without need for a dye or assay
5. Quantification of individual carry-over chemicals, process inhibitors and sample source constituents
6. Works across a wide linear range, without need for dilution series
7. Selection of standard single point background correction or unique full spectral turbidity analysis background correction possible

Contractors submitting a response to this Small Business Sources Sought notice shall possess the ability to achieve the salient government essential features of this potential requirement. Specifically, Offerors to this Small Business Sources Sought notice shall document evidence of being able to provide the subject supply that will allow for the essential features described herein to be accomplished.

Delivery/Warranty
Offerors should indicate an estimated delivery time in full after receipt of an order and any other training or warranty considerations that apply. Inspection and acceptance will be performed at NCATS located at 9800 Medical Center Drive, Rockville, MD 20852.

CAPABILITY STATEMENTS SOUGHT
Interested parties are expected to review this notice to familiarize itself with the requirements of this project. Failure to do so will be at your firm's own risk.

Respondents 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 this announcement; (d) quantity; (e) shipping, handling, and/or installation instructions, and/or any special delivery conditions after receipt of an order.

Respondents that believe that they are manufacturers or authorized re-sellers of the equipment 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; (d) quantity; (e) estimated price or cost; (f) shipping, handling, and/or installation charges; and delivery date after receipt of order.

The respondent must also provide 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 information submitted must be in outline format that addresses each of the elements of this requirement. A cover page and an executive summary may be included but is not required.
The response is limited to ten (10) pages. The 10-page limit does not include the cover page, executive summary, or references, if requested.

The response must include the respondents' technical and administrative points of contact, including names, titles, addresses, telephone and fax numbers, and e-mail addresses.
Respondents must reference the announcement number on all correspondence related to this Small Business Sources Sought notice. The response must be submitted to Hunter Tjugum electronically, at hunter.tjugum@nih.gov, and be received prior to the closing date specified in this announcement.

CONCLUDING STATEMENTS
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 perform the work. 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 pre-solicitation 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).

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