The U.S. Food and Drug Administration (FDA), Jefferson Laboratories, in Jefferson, Arkansas, is conducting market research to support a Center for Biological Evaluation & Research (CBER) requirement for a Multidetection Microplate Reader. The Division of Product Quality (DPQ), is responsible for lot-release testing before biological drugs are approved for release to the general public. The Multidetection Microplate Reader will be used for specific measurement of thrombin activity of immunoglobulin for intravenous (IGIV) products using a fluorogenic substrate method. This assay is a dynamic test for thrombin generation versus test time. This analysis will ultimately be used to evaluate samples submitted for lot release. The laboratory performing this assay will be operating under International Standard (ISO) 17025 which are general requirements for competence of testing and calibration laboratories. Therefore any equipment operated in the laboratory must conform to the requirements outlined in the standard.

Currently, DPQ is in the process of transferring the Test Method used to evaluate the products described above. During development, the Multidetection Microplate Reader will be the main instrument used in the assay. Once the assay is successfully transferred, the instrument will be used for lot release activity under ISO 17025 requirements, therefore annual preventive maintenance is required to be performed by qualified personnel.

Only new equipment will be considered. Used or refurbished equipment will not acceptable.

Item #1
Multidetection Microplate Reader

Automated Dichroic based microplate reader for measurement of Absorbance, Fluorescence Intensity, Time Resolved Fluorescence, Dual Emission Fluorescence, Fluorescence Resonance Energy Transfer, Z-Axis Focusing (Z-Height Optimization).

The device should be capable of handling 96 and 384 well plates. The speed of the instrument must fall at or below 40 seconds for the whole plate. The assay to be performed requires temperature and dynamic control therefore must provide 37 degree temperature incubation. The ability to control the Z-position (axis) is vital to reading measurements. As the assay is a fluorescent and absorbance based, the reader must have the capability to read both. Reports will be generated and exported in an Excel format to ultimately be read by a OriginPro 8.5 (Origin Labs Corp.) software, which is used to analyze data generated from the microplate reader. The software provided by the instrument must be able to control reading the plates. The assay will be used for lot release activity under ISO 17025 requirements, therefore annual preventive maintenance is required to be performed by qualified personnel. In order to accurately perform calibration and preventative maintenance an IQOQ QC plate with software functions should be included. The device must include an operator/user manual. Types of available training should also be included in the package. The device should be compatible with the existing ISO 17025 Laboratory Test Method used in the Division of Hematology laboratory.

Including the following characteristics:
 Bottom Read VIS
 380nm Fluorescence Filter, BW+/-20nm
 430nm Fluorescence Filter, BW+/-35nm
 Ability to measure in wavelength range 230-900 nm for Fluorescence and 230-1000 nm for Absorbance
 Temperature control at 37o C
 Heated incubation to 42ºC
 Shaking capabilities
 Accommodates plate formats from 6 to 384 wells in all detection modes
 Capable to read 96-well and 384 -wells in less than 40 seconds
 One 6 position bar-coded excitation slide
 One 6 position bar-coded emission slide
 Obtain optimal Z-position of wells in real time
 Read absorbance and florescence signals
 High florescent sensitivity
 Generate real time result report in Excel format
 Dynamically display the curve for each well
 Ability to optimize the gain of plate reader for different assay conditions
 Software for selecting measurement parameters and viewing data with a software utility for creating/customizing plate definitions and control via MS Excel
 Calibration devices and software
 Able to complete periodic quality control (preventive maintenance and calibration
 Minimum of 1 Year Warranty

 Indicate if any maintenance or service plan(s) are necessary and/or available after expiration of Manufacturers' Warranty

Firms believing they offer an equivalent Multidetection Microplate Reader to the above specifications are encouraged to respond electronically via email to the attention of Howard Nesmith at [email protected] on or before June 2, 2011 by 9:00 AM (Central Time) with no less than the following information:

• Business name, DUNS number, business address, business website, business size status (i.e., SB, VOSB, SDVOSB, HUBZone SB, SDB, WOSB, LB), point of contact name, mailing address (if different from business address), phone number and email address; [North American Industry Classification System (NAICS) Code is 334516 - Analytical Laboratory Instrument Manufacturing. Small Business Size Standard is 500 employees.]
• Sufficient descriptive literature that unequivocally demonstrates that offered products meet or exceed above specifications.
• Discussion of the service support furnished with the Multidetection Microplate Reader
• Though this is not a request for quote, informational pricing may be submitted.

The government is not responsible for locating or securing any information, not identified in the response.

For information regarding this market research effort, please contact Howard Nesmith at [email protected].

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 FedBizOpps. 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).

Notice of Intent
In the event no responses (included no acceptable response) received to this market research effort this will serve as the notice effort to enter into a sole source contract with Tecan US Inc., for their Infinite F500 Multidetection Microplate Reader (Part No. 30019337) with Bottom Read VIS option (Part No. 30017959), Fluorescence Filter, (Part No. 30000416), Fluorescence Filter, (Part No. 30000434), Magellan Tracker 21 CFR, Part 11 "data reduction" Reader Software (Part No. 30053752), Multicheck Infinite F500 IQOQ QC Plate, and Software (Part No. 30030270).