SOURCES SOUGHT
A -- Development of AchE enzyme meter
- Notice Date
- 2/13/2018
- Notice Type
- Sources Sought
- NAICS
- 541714
— Research and Development in Biotechnology (except Nanobiotechnology)
- Contracting Office
- Department of the Army, U.S. Army Medical Research Acquisition Activity, U.S. Army Medical Research Acquisition Activity, Attn: MCMR-AAA, 820 Chandler Street, Frederick, MD 21702-5014, Maryland, 21702-5014, United States
- ZIP Code
- 21702-5014
- Solicitation Number
- W81XWH18SN0003
- Archive Date
- 3/8/2018
- Point of Contact
- Susan E. Ruzicka, Phone: 3016198802, Erin J. Maddox, Phone: 4104170028
- E-Mail Address
-
susan.e.ruzicka2.civ@mail.mil, erin.j.maddox.civ@mail.mil
(susan.e.ruzicka2.civ@mail.mil, erin.j.maddox.civ@mail.mil)
- Small Business Set-Aside
- N/A
- Description
- In accordance with FAR Part 10, the Government is performing market research for a potential requirement to develop an in vitro diagnostic test system including test strips and prototype testing meters to detect acetylcholinesterase (AchE) enzyme activity. This is a REQUEST FOR INFORMATION for market research purposes. THIS IS NOT A REQUEST FOR PROPOSALS. INFORMATION RECEIVED WILL BE USED FOR MARKET RESEARCH PURPOSES ONLY. After the results of this market research are obtained and analyzed, USAMRAA may conduct a competitive procurement and subsequently award a contract. The United States Army Medical Research Institute of Chemical Defense at the Aberdeen Proving Ground in Aberdeen, MD requires is seeking vendors specialized in the development and production of in-vitro testing equipment and supplies to provide further research and development into a handheld meter that will detech AchE enzyme activity. The following items capture the draft deliverables the Government is seeking to develop. 1) Screen printed test strips with a single channel coated with a chemical formulation that are 14 mm wide and ranging in length from 30-50 mm. The ability to produce a quantity of 3000-4000 test strips, machine cut, and dispensed in desiccated vials. 2) The ability to produce up to six prototype meters and associated components for meter tuning and validation with integrated software algorithms that allow "fill detection" to ensure blood has adequately filled the sample chamber of the test strip before initiating assessment. The meter hardware should allow for accurate temperature detection in combination with algorithm engineering to provide real-time temperature correction during assessments. 3) The ability to develop hematocrit parameters and integrate them into the meter software algorithm for instantaneous normalization of red blood cell acetylcholinesterase activity. 4) The ability to develop temperature correction factors and integrate them into the meter software algorithm for instantaneous normalization of blood cholinesterase activity. The temperature correction factors should be for an ambient temperature range from 10 to 40°C using donor human blood. 5) The ability to conduct an accelerated shelf life study to evaluate test strip stability. The study should be conducted over six months and evaluate stability using 40°C and 50°C temperatures in order to predict long-term storage stability. 6) The ability to determine real time stability of the test strips at 23°C. 7) The ability to develop external quality assurance tests for the test system to evaluate and report system integrity including developing check strips for each meter developed and develop a quality control solution to evaluate test strip integrity. Interested vendors should submit the following: 1) Proof of good manufacturing practice (cGMP) compliance and approval by the US Food and Drug Administration (FDA). 2) Proof of ISO 9001 and ISO 13485 certification for laboratory and production facilities. 3) A description of prior research and development of medical testing equipment, specifically handheld fluid testers from initial project development through FDA approval and production. 4) A description of the laboratory and production facilities equipment and capabilities. 5) An abstract not to exceed three pages describing the vendor's approach to accomplishing the draft deliverables as written above. Interested vendors should provide their response via email to Susan Ruzicka at susan.e.ruzicka2.civ@mail.mil no later than 11:00 am Eastern on Wednesday, 21 February 2017.
- Web Link
-
FBO.gov Permalink
(https://www.fbo.gov/spg/USA/USAMRAA/DAMD17/W81XWH18SN0003/listing.html)
- Record
- SN04822347-W 20180215/180213232151-8c7b314dd314f72095db3cec1733bc92 (fbodaily.com)
- Source
-
FedBizOpps Link to This Notice
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