MODIFICATION
66 -- Serological Analyzers Leasing, Reagents, and Consumables RFI
- Notice Date
- 3/20/2015
- Notice Type
- Modification/Amendment
- NAICS
- 334516
— Analytical Laboratory Instrument Manufacturing
- Contracting Office
- US Army Medical Research Acquisition Activity, ATTN: MCMR-AAA, 820 Chandler Street, Frederick, MD 21702-5014
- ZIP Code
- 21702-5014
- Solicitation Number
- SEROLOGY-WRAIR-RFI
- Response Due
- 4/9/2015
- Archive Date
- 5/19/2015
- Point of Contact
- Sharew Hailu, 301-619-9201
- E-Mail Address
-
US Army Medical Research Acquisition Activity
(sharew.hailu.civ@mail.mil)
- Small Business Set-Aside
- N/A
- Description
- Serological Analyzers Leasing, Reagents, and Consumables RFI 1.0 SUBJECT: In support of the Walter Reed Army Institute of Research (WRAIR) mission to conduct biomedical research that is responsive to Department of Defense and US Army requirements and deliver life saving products including knowledge, technology and medical material that sustain the combat effectiveness of the Warfighter. Provide the leasing, installation and validation of serological automated analyzers with UPS backup systems to include all applicable maintenance and services along with reagents for the screening and confirmation of the HIV virus and all necessary consumables required to perform testing. 2.0 DISCLAIMER: This RFI is issued solely for information and planning purposes and does not constitute a solicitation. Neither unsolicited proposals nor any other kind of offers will be considered in response to this RFI. Responses to this notice are not offers and will not be accepted by the Government to form a binding contract. Responders are solely responsible for all expenses associated with responding to this RFI. All information received in response to this RFI that is marked Proprietary will be handled accordingly. Responses to the RFI will not be returned. At this time, questions concerning the composition and requirements for a future RFP will not be entertained. 3.0 DESCRIPTION: This request for information is seeking entities interested in supporting the leasing, installation and validation of serological automated analyzers with UPS backup systems to include all applicable maintenance and services. The analyzers include four (4) serological screening analyzers and two (2) confirmation serology analyzers for HIV detection. The requirement also provides for the inclusion of reagents for the screening and confirmation of the HIV virus and all necessary consumables required to perform testing. Minimum Essential Characteristics (MEC) Analyzer MECs Specimen and reagent mechanism that involves the use of a single independent processing system for each unique specimen and reagent; thus preventing cross contamination between specimens and/or reagent reservoirs. The mechanism can include a multiple channel, but must be an independent process system. Sampling system which auto-detects specimen volume integrity as well as loss of integrity of the pressure gradient for any independent processing unit. Must be capable of performing high-volume testing with minimal personnel intervention (staffing must be able to load analyzer, then walk away). To enable workflow efficiency and minimal processor staffing initial run set up must be equal to or greater than 700 samples per analyzer with the ability to continuously load specimens and walk away. Must be able to perform up to 1600 samples within an 8 hour period, 6 days per week. Must be able to perform testing from an 8.5mL 16x100 mm SST blood tube. Must be capable of performing testing on grade 4+ (gross) hemolytic specimens. Must employ fully automated, robotic processing from addition of diluents, samples, incubation, wash steps, and calculation of results with limited operator interaction. Must have the capability to interface with a variety of Laboratory Information Systems (LIS) such as Labware, and Laboratory Information Management System (LIMS). Power supply must include conditioner power source which will help to eliminate the fluctuation in power going to the instrument especially during a power failure which could affect the operation of the instrument. Must not require plumbing or a drainage system or external ventilation of analyzers. Must be a FDA approved as Class III in vitro diagnostic device or instrument for conduct of a FDA approved 4th Generation HIV-1/HIV-2 screening test. Service agreement must be standard, 8 hours/day, 6 days/week, as well as bi-annual preventive maintenance. Confirmation Analyzer MECs HIV confirmation analyzer must be compatible to the Western Blot test system. HIV confirmation analyzer must be able to detect the separate bands of the HIV-1 and HIV-2 virus. Must be FDA approved for use in confirmation testing for the presence of the HIV virus. Reagents MECs Reagents (assay) must be capable of being run as comparator, anti-HIV-1 antibody assay in a manual test format, or on an open analyzer system. Combo HIV-1/HIV-2 reagents must be able to detect HIV p24 antigen as well at the presence of HIV antibodies. Combo HIV-1/HIV-2 reagent sensitivity must be able to detect the presence of HIV antigen/antibodies within 7-10 days of infection. Must be able to ship reagents on minimum purchase order to cover 10,000 screening test and maximum purchase order of 48,000 screening tests. The kit test size shall be the most appropriate size in order to decrease the storage space required. HIV Confirmation Reagents MECs Must be able to differentiate between HIV-1 and HIV-2. Must be compatible with the Western Blot System. Must be capable of detecting the separate bands of the HIV Virus. Maximum purchase order to cover 500 HIV confirmation tests and minimum purchase order would be 200 HIV confirmation tests. The kit test size will be left to the discretion of the vendor. 4.0 SUBMISSION INSTRUCTIONS: Entities interested in submitting a response must furnish in writing, a 2-3 page (not including cover page, index or list of references) synopsis of their capability in providing leasing of analyzers along with all associated reagents and consumables to satisfy the Government's requirement. Companies responding to this notice must provide complete contact information (telephone, address, email address). Responders must identify their company's business size (based on the NAICS size standard), business status (i.e. small business, disadvantaged, HUB zone, woman owned, service disabled veteran owned). Please also include information regarding any prior experience with U.S. Government contracts and favorable experience working with the FDA. 5.0 SUBMISSION CONTACT INFORMATION: Interested entities shall forward submissions to Mr. Sharew Hailu at Sharew.Hailu.civ@mail.mil or Mrs. Amanda Best at amanda.l.best7.civ@mail.mil no later than the close of business 09 April 2015. Telephonic communication will not be considered as submission or receive response.
- Web Link
-
FBO.gov Permalink
(https://www.fbo.gov/spg/USA/USAMRAA/DAMD17/SEROLOGY-WRAIR-RFI/listing.html)
- Place of Performance
- Address: US Army Medical Research Acquisition Activity ATTN: MCMR-AAA, 820 Chandler Street Frederick MD
- Zip Code: 21702-5014
- Zip Code: 21702-5014
- Record
- SN03675212-W 20150322/150320235514-f61ef4ddc3bdab18527244f0bdfdb4fd (fbodaily.com)
- Source
-
FedBizOpps Link to This Notice
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