SPECIAL NOTICE
66 -- ShEEP PCR Analysis System for the Charleston VAMC
- Notice Date
- 5/1/2020 10:13:41 AM
- Notice Type
- Special Notice
- NAICS
- 334516
— Analytical Laboratory Instrument Manufacturing
- Contracting Office
- RPO EAST (36C24E) PITTSBURGH PA 15212 USA
- ZIP Code
- 15212
- Solicitation Number
- 36C24E20Q0132
- Archive Date
- 05/01/2020
- Point of Contact
- Linda A Buccigrossi-Contractor Contractor (412) 822-3763
- E-Mail Address
-
linda.buccigrossi@va.gov
(linda.buccigrossi@va.gov)
- Awardee
- null
- Description
- INTENT TO SOLE SOURCE The Charleston VA Medical Center located at 109 Bee Street, Charleston SC, 29401 intends to sole source to Bio-Rad , located at 1000 Alfred Nobel Drive, Hercules, CA 94547 for various equipment and extended service plan coverage (see following page), Gray Market Prevention Language (a) Gray market items are Original Equipment Manufacturers (OEM) goods sold through unauthorized channels in direct competition with authorized distributors. This procurement is for new OEM medical supplies, medical equipment and/or services contracts for maintenance of medical equipment (i.e. replacement parts) for VA Medical Centers.� No remanufactures or gray market items will be acceptable. � (b) Vendor shall be an OEM, authorized dealer, authorized distributor or authorized reseller for the proposed medical supplies, medical equipment and/or services contracts for maintenance of medical equipment (i.e. replacement parts), verified by an authorization letter or other documents from the OEM, such that the OEM s warranty and service are provided and maintained by the OEM.� All software licensing, warranty and service associated with the medical supplies, medical equipment and/or services contracts for maintenance of medical equipment shall be in accordance with the OEM terms and conditions. (c) The delivery of gray market items to the VA in the fulfillment of an order/award constitutes a breach of contract.� Accordingly, the VA reserves the right enforce any of its contractual remedies. This includes termination of the contract or, solely at the VA s election, allowing the Vendor to replace, at no cost to the Government, any remanufactured or gray market item(s) delivered to a VA medical facility upon discovery of such items.� This notice of intent to sole source is not a request for competitive quotes; however, any responsible source who believes it can meet this requirement may submit a capability statement to the contracting officer later than Friday, April 3, 2020 at 11:00 AM ET. Interest/Capability statements may be sent to Linda Buccigrossi at Linda.buccigrossi@va.gov. No telephone responses will be accepted. A determination not to compete the proposed requirement based upon the responses to this notice is solely within the discretion of the Government. QX200 AutoDG Droplet Digital PCR System Must contain an automated droplet generator that can partition a 20 ml PCR reaction into 20,000 uniform nanoliter-sized droplets that are approximately 120 mm in diameter. The droplet generator must be able to hold at least 3-cartridges that can generate droplets from up to 96 individual reaction samples. Droplet generation must be quick; under an hour. The droplet reader must be able to analyze a full 96-well plate in less than 2.5 hours. The system must be able to accurately count target copies when multiple targets copies are distributed in a single droplet. The droplet reader must illuminate and detect fluorescence from each individual droplet. The droplet reader must able to perform excitation and detection of up to 2 fluorescent dyes per droplet simultaneously. The system must utilize at least two light emitting diodes for illumination (excitation) and must be able to detect emission using two filtered multipixel photon counters (one for each channel). The system must be able to detect fluorescence from both channels automatically during the reading process. The droplet reader must have a minimum linear dynamic range of 5 orders of magnitude for detection of input samples. The droplet digital system must be able to detect a single target sequence in a complex mixture of DNA. The droplet digital system must be able to distinguish between 4 and 5 copies of input target nucleic acid, between samples. The droplet digital system must be compatible with TaqMan probe chemistry and must be able to detect EvaGreen DNA binding chemistry The droplet reader must be able to fit within a space that is 68 x54 x 31 cm (WxDxH). ea 1 The software must be able to run on a computer (at minimum) equipped with an Intel Core i7-4702MQ Quad Core Processor, with 8GB RAM, a 7200-rpm 500 GB hard drive, running Windows Professional 64-bit, with a monitor driven by an Intel HD Graphics 4600 card, and can display 1920x1080 pixels. QX200 AutoDG Droplet Digital PCR Analysis Software The analysis software must be able to display florescence amplitude values per droplet from the following dye chemistries: FAM, HEX (or VIC), and EvaGreen. The software must be able to show multiplex data for up to targets per fluorophore, from up to two fluorophores. The software must be able to compute nuclei acid concentrations (copies/ml and copies per 20 ml reaction) for each sample. The software must be able to calculate copy number for targets of interest using a reference target for copy number variation analysis. The software must be able to calculate fractional abundance of mutant targets in a wild-type background, for mutant detection analysis. The software must be able to merge results from replicate wells. The software must fit negative droplet data for each sample, to a Poisson algorithm to determine absolute copy number of target DNA. The software must allow the data to be exported in a .csv file format. The software must allow the graphs and tables to be copied to the clipboard for printing and transfer. ea 1 PX1 PCR Plate Sealer (included with the QX200 AutoDG Droplet Digital PCR System) This is a specialized heat-sealing instrument designed to work with 96-well and 384-well plates. This system will provide consistent and uniform sealing across an entire microplate. The system is semi-automated and ready to seal in less than 3 minutes. The system is designed to remove human variability from plate sealing in order to minimize evaporation, which is essential for highly sensitive applications, like ddPCR. ea 1 C1000-Touch PCR Thermal Cycler (included with the QX200 AutoDG Droplet Digital PCR System) This standard thermal cycler is used to run end-point PCR reactions (taking place inside the droplets generated by the QX200 droplet generator), and has a 96-deep well reaction module with a touch screen interface. The system is accurate to +/-0.2oC, displays well-to-well uniformity of +/-0.4oC within 10 seconds, has a maximum ramp rate of 5oC/sec, and a temperature range from 0-100oC. The system must have an independent USB interface to facilitate PCR data export. ea 1 QX200 AutoDG Droplet Digital PCR System This system has recently received FDA 510(k) clearance for use as a diagnostic tool for the monitoring of BCR/ABL1 mutations, by the U.S. FDA. This system and/or its use, is covered by claims of U.S. patents, and/or pending U.S. and non-U.S. patent applications, owned by or under license to Bio-Rad Laboratories, Inc. There are no other vendors that make or sell a ddPCR system that meets these requirements and sample workflow throughput. Purchase of the system must include direct delivery, onsite installation, and system/analysis training. Purchase of the system must include 1 additional year of warranty/service coverage. ChemiDoc MP Imaging System The system must use a deeply cooled (-15oC absolute, Peltier cooling) high-efficiency charge-coupled device (CCD) with a sensor that allows long integration time to detect weak signals, but has low read noise and low dark noise levels in order to provide reduced background and enhanced sensitivity, to be able to match the qualities of X-ray film. The CCD must use a sensor that can acquire 16-bit data, in high-resolution to resolve closely spaced bands on a gel or blot. The detection capability of the system must span 4 orders of magnitude in linear dynamic range, in order to acquire both intense and weak signals from a single image. The CCD must be able to acquire an image of 2750 x 2200 pixels (>6 mega pixels), with a 4.54 x 4.54 mm pixel size, using an f/0.95 fast lens. The system must include a mechanical zoom feature that can maintain optical resolution over any field of view, without compromising sensitivity. The system must include anti-reflective lens coating that can optimize transmission of light between 400 850 nm. The inside of the instrument must be coated with low autofluorescence and solarization-resistant materials to ensure low background noise on the interior of the instrument. The system includes an integrated baffled epi-cooling unit to direct the excitation light path and ensure the temperature stability of the light-emitting diodes. The system includes three sample trays that are used interchangeably depending on the fluorophore and application chosen: a Blot/UV/Stain-free Sample Tray for chemiluminescence and fluorescent dyes and stains, a White Sample Tray for trans-white illumination (colorimetric stains), and a Blue Sample Tray for trans-blue illumination (blue-light excitable stains like SYBR). A range of illumination sources and filters (required for performing protein and DNA gel and PVDF/nitrocellulose blot imaging) designed to achieve specific spectral wavelengths between 302nm and 860nm. Smart tray technology designed to recognize the downstream application based on the tray being inserted into the system. The system must be calibrated and tested by trained experts to verify the optimal focus and image uniformity for each application, prior to shipping so that it is useable right out of the box. The system must contain appropriate system lockouts for applications that utilize UV light. The system must contain multiple USB ports for easy data and image export, and must be networkable via a high-speed Ethernet port. Most importantly, the system must be compatible with Bio-Rad s stain-free gel technology. This utilizes a proprietary polyacrylamide gel chemistry to make proteins fluorescent in the gel with a short photoactivation step, total protein can be immediately visualized at any point during electrophoresis and blotting, without the need for staining/destaining the gel or membrane. While this provides instant verification of protein transfer in Western blotting applications, it more importantly allows for the normalization of individual protein bands (achieved by western blotting) to the total protein transferred in each lane. This eliminates the inherent need, and problematic use, of unaffected housekeeping proteins as loading controls, permitting truly quantitative western blotting data. ea 1 ChemiDoc MP Imaging System Purchase of the system must include direct delivery, onsite installation, and system/analysis training. Purchase of the system must include 1 additional year of warranty/service coverage.
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