SAM #75N98026Q00714

Procurement of Applied Biosystems QuantStudio 3 Real-Time PCR System for NIH/NIAMS

The National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS), part of the National Institutes of Health (NIH), is seeking to acquire a new real-time PCR system to support ongoing research workflows. - Government Buyer: - National Institutes of Health (NIH) - National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) - OEMs and Vendors: - Applied Biosystems (a Thermo Fisher Scientific brand) is the specified OEM - Products/Services Requested: - One (1) Applied Biosystems QuantStudio 3 Real-Time PCR System (part number: QuantStudio 3) - 96-well 0.1 ml plate block format - Touchscreen interface and onboard computer - Includes software for data analysis - Compatible with existing StepOnePlus protocols - Supports trade-in of current StepOnePlus model (Serial number 272008444) - Unique or Notable Requirements: - System must be delivered and installed within 30 calendar days of award - Must maintain compatibility with existing laboratory protocols and workflows - Instrument must support integration with data analysis software and enable seamless transition from the StepOnePlus system - Compliance with relevant ISO and safety certifications is required - Integration with the Connect platform for data sharing and remote monitoring is specified

Description

Requirements: To ensure continuity of research, NIAMS proposes the acquisition of an Applied Biosystems QuantStudio 3 Real-Time PCR System. qPCR is a core technology used for nucleic acid amplification, quantification, and analysis and supports a wide range of research applications, including gene expression studies, pathogen detection, transcript quantification, and validation of experimental results. The QuantStudio 3 is the closest replacement to the current StepOnePlus systems, allowing researchers to maintain established workflows and consistency in experimental design and data interpretation. The QuantStudio 3 offers several operational advantages, including: User-friendly software Compatibility with both Mac and PC platforms Touchscreen operation The ability to function as a standalone instrument or in conjunction with a computer Its thermal block design is similar to the existing systems, minimizing the learning curve for users and supporting a broad range of genomic applications. In addition, the manufacturer offers trade-in credit for the current instruments, reducing the overall acquisition cost while providing access to a fully supported platform with available parts and technical support. Acquiring the QuantStudio 3 at this time will help prevent interruptions to research activities, maintain reliable and consistent data generation, and ensure that NIAMS laboratories have access to a supported and dependable qPCR platform. 4.1 PRODUCT FEATURES/SALIENT CHARACTERISTICS The contractor shall provide one Applied Biosystems QuantStudio 3 Real-Time PCR System or an equal system that meets all the following minimum requirements. 4.1.1. System Features/Benefits Utilize a platform providing 1 TB or storage space for data sharing at user discretion Be used with online scientific apps Come with desktop-based software, allowing single-plate run setup and analysis 4.1.2. Technical specifications – Instrument Have a 96 well 0.1 ml plate block format and the option to run fast protocols <30 minutes Not require a field service engineer for set up by end user. Set up should be easy for end user – directly out of the box. Not require a computer for installation Use an RNase P verification plate to verify performance Not require dye calibration upon installation Have dimensions of 27 x 50 x 40 cm and be designed to maximize horizontal and vertical bench space Be capable of analyzing 96 samples simultaneously in various formats including both 96-well plates, 8-tube strips, and individual tubes The 96-well block should be made of at least 3 separated Peltier elements – VeriFlex Blocks. The maximum temperature difference programmable across the block should be 10°C. 5°C should be the maximum difference in temperature allowed between adjacent blocks. Support reaction volumes of 10-30 uL on 0.1 mL the 96-well block Be factory calibrated with FAM, SYBR Green 1, VIC, NED, ABY, JUN, TAMRA, and ROX dyes Have melt or dissociation curves that take place in steps with delta T varying between 0.015°C and 3.66°C Have a maximum block ramp rate of 9.0°C/sec for the 0.1 mL block Have a block with a temperature range of 4-99.9°C Have a heated cover with temperature range of 50-110°C Have a long-lasting bright white LED source with median lifetime of at least 60,000 hours Have a CMOS imager for data acquisition and collect data for each filter combination in less than 2 seconds Be used with 120-240 V outlets without modification or special plug requirements Include a heated lid assembly to heat tops of sample plates and minimize reaction evaporation 4.1.3 Technical specifications – Instrument onboard computer Possess the capability to run in stand-alone mode, without an attached computer Include a touchscreen interface and store protocols for quick starts with no computer needed Have a touchscreen interface that enables viewing amplification plots and filtering them by sample, target, and task Have a touchscreen interface that facilitates uploading of protocols or downloading of run files via a USB, local network, and the Connect platform Have a touchscreen interface that allows uploading of protocols and run files directly to the Connect platform Contain onboard storage with memory capacity of 10 GB for storing 1,000-5,000 standard absolute quantification run files, and be designed for run protection in case of power outages Be able to be customized through the touchscreen for time zones and service/calibration notification settings Have a touchscreen interface that supports the creation of local user accounts with PIN-protected access that can be linked to the Connect platform to online accounts on thermofisher.com Have a touchscreen interface that allows creation and running of protocols as guests Have a touchscreen interface that allows for editing of protocols at all stages of the reaction cycle as well as block settings, temperature settings, duration, ramp rate, etc. Have a touchscreen interface that allows a template to be loaded from a USB, local network, or the Connect platform Have a touchscreen interface that allows user to enter reagent information Have a touchscreen interface that allows a run to be paused and during that pause for the block temperature to be set as well as for the drawer to be opened and closed Have a touchscreen interface that allows editing of sample and target assignments Have a touchscreen interface that allows the repeat of a previous run Have a touchscreen interface that allows users to perform dye calibrations and view results on the touchscreen Have a touchscreen interface that allows RNase P verification runs and automatically provides pass/fail results Have a touchscreen interface that allows a user to run a self-verification test Have a touchscreen interface that allows the user to view the QC assessment after calibration and RNase P plate runs are finished Have a touchscreen interface that allows progress monitoring 4.1.4 Performance Requirements Complete 40-cycle real-time PCR runs using fluorogenic 5’ nuclease assay and Fast chemistry in a standard 96-well plate in less than 30 minutes as well as being able to run in standard ramping mode with standard chemistry Include an OptiFlex system that combines four coupled excitation, and emission filter sets to allow multiplexing up to four unique wavelengths Support at least two reaction chemistries—TaqMan® Probes and SYBR Green dye Have real-time quantitative PCR installation specifications to be able to distinguish between 5,000 and 10,000 template copies at a 99.7% confidence level 4.1.5 Software Requirements Allow flexible customization of run protocols Allow the creation of secure templates that are locked with a password to limit modification of run setup Provide run monitoring of connected instruments Include preoptimized run protocols for applications like standard curve, relative standard curve, relative quantification of gene expression, and SNP genotyping with TaqMan® or SYBR Green chemistries Include a copy of free software to analyze data for absolute and relative quantification, SNP detection, and other assays Collect information on both TaqMan and SYBR assays in the same run Have a genotyping optimization tool that uses real-time data Provide raw fluorescence data and multicomponent data for troubleshooting Allow conversion of protocols for the Applied Biosystems StepOnePlus and 7500 to the QuantStudio 3 system protocols Allow batch analysis of up to 500 experiments simultaneously Can control the instrument and analyze data from a remote computer on the same network Provide status monitoring of connected instruments and real-time plots Statement of Need (SON): The software shall have the ability to send user notifications when a run is started, stopped, or has an error, and allow registered users of the Connect platform to monitor any connected instrument. It shall also allow users to run an assay plate without performing plate setup prior to beginning of run and to correct plate setup after the run. Export of all run results to Excel and saving graphs as .jpg files shall be supported. The software shall also allow import of a standard curve from one plate for analysis of another plate of the same instrument type, selection of endogenous controls, statistical analysis tools, and command-line functions for batch exporting of analyzed run files. Users shall be able to save predefined analysis settings for auto-exporting run data into formats of their choice. It shall contain an online high-resolution melt application for specifying number of clusters/variants and saving defined controls and analysis settings. 4.1.6 Instrument Ecosystem Be part of a desktop ecosystem that includes a suite of qPCR applications. Instrument data can be grouped (multi-plate) for various analyses including relative quantitation, SNP genotyping, standard curve, HRM analysis, and presence/absence analysis. Be part of the Connect platform and able to connect for run setup download and data uploads. Allow monitoring of a run via web browser or mobile device. Support batch analysis of up to 500 experiments simultaneously through an online relative quantitation module. Provide an endogenous control selection tool for gene expression experiments in both desktop and online software. Contain statistical analysis tools in both desktop and online software. Contain a genotyping optimization tool that uses real-time data to select the best cycle number for calling genotype in both desktop and online genotyping software. Allow the user to specify number of clusters/variants and save defined controls and analysis settings with both desktop and online software. 4.1.7. Design Have an application programming interface (API) included that allows programming routines to be developed for controlling the instrument. Be cUL, UL, CE, C-TICK, and WEEE compliant. Be developed and manufactured in a facility with quality system requirements that comply with ISO 13485 and ISO 9001 standards. 4.1.8 Gene expression profiling Users shall be able to select from more than 61,000 predesigned human, mouse, and rat Applied Biosystems™ TaqMan® Assays. 4.1.9 Able to accept the trade-in of Model STEPONEPLUS. Serial number 272008444. 4.1.10 Must be compatible with protocols from Applied Biosystems StepOnePlus Real Time PCR (qPCR) allowing for consistency in experimental setup. 4.2 DELIVERY / INSTALLATION The contractor shall deliver and install the equipment within thirty (30) calendar days after receipt of award.

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