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Accurate, sensitive, and reliable real-time PCR system designed for the clinical laboratory
The Applied Biosystems QuantStudio 5 Dx system is an IVDR-compliant qPCR system designed for molecular diagnostic labs and supporting the regulated CE-IVD market, which helps enable patient safety.
The QuantStudio 5 Dx system is an in vitro diagnostic device intended to perform fluorescence-based PCR to provide detection of nucleic acid sequences in human-derived specimens. The system is intended for use by trained personnel in a professional environment with IVD-marked or approved assays.
The QuantStudio 5 Dx system incorporates multimode software that allows it to be used either in development mode for assay development applications or in IVD mode for routine in vitro diagnostics, making it suitable for independent testing labs, hospitals, government/public health labs, and diagnostic test developers
Customer testimonial
Features
Features of the QuantStudio 5 Dx Real-Time PCR System include:
Results you can trust
Detect differences in target quantity as small as 1.5-fold in singleplex reactions and obtain 10 logarithmic units of linear dynamic range
Designed with the clinic in mind
An interactive diagnostic instrument with short run times and minimal maintenance that also uses existing plastic consumables for added convenience in clinical laboratories
Established system
Thermo Fisher Scientific has over 10 years of experience manufacturing clinical real-time PCR instruments
Enhanced security
Security, auditing and e-signature functionalities that enable you to comply with regulations, including 21 CFR Part 11
Simple, powerful software
A single, easy-to-use software interface allows users to set up a run, lay out assays, control the instrument, and conduct plate analysis
IVD Test mode
The in vitro diagnostic (IVD) test menu allows only authorized IVD tests to be run, reducing the risk of unauthorized use and accidental or intentional misuse
Highly flexible
Diagnose or develop, the choice is yours with software options that guide you through every step of test development* and IVD modes
QuantStudio performance
High reliability, sensitivity, and accuracy with an intuitive and simple-to-use interface that allows users of any experience level to operate the system with ease
Superior support
Comprehensive range of service and support options available globally
Maximize benchtop space
Compact instrument preserves space for other equipment
CE-IVD
Innovations in software, firmware, and algorithmic analysis to meet IVDR requirements
Features that help you comply with requirements of accrediting bodies
Maintenance and calibration reports |
Records are updated automatically with maintenance and calibration events and can be printed on demand, documenting that the system has been maintained and calibrated to vendor specifications. |
Reagent tracking |
Information about the reagents used with each test run, including lot number and expiration date, is stored and archived. Archived files can be retrieved when required to track samples that were tested with a given set of reagents. |
Sample tracking |
The system enables laboratories to more easily track samples associated with a particular plate, set of reagents, run date and time, and data files. |
E-signature history |
Security, auditing, and e-signature software records test events, actions taken, dates, usernames, user roles, and the activity performed for documentation and archiving purposes. |
Experimental results |
For documentation, archiving, and review-at-a-glance needs, detailed reports include experiment name, barcode, file name, time stamps (creation, run start, run finish, duration, and modifications), instrument name, serial number, experiment type, results summary, plate layout image, standard curves, results table, and QC summary. |
Specifications
Sample capacity |
96 |
Reaction volume |
96-well 0.2-mL block: 10–100 μL |
Excitation source |
Bright white LED |
Filter or color combinations |
6 decoupled filters, CMOS camera |
Excitation/detection range |
450–680 nm/500–730 nm |
Multiplexing |
5-plex + 1 passive reference, 6-plex with no passive reference |
Maximum block ramp rate |
6.5°C/sec |
Average sample ramp rate |
3.66°C/sec |
Temperature uniformity |
0.4°C |
Temperature range |
4–99.9°C |
Heating and cooling method |
Peltier |
Independent temperature zones |
6 VeriFlex zones (5°C zone to zone) |
Chemistries |
Fast and standard |
Run time |
<30 min |
Compatible dyes |
FAM, SYBR Green, VIC, ABY, NED, TAMRA, JUN, ROX, Mustang Purple, Cy5 |
Throughput |
Medium |
Thermal block style |
Fixed |
Thermal block format |
96-well (0.2-mL block) |
Attached computer |
Required |
Automation capable |
No |
Instrument size |
40 x 27 x 50 cm; 27 kg |
Touchscreen size |
8.5 inch |
Multiplexing and filters |
Up to 6 targets; 21 filter combinations |
Hands-free functionality |
No |
Smart Help |
No |
Security, audit, and e-signature functionality |
The audit function is always enabled in IVD mode and on the desktop software when in Development mode*. In Development mode, audit mode can be set to Optional or Required depending on traceability needs. |
Ordering information
Reagents
Applied Biosystems TaqPath master mixes are IVDR-compliant Class A medical devices. These general-purpose reagents are labeled for laboratory use and are optimized to work with the QuantStudio Dx line of instruments.
TaqPath real-time PCR master mixes deliver confidence and reliability for your most demanding molecular diagnostic development and testing needs. Application-specific formulations of TaqPath master mixes are available for qPCR and one-step RT-qPCR using 5-prime nuclease assays in singleplex or multiplex format. Each reagent is manufactured and labeled in accordance with requirements for general-purpose reagents and is functionally tested to help ensure lot-to-lot reproducibility for Cq consistency and a wide dynamic range.
Plastics
Applied Biosystems real-time PCR plastics have been designed, tested, and ensured regulatory compliant to work with our instruments and enable optimal performance.
Customize TaqMan primers and probes your way
Our Specialty Manufacturing service offers even more customized solutions for those truly challenging real-time PCR assay designs and formats. From off-catalog dye offerings to specialized formulation and volume requirements to specific assay plating arrangements, our Specialty Manufacturing team will work with you to design your perfect assay.
Global support and service
Thermo Fisher Scientific also offers comprehensive and world class service and support to ensure customers have maximum uptime.