quantstudio-5-dx-real-time-pcr-system-270

Effortless, reliable, IVD qPCR system to meet your unique needs

For over 10 years, Thermo Fisher Scientific has developed high-performance, superior, real-time PCR (qPCR) instruments for clinical laboratories all over the world. We have also been committed to developing systems that meet the specific needs of clinical, diagnostic, and assay developers, with the increased security and compliance of an IVD device.

The Applied Biosystems QuantStudio 5 Dx Real-Time PCR System is designed to simplify workflows and minimize training needs to help customers get to their clinical answers quickly and to fit seamlessly into established workflows. This compact, flexible system provides confidence in performance and supports both development* and IVD needs.

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Video: QuantStudio 5 Dx system features

The QuantStudio 5 Dx system is an instrument with premium performance at an affordable price that provides:

  • 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
  • Simple, powerful software—allows users to set up a run, lay out assays, control the instrument, and conduct plate analysis within a single, easy-to-use software interface
  • Proven performance—over 10 years of clinical real-time PCR instrument manufacturing
  • Designed with the clinic in mind—interactive diagnostic instrument with short run times, minimal maintenance, and use of existing plastic consumables
  • Enhanced security—auditing and e-signature functionalities that enable you to comply with regulations
  • Peace of mind—IVD test menu allows only authorized IVD tests to be run through IVD mode, helping to reduce the risk of unauthorized use and accidental or intentional misuse
  • Flexibility you need—diagnose or develop, the choice is yours with software options that guide you through every step of test development* and in vitro diagnostic (IVD) modes
  • Maximize benchtop space—compact instrument
  • Superior support—support available globally by highly skilled, customer-focused staff
  • QuantStudio performance—reliability, sensitivity, and accuracy you expect coupled with an intuitive and simple-to-use interface that allows users of any experience level to operate the system with ease
 

QuantStudio 5 Dx system

Sample capacity (wells)96
Reaction volume96-well 0.2 mL block: 10-100 μL
Excitation sourceBright white LED
Filter or color combinations6 decoupled filters, CMOS camera
Excitation/detection range450-680 nm/500-730 nm
Multiplexing5-plex + 1 passive reference, 6-plex with no passive reference
Maximum block ramp rate6.5°C/sec
Average sample ramp rate3.66°C/sec
Temperature uniformity0.4°C
Temperature range4-99.9°C
Heating and cooling methodPeltier
Independent temperature zones6 VeriFlex zones (5°C zone to zone)
ChemistriesFast and standard
Run time<30 min
Compatible dyesFAM, SYBR Green, VIC, ABY, NED, TAMRA, JUN, ROX, Mustang Purple, Cy5
Security, auditing, and e-signature (SAE) featuresThe 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.
Automation compatibleNo
Footprint (H x W x D)40 x 27 x 50 cm
Weight27 kg

Features that help you comply with requirements of accrediting bodies

Maintenance and calibration reportsRecords 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 trackingStores and archives information about reagents used with each test, including lot number and expiration date, with each run. Archived files can be retrieved when required to track samples that were tested with a given set of reagents.
Sample trackingEnables laboratories to more easily track samples associated with a particular plate, set of reagents, run date and time, and data files.
E-signature historySecurity, auditing, and e-signature software records test events, actions taken, dates, user names, user roles, and activity performed, for documentation and archiving purposes.
Experimental resultsReport output records details for documentation, archiving, and review-at-a-glance needs, including 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

Design your assays to work with this flexible, reliable, and compact instrument

OEM & Commercial Supply

Design your own molecular diagnostic assay using our master mixes, assays, and instruments.  We have a specialized offering for our OEM partners including lyo-ready reagents, lyophilization, kitting, and custom services.  When you bring our experienced OEM team onboard, whether your project is large or small, your commercialization goals become our goals. 

By leveraging our superior combination of quality, global distribution, and professional commercial services and support, you can maximize your efficiency and scale, while minimizing risk.

Learn more at thermofisher.com/oem

Keep your real-time PCR systems up and running with superior services and support

Maximize system uptime, reduce repair costs and turnaround time, extend the life of your instrument, and help keep it running at peak performance with one of our comprehensive service plans. Choose from a variety of service options that balance your budget, productivity, uptime, and regulatory requirements. Our service plans include digital service innovations and pioneering on-demand tools such as remote support using augmented-reality technology, instrument-driven support, and on-demand instrument training.

Explore our services and support solutions at thermofisher.com/instrumentservices

Qualification services

Instrument hardware qualifications for the QuantStudio Real-Time PCR Systems include installation qualification (IQ) and operational qualification (OQ) to document and verify that instruments are installed and operating according to manufacturer’s specifications. An IQ/OQ is recommended at installation and when moving the instrument. Our qualification specialists will partner with you to deliver timely, cost-effective, and trusted qualification services that include reliable, audit-style documentation that will help ensure your instruments meet regulatory requirements.

Contact an instrument qualifications specialist at thermofisher.com/iqoqpq

Computer system validation services

Laboratories operating under GAMP5, 21 CFR Part 11, and Annex 11 security auditing and e-signature compliance require validation of instrument computer systems to help ensure accurate, reliable, and consistent records. To help reduce compliance risk, our computer system validation (CSV) consulting services provide flexible and comprehensive, audit-style documentation packages that help customers to comply with regulations and standards. The services are managed and delivered by an experienced compliance specialist and help ensure that electronic records are generated, maintained, and archived in an accurate, reliable, and secure manner.

Education services

It can be difficult to prepare yourself for what’s next while you’re focused on the work you have now. Our professional, interactive training courses make it easier.

We offer a combination of virtual and in-person classroom instruction, and hands-on learning in your lab to match your schedule, budget, and learning preferences. Whichever course style you choose, you’ll learn from one of our 300 highly skilled application scientists who are available to lead sessions online, at your location, or at one of our 12 training centers located worldwide.

Explore courses at thermofisher.com/educationservices

 

QuantStudio 5 Dx system

Sample capacity (wells)96
Reaction volume96-well 0.2 mL block: 10-100 μL
Excitation sourceBright white LED
Filter or color combinations6 decoupled filters, CMOS camera
Excitation/detection range450-680 nm/500-730 nm
Multiplexing5-plex + 1 passive reference, 6-plex with no passive reference
Maximum block ramp rate6.5°C/sec
Average sample ramp rate3.66°C/sec
Temperature uniformity0.4°C
Temperature range4-99.9°C
Heating and cooling methodPeltier
Independent temperature zones6 VeriFlex zones (5°C zone to zone)
ChemistriesFast and standard
Run time<30 min
Compatible dyesFAM, SYBR Green, VIC, ABY, NED, TAMRA, JUN, ROX, Mustang Purple, Cy5
Security, auditing, and e-signature (SAE) featuresThe 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.
Automation compatibleNo
Footprint (H x W x D)40 x 27 x 50 cm
Weight27 kg

Features that help you comply with requirements of accrediting bodies

Maintenance and calibration reportsRecords 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 trackingStores and archives information about reagents used with each test, including lot number and expiration date, with each run. Archived files can be retrieved when required to track samples that were tested with a given set of reagents.
Sample trackingEnables laboratories to more easily track samples associated with a particular plate, set of reagents, run date and time, and data files.
E-signature historySecurity, auditing, and e-signature software records test events, actions taken, dates, user names, user roles, and activity performed, for documentation and archiving purposes.
Experimental resultsReport output records details for documentation, archiving, and review-at-a-glance needs, including 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

Design your assays to work with this flexible, reliable, and compact instrument

OEM & Commercial Supply

Design your own molecular diagnostic assay using our master mixes, assays, and instruments.  We have a specialized offering for our OEM partners including lyo-ready reagents, lyophilization, kitting, and custom services.  When you bring our experienced OEM team onboard, whether your project is large or small, your commercialization goals become our goals. 

By leveraging our superior combination of quality, global distribution, and professional commercial services and support, you can maximize your efficiency and scale, while minimizing risk.

Learn more at thermofisher.com/oem

Keep your real-time PCR systems up and running with superior services and support

Maximize system uptime, reduce repair costs and turnaround time, extend the life of your instrument, and help keep it running at peak performance with one of our comprehensive service plans. Choose from a variety of service options that balance your budget, productivity, uptime, and regulatory requirements. Our service plans include digital service innovations and pioneering on-demand tools such as remote support using augmented-reality technology, instrument-driven support, and on-demand instrument training.

Explore our services and support solutions at thermofisher.com/instrumentservices

Qualification services

Instrument hardware qualifications for the QuantStudio Real-Time PCR Systems include installation qualification (IQ) and operational qualification (OQ) to document and verify that instruments are installed and operating according to manufacturer’s specifications. An IQ/OQ is recommended at installation and when moving the instrument. Our qualification specialists will partner with you to deliver timely, cost-effective, and trusted qualification services that include reliable, audit-style documentation that will help ensure your instruments meet regulatory requirements.

Contact an instrument qualifications specialist at thermofisher.com/iqoqpq

Computer system validation services

Laboratories operating under GAMP5, 21 CFR Part 11, and Annex 11 security auditing and e-signature compliance require validation of instrument computer systems to help ensure accurate, reliable, and consistent records. To help reduce compliance risk, our computer system validation (CSV) consulting services provide flexible and comprehensive, audit-style documentation packages that help customers to comply with regulations and standards. The services are managed and delivered by an experienced compliance specialist and help ensure that electronic records are generated, maintained, and archived in an accurate, reliable, and secure manner.

Education services

It can be difficult to prepare yourself for what’s next while you’re focused on the work you have now. Our professional, interactive training courses make it easier.

We offer a combination of virtual and in-person classroom instruction, and hands-on learning in your lab to match your schedule, budget, and learning preferences. Whichever course style you choose, you’ll learn from one of our 300 highly skilled application scientists who are available to lead sessions online, at your location, or at one of our 12 training centers located worldwide.

Explore courses at thermofisher.com/educationservices

*Development mode is For Research Use Only. Not for use in diagnostic procedures.