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.
We’re with you through the rough terrain. For more information about a personalized IVD transition plan, please contact the Thermo Fisher Scientific transition team.
Contact our IVDR transition team
View information about the QuantStudio 5 Dx Real Time PCR System (CE-IVD, IVDR) ›
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.
Request a quote Request a demo Download brochure Contact OEM Services
Video: QuantStudio 5 Dx system features
The QuantStudio 5 Dx system is an instrument with premium performance at an affordable price that provides:
QuantStudio 5 Dx system | |
|---|---|
| Sample capacity (wells) | 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 |
| Security, auditing, and e-signature (SAE) features | 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. |
| Automation compatible | No |
| Footprint (H x W x D) | 40 x 27 x 50 cm |
| Weight | 27 kg |
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 | Stores 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 tracking | 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, user names, user roles, and activity performed, for documentation and archiving purposes. |
| Experimental results | Report 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 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
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
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
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.
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 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 |
| Security, auditing, and e-signature (SAE) features | 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. |
| Automation compatible | No |
| Footprint (H x W x D) | 40 x 27 x 50 cm |
| Weight | 27 kg |
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 | Stores 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 tracking | 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, user names, user roles, and activity performed, for documentation and archiving purposes. |
| Experimental results | Report 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 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
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
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
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.
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.
For In Vitro Diagnostic Use.
