The QuantStudio Dx instrument provides your clinical laboratory with performance you can trust, security you demand, and flexibility you need in your workflow to meet the needs of your lab today and tomorrow.
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.
Performance you can trust
The QuantStudio Dx instrument’s proven performance, security, and reliability—combined with the outstanding sensitivity and specificity of real-time PCR—help you deliver the right answers that help with providing better outcomes.
Flexibility you want
In Test Development Mode, the QuantStudio Dx instrument enables the creation of new assays in 96-or 384-well plates, and qPCR Microfluidic Card formats provide easily interchangeable thermal cycling blocks to accommodate your lab’s throughput assay development. The 96-well fast block can be used in IVD mode.
Security you demand
The QuantStudio Dx Software enables you to maintain secure access to instruments, specify user access to various software functions, record all actions completed by users, and sign data electronically. In addition, the onboard software for the QuantStudio Dx Real-Time PCR Instrument assists with compliance for 21 CFR Part 11.
Flexible software designed to meet your needs
Have confidence in an instrument that helps ensure compliance for fully regulated laboratories in the United States and Europe.* QuantStudio Dx Software runs IVD tests in a secure mode with set parameters for run and analysis.
In test development mode, the flexible QuantStudio Dx Software enables you to create new assays and perform clinical research using the 96-well standard and Fast blocks, the 384-well block, or the qPCR microfluidic card block.†,‡ You can also use the proprietary Applied Biosystems qPCR microfluidic card to perform 8 x 48 simultaneous reactions without the need for liquid-handling robots.
One instrument, multiple applications
The QuantStudio Dx instrument has you covered across several applications—whether you perform pathogen detection, gene expression analysis, SNP genotyping, copy number analysis, mutation detection with castPCR technology, microRNA and other noncoding RNA analyses, or high-resolution melt analysis.§,††
* The QuantStudio Dx Real-Time PCR Instrument is for distribution in the United States and specific European and non-European countries only. TheQuantStudio Dx Real-Time PCR Instrument with QuantStudio Dx Software is intended to perform fluorescence-based PCR to provide detection of nucleic acid sequences in human-derived specimens in IVD-labeled tests. The QuantStudio Dx Real-Time PCR Instrument with QuantStudio Dx Software is intended for In Vitro Diagnostic use by trained laboratory technologists in combination with nucleic acid reagent kits/tests manufactured and labeled for diagnostic purposes on this instrument. The QuantStudio Dx Real-Time PCR Instrument and accessories also meet the requirements of the EU In Vitro Medical Devices Directive (98/78/EC).
† These blocks are CE-marked in Europe.
‡ These blocks in Test Development Mode are RUO in the United States.
§ Applications are intended for use in research use only (RUO) mode.
†† High-resolution melt analysis requires purchase of an additional software license.
Product Brochure
(4.11 MB)
Get detailed information on QuantStudio™ Dx instrument features and benefits.
Specification Sheet
(351 KB)
Review key hardware specifications for the QuantStudio™ Dx instrument.
TaqMan Array Cards
(556 KB)
Get detailed information on Array Cards technology and applications.
What formats does the instrument support?
For assay development: qPCR Microfluidic Card, 96-well Fast and standard, and 384-well formats in the US.†
For IVD: 96-well Fast format in US; qPCR Microfluidic Card, 96-well Fast and standard, and 384-well formats in Europe.
What is a qPCR Microfluidic Card?
It is a proprietary 384-well qPCR Microfluidic Card designed to perform 8 x 48 simultaneous reactions without the need for liquid-handling robots.
What applications does the instrument support?
The QuantStudio Dx instrument has you covered across several applications, whether you perform pathogen detection, gene expression analysis, SNP genotyping, copy number analysis, mutation detection with castPCR™ technology, microRNA and other non-coding RNA analysis, or high-resolution melt (HRM) analysis.§
What size is the instrument?
The instrument dimensions are 53.0 cm (20.9 in) x 70.0 cm (27.6 in) x 75.0 cm (29.5 in). It weighs 70 kg (154.3 lb).
How long does it take to run a typical PCR assay?
Cycle times depend on the test being performed and the thermodynamic requirements. Typically it takes less than 60 minutes from sample acquisition to reporting.
What is the hands-on time?
Approximately 15 minutes. It takes less than 10 minutes to setup the plate, 1 minute to cycle and image, and less than 5 minutes to analyze the data and generate the report.
*The QuantStudio Dx Real-Time PCR Instrument is for distribution and use in the United States and specific European countries only. The QuantStudio Dx Real-Time PCR Instrument with QuantStudio Dx Software is intended to perform fluorescence-based PCR to provide detection of nucleic acid sequences in human-derived specimens in IVD labeled tests. The QuantStudio Dx Real-Time PCR Instrument with QuantStudio Dx Software is intended for in vitro diagnostic use by trained laboratory technologists in combination with nucleic acid reagent kits/tests manufactured and labeled for diagnostic purposes on this instrument. The QuantStudio Dx Real-Time PCR Instrument and accessories also meet the requirements of the EU In Vitro Medical Devices Directive (98/78/EC).
† These blocks are CE-marked in Europe.
§ Applications are intended for research use only in Test Development Mode use only (RUO).
A growing list of assays
The list of available assays for your testing needs continues to grow, including C. difficile, influenza A + B, RSV + hMVP, HSV 1 + 2/VZV, and other assays in the United States.
Performance you can trust
The QuantStudio Dx instrument’s proven performance, security, and reliability—combined with the outstanding sensitivity and specificity of real-time PCR—help you deliver the right answers that help with providing better outcomes.
Flexibility you want
In Test Development Mode, the QuantStudio Dx instrument enables the creation of new assays in 96-or 384-well plates, and qPCR Microfluidic Card formats provide easily interchangeable thermal cycling blocks to accommodate your lab’s throughput assay development. The 96-well fast block can be used in IVD mode.
Security you demand
The QuantStudio Dx Software enables you to maintain secure access to instruments, specify user access to various software functions, record all actions completed by users, and sign data electronically. In addition, the onboard software for the QuantStudio Dx Real-Time PCR Instrument assists with compliance for 21 CFR Part 11.
Flexible software designed to meet your needs
Have confidence in an instrument that helps ensure compliance for fully regulated laboratories in the United States and Europe.* QuantStudio Dx Software runs IVD tests in a secure mode with set parameters for run and analysis.
In test development mode, the flexible QuantStudio Dx Software enables you to create new assays and perform clinical research using the 96-well standard and Fast blocks, the 384-well block, or the qPCR microfluidic card block.†,‡ You can also use the proprietary Applied Biosystems qPCR microfluidic card to perform 8 x 48 simultaneous reactions without the need for liquid-handling robots.
One instrument, multiple applications
The QuantStudio Dx instrument has you covered across several applications—whether you perform pathogen detection, gene expression analysis, SNP genotyping, copy number analysis, mutation detection with castPCR technology, microRNA and other noncoding RNA analyses, or high-resolution melt analysis.§,††
* The QuantStudio Dx Real-Time PCR Instrument is for distribution in the United States and specific European and non-European countries only. TheQuantStudio Dx Real-Time PCR Instrument with QuantStudio Dx Software is intended to perform fluorescence-based PCR to provide detection of nucleic acid sequences in human-derived specimens in IVD-labeled tests. The QuantStudio Dx Real-Time PCR Instrument with QuantStudio Dx Software is intended for In Vitro Diagnostic use by trained laboratory technologists in combination with nucleic acid reagent kits/tests manufactured and labeled for diagnostic purposes on this instrument. The QuantStudio Dx Real-Time PCR Instrument and accessories also meet the requirements of the EU In Vitro Medical Devices Directive (98/78/EC).
† These blocks are CE-marked in Europe.
‡ These blocks in Test Development Mode are RUO in the United States.
§ Applications are intended for use in research use only (RUO) mode.
†† High-resolution melt analysis requires purchase of an additional software license.
Product Brochure
(4.11 MB)
Get detailed information on QuantStudio™ Dx instrument features and benefits.
Specification Sheet
(351 KB)
Review key hardware specifications for the QuantStudio™ Dx instrument.
TaqMan Array Cards
(556 KB)
Get detailed information on Array Cards technology and applications.
What formats does the instrument support?
For assay development: qPCR Microfluidic Card, 96-well Fast and standard, and 384-well formats in the US.†
For IVD: 96-well Fast format in US; qPCR Microfluidic Card, 96-well Fast and standard, and 384-well formats in Europe.
What is a qPCR Microfluidic Card?
It is a proprietary 384-well qPCR Microfluidic Card designed to perform 8 x 48 simultaneous reactions without the need for liquid-handling robots.
What applications does the instrument support?
The QuantStudio Dx instrument has you covered across several applications, whether you perform pathogen detection, gene expression analysis, SNP genotyping, copy number analysis, mutation detection with castPCR™ technology, microRNA and other non-coding RNA analysis, or high-resolution melt (HRM) analysis.§
What size is the instrument?
The instrument dimensions are 53.0 cm (20.9 in) x 70.0 cm (27.6 in) x 75.0 cm (29.5 in). It weighs 70 kg (154.3 lb).
How long does it take to run a typical PCR assay?
Cycle times depend on the test being performed and the thermodynamic requirements. Typically it takes less than 60 minutes from sample acquisition to reporting.
What is the hands-on time?
Approximately 15 minutes. It takes less than 10 minutes to setup the plate, 1 minute to cycle and image, and less than 5 minutes to analyze the data and generate the report.
*The QuantStudio Dx Real-Time PCR Instrument is for distribution and use in the United States and specific European countries only. The QuantStudio Dx Real-Time PCR Instrument with QuantStudio Dx Software is intended to perform fluorescence-based PCR to provide detection of nucleic acid sequences in human-derived specimens in IVD labeled tests. The QuantStudio Dx Real-Time PCR Instrument with QuantStudio Dx Software is intended for in vitro diagnostic use by trained laboratory technologists in combination with nucleic acid reagent kits/tests manufactured and labeled for diagnostic purposes on this instrument. The QuantStudio Dx Real-Time PCR Instrument and accessories also meet the requirements of the EU In Vitro Medical Devices Directive (98/78/EC).
† These blocks are CE-marked in Europe.
§ Applications are intended for research use only in Test Development Mode use only (RUO).
A growing list of assays
The list of available assays for your testing needs continues to grow, including C. difficile, influenza A + B, RSV + hMVP, HSV 1 + 2/VZV, and other assays in the United States.
The QuantStudio Dx Real-Time PCR Instrument is supported by:
| AB Assurance Plan with Qualification Service | AB Assurance Plan with System Performance Check | |
|---|---|---|
| Onsite response time for repairs | Guaranteed 2 business days | Guaranteed 2 business days |
| Remote instrument monitoring and diagnostics | + | + |
| Priority phone and email access to instrument support | + | + |
| Instrument operating software upgrades | + | + |
| Instrument qualification services | + | NA |
| Instrument system performance check | NA | + |
| Planned maintenance | + | + |
| Parts, labor and travel | + | + |
NA = not applicable
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