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

“Thermo Fisher is a valued partner, supporting us in the development of clinical trial assays and companion diagnostics,” said Michael Sloan, global vice president of commercial operations at Almac Diagnostic Services. “Thermo Fisher’s QuantStudio qPCR systems offers a seamless integration into our assay development workflows. QuantStudio 5 Dx offers the flexibility of customizable solutions and provide high-quality data output for molecular diagnostic testing.”

Michael Sloan

Global Vice President of Commercial Operations

Almac Diagnostic Services


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.


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