QuantStudio 7 Pro Dx Real-Time PCR System is IVDR Compliant

Powered by proven technology, the Applied Biosystems QuantStudio 7 Pro Dx Real-Time PCR System is a standalone qPCR platform that is versatile, highly expandable, and easy to use. Designed to support in vitro diagnostic (IVD) applications, the QuantStudio 7 Pro Dx system incorporates smart features such as hand-free functionality. Whether your laboratory is running routine assays or developing new ones, the QuantStudio 7 Pro Dx can support your work.

 

With sensitivity down to 1.5-fold in singleplex reactions and 10 logarithmic units of linear dynamic range, the QuantStudio 7 Pro Dx system supports the development of molecular diagnostic (MDx) assays. The compact footprint, software features, and up to six-color multiplexing helps enable laboratory productivity and innovation. 

 

Customer testimonial

"The ability to import plate set-up files from external software and export result sets in a customizable structure made it easy to integrate the QuantStudio 7 Pro Dx Real-Time PCR System with our laboratory information  management software,” said  Dr. Gustav Quade,  laboratory medicine and technical development specialist at the Quade Laboratory in Germany.“ The new Diomni Software makes it easy to work collaboratively and we can set up runs, manage past runs and documentation, and interpret fluorescent curves remotely and efficiently without the need to install special software."

Dr. Gustav Quade

Germany


Intended use

The automated QuantStudio 7 Pro Dx Real-Time PCR 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 QuantStudio 7 Pro Dx Real-Time PCR System is intended to be used by trained professionals in combination with in vitro diagnostic assays.


Features

Key features of the QuantStudio 7 Pro Dx system include:

Enhanced security for confidence

Security, auditing, and e-signature (SAE) functionalities assist in compliance with regulatory requirements and support multiple clients. SAE settings that can be applied to multiple instruments on the same network, allow better control for your IT department. 

Easy-to-use, powerful software 

The included software is designed to guide users through workflow steps for test development* or in vitro diagnostics. Suitable for clinics, hospitals, and diagnostic test developers, the QuantStudio 7 Pro Dx software enables users to set up a run, lay out assays, control the instrument, and conduct plate analysis on an easy-to-use touchscreen interface.

Assay-driven qPCR workflows 

For ease of use and error reduction, create and manage assay definitions files (ADFs) for a specific assay, panel, or test. The ADFs incorporate all of the qPCR setup and analysis parameters required for a particular assay. Once installed on the instrument, operators select a specific ADF to run, helping reduce setup time on the device and user error.  ADFs help reduce risk of unauthorized use and accidental or intentional misuse by embedding regulatory status of an assay in the file.

Compact, stand-alone instrument

Featuring a small footprint without the requirement for an attached computer, the graphical user interface (GUI) enables end-to end workflows from the touchscreen. The SAE administrative console can be run in server configuration to free up valuable bench space.

Green features enhance efficiency

Use up to 54% less material, generate 91% less waste during calibration, and use up to 26% less energy than comparable instruments.

6-color multiplexing

A six-color, decoupled OptiFlex filter system with bright white LED is engineer-calibrated during installation to enable optimal performance.

Smart features

Hands-free functionality includes the ability to perform basic operations using voice commands. The QuantStudio 7 Pro Dx system also includes smart support and smart help to report issues or request instrument services to reduce downtime.

Interchangeable Block Options

Achieve maximum flexibility with interchangeable block options of 96-well 0.2 mL and 384-well. With interchangeable blocks, test development and in vitro diagnostics are possible on the same instrument. Increasing test volumes can be accommodated if protocol is validated on both 96-and 384-well blocks.


Instrument calibration and verification kits


Ordering information


Specifications


For In Vitro Diagnostic Use.

 

This instrument may not be available in your region.