SCIEX发布符合欧盟认证的IVD质谱用于欧洲体外诊断

AB SCIEX launches IVD-MS Analyzer CE marked for general in vitro diagnostic use in Europe

Published on November 27, 2013 at 1:35 AM

Continuing to rapidly expand its presence in the clinical diagnostics field, AB SCIEX, a global leader in analytical technologies, today announced the launch of its AB SCIEX IVD-MS™ Analyzer CE marked for general in vitro diagnostic use in Europe.

The release of this mass spectrometry-based analyzer is in response to growing demand within hospitals and clinical diagnostic laboratories for faster, more accurate results than what is currently achievable with the most commonly used analyzers in the majority of diagnostic facilities today.

"We have redefined what a mass spectrometry analyzer is capable of doing for in vitro diagnostics," said Rainer Blair, President of AB SCIEX. "By combining the peace of mind of proven technology with the latest advancements in the user interface and integrated software development, we are making LC/MS/MS technologies as easy to use as ever in a clinical lab. Now available to a significant number of European clinical laboratories is the ability to improve the quality of in vitro diagnostic results while reducing costs compared to other technologies."

The new AB SCIEX IVD-MS™ Analyzer provides a combination of the high sensitivity and selectivity of mass spectrometry (MS) technology and the molecular separation power of liquid chromatography (LC) with a technician-friendly, intuitive interface.

AB SCIEX, which has been highly successful in the research (RUO) market for decades, has re-engineered its software application specifically for medical technologists, making the user interface more intuitive, simpler to navigate and ideal for new users in fast-paced clinical settings.

The new SCIEX ClearCore™ MD Software provides streamlined data processing, reporting and review functionality. This will help make the adoption of LC/MS/MS for routine analysis significantly easier.

The ClearCore software enables quantitation and data exploration without the need for additional software packages. It provides simple method development tools with separate LC and MS method editors. It also provides customizable access to modules based on user security levels, including routine users, method developers, data reviewers and administrators, so personnel is only able to access approved modules. This software drives the workflow that utilizes the power of the analyzer.

The new IVD-MS™ Analyzer joins the company"s growing line of in vitro diagnostic devices for certain European countries, including the AB SCIEX 3200MD CE-IVD series of MS systems -the API 3200MD™ and 3200MD QTRAP® LC/MS/MS systems -launched earlier in 2013. The new analyzer utilizes the company"s state-of-the-art LC and MS technologies that have a proven track record with AB SCIEX customers.

The intended use of this regulatory-compliant device is to identify inorganic or organic compounds in human specimens for clinical use, providing routine diagnostic testing laboratories in certain countries in Europe with the ability to quantitate multiple trace level compounds in a single analysis with high confidence in the results.

The company plans to extend its in vitro diagnostic solutions into other parts of the world in the future.