Automated Mass Spectrometry-Based Clinical Analyzer Could Transform Lab Testing

Mass spectrometry, known for its higher sensitivity and specificity compared to immunoassays, is particularly effective for testing molecules like Vitamin D and certain hormones where antibody-based tests struggle to differentiate between similar forms. This method allows for more precise testing. Researchers and clinicians have been investigating the use of mass spectrometry for such assays for several years. However, due to its complexity compared to standard immunoassays, mass spectrometry has largely been limited to large clinical reference laboratories and specialized testing companies that have the necessary resources and expertise to develop and conduct these tests. Now, a fully automated clinical mass spectrometry system being developed for routine lab testing could change that.

Roche Diagnostics (Basel, Switzerland) is currently developing a fully automated, standardized liquid chromatography-mass spectrometry (LC-MS) solution that will seamlessly integrate into existing clinical chemistry and immunochemistry testing as part of its cobas Pro integrated solutions, as well as laboratory automation and IT systems. Roche had recently provided a glimpse of its upcoming mass spectrometry analyzer, cobas Mass Spec, at EuroMedLab 2023. The Roche instrument, slated to be a complete automated sample-to-answer system, is designed to offer an experience similar to using traditional clinical analyzers. Additionally, the system will feature intelligent software to provide fully integrated results, setting the cobas Mass Spec apart from current mass spectrometry analyzers used in various laboratories. The instrument is expected to offer a wide in-vitro diagnostics (IVD) testing menu and replicate the user experience of conventional immunoassay or clinical chemistry analyzers.

The cobas Mass Spec will be incorporated into Roche's existing cobas Pro integrated solutions analyzer, tailored for mid- to high-throughput laboratories. This integration will facilitate its incorporation into existing laboratory workflows. The full integration with the cobas Pro chemistry and immunochemistry analyzers could allow labs to establish workflows where positive samples from initial screenings, like drugs-of-abuse tests, are automatically confirmed using the mass spec analyzer. Automated mass spec analysis would be particularly beneficial in toxicology and endocrine testing, where it can overcome interference issues often encountered in immunoassay testing. The system is anticipated to appeal to both smaller laboratories looking to adopt mass spec-based testing without existing expertise and larger labs, such as national laboratories, which may view the new instrument as an opportunity to streamline their operations. Roche reportedly plans to launch the cobas Mass Spec in 2024, initially in the EU, followed by releases in the US and China.

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