A multiplex, mass spectrometry-based quantitative clinical chemistry proteomics (qCCP) test for cardiovascular assessment has been developed, analytically validated, implemented and scaled up for a large clinical research study. The entire test process is made to be in compliance with ISO 15189:2012. Lab staff running the application are trained to an equal level of performance. To evaluate utility of this qCCP test about 26,000 specimens from a randomized control trial are analyzed. Multiple LC-MS instruments and liquid handling robots have been implemented to meet the agreed timelines.
It is demonstrated that the analytical performance of this qCCP test meets desirable analytical performance requirements needed for fitness for purpose with the selected instrumentation set-up and preventive maintenance frequency, experienced academic staff, and stringent quality and data management procedures. To become applicable in a routine setting, more automation readiness is needed. Intense collaboration between mass spectrometry manufacturers and academia is essential to introduce quantitative proteomics in clinical research laboratories.
*For Research Use Only. Not for use in diagnostic procedures.
Attend this webinar to learn about:
- Discover opportunities that exist in clinical research testing for protein biomarkers (particularly in cardiovascular disease)
- Learn the advantages in performing protein quantification at higher flow rates
- Understand the considerations for implementing an LC-MS analysis for protein biomarker quantification in a clinical translational context