Bioanalytics – Chemical
2019 PharmSci 360
The culture of clinical medicine is inherently risk-averse and this cautiousness extends to the practice of diagnostic and laboratory medicine. Any new tool has to measure up to the quality, robustness and repeatability standards of diagnostic tests that may have been in use for 100 years and have the benefit of 40 years of robotic automation. LC-MS/MS has been in use in clinical laboratory environments since the mid 1990s and is now more or less part of routine care, albeit far from ubiquitous. The reason that LC-MS/MS based lab developed tests are not used everywhere is related to the rigor required to validate the test, the throughput requirements, and the unexpected challenges that arise in dealing with samples from a wide variety of disease states. Our lab has been reporting LC-MS/MS results daily for 12 years and has been routinely reporting protein analyses using LC-MS/MS for 5 years. This session will discuss the challenges in transiting a biomarker analyte into a routine hospital environment using mass spectrometry from the perspective of administrative challenges, staff technical ability, instrument usability, lab information system connectivity and the surprises related to specific disease states. Examples will include more difficult steroid analyses such as aldosterone, estradiol, 1,25 dihydroxyvitamin D and modern protein mass spectrometry techniques such as mass spectrometric immunoassay (MSIA) and "Stable isotope standards and capture by anti-peptide antibodies” (SISCAPA) in application to synthetic insulin analogues, immunoglobulins and therapeutic monoclonal antibodies, and thyroglobulin.