Quality Rules versus Exceptions for Complex Assays

Article for Today’s Clinical Lab written by ADAM ZABELL, PHD & Business Analyst at Indigo BioAutomation

One of the most powerful instrumentation setups for the clinical laboratory is LC-MS/MS. The ability to separate analytes of interest with orthogonal methods (chromatography and mass spectrometry), the wide availability of differing chromatography chemistries, the highly selective nature of mass detection, and wide quantitative range with minimal sample volume make this device particularly attractive when there is a need to develop an assay not otherwise available on the commercial market. The ability to extend an existing instrument into a wholly new test system (e.g. vitamin D in urine, testosterone in blood, drugs of abuse in saliva) without requiring a larger footprint in the lab adds to the attraction. This combination of flexibility and complexity requires anyone who works with LC-MS/MS to develop a solid understanding of effective quality rules.