Metrological Traceability of Assays and Comparability of Patient Test Results.
At the start of the twenty-first century, a dramatic change occurred in the clinical laboratory community. Concepts from Metrology, the science of measurement, began to be formally applied to clinical laboratory field methods, resulting in a new appreciation of metrological calibrator traceability. It is a change because clinical laboratories test complex patient samples, for example, whole blood, serum, plasma, urine, and so forth, using commercial assay systems, not reference methods, and patient samples are tested once, not in replicate. Analytical harmonization is necessary for optimal patient care but is challenging to achieve.
Clinical Chemistry, Abbott Diagnostics, Department 09AC, Building CP1-5, 100 Abbott Park Road, Abbott Park, IL 60064, USA. Electronic address: david.armbruster@abbott.com.
David
D
Armbruster
D002138:Calibration; D064790:Clinical Laboratory Services / Q000592:standards; D019411:Clinical Laboratory Techniques / Q000592:standards* / Q000639:trends; D000068598:Data Accuracy; D057286:Electronic Health Records; D006801:Humans; D012015:Reference Standards
Comparability; Harmonization; Metrology; Standardization; Traceability