The purpose of method evaluation is performance assessment, which can be expressed under the Total Error (TE) model or Measurement Uncertainty (MU) model. The similarity of TE and MU models is that they both express the reliability of the test result. However, these models have their differences. The first presentation will discuss the major challenges of TE and MU in method evaluation in the clinical laboratory. Liquid chromatography–tandem mass spectrometry (LC-MS/MS) is an emerging technology being adopted in the clinical laboratory to measure novel and established biomarkers for clinical care. Often, these measurement procedures are developed at least in part in the laboratory (i.e. laboratory-developed tests), which requires careful validation to ensure fitness for clinical purposes. The second lecture discusses approaches and specific requirements for bringing this technology into clinical service and its dissemination in laboratory medicine peer-reviewed journals. The handling of validation and verification of method performance often still differs widely from laboratory to laboratory, and even in developed countries, there are still controversies that need to be harmonised/ standardised on the subject. Is there any practical protocol that is simple enough to be applicable in laboratories with wide variety of knowledge and resourses? The last presentation will present the practical experiences in method evaluation in resource limited setting to ensure that a method performs to an acceptable quality standard, and fit for the clinical purpose.

This webinar comprises of three following presentations of 20 min each followed by 20 min of panel discussion at the end.

Chair: Prof. Ronda F Greaves/ Dr. Tze Ping Loh

Talk 1- "Total error vs Measurement Uncertainty for method evaluation" - Prof. Elvar Theodorsson

Talk 2- "Mass Spectrometry Method Validation" - Dr. Brian Cooke

Talk 3- "Method Evaluation in Resource Limited Setting" - Dr. Tran Thi Chi Mai

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