Verification and Validation of Examination Methods in the medical laboratory
Pishgaman Modiriyat Parto recently organized a training course on the Verification and Validation of Examination Methods in medical laboratories. The course utilized Analyse-it and XLSTAT software and was in accordance with the ISO 15189:2022 standard requirements. The course took place at the NWA Clinical Diagnosis Laboratory, which is a modern facility offering high-quality diagnostic services in the Iraqi country. The laboratory provides over 500 standard and rare tests, as well as 5,400 genetic tests, covering various fields such as molecular biology, hematology, hormone testing, virology, clinical chemistry, immunology, ELISA, microbiology, parasitology, metabolic disorders, and allergy testing. Dr. Mustafa Dastmardi presented the course, which took place from the 1st to the 5th of April at the NWA Clinical Diagnosis.
Aims of this training course
This course is designed to provide you with the essential skills and knowledge required to:
– Understand the requirements for verification and validation examination methods based on ISO 15189:2022;
– Select and apply appropriate statistical techniques during the verification and validation of examination methods;
– Practice statistical principles through hands-on, laptop-based workshops.
– Ability to work with Analyse-it and XLSTAT software for statistical analysis
table of contents
1- Verification and Validation of Examination Methods: General
2- Basic Statistical Concepts in the Evaluation of Test Method Performance Characteristics
2-1- Measure of central tendency and variability
2-2- Testing the assumption of normality
2-3- Detection and treatment of outliers
3- Evaluating Precision of Quantitative Measurement Procedures
3-1- Glossary of terms used in the evaluating precision
3-2- Evaluation of Precision of Quantitative Measurement Procedures
3-3- Verification of Manufacturer’s precision Claim
3-4- Comparing the precision of two methods
4- Evaluating the bias (Trueness) of a Quantitative Measurement Procedures
4-1- Glossary of terms used in the evaluating trueness
4-2- Estimation of Bias by Testing Materials With Known Concentrations
4-3- Measurement Procedure Comparison and Bias Estimation Using Patient Samples
5- Evaluation of Total Analytical Error for Quantitative Medical Laboratory Measurement Procedures
6- Evaluation of Linearity of Quantitative Measurement Procedures
7- Evaluation of Detection Capability for Clinical Laboratory Measurement Procedures
7-1- Overview of Detection Capability
7-2- Protocols for Evaluation of the Limit of Blank and Limit of Detection
7-3- Protocol for Evaluation of the Limit of Quantitation
7-4- Verification of Detection Capability Claims
8- Interference Testing in Clinical Chemistry (Analytical Specificity)
9- User Protocol for Evaluation of Qualitative Test Performance
9-1- Glossary of terms used in the Evaluation of Qualitative Test Performance
9-2- Bias and Imprecision Studies for Qualitative Test
9-3- Estimating Sensitivity and Specificity For Qualitative Test
9-4- Estimating Sensitivity and Specificity of Laboratory Tests Using ROC Curves
10- References
Coordination for holding training course
You can contact us to enroll in the “Verification and Validation of Examination Methods in Medical Laboratory” training course.
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