Verification and Validation of Examination Methods in the medical laboratory

The training course on Verification and Validation of Examination Methods in the medical laboratory with Analyse-it and XLSTAT software based on the requirements of ISO 15189:2022 standard was held at smart health tower. Smart Health Tower is a modern hospital that uses sophisticated technology to provide a high-quality service to its patients in Iraq and outside of Iraq. Smart Health Tower is composed of many different branches providing different medical services i.e. Smart Hospital, Smart Radiology Center, Smart Laboratories, Smart Pharmacy, Smart Clinics, etc. We take a wholesome approach to providing the best and most cost-efficient care to our patients.

Venue of the course: Sulaymaniyah – smart health tower

Date of the course: 3 to 6 December

presented by: Dr. Mustafa Dastmardi

The purpose of this training course:

Understand Verification of examination methods requirements base on ISO 15189:2022;

Understand Validation of examination methods requirements base on ISO 15189:2022;

Select and apply the statistics required during Verification and Validation of examination Methods;

Apply statistical principles through 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 the Verification and Validation of Examination Methods in the medical laboratory training course:

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