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Comprehensive Validation in Global Health Laboratories

This training course by KEMRI-Wellcome Trust introduces the concept of validation in laboratory testing, covering purposes, requirements, validation plan, method components, and best practices. Learn how validation ensures accuracy and reliability in global health testing.

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Comprehensive Validation in Global Health Laboratories

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  1. www.GlobalHealthLaboratories.org This teaching material has been made freely available by the KEMRI-Wellcome Trust (Kilifi, Kenya). You can freely download, adapt, and distribute this presentation under the conditions that: the Global Health Laboratories and The Global Health Network are referenced; the work is not used for commercial purposes, and any altered forms of this document are distributed freely under the same conditions.

  2. VALIDATIONS GCLP TRAINING COURSE KEMRI-Wellcome Trust Research Programme

  3. What is validation? • Validation is the confirmation by examination and the provision of objective evidence that the particular requirements for a specific intended use are fulfilled

  4. Purposes of Validation : • To quantifiably characterize system performance • To assess potential for error • To identify method-to-method differences • To meet regulatory guidelines • Increase confidence that the output conform to reality in the required range.

  5. Validation requirements • Qualified and calibrated instruments • Documented methods e.g. protocol manuals • Reliable reference standards • Qualified analysts • Sample integrity • Manufacturer’s package inserts

  6. Validation Plan • Statement of purpose and scope • Responsibilities • Documented test method • List of materials and equipment • Procedure for the experiments for each parameter • Statistical analysis • Acceptance criteria for each performance parameter

  7. When to Do Method Validation Studies: • When considering purchasing a new system • When placing a new system into service • At regular intervals to assess on-going system performance • When troubleshooting questionable system performance

  8. Basic Components of Method Validation • Accuracy • Precision • Repeatability • Reproducibility

  9. Basic Components of Method Validation • Range Validation and Verification • Linearity and range • Specificity • Sensitivity • Limit of detection • Limit of quantification

  10. Basic Components of Method Validation • Range Validation and Verification • Reportable Range • Critical Limits • Analytical Measurement Range • Clinically Reportable Range • Calibration Verification / Linearity • Reference Range Studies

  11. Validation Good Practices • To select analytical procedures suitable for answering the analytical questions. • To perform the selected test in • Traceable manner • According to clear and transparent procedures under proper conditions.

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