labqaqcmod8 - Module 8: Validation Page 1 of 8 Printable...

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Print Save to File Printable View of: Module 8: Validation File: Overview File: Components of Analytical Procedures Overview Overview Having decided upon an analytical method to verify the identity and pu There are many approaches that may be taken to validate an analytica Objectives At the end of this module students should: Understand the need for validating analytical methods Know the requirements for the validation of an analytical method Understand the difference between accuracy and precision Understand the limit of detection and limit of quantitation Assignment Please note: The assignment is listed below and again on the final page of this module. You should Many accreditation standards now require that the uncertainty of measurement for an analytical meth Components of Analytical Procedures Module 8: Validation of Analytical Procedures Page 1 of 8 Module 8: Validation 8/2/2009 https://elearning.courses.ufl.edu/webct/urw/lc2793842980071.tp2801654586071/selectItem. ..
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Components of Analytical Procedures An analytical procedure can generally be considered to include the following components: extraction of the test compound from a matrix construction of a standard curve quantitation of the test article quality control of the analytical process The following are key parameters that should be considered when validating such a process: Purity and identity of the neat test sample Homogeneity of solutions Extraction recovery Range of standard curve and control samples Linearity and precision of standard curves Sensitivity Specificity Accuracy and precision Stability Quality control In the case of validation of procedures for DNA laboratories, the validation is split into developmental and internal validation. Developmental Validation Developmental Validation must include:characterization of the locus, species specificity studies, sensitivity, stability and mixture studies. In addition, a number of samples from a population must be obtained and analyzed in order for independence studies and allele frequency determinations to be made. Internal Validation Internal Validation must be conducted by any laboratory when developmental validation has been performed at by another laboratory or at another site of a multi-site laboratory system. "Internal validation studies must be sufficient to show the reliability of the technique as practiced by that laboratory." (Reference - The FBI Quality Assurance Standards for Forensic DNA Testing Laboratories and Convicted Offender DNA Databasing Laboratories) The FBI Quality Assurance Standards for Forensic DNA Testing Laboratories and Convicted Offender DNA Databasing Laboratories require that the following studies are completed: accuracy, precision and reproducibility 1.
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This note was uploaded on 09/01/2011 for the course VME 6766 taught by Professor Dr.grundmann during the Spring '09 term at University of Florida.

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labqaqcmod8 - Module 8: Validation Page 1 of 8 Printable...

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