MLAB2337Lab4QualityAssuranceSummer2015.doc

MLAB2337Lab4QualityAssuranceSummer2015.doc - MLAB 2337...

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MLAB 2337 Molecular Diagnostics Techniques Laboratory 4: Quality Assurance in the Molecular Laboratory Objectives Quality Assurance in the Molecular Laboratory 1. List and describe four elements which must be addressed in a quality assurance plan during the pre- analytic phase of testing. 2. List and describe ten elements which must be addressed in a quality assurance plan during the analytic phase of testing. 3. List and describe four elements which must be addressed in a quality assurance plan during the post- analytic phase of testing. 4. Briefly describe the content and importance of a well written Standard Operating Procedure (SOP) manual. 5. List four characteristics of a quality laboratory as it relates to documentation of data. 6. List the criteria required by the Food and Drug Administration (FDA) for proper recording of laboratory data to be in compliance with Good Laboratory Practices (GLP). 7. State the proper method for correcting an incorrect entry of laboratory data, both manual and computer. 8. List and describe ten elements which should be in place to monitor quality systems in the molecular laboratory. Micropipette Validation of Calibration 1. List and describe four elements involved with proper maintenance of micropipettes. 2. List six elements which must be addressed when performing calibration of micropipettes using the measured water protocol. 3. Given a set of a micropipettes water measurements calculate the percent accuracy, percent error, standard deviation and coefficient of variation. 4. Briefly describe the gravimetric validation procedure for micropipettes. 5. Briefly describe the colorimetric validation procedure for micropipettes. 6. List three types of problems and possible solutions when micropipettes are not working correctly. Discussion Molecular research projects and the Human Genome Project has ushered in a new era for the clinical lab by making available uniquely specific analytical methods for detection of pathogens and human genetic disorders. A molecular test can deliver to a physician a result that is frequently considerably quicker than traditional approaches, with detailed information that can direct a highly tailored course of treatment. Owing to the extreme sensitivity of many molecular techniques, a less invasive sample collection is required for molecular analysis. The rapid development of automation and streamlining of molecular procedures has made molecular diagnostics a commercial option that more and more clinical labs are now bringing on board. Molecular diagnostic is today the fastest-growing segments in in-vitro diagnostics due to the improvements in turnaround time, the specificity of information derived from molecular approaches, the less invasive tissue collection, high through-put automation in instrumentation, and cost advantages. The global market for molecular diagnostics in 2005 was $6.5 billion, or approximately 3.3% of the total diagnostics market and approximately 14% of the in vitro diagnostic market. By 2010, the molecular diagnostics market is projected to expand to $12 billion, nearly doubling in 5 years.
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