Assay Validation: Make Sure You Do It Right The First Time (by 4CEUINC)

1 P.A.C.E. contact hour(s)

(based on 6 customer ratings)

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4CEUINC

Course provided by 4CEUINC.

Content Pages: 33

Quiz Questions: 9




At the end of this course you will be able to:


  1. List necessary steps to validate a new assay
  2. Describe the different types of method systematic error
  3. Apply total allowable error to assay validation studies
  4. Differentiate between Limit of Detection and Limit of Quantification
  5. Describe the different ways a reference range can be determined and validated

See more courses in: Lab Management

Continuing Education Credits

P.A.C.E.® Contact Hours (acceptable for AMT, ASCP, and state recertification) (CEU Unlimited): 1 hour(s)
Course number 511-026-17, approved through 6/30/2019
Florida Board of Clinical Laboratory Personnel Credit Hours - Supervision/Administration, Quality Control/Quality Assurance, and Safety: 1 hour(s)
Course number 20-601212, approved through 6/30/2019

Objectives

  • List necessary steps to validate a new assay.
  • Describe the different types of method systematic error.
  • Apply total allowable error to assay validation studies.
  • Differentiate between Limit of Detection and Limit of Quantification.
  • Describe the different ways a reference range can be determined and validated.

Customer Ratings

(based on 6 customer ratings)

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Course Outline

  • Download Copy of PDF
      • Download PDF FIles
  • Course Intro
      • Title Page
      • Course Details
      • Course Objectives
      • About the Author
      • What Are We Going To Cover
  • New Clinical Assays
      • Considerations Prior To Choosing A New Clinical Assay
      • Considerations Prior To Choosing A New Clinical Assay
  • CLIA
      • What Does CLIA Say?
  • Accuracy vs. Precision
      • Defining Accuracy vs. Precision
  • Evaluation of Error
      • Evaluation of Error
      • Types of Systematic Error
      • Constant and Proportional Systematic Error
      • Total Analytic Error (TE)
      • Linearity Study
      • Maximum Dilution/Concentration
      • Limit of Detection, Blank, and Quantification
      • Precision Studies
  • Correlation
      • Correlation
      • Specimen Selection
      • Once You Have Your Data
      • Creating A Scatter Plot For Analysis
      • Calculate The Correlation Coefficient
      • Notes On Evaluating Method Correlation
  • Reference Ranges
      • Notes On Reference Ranges
      • How Many Samples Are Needed For A Reference Range Study?
      • Transferring A Reference Range - Is It Possible?
      • Last Option For Determining Reference Ranges
  • Interference Studies
      • When To Perform
      • Interference Study Steps
  • Special Validation Considerations
      • Department Specific - Molecular and Immunology
      • Department Specific - Microbiology
      • Department Specific - Hematology
  • Conclusion
      • Summary
      • References
      • Contact Us
      • Thank You

Additional Information

This Basic Level course is intended for all lab personnel including Technicians and Technologists, but may be of particular interest to Lab Supervisors, Lab Directors, and Pathologists. Students may also benefit from this course.

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Course provided by 4CEUINC.
SU023 - Main


Precision Accuracy


Systematic Error


Assay Correlation



 
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