NOV 16, 2022 8:00 AM PST

Verification of Autoantibody Serology Tests: Practical Considerations for the Clinical Laboratory

Sponsored by: Bio-Rad Laboratories
C.E. Credits: P.A.C.E. CE Florida CE

Event Date & Time
Date:  November 16, 2022
Time: 8:00am (PST),  11:00am (EST), 5:00pm (CET)
Autoantibody assays may have significant differences due to the heterogeneity of autoantibodies, including epitope specificity, isotype, and affinity/avidity. This makes it challenging for clinical laboratories when changing methods for autoantibody serology testing or when bringing such testing in-house.
To perform routine autoantibody testing, clinical laboratories must develop robust procedures for quality control, lot-to-lot evaluation, and proficiency assessment. However, these procedures may need to be modified or adapted to the unique differences of each autoantibody assay.
To implement any new test, certain regulatory requirements must be met and documented as part of the verification process. The verification of autoantibody serology tests requires a careful consideration of the analytical and clinical performance differences of the test methods. Existing test verification guidelines and best practices are primarily designed for quantitative chemistry tests, and do not account for the unique characteristics of autoantibody serology tests.
This webinar will examine how laboratories can fulfill regulatory requirements for verification of an autoantibody serology test, while acknowledging the unique challenges presented by these methods and heterogeneous analytes.
This webinar is on the topic of autoimmune, autoimmunity, and autoimmune testing.
Learning Objectives
  • Recognize inherent heterogeneity of autoantibodies and its impact on clinical testing
  • Describe regulatory parameters required for verification of FDA-cleared and laboratory-developed tests, respectively
  • Identify approaches for verification of precision, accuracy, reference range and reportable range for autoantibody assays
  • Discuss the drawbacks of using method comparison to assess accuracy of an autoantibody serology test
Webinars will be available for unlimited on-demand viewing after live event.
LabRoots is approved as a provider of continuing education programs in the clinical laboratory sciences by the ASCLS P.A.C.E. ® Program. By attending this webinar, you can earn 1 Continuing Education credit once you have viewed the webinar in its entirety.

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