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

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