Strategies for Lot-to-Lot Evaluations of Autoantibody Serology Assays

Maintaining consistent assay performance over time is critical for clinical laboratories. While assay performance characteristics may be clearly understood at the time of validation, variations can occur within kit components and reagents between production lots. These variations can affect long term analytical and clinical performance.

 

For clinical laboratories, assessments of new lots (“lot-to-lot evaluations”) are a regulatory requirement. However, the manner in which these evaluations are performed is largely at the discretion of individual laboratories. Many factors must be considered when designing a lot-to-lot evaluation program, and approaches may differ depending on the analyte, specimen matrix, and platform. Regardless of the approach, lot-to-lot evaluations should identify variations in newly manufactured reagents or kits that could alter the clinical performance of the testing. Lot-to-lot evaluations for autoantibody serology testing pose unique challenges. Selection of appropriate evaluation parameters and acceptance criteria for semi-quantitative assays may not be straightforward, and acquiring an optimal set of samples for the evaluation may be beyond the scope of many laboratories.

 

In this webinar, Dr. Snyder will review regulatory requirements for lot-to-lot evaluations and discuss strategies labs might implement for their lot-to-lot program. Data from example lot-to-lot assessments will be presented and evaluated. The goal of this webinar is to enable laboratories to develop a lot-to-lot evaluation program for autoantibody serology testing that is most appropriate for their practice.

 

Learning Objectives