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Anti-drug antibody (ADA) assay

Aim:

The aim of measurements of ADA is to predict the potential of the test item to induce ADA with all consequences for toxicological effects, test item kinetics and efficacy.

Species:

Part of a toxicity study or clinical trial.

Design:

Anti-drug antibody assay is usually an ELISA-based screening assay which is validated for the given antibody product. The target analyte is generally polyclonal, consisting of antibodies of various isotype classes, specificities and affinities. As a result of the nature of the assay and the lack of an accurate reference standard (parallelism between sample and calibrator is not given for antibodies) a threshold value will be used to identify positive samples from non-specific background noise. Therefore, for each assay an assay cut point is set with the application of a risk-based approach. This is done by a parametric approach using the mean absorbance of blank samples plus 1.645 x standard deviation, where 1.645 is the 95th percentile of the normal distribution.

In a first step the method is established and subsequently, method validation is performed. The following parameters are tested during method validation:

  • Analysis of the analytical ranges
  • Set-up of three-level quality controls (LQC, MQC, HQC)
  • Determination of assay specific cut points
  • Intra-plate precisions
  • Inter-plate precisions
  • Evaluation of Assay Drift

Sample measurement and outcome:

  • Selection of positive samples
  • Confirmatory test with positive samples
  • Titer investigation in case of confirmed positive samples
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