Assay concept for detecting anti-drug IgM in human serum samples by using a novel recombinant human IgM positive control

使用新型重组人 IgM 阳性对照检测人血清样本中的抗药 IgM 的检测概念

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作者:Christian Künzel, Afsaneh Abdolzade-Bavil, Alfred M Engel, Mirko Pleitner, Eginhard Schick, Kay Stubenrauch

Aim

Development and qualification of an easy-to-use ELISA for detection of IgM anti-drug antibodies (ADA) and its use in a clinical Phase I trial.

Conclusion

The easy-to-use ELISA allowed IgM-ADA detection in clinical samples. Conjugated and recombinant IgM PCs were comparable regarding assay sensitivity, precision and suitability.

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