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Validation of Kinetic Method for the PKA Assay in Plasma-Derived Products

Shin, In-Soo    (Center for Biologics Evaluation, Korea Food & Drug Administration, College of Medicine, Graduate School, Hanyang University   ); Hong, Choong-Man    (Center for Biologics Evaluation, Korea Food & Drug Administration   ); Koh, Hyun-Chul    (College of Medicine, Graduate School, Hanyang University   ); Hong, Seung-Hwa    (Center for Biologics Evaluation, Korea Food & Drug Administration  );
  • 초록

    A kinetic assay was carried out in order to compare the ability of detection for prekallikrein activator(PKA) in plasma-derived products with that of an endpoint assay and a commercial method. Using these methods, 9 human albumin preparations were assayed and compared to each other. The coefficient of variation between the Kinetic assay and the end point assay was found within 6.6% and this result showed that two methods were highly correlative and the end point assay could act as a replacement of the kinetic assay. Another important goal of this study was to investigate the reproducibility among laboratories on the kinetic assay. A collaborative study was performed to validate the kinetic method with intra and inter assays. The coefficient of variation for the intra assay of each laboratory was less than 4% and that for between individuals in the inter assay was 4.1%. These results revealed that the kinetic assay showed good reproducibility. The contents of PKA in plasma-derived products were also determined by the kinetic assay. As a result, it was found that trace amounts of PKA were present in 32 human immunoglobulin preparations, however the average concentration of PKA in 171 albumin preparations was 5.8 IU/mL.


  • 주제어

    PKA .   Plasma derived products .   Collaborative study .   Validation.  

  • 참고문헌 (16)

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