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

Shin, In-Soo; Hong, Choong-Man; Koh, Hyun-Chul; Hong, Seung-Hwa

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

The journal of applied pharmacology : the official journal of the Korean Society of Applied Pharmacology, v.13 no.1, 2005년, pp.59 - 63

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)

Abstract ▼ AI-Helper

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.

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문제 정의

The national authorities of the European Union already regu lated the level of PKA present in plasma-derived products, and WHO has also issued a guideline on PKA and recommended that the test should be performed in some plasma-derived prod ucts. The purpose of this study is to compare to the kinetic assay with other methods and confirm the reliability using the collaborative study. Additionally, the levels of PKA in plasma- derived products have also been determined by the kinetic assay.

제안 방법

The reproducibility tests were carried out using an intra assay(day to day) and inter assays(for between individuals and between laboratories). All participants performed 5 independent assays on the 7 lots of albumin in order to evaluate the reproducibility of method.
In order to validate the method, we carried out the collabora tive study for checking the reproducibility between days, indi viduals and laboratories. One of reported results was rather higher than those of the others but this might be due to the tech nical errors.
992(Table II). The assays were performed more than 10 times at each laboratories as 5 independent assays in order to confirm reproducibility of the inter assay between laboratories. The average standard deviation was determined as ±1.
In order to measure the kinetic signal, the change of optical density at 405 nm was monitored after 10 seconds lag time for 5 minutes. The measurements were carried out using a programmed 6-channel UV/VJS array spectrophotometer(DU 7500, Beckman, USA).
The reproducibility tests were carried out using an intra assay(day to day) and inter assays(for between individuals and between laboratories). All participants performed 5 independent assays on the 7 lots of albumin in order to evaluate the reproducibility of method.
The studies were carried out using the intra assay(day to day) and inter assays(between individuals, between laboratories) on 7 lots of human albumin in order to evaluate the reproducibility. In the intra assay, participants performed 5 independent assays to calculate the variability between days.

대상 데이터

The PKA assays were carried out in albumin preparations in order to compare the end-point assay with kinetic assay. A total of 9 lots were tested. The reproducibility is characterized by the mean coefficient of variation(CV) of ±6.
203 human plasma-derived products were obtained from two local manufacturers. Samples from 171 lots of human albumin and 32 lots of human immunoglobulin preparations were tested.
Louis, MO, USA). The chromogenic substrate, S-2302 (H-D-Pro-Phe-Arg- pNA-2HCl, mw 611.6), was purchased(Chromogenix, Italy). 25 mg of *2302 was dissolved in 6.
The study was carried out on 171 lots of albumin prepara tions derived from domestic and abroad plasma. It was found that am_이mts of PKA showed the relatively high level in the early stage of this study although it was not out of the specifi cation, and the level of PKA was gradually decreased and sta bilized.

이론/모형

The level of PKA in plasma derived products for intravenous use was determined by the kinetic method. In the early stage of this study, PKA contents were detected as the relatively high concentrations in human albumin preparations.
6t/(2002). The commercial assay for PKA was performed using the Chromogenix method.

성능/효과

The study was carried out on 171 lots of albumin prepara tions derived from domestic and abroad plasma. It was found that am_이mts of PKA showed the relatively high level in the early stage of this study although it was not out of the specifi cation, and the level of PKA was gradually decreased and sta bilized. The trend of PKA level was observed as the mean value in albumin(Fig.

참고문헌 (16)

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원문보기 상세보기
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