Feasibility and limitations of the round robin test for assessment of in vitro chondrogenesis evaluation protocol in a tissue-engineered medical product
Feasibility and limitations of the round robin test for assessment of in vitro chondrogenesis evaluation protocol in a tissue-engineered medical product
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组织工程医疗产品体外软骨形成评估方案循环试验的可行性和局限性
DOI：
10.1002/term.460
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发表时间：
2011
影响因子：
3.3
通讯作者：
et al.
中科院分区：
文献类型：
--
作者：
Masako Yokoi;et al.
组织工程医疗产品（TEMPs）应在植入前进行评估。因此，在再生医学中建立评价方案是必不可少的。这种评估协议是否合理，通常通过“循环”测试来验证。然而，TEMPs的循环测试本质上包括一个缺陷，因为“相同”的标本不能为TEMPs准备。该研究的目的是通过使用准备好的评估方案来评估TEMPs循环测试的可行性和局限性。我们采用组织工程软骨构建体作为递送样本，并采用测量sGAG含量的方案作为ISO TC 150/SC 7提出的评价方案，这是一种侵入性但通常应用的方法，尽管在评价TEMPs时迫切需要非侵入性方法。结果表明：（a）实验室内测试中测量的sGAG含量的变异系数（CV）最多为~5%;（B）每个参与实验室测量不同构建体的方案中sGAG含量的CV与每个参与实验室与组织实验室一起测量构建体的一半沿着的方案中sGAG含量的CV相当;（c）由样本以外的因素引起的CV约为15%，与生物医学领域的可重复实验相当。基于这些结果，该研究得出结论，在交付的TEMP具有足够的重现性，使得组织实验室中测量值的CV < 5%的条件下，TEMP的循环测试可能是有价值的。版权所有© 2011约翰威利父子有限公司.
Tissue‐engineered medical products (TEMPs) should be evaluated before implantation. Therefore, it is indispensable to establish evaluation protocols in regenerative medicine. Whether or not such evaluation protocols are reasonable is generally verified through a 'round robin' test. However, the round robin test for TEMPs intrinsically includes a deficiency, because 'identical' specimens can not be prepared for TEMPs. The aim of the study was to assess the feasibility and limitations of the round robin test for TEMPs by using a prepared evaluation protocol. We adopted tissue‐engineered cartilage constructs as delivered specimens and a protocol of measuring sGAG content as an evaluation protocol proposed to ISO TC150/SC7, which is an invasive, but usually applied, method, although non‐invasive methods are keenly required in evaluating TEMPs. The results showed that: (a) the coefficient of variation (CV) of the measured sGAG contents in intralaboratory tests was ~5% at most; (b) the CV of sGAG content in the scheme where each participating laboratory measured different constructs was comparable with that in the scheme where each participating laboratory measured one half of a construct along with the organizing laboratory; (c) the CV caused by factors other than the specimen was ~15%, comparable to that in reproducible experiments in biomedical fields. Based on these results, the study concludes that a round robin test for a TEMP could be valuable, under the condition that the delivered TEMPs are sufficiently reproducible so that the CV of the measured values is < 5% in the organizing laboratory. Copyright © 2011 John Wiley & Sons, Ltd.