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首页> 外文期刊>Journal of tissue engineering and regenerative medicine >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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Feasibility and limitations of the round robin test for assessment of in vitro chondrogenesis evaluation protocol in a tissue-engineered medical product

机译：轮循试验在组织工程医疗产品中评估体外软骨形成评估方案的可行性和局限性

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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.
机译：植入前应评估组织工程医疗产品（TEMP）。因此，建立再生医学评估方案必不可少。此类评估协议是否合理，通常通过“轮循”测试进行验证。但是，由于无法为TEMP准备“完全相同”的标本，因此TEMP的循环测试本质上存在缺陷。该研究的目的是通过使用准备好的评估方案评估TEMP的循环法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交付的标本，并采用测量sGAG含量的方案作为对ISO TC150 / SC7提出的评估方案，这是一种侵入性方法，但通常会被应用，尽管在评估TEMP方面迫切需要非侵入性方法。结果表明：（a）在实验室内测试中测得的sGAG含量的变异系数（CV）最高为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一半构建体的方案中的sGAG含量相当; （c）由非标本因素引起的CV约为15％，与生物医学领域的可重复实验中的CV相当。根据这些结果，研究得出结论，在所交付的TEMP具有足够的可重复性，以使组织实验室中测量值的CV小于5％的情况下，TEMP的循环测试可能很有价值。

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