北京生物医学工程

RTCA法用于医疗器械细胞毒性检测的研究

A study of RTCA method in the cytotoxicity tests of medical devices

作者：黄婷陈捷郭欢张寒旭王晓亮李炎黄明荣祖元

单位：四川省食品药品检验检测院(四川省医疗器械检测中心)（成都 611731）

关键词： real time cell analysis; MTT; 医疗器械; 细胞毒性

分类号：R318

出版年·卷·期（页码）：2020·39·6（594-600）

摘要：

目的通过实时无标记细胞分析法（real time cell analysis, RTCA）与MTT法的比较研究，探讨RTCA法用于医疗器械细胞毒性常规检测的可行性。方法首先，通过筛选细胞接种密度建立基于L929细胞的RTCA细胞毒性检测方法。然后，使用不同浓度的DMSO稀释液、标准对照材料浸提液、56批真实世界的医疗器械产品，从简单到复杂分别比较RTCA法与MTT法用于细胞毒性检测结果的一致性，并且汇总多次试验的阴性对照和阳性对照结果比较两种方法的可重复性。结果 RTCA法检测不同浓度的DMSO稀释液没有剂量效应关系，检测标准对照材料浸提液与MTT法结果完全一致并高度相关（R=0.989 8），检测56批医疗器械产品与MTT法结果一致率为80.4%仅中度相关（R=0.618 3）。RTCA法的可重复性不比MTT法好。结论 RTCA法能有效检测医疗器械细胞毒性，但是部分产品可能因溶出物干扰检测结果而不适用。RTCA作为一种新型的医疗器械细胞毒性检测方法的适用性还需要进一步研究。

Objective A comparative study of Real Time Cell Analysis（RTCA）method with MTT method was conducted to demonstrate the feasibility of RTCA method on cytotoxicity tests of medical devices. Methods First，RTCA cytotoxicity test method based on L929 cell was established by screening cell seeding density. Then, different concentrations of DMSO diluents, extracts of standard reference materials, 56 batches of medical device products in the real world were used, from simple to complex, to compare for the consistency of RTCA and MTT methods in cytotoxicity test. The results of negative and positive controls from multiple experiments were collected to compare the repeatability of the two methods. Results The results of RTCA method showed no dose-effect relationship in the test of DMSO diluents. In the test of standard control material extracts, the results of RTCA method were completely consistent with MTT method and highly correlated (R=0.9898). In the test of 56 batches of medical device products, the consistency rate was 80.4% and only moderately correlated (R=0.6183). The repeatability of RTCA method is no better than that of MTT method. Conclusions RTCA method can effectively detect the cytotoxicity of medical devices, but some products are not applicable because their dissolves may interfere with the detection results. The applicability of RTCA as a new method to detect the cytotoxicity of medical devices needs further study.

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