北京生物醫(yī)學(xué)工程

RTCA法用于醫(yī)療器械細(xì)胞毒性檢測(cè)的研究

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

作者：黃婷陳捷郭歡張寒旭王曉亮李炎黃明榮祖元

單位：四川省食品藥品檢驗(yàn)檢測(cè)院(四川省醫(yī)療器械檢測(cè)中心)（成都 611731）

關(guān)鍵詞： real time cell analysis; MTT; 醫(yī)療器械; 細(xì)胞毒性

分類號(hào)：R318

出版年·卷·期（頁(yè)碼）：2020·39·6（594-600）

摘要：

目的通過實(shí)時(shí)無(wú)標(biāo)記細(xì)胞分析法（real time cell analysis, RTCA）與MTT法的比較研究，探討RTCA法用于醫(yī)療器械細(xì)胞毒性常規(guī)檢測(cè)的可行性。方法首先，通過篩選細(xì)胞接種密度建立基于L929細(xì)胞的RTCA細(xì)胞毒性檢測(cè)方法。然后，使用不同濃度的DMSO稀釋液、標(biāo)準(zhǔn)對(duì)照材料浸提液、56批真實(shí)世界的醫(yī)療器械產(chǎn)品，從簡(jiǎn)單到復(fù)雜分別比較RTCA法與MTT法用于細(xì)胞毒性檢測(cè)結(jié)果的一致性，并且匯總多次試驗(yàn)的陰性對(duì)照和陽(yáng)性對(duì)照結(jié)果比較兩種方法的可重復(fù)性。結(jié)果 RTCA法檢測(cè)不同濃度的DMSO稀釋液沒有劑量效應(yīng)關(guān)系，檢測(cè)標(biāo)準(zhǔn)對(duì)照材料浸提液與MTT法結(jié)果完全一致并高度相關(guān)（R=0.989 8），檢測(cè)56批醫(yī)療器械產(chǎn)品與MTT法結(jié)果一致率為80.4%僅中度相關(guān)（R=0.618 3）。RTCA法的可重復(fù)性不比MTT法好。結(jié)論 RTCA法能有效檢測(cè)醫(yī)療器械細(xì)胞毒性，但是部分產(chǎn)品可能因溶出物干擾檢測(cè)結(jié)果而不適用。RTCA作為一種新型的醫(yī)療器械細(xì)胞毒性檢測(cè)方法的適用性還需要進(jìn)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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