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目的了解RTCA法是否适用于医疗器械体外细胞毒性的评价。方法采用L929细胞,对RTCA法的线性范围、精密度和重复性进行考察,并与MTT比色法进行结果比较。结果接种14个浓度的细胞后,2 h时细胞数量和细胞指数的相关性最好。线性范围为98~2.5×10~4个/ml;高、中、低3个质控浓度的相对标准偏差(RSD)均<15%,日内、日间变异均<15%,符合样品分析要求;连续接种中浓度的细胞悬液测定的RSD值<15%,重复性良好;同时采用常规细胞毒性检测法MTT比色法,对8种医疗器械产品进行检测,两种方法结果的相关较高(R=0.994)。结论 RTCA法方便快捷、结果准确可靠,适用于医疗器械体外细胞毒性评价。
Objective To understand whether RTCA method is suitable for evaluating the cytotoxicity of medical devices in vitro. Methods L929 cells were used to investigate the linear range, precision and reproducibility of RTCA method. The results were compared with MTT colorimetric method. Results After inoculation of 14 concentrations of cells, the correlation between cell number and cell index was best at 2 h. The linear range was 98 ~ 2.5 × 10 ~ 4 / ml. The relative standard deviations (RSDs) of high, middle and low control concentrations were all less than 15%, the intra- and inter-day variation was less than 15%, which met the requirements of sample analysis ; The RSD value of continuous inoculation medium concentration cell suspension measured <15%, good repeatability; meanwhile using conventional cytotoxicity assay MTT colorimetric method to test 8 kinds of medical device products, the correlation between the two methods is higher (R = 0.994). Conclusion The RTCA method is convenient and fast, the results are accurate and reliable, and it is suitable for the evaluation of cytotoxicity of medical devices in vitro.