Biocompatibility test procedures for materials evaluation in vitro. I. Comparative test system sensitivity.
Biocompatibility test procedures for materials evaluation in vitro. I. Comparative test system sensitivity.
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DOI：
10.1002/jbm.820170403
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发表时间：
1983-07
期刊：
影响因子：
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通讯作者：
H. J. Johnson;S. Northup;P. Seagraves;P. Garvin;R. F. Wallin
中科院分区：
文献类型：
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作者：
H. J. Johnson;S. Northup;P. Seagraves;P. Garvin;R. F. Wallin
对体外生物相容性测试系统的相对敏感性进行了考察。12个标准化细胞系对代表一系列毒性的20种材料的细胞反应进行了测量。使用四种不同的培养方法对每个细胞系和材料组合进行一式两份的测试，每个培养板由两名分级员进行检查。组织培养试验的结果与体内相同材料的组织培养试验结果进行了比较，这些结果是通过5天的兔肌肉植入试验获得的。在血清强化的培养液中测量细胞生长(菌落计数或融合百分率)的方法通常比直接将测试材料放置在细胞培养中的方法(生长抑制区的测量)更敏感和有区分性。评分员之间对所有测试方法都有很好的一致性。测试程序中没有使用抗生素。根据灵敏度、重复性、区分材料的能力和分级一致性，12个细胞系中的4个和4种测试方法中的2种似乎最适合于材料的筛选和评估。使用这四个细胞系的结果与30种材料的肌肉内植入试验的结果的一致性在60%到90%之间。
Relative sensitivity of in vitro biocompatibility test systems was explored. Cellular responses of 12 standardized cell lines to 20 materials representing a range of toxicity were measured. Each cell line and material combination was tested in duplicate using four different culture methods, and each culture plate was examined by two graders. Results of the tissue culture assays were compared to those obtained for the same materials in vivo using a 5-day rabbit intramuscular implant assay. Methods involving measurement of cellular growth (colony counts or percent of confluence) in serum-fortified media extracts of test samples were generally more sensitive and discriminating than those in which test materials were placed directly in cell cultures (measurement of zone of growth inhibition). There was good agreement between graders for all test methods. Antibiotics were not used in the test program. Based upon sensitivity, reproducibility, ability to discriminate materials, and grader agreement, 4 of the 12 cell lines and 2 of the 4 test methods appeared most suitable for screening and evaluation of materials. Agreement of results using these four cell lines with intramuscular implantation tests for the 30 materials ranged from 60 to 90%.