Johnson H J, Northup S J, Seagraves P A, Garvin P J, Wallin R F
J Biomed Mater Res. 1983 Jul;17(4):571-86. doi: 10.1002/jbm.820170403.
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%.
对体外生物相容性测试系统的相对敏感性进行了探索。测量了12种标准化细胞系对代表一系列毒性的20种材料的细胞反应。每种细胞系和材料组合使用四种不同的培养方法进行重复测试，每个培养板由两名评分员进行检查。将组织培养试验的结果与使用5天兔肌肉植入试验在体内对相同材料获得的结果进行比较。涉及测量测试样品血清强化培养基提取物中细胞生长（集落计数或汇合百分比）的方法通常比将测试材料直接置于细胞培养物中的方法（测量生长抑制区）更敏感且更具区分性。所有测试方法的评分员之间都有良好的一致性。测试程序中未使用抗生素。基于敏感性、可重复性、区分材料的能力和评分员的一致性，12种细胞系中的4种和4种测试方法中的两种似乎最适合材料的筛选和评估。使用这四种细胞系对30种材料进行的结果与肌肉植入试验的一致性在60%至90%之间。
