Manufacture of an Automatic Test System Based on Standard Antifungal Agent Sensitivity Testing Metho

基于标准抗真菌药物敏感性测试方法的自动测试系统的研制

基本信息

批准号：
07557322
负责人：
UCHIDA Katsuhisa
金额：
$ 0.58万
依托单位：
Teikyo University
依托单位国家：
日本
项目类别：
Grant-in-Aid for Scientific Research (A)
财政年份：
1995
资助国家：
日本
起止时间：
1995 至 1996
项目状态：
已结题

项目摘要

We have trial produced and evaluated a kit for performing antifungal agent sensitivity test using the satndard micro-broth dilution method. Firt, to ensure that the kit will be easily available for routine testing in medical facilities, we determined the condition for producing antifungal agent-incorporated 96-well microplate that can be stored frozen. Nex, we distributed the kits that contained the frozen plate, sterile RPMI 1640 medium for culture and sterile physiological saline for preparing fungal inoculum, to evaluating facilities or facilities cooperated in evaluation. Using these kits, antifungal agent sensitivity tests were conducted on fresh clinical isolates of yeast-like fungi. End-points were determined both visually and using a plate analyzer. Standard fungal stain was always tested in parallel during testing for quality control. A total of 150 yeast-like fungal strains belonging to 13 species were tested in various facilities in Japan. The showed a good correlation between the results obtained using the trial produced plates and those by conventional standard method. Furthmore, good correlation was also obtained between the results of the facilities and those of researchers repeating the tests, confirming good reproducibility. We concluded that this kit when used in routine clinical testing produced reliable results, showing that it is highly useful test system. Based on these results, we applied for permission to namufacture this kit as a diagnostic product, and obtained approval.

我们试制并评估了采用标准微量肉汤稀释法进行抗真菌药物敏感性试验的试剂盒。首先，为了确保该试剂盒能够方便地用于医疗机构的常规检测，我们确定了生产可冷冻保存的掺有抗真菌剂的96孔微孔板的条件。接下来，我们将含有冷冻板、用于培养的无菌RPMI 1640培养基和用于制备真菌接种物的无菌生理盐水的试剂盒分发给评估机构或评估合作机构。使用这些试剂盒，对酵母样真菌的新鲜临床分离株进行抗真菌剂敏感性测试。目视和使用平板分析仪确定终点。在质量控制测试过程中始终平行测试标准真菌染色剂。在日本的多个设施中对属于 13 个物种的总共 150 种酵母样真菌菌株进行了测试。结果表明，使用试制板获得的结果与传统标准方法获得的结果之间具有良好的相关性。此外，设备的结果与研究人员重复测试的结果之间也获得了良好的相关性，证实了良好的再现性。我们的结论是，该试剂盒在常规临床测试中使用时产生了可靠的结果，表明它是非常有用的测试系统。基于这些结果，我们申请了将该试剂盒命名为诊断产品的许可，并获得了批准。