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

我们试制并评价了一种采用微量肉汤稀释法进行抗真菌药物敏感试验的试剂盒。首先，为了确保该试剂盒易于用于医疗机构的常规检测，我们确定了生产可冷冻储存的抗真菌剂掺入的96孔微孔板的条件。接下来，我们将包含冷冻平板、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价机构或配合评价的机构。使用这些试剂盒，抗真菌药物敏感性试验进行了新鲜的临床分离的酵母样真菌。通过目视和平板分析仪确定终点。在质量控制检测期间，始终平行检测标准真菌染色剂。在日本的各种设施中测试了属于13个种的总共150个酵母样真菌菌株。结果表明，用试制板测得的结果与用常规标准方法测得的结果有很好的相关性。此外，设备的结果与重复测试的研究人员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，该试剂盒用于常规临床检测时，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，我们申请将该试剂盒作为诊断产品生产，并获得批准。

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.