Robison R A, Bodily H L, Robinson D F, Christensen R P
Microbiology Section, Clinical Research Associates, Provo, Utah 84604.
Appl Environ Microbiol. 1988 Jan;54(1):158-64. doi: 10.1128/aem.54.1.158-164.1988.
In-use testing of disinfectants is necessary to ensure efficacy over time. The current official procedure for testing disinfectants, the Association of Official Analytical Chemists (AOAC) use-dilution method, cannot be adapted to repeated sampling techniques of use-life testing. It is therefore necessary to use an alternative method when evaluating the activity of a disinfectant under actual use. The Clinical Research Associates (CRA) suspension method was developed to fill this need. It consists of adding 0.5 ml of a standard culture to 5.0 ml of test disinfectant and sampling the mixture after 10 min for surviving bacteria. When this test was compared with the AOAC use-dilution method under a simulated use situation, the two methods were generally equivalent in identifying disinfectant inactivation. In addition, the CRA method was less time consuming, easier to perform, and less variable than the AOAC method. Use of the CRA method in a clinical study demonstrated the need for reuse claims to be based on clinical use studies rather than on laboratory testing only.
对消毒剂进行使用中测试对于确保其长期有效性至关重要。当前官方用于测试消毒剂的程序，即美国官方分析化学家协会（AOAC）使用稀释法，无法适用于使用寿命测试的重复采样技术。因此，在评估消毒剂在实际使用中的活性时，有必要使用替代方法。临床研究协会（CRA）悬浮法就是为满足这一需求而开发的。该方法是将0.5毫升标准培养物加入5.0毫升测试消毒剂中，10分钟后对混合物进行采样以检测存活细菌。当在模拟使用情况下将该测试与AOAC使用稀释法进行比较时，两种方法在识别消毒剂灭活方面通常是等效的。此外，CRA方法比AOAC方法耗时更少、操作更简便且变异性更小。在一项临床研究中使用CRA方法表明，重复使用声明需要基于临床使用研究，而不能仅基于实验室测试。
