Arlea Crystal, King Sharon, Bennie Barbara, Kemp Kere, Mertz Erin, Staub Richard
Lonza Inc., 25 Commerce Dr, Allendale, NJ 07401, USA.
J AOAC Int. 2008 Jan-Feb;91(1):152-8.
The AOAC use-dilution test (UDT) for bactericidal disinfectant efficacy (Method 964.02) has often been criticized for its extreme variability in test results, particularly for quaternary ammonium compound (QAC)-based disinfectants against Pseudomonas aeruginosa. While efforts are under way to develop a new and better test method for hospital disinfectant products that is globally acceptable, U.S. manufacturers and formulators of QAC products must continue in the interim to measure their product performance against the current UDT method. Therefore, continued variability in the UDT places an unnecessary and unfair burden on U.S. QAC product manufacturers to ensure that their products perform against an, at best, unreliable test method. This article reports on evaluations that were conducted to attempt to identify key sources of UDT method variability and to find ways to mitigate their impact on test outcomes for the method. The results of testing across 4 laboratories, involving over 6015 carriers, determined that operator error was a key factor in test variability. This variability was found to be significantly minimized by the inclusion of a simple culture dilution step. The findings from this study suggest possible refinements to the current AOAC UDT method that would serve to improve the overall ruggedness and reliability of the method and to optimize recovery of cells from the carrier surface, thereby further improving the accuracy and reproducibility of counts and test outcomes until such time as a replacement method is implemented.
美国公职分析化学家协会(AOAC)用于检测杀菌消毒剂效力的使用稀释试验(UDT,方法964.02)常因测试结果的极大变异性而受到批评,尤其是对于基于季铵化合物(QAC)的消毒剂针对铜绿假单胞菌的测试。虽然目前正在努力开发一种全球通用的、更好的医院消毒产品测试方法,但在此期间,美国QAC产品的制造商和配方师必须继续根据现行的UDT方法来衡量其产品性能。因此,UDT持续存在的变异性给美国QAC产品制造商带来了不必要且不公平的负担,他们需要确保其产品能通过一种充其量不可靠的测试方法。本文报告了为试图确定UDT方法变异性的关键来源并找到减轻其对测试结果影响的方法而进行的评估。在4个实验室进行的涉及6015多个载体的测试结果表明,操作误差是测试变异性的一个关键因素。通过加入一个简单的培养物稀释步骤,发现这种变异性可显著降低。这项研究的结果表明,可能对现行的AOAC UDT方法进行改进,这将有助于提高该方法的整体耐用性和可靠性,并优化从载体表面回收细胞的过程,从而在实施替代方法之前进一步提高计数和测试结果的准确性及可重复性。