Culture variability associated with the US Environmental Protection Agency Tuberculocidal Activity Test Method
Culture variability associated with the US Environmental Protection Agency Tuberculocidal Activity Test Method
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DOI：
10.1128/aem.62.8.2681-2686.1996
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发表时间：
1996-08-01
影响因子：
4.4
通讯作者：
Ascenzi, JM
中科院分区：
文献类型：
--
作者：
Robison, RA;Osguthorpe, RJ;Ascenzi, JM
结核病仍然是世界健康的主要威胁，其病原体是对化学消毒最有抵抗力的营养生物体之一。化学杀菌剂监管审批的结核菌功效测试在过去十年中取得了很大进展，目前使用的一种方法是环境保护局结核菌活性测试方法，这是一种使用在特定条件下生长并冷冻保存直至使用的牛分枝杆菌培养物的悬浮测试。具有相似配方的产品的不同结核标签声明引起了关于不同实验室制备的测试悬浮液的等效性的问题。将目前进行该测试的实验室的五种牛支原体悬浮液与单一测试地点的三种消毒剂进行比较，发现测试培养物之间存在显着差异，其中两种夏娃与其他三种以及彼此之间也表现出显着差异。存在显着的培养物与消毒剂相互作用，表明五种培养物在使用不同消毒剂时没有以一致的方式做出反应。然而，这些差异是由于培养物未按照标准程序制备或不符合测试悬浮标准造成的。此外，0.55% 次氯酸钠溶液被发现是培养物变异性的敏感指标。这些数据强调了在培养和制备杀结核菌试验悬浮液时遵守已公布的程序和指南的必要性，并揭示了与此类试验相关的变量。
Tuberculosis continues to be a major world health threat, The etiologic agent is among the vegetative organisms most resistant to chemical disinfection. Tuberculocidal efficacy testing for regulatory approval of chemical germicides has evolved considerably over the past decade, A method currently in use is the Environmental Protection Agency Tuberculocidal Activity Test Method, a suspension test using a Mycobacterium bovis culture grown under specific conditions and stored frozen until used. Differing tuberculocidal label claims on products with similar formulations have raised questions concerning the equivalence of test suspensions prepared by different laboratories. Five M. bovis suspensions from laboratories currently performing this test were compared against a battery of three disinfectants at a single test site, A significant difference between test cultures was found, with two of the Eve exhibiting a significant difference from the other three and also from each other, There was a significant culture-by-disinfectant interaction, indicating that the five cultures did not respond in a consistent manner across the different disinfectants used. However, these differences were due to cultures that were not prepared in accordance with the standard procedure or otherwise did not meet the test suspension criteria. In addition, a 0.55% sodium hypochlorite solution was found to be a sensitive indicator of culture variability. These data reinforce the need to adhere to published procedures and guidelines when growing and preparing a tuberculocidal test suspension and shed light on the variables associated with this type of testing.