Brocious Jeffrey, Tarver Michelle E, Hampton Denise, Eydelman Malvina
Office of In Vitro Diagnostics and Radiological Health (J.B.), Center for Devices and Radiological Health, Food and Drug Administration, Silver Spring, MD; and Office of Device Evaluation (M.E.T., D.H., M.E.), Center for Devices and Radiological Health, Food and Drug Administration, Silver Spring, MD.
Eye Contact Lens. 2018 Nov;44(6):351-354. doi: 10.1097/ICL.0000000000000470.
With the increasing incidence of more pathogens that can cause microbial keratitis (MK), it is necessary to periodically reassess disinfection multipurpose solutions testing requirements to ensure that relevant organisms to challenge them are being used. Current testing protocols have included common pathogens such as Pseudomonas aeruginosa, Staphylococcus aureus, Serratia marcescens, Candida albicans, and Fusarium solani but have omitted less common pathogens such as Acanthamoeba. Specifically, Acanthamoeba sp. has recently been identified as a prevalent cause of MK in certain countries. Developing an appropriate protocol for this unique organism presents a challenge, given its two distinct life stages, methods to grow the organism, encystment techniques, and many other parameters that can affect testing outcomes. Therefore, the appropriate combination of these parameters is crucial to developing a protocol that ensures consistent, accurate results. The FDA has recognized the importance of establishing a standardized testing protocol for this pathogen and embarked on research efforts to provide a recommended testing protocol for testing contact lens care products.
随着可导致微生物性角膜炎（MK）的病原体种类日益增多，有必要定期重新评估消毒护理液的测试要求，以确保所使用的挑战微生物是相关的。当前的测试方案已涵盖常见病原体，如铜绿假单胞菌、金黄色葡萄球菌、粘质沙雷氏菌、白色念珠菌和茄病镰刀菌，但遗漏了不太常见的病原体，如棘阿米巴。具体而言，棘阿米巴最近在某些国家被确认为MK的一个常见病因。鉴于这种独特生物体具有两个不同的生命阶段、培养该生物体的方法、包囊化技术以及许多其他可能影响测试结果的参数，为其制定合适的方案面临挑战。因此，这些参数的恰当组合对于制定一个能确保结果一致、准确的方案至关重要。美国食品药品监督管理局（FDA）已认识到为这种病原体建立标准化测试方案的重要性，并着手开展研究工作，以提供用于测试隐形眼镜护理产品的推荐测试方案。
