Tuberculosis Research Laboratory, Foundation for Innovative New Diagnostics, Kampala, Uganda.
PLoS One. 2010 Dec 28;5(12):e15206. doi: 10.1371/journal.pone.0015206.
Direct smear microscopy using Ziehl-Neelsen (ZN) staining is the mainstay of tuberculosis (TB) diagnosis in most high burden countries, but is limited by low sensitivity in routine practice, particularly in high human immunodeficiency virus (HIV) prevalence settings.
We compared the performance of three commercial light emitting diode (LED)-based microscopy systems (Primostar™ iLED, Lumin™ and AFTER®) for fluorescent detection of Mycobacterium tuberculosis with ZN microscopy on slides prepared from sputum of TB suspects. Examination time for LED-based fluorescent microscopy (LED FM) and ZN slides was also compared, and a qualitative user appraisal of the LED FM systems was carried out.
LED FM was between 5.6 and 9.4% more sensitive than ZN microscopy, although the difference was not statistically significant. There was no significant difference in the sensitivity or specificity of the three LED FM systems, although the specificity of Fraen AFTER was somewhat lower than the other LED FM methods. Examination time for LED FM was 2 and 4 times less than for ZN microscopy. LED FM was highly acceptable to Ugandan technologists, although differences in operational performance of the three systems were reported.
LED FM compares favourably with ZN microscopy, with equivalent specificity and a modest increase in sensitivity. Screening of slides was substantially quicker using LED FM than ZN, and LED FM was rated highly by laboratory technologists. Available commercial systems have different operational characteristics which should be considered prior to programmatic implementation.
在大多数高负担国家,使用齐-尼氏(Ziehl-Neelsen,ZN)染色的直接涂片显微镜检查是结核病(tuberculosis,TB)诊断的主要方法,但由于在常规实践中灵敏度较低,特别是在高人类免疫缺陷病毒(human immunodeficiency virus,HIV)流行环境中,其受到了限制。
我们比较了三种基于商用发光二极管(light emitting diode,LED)的显微镜系统(Primostar™ iLED、Lumin™和 AFTER®)对来自疑似结核病患者的痰液标本进行 ZN 染色的荧光检测性能,与 ZN 显微镜相比。还比较了基于 LED 的荧光显微镜(LED FM)和 ZN 载玻片的检查时间,并对 LED FM 系统进行了定性用户评估。
LED FM 比 ZN 显微镜的灵敏度高 5.6%至 9.4%,尽管差异无统计学意义。三种 LED FM 系统的灵敏度或特异性没有显著差异,尽管 Fraen AFTER 的特异性略低于其他 LED FM 方法。LED FM 的检查时间比 ZN 显微镜少 2 到 4 倍。尽管报告了三种系统的操作性能存在差异,但 LED FM 仍受到乌干达技术人员的高度认可。
LED FM 与 ZN 显微镜相比具有优势,特异性相当,灵敏度略有提高。与 ZN 相比,使用 LED FM 对载玻片进行筛查的速度要快得多,并且 LED FM 受到了实验室技术人员的高度评价。现有的商业系统具有不同的操作特性,在进行方案实施之前应考虑这些特性。