【摘要】 目的评价发光二极管荧光显微镜(LED)在结核病临床检测中的效果。方法收集中国卫生部-盖茨基金会结核病防治合作项目新型诊断工具可行性子项目江苏省淮安市淮阴区项目点在验证阶段共3881张痰涂片,分别经萋-尼(Ziehl-Neelsen,Z-N)染色和荧光染色后,比较LED与传统光学显微镜(conventional microscopy,CM)、传统荧光显微镜(fluorescence microscopy,FM)在阳性检出率上的差异。运用回顾性研究分析Z-N染色及荧光染色与临床诊断结果之间的关系。结果 3881张涂片经省疾控中心结核病实验室复核后,Z-N阳性284张,阳性率为14.6%(284/1941),低假阳性4张,低假阴性9张;LED阳性498张,经FM复检后阳性464张,阳性率23.9%(464/1940),低假阳39张,低假阴性6张。经增强配对卡方检验(McNemar-Bowker test)分析表明,发光LED与CM、FM检测结果差异均具有统计学意义(P值均<0.001)。Kappa检验LED和FM一致性较高(Kappa=0.903),LED和Z-N一致性一般(Kappa=0.409)。对于78例新发涂阳患者,LED和Z-N的检测结果差异无统计学意义;在Z-N阴性的涂阴结核患者中LED检出了14例阳性,在涂阳随访患者中LED和Z-N检出的涂阳患者数分别为228例和195例。结论 LED与传统荧光显微镜一致性较高,较传统光学显微镜在临床结核患者的发现及随访疗效监测方面有明显优势。更多还原

【Abstract】 Objective To assess the efficacy of fluorescence microscopy with light-emitting diodes(LED) in clinical tuberculosis detection. Methods With 3881 sputum smears from TB lab in Huaiyin district,Huaian city,the positive rate of the smears by Ziehl-Neelsen(Z-N),conventional fluorescence microscopy(FM) and LED were compared respectively.Moreover,the relevance between the clinical diagnosis and Z-N or LED was analyzed through retrospective study. Results All 3881 smears were rechecked by provincial reference Lab(PRL).Of Z-N smears 284 were positive,with positive rate 14.6%(284/1941),4 were low-false-positive,and 9 low-false-negative;of fluorescent smears,LED detected 498 positive and there were 464 positive after rechecking by FM,39 were low-false-positive and 6 were low-false-negative.The positive rate of fluorescent smears was 23.9%(464/1940).With McNemar-Bowker test analysis,there were significant differences among the results of LED and the other two methods(P<0.001).The consistency of LED vs FM(Kappa=0.903) was much higher than LED vs Z-N(Kappa=0.409).For 78 new smear-positive patients,there was no difference between Z-N and LED.But LED detected 14 positive patients out of Z-N-negative.During follow-up patients,the positive of LED and Z-N was 228 and 195 respectively. Conclusion LED had a high consistency with FM and was obviously better than Z-N in detecting Mycobacterium tuberculosis and monitoring the follow-up.更多还原