目的 利用全自动尿有形成分分析仪UF-5000细菌及白细胞的检测结果,与实验室常规方法检测的结果进行比较分析,探讨其在尿道感染疾病辅助检测中的应用价值.方法 收集2017年10至12月广东省人民医院检验科门诊与住院,怀疑尿道感染的患者清洁中段尿共1 021份,采用UF-5000检测所有患者标本,以评价其相关检测结果的重复性、线性、携带污染率、稳定性以及复检报警效率等;以尿细菌培养和临床诊断作为参考标准,计算其细菌检测结果与纯化细菌符合率、与细菌培养符合率、与培养菌落数一致率;以尿真菌培养和临床诊断作为参考标准,计算其真菌检测的符合率、灵敏度、特异度.以细菌培养结果及临床诊断为标准,分析UF-5000检测白细胞、细菌用于诊断UTI的效能;UF-5000检测的相关结果、尿干化学分析仪UC-3500检测的相关结果,细菌涂片镜检结果分别与尿细菌培养结果做比较,以判定3种方法各自检测细菌的灵敏度、特异度及与培养方法之间的一致率.统计学分析采用方差分析、Wilcoxon秩和检验、一致率检验(Kappa检验)及受试者工作特征曲线(ROC曲线)等.结果 UF-5000检测尿液标本中的细菌总数和白细胞数、UC-3500检测尿液标本中的中性粒细胞酯酶和亚硝酸盐,其重复性均符合EP5-A要求;细菌总数在0～10 000个/μl范围内时均呈线性,R均为0.999;UF-5000检测细菌和白细胞的携带污染率分别为0.00％和0.01％;细菌结果在常温2h稳定和4℃6h稳定,白细胞结果在常温4h稳定和4℃4h稳定;对照全自动尿有形成分分析仪UF-1000i,UF-5000的复检报警率降低77.8％;UF-5000细菌检测与纯化细菌符合率为100.0％(16/16),与革兰阴性菌(G-)符合率为94.0％(110/117),与革兰阳性菌(G+)符合率为82.2％(37/45),与培养菌落数比较,一致率为95.1％(216/227);与真菌培养符合率为77.1％ (749/972),真菌检测敏感度达到81.9％(118/144),特异度为76.2％(631/828).UF-5000、UC-3500、细菌涂片镜检3种方法提示尿道细菌感染的能力与传统细菌培养结果比较,UF-5000尿道感染报警(UTI)一致率最高,达到84.1％(180/214),敏感度为70.3％(52/74),特异度为91.4％(128/140);UC-3500的一致率为73.8％(158/214),敏感度为25.7％(19/74),特异度为99.3％(139/140);细菌涂片镜检一致率为66.4％(142/214),敏感度为82.4％(61/74),特异度为57.9％(81/140).结论 UF-5000的细菌总数及白细胞数检测、细菌革兰阴、阳性的报警提示及UTI的报警提示,在尿道感染疾病快速辅助检测上有一定的临床应用价值.%Objective To explore the value of UF-5000 urinary sediment analyzer in assistant examination of urinary tract infections by comparing the results of bacteria and white blood cells for UF-5000 with those of routine laboratory methods.Methods A total of 1 021 clean mid-stage urine samples suspected urinary tract infection were collected from the inpatients and outpatients of the Guangdong Provincial People's Hospital from October to December 2017.All specimens were detected by UF-5000 to evaluate the repeatability,linearity,carrying contamination rate,stability and efficiency of review flag by the instrument.Urine bacterial culture and clinical diagnosis were used as reference standards to calculate the coincidence rate of bacterial test results with purified bacteria,coincidence rate with bacterial culture,and agreement rate with cultured colonies.The urinary fungal culture and clinical diagnosis were used as reference standards to calculate the coincidence rate,sensitivity and specificity of the fungal test.Based on the results of bacterial culture and clinical diagnosis,UF-5000 was used to detect the efficacy of white blood cells and bacteria for the diagnosis of UTI.The results of UF-5000 detection,the results of urinary dry chemistry analyzer UC-3500,and the results of bacterial smear microscopy were compared with the results of urinary bacterial culture to determine the sensitivity,specificity and sensitivity of each method,and the coincidence rate of with the culture method.Statistical analysis was performed using variance analysis,Wilcoxon rank sum test,coincidence rate test (Kappa test),and receiver operating characteristic curve (ROC curve).Results UF-5000 was used to detect bacteria and white blood cells,UC-3500 was used to detect neutrophil esterase and nitrite with good repeatability,which met the EP5-A requirements;the linear relationship between bacteria was very good in the range of 0-10 000/ml,R=0.999;the contamination rate of UF-5000 was 0.00％ for bacteria,0.01％ for white blood cells.The rate of UC-3500 was qualified;the bacteria was stable for 2 hours at room temperature and 6 hours at 4 ℃,and the white blood cells were stable for 4 hours at room temperature and 4 hours at 4 ℃.Compared with UF-1000i,the review flag rate of UF-5000 reduced about 77.8％.The coincidence rate of detection and purification of UF-5000 bacteria was 100.0％(16/16),that of Gram-negative bacteria (G-) was 94.0％ (110/117),that of Gram-positive bacteria (G+) was 82.2％(37/45).The agreement rate of compared with bacterial colonies was 95.1％(216/227),and that of fungi culture was 77.1％ (749/972),that of sensitivity was 81.9％(118/144),and that of specificity was 76.2％(631/828).UF-5000,UC-3500,and bacterial smear microscopy showed that the ability of bacterial infection of urinary tract was compared with the results of traditional bacterial culture.The UF-5000 urinary tract infection flag (UTI) had the highest agreement rate,reaching 84.1％ (180/214).The sensitivity was 70.3％ (52/74),the specificity was 91.4％ (128/140);the coincidence rate of UC-3500 was 73.8％ (158/214),the sensitivity was 25.7％ (19/74),and the specificity was 99.3％ (139/140);the consistency of bacterial smear microscopy was 66.4％ (142/214),the sensitivity was 82.4％ (61/74),and the specificity was 57.9％ (81/140).Conclusion The total number of bacteria and white blood cell counted by UF-5000,the flag of bacterial and the UTI information,have partial clinical significance in the rapid detection of urinary tract infection.
展开▼
