摘要
目的评价沃文特FA160粪便分析仪的检测性能,制备潜血阳性质控品并评价。方法利用自制标本和临床粪便标本,以人工法(人工显微镜检测法和宝创潜血双联试纸条)为金标准,对FA160的空白试验、重复性试验、携带污染试验、准确性试验、潜血检测性能验证试验及临床标本检测性能试验进行全面评价。制备阳性临界值浓度的血红蛋白液作为潜血阳性质控品,并评估其在不同储存条件下的稳定性。结果仪器自动潜血检测与广州宝创潜血双联试纸条检测潜血结果一致性极好(kappa=0.935)。以人工镜检法为金标准,FA160全自动粪便分析仪检测红细胞、白细胞、虫卵和真菌孢子的敏感度分别为91.89%、94.53%、85.71%和90.41%;特异度分别为95.71%、96.04%、99.78%和97.80%;准确率分别为95.52%、95.96%、99.74%和97.57%,两方法一致性比较的kappa值分别为0.642、0.702、0.665、0.690。浓度为1μg/mL的血红蛋白液可作为粪便潜血阳性质控品,4℃无防腐剂可作为自制潜血阳性质控品的保存条件。结论 FA160粪便分析仪基本检测性能良好,各检测指标与人工法一致性好,适合临床应用。自制潜血阳性质控品简单实用,在4℃无防腐剂下保存稳定。
Objective To evaluate the test performance of FA160 feces analyzer and to prepare the positive quality control materials for occult blood(OB) test and then evaluate it. Methods The results of manual methods(including manual microscopy and double test strip of Baochuang) were regarded as gold standard. Laboratory prepared samples and specimens of patients were both tested by manual method and FA160 feces analyzer. The test performance analysis, including blank test, repeatability test, carrying pollution test, accuracy test, OB test and clinical specimen test, were be evaluated. At the same time, solution with positive critical concentration of hemoglobin was prepared and regarded as quality control materials for positive OB test, and its stability under different storage conditions was evaluated. Results The results of OB by FA160 and double test strip showed excellent consistency(kappa=0.935). The sensitivities of red blood cell(RBC), white blood cell(WBC), parasite and fungal spore were 91.89%, 94.53%, 85.71% and 90.41%, respectively. The specificities of RBC, WBC, parasite and fungal spore were 95.71%, 96.04%, 99.78% and 97.80%, respectively. The accuracies of RBC, WBC, parasite and fungal spore were 95.52%, 95.96%, 99.74% and 97.57%, respectively. The kappa values of RBC, WBC, parasite and fat globule were 0.642, 0.702, 0.665 and 0.690, respectively. Concentration of 1 μg/mL of hemoglobin could be used as positive fecal OB quality control material and stalely stored under 4℃. Conclusions The FA160 fecal analyzer has good performance in basic test performance and its test indicators are consistent with the manual method. It is suitable for clinical application. In-housel prepared positive OB quality control materials is simple and practical.
作者
林馥嘉
欧财文
林海标
胡珺
庞鑫
彭玉连
潘婉仪
LIN Fu -jia;OU Cai-wen;LIN Hai-biao;HU Jun;PANG Xin;PENG Yu-lian;PAN Wan-yi(Department of Clinical Laboratory, the Second Affiliated Hospital of Guangzhou University of Chinese Medicine, Guangzhou510120, Guangdong, China)
出处
《广东医学》
CAS
2019年第8期1058-1063,共6页
Guangdong Medical Journal
基金
广东省中医药局建设中医药强省科研课题(编号:20161081)
关键词
潜血试验
性能评价
质控品
occult blood test
performance evaluation
quality control materials
