FA280自动粪便处理分析系统检测性能评价  

Performances evaluation of FA280 fully automatic digital feces analyzer

作　　者：龙婷婷 邓山鹰[1] 张春莹[1] 蒙强 江虹[1] LONG Ting-ting;DENG Shan-ying;ZHANG Chun-ying;MENG Qiang;JIANG Hong(Laboratory Medicine Department,West China Hospital of Sichuan University,Chengdu 610041,China)

机构地区：[1]四川大学华西医院实验医学科,成都610041

出　　处：《医疗卫生装备》2021年第12期48-52,共5页Chinese Medical Equipment Journal

摘　　要：目的:评价FA280自动粪便处理分析系统(以下简称“FA280”)的检测性能。方法:以仪器配套稀释液为标本对FA280进行空白试验。取阳性标本重复检测11次,对比第2~11次的检测结果与第1次的差异,以评价仪器的重复性。将阳性标本及样本稀释液交叉放置于FA280上进行自动检测,观察样本稀释液中是否报告阳性成分,以评价仪器的携带污染性。配制不同浓度的血红蛋白(Hb)溶液,用FA280进行隐血检测,以验证卡式便隐血试剂的阳性报告范围。对比FA280与手工法检测粪便常规的结果差异,评价FA280检测的准确性。采用SPSS 22.0软件进行统计学分析。结果:FA280检测配套稀释液,未检出红细胞(RBC)、白细胞(WBC)、真菌、脓细胞、寄生虫虫卵等成分,且便隐血试验均为阴性,检测符合率为100%,空白试验通过。重复检测阳性标本11次,第2~11次结果与第1次完全一致,检测重复性好。在携带污染试验中,阳性标本均查出RBC、WBC及真菌,且隐血结果全为阳性;样本稀释液管中未查出有形成分,隐血试验均呈阴性,未出现交叉污染。卡式便隐血试剂检测Hb浓度为0.2~2000μg/mL时结果为阳性,低于0.2μg/mL时结果逐渐变为阴性,高达3000μg/mL时结果为阴性,与试剂说明书相符。FA280与手工法检测粪便进行比对,RBC、WBC、真菌及隐血结果符合率分别为99.0%、97.5%、96.5%、96.0%,Kappa值分别为0.852、0.802、0.701、0.870,比对合格。结论:FA280性能良好,适应于临床粪便标本的检测。Objective To evaluate the performances of FA280 fully automatic digital feces analyzer.Methods A blank test was performed on a FA280 fully automatic digital feces analyzer using its matching dilution as the specimen.The specimens with positive results were tested 11 times in duplicate and the results of the 2nd to 11th times were compared with that of the 1st test to evaluate the repeatability of FA280 analyzer.Positive specimens and sample dilutions were placed at intervals in the FA280 analyzer for automated testing,and the analyzer's carryover was assessed by determining the existence of the positive components in the sample dilutions.Different concentrations of hemoglobin(Hb)solutions were prepared and tested for occult blood using FA280 analyzer to verify the positive reporting range of the fecal occult blood card.The accuracy of FA280 analyzer was evaluated by comparing it with the manual method for routine fecal testing.SPSS 22.0 software was used for statistical analysis.Results The absence of red blood cells(RBC),white blood cells(WBC),fungi,pus cells and parasite eggs in the matching dilutions was proved by FA280 analyzer,along with negative results for feces occult blood test and 100%test coincidence rate which meant that FA280 analyzer passed the blank test.The positive specimens were tested 11 times,and the results of the 2nd to 11th times were identical to that of the 1st time,proving the high repeatability of FA280 analyzer.In the carryover test,RBC,WBC and fungi were detected in all the positive specimens and positive results were gained in all the occult blood tests;no formed element was detected in the sample dilution tubes,negative results were gained in all the occult blood tests,and no cross contamination occurred.The results of the fecal occult blood card were positive for Hb concentrations between 0.2 and 2000μg/mL,becoming negative below 0.2μg/mL and up to 3000μg/mL,which conformed to the reagent instructions.FA280 analyzer gained high coincidence rates with the manual method when detec

关 键 词：FA280自动粪便处理分析系统 粪便检测 性能评价 有形成分检测 便隐血检测 

分 类 号：R318.6[医药卫生—生物医学工程] TH776[医药卫生—基础医学]