六种国产粪便隐血检测试剂的诊断性能评价
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摘要
目的综合评价六种国产粪便隐血试剂的诊断性能。方法采用高值人血红蛋白稀释法对六种粪便隐血试剂的最低检测限和高浓度人血红蛋白检测能力进行评价,采用动物血红蛋白、维生素C和辣根过氧化物酶对六种粪便隐血试剂的抗干扰性进行评价。检测120例消化内科就诊患者和80例健康体检者来源的新鲜粪便样本,比较六种粪便隐血试剂对临床标本的检测结果。结果六种国产粪便检测试剂(贝索、艾博、波生、新创、万华和万孚)的最低检测限分别为25,50,100,150,200和200ng/ml,检测人血红蛋白高值分别为7,10,10,7,3和3mg/ml。500μg/ml的动物血红蛋白和高于0.1mg/ml的维生素C对部分检测试剂有干扰。六种粪便检测试剂检测消化内科就诊患者来源的新鲜粪便的阳性率在23.3%～60.0%之间,六种粪便检测试剂的检出阳性率不同(P<0.05)。结论六种国产粪便隐血试剂最低检测限、高浓度血红蛋白检测能力、抗干扰性和临床样本的检出阳性率不全一致。在选用诊断试剂产品前应做好性能评价,了解试剂的真实诊断性能。
Objective To gain a comprehensive evaluation on the performance of six kinds of domestic fecal occult blood(FOB)reagents.Methods Human hemoglobin was used to determine the lower and upper detection limits of tested reagent.Animal hemoglobin,vitamin C,and horseradish peroxidase were employed to evaluate the anti-interference capacity of tested FOB reagent.Fresh fecal sample collected from 120 patients in the outpatient department of gastroenterology and 80 healthy subjects who attended in regular examination were used to conduct the performance evaluation.Results The lower detection of six kinds of FOB reagent(Baso,Aibo,Boson,Xinchuang,Wanhua and Wanfu)were 25,50,100,150,200,and200 ng/ml,respectively.As for the upper limits for detecting human hemoglobin,the results were 7,10,10,7,3 and 3 mg/ml,respectively.Animal hemoglobin of 500μg/ml or vitamin C higher than 0.1 mg/ml could impose interference in some kinds of FOB reagent.The positive rate of testing samples collected from patients in the department of gastroenterology for six tested FOB reagent was ranging from 23.3%～60.0%,and significant difference was observed in comparing the positive rate(P<0.05).Conclusion There were difference in lower detection limit,capacity of detecting high concentration of human hemoglobin,anti-interference capacity,and positive rate between six kinds of FOB reagent.Therefore,recommend that the clinical evaluation should be conducted to understand the diagnostic performance prior to reagent application.
Objective To gain a comprehensive evaluation on the performance of six kinds of domestic fecal occult blood(FOB)reagents.Methods Human hemoglobin was used to determine the lower and upper detection limits of tested reagent.Animal hemoglobin,vitamin C,and horseradish peroxidase were employed to evaluate the anti-interference capacity of tested FOB reagent.Fresh fecal sample collected from 120 patients in the outpatient department of gastroenterology and 80 healthy subjects who attended in regular examination were used to conduct the performance evaluation.Results The lower detection of six kinds of FOB reagent(Baso,Aibo,Boson,Xinchuang,Wanhua and Wanfu)were 25,50,100,150,200,and200 ng/ml,respectively.As for the upper limits for detecting human hemoglobin,the results were 7,10,10,7,3 and 3 mg/ml,respectively.Animal hemoglobin of 500μg/ml or vitamin C higher than 0.1 mg/ml could impose interference in some kinds of FOB reagent.The positive rate of testing samples collected from patients in the department of gastroenterology for six tested FOB reagent was ranging from 23.3%～60.0%,and significant difference was observed in comparing the positive rate(P<0.05).Conclusion There were difference in lower detection limit,capacity of detecting high concentration of human hemoglobin,anti-interference capacity,and positive rate between six kinds of FOB reagent.Therefore,recommend that the clinical evaluation should be conducted to understand the diagnostic performance prior to reagent application.
引文
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[10]RUBECA T,RAPI S,DEANDREA S,et al.Guidance for faecal occult blood testing:quantitative immunochemical method(FIT-HB)in colorectal cancer screening programmes[J].Epidemiologia&Prevenzione,2017,41(5/6suppl 1):1-32.
[11]中国合格评审国家认可委员会.CNAS-CL39医学实验室质量和能力认可准则在临床免疫学定性检验领域的应用说明[M].北京:中国计量出版社,2012.China National Accreditation Service for Conformity Assessment.CNAS-CL39Guidance on the Application of Accreditation Criteria for the Medical Laboratory Quality and Competence in the Field of Clinical Qualitative Immunology[M].Beijing:China Metrology Publishing House,2012.
[12]王萍,刘辉,张铁,等.体外模拟胃肠道消化环境对免疫法粪便隐血实验的影响[J].中华检验医学杂志,2017,40(4):294-297.WANG Ping,LIU Hui,ZHANG Tie,et al.Effect of in vitro gastrointestinal environment on immunochemical fecal occult blood test[J].Chinese Journal of Laboratory Medicine,2017,40(4):294-297.
[13]NISHIWAKI S,MAEDA M,YAMADA M,et al.Clinical efficacy of fecal occult blood test and colonoscopy for dasatinib-induced hemorrhagic colitis in CML patients[J].Blood,2017,129(1):126-128.
[14]张家超,薛国平,叶纪纲.粪便中血红蛋白和转铁蛋白联合检测在消化道出血诊断中的应用价值[J].实验与检验医学,2017,35(2):267-268,273.ZHANG Jiachao,XUE Guoping,YE Jigang.Application value of combined detection of hemoglobin and transferrin in feces in gastrointestinal tract bleeding[J].Experimental and Laboratory Medicine,2017,35(2):267-268,273.
[15]MULLER I,BRADE V,HAGEDORN H J,et al.Is serological testing a reliable tool in laboratory diagnosis of syphilis?Meta-analysis of eight external quality control surveys performed by the german infection serology proficiency testing program[J].Journal of Clinical Microbiology,2006,44(4):1335-1341.
[2]郑惠心.应用CLSI EP12-A2评价免疫-化学双联法检测粪便隐血试验准确度[J].国际检验医学杂志,2017,38(8):1132-1134.ZHENG Huixin.Evaluation of accuracy of immunochemistry faecal occult blood test by CLSI EP12-A2[J].International Journal of Laboratory Medicine,2017,38(8):1132-1134.
[3]ALLISON J E,SAKODA L C,LEVIN T R,et al.Screening for colorectal neoplasms with new fecal occult blood tests:update on performance characteristics[J].Journal of the National Cancer Institute,2007,99(19):1462-1470.
[4]张惠娟.对胶体金试纸法测定便隐血试验的评价与比较[J].现代中西医结合杂志,2007,16(23):3376.ZHANG Huijuan.Evaluation and comparison of colloidal go-ld strip test for fecal occult blood test[J].Modern Journal of Integrated Traditional Chinese and Western Medicine,2007,16(23):3376.
[5]中国生物制品标准化委员会.中国生物制品规程(2000年版):2002年增补本[M].北京:化学工业出版社,2002.China Biological Products Standardization Committee.Chinese Biological Products Regulations(2000Edition):Supplement to 2002[M].Beijing:Chemical Industry Press,2002.
[6]MARTIN L R,MATIAS D J,RON L M,et al.Utility of faecal occult blood test(FOBT)out of colorectal cancer screening programme[J].Endoscopy,2018,50(4):s95.
[7]冯怡锟,蒋玉涵,刘维伟,等.371例结直肠息肉患者临床特征及其与粪便隐血和血CEA之间的关系[J].重庆医学,2018,47(9):1183-1185.FENG Yikun,JIANG Yuhan,LIU Weiwei,et al.Relationship between clinical features in 371cases of colorectal polyps with fecal occult blood and CEA[J].Chongqing Medical,2018,47(9):1183-1185.
[8]BANASZKIEWICZ Z,BUDZYNSKI J,TOJEK K,et al.The fecal occult blood test as a tool for improved outpatient qualification for colonoscopy.A single-center experience and 10-year follow-up survey[J].Advances in Medical Sciences,2017,62(1):171-176.
[9]范公忍,周海峰,刘军,等.3种粪便隐血检测试剂在结直肠癌筛查中的性能评价与比较[J].国际检验医学杂志,2014,35(14):1938-1940.FAN Gongren,ZHOU Haifeng,LIU Jun,et al.Evaluation and comparison of 3fecal occult blood test reagents in colorectal cancer screening[J].International Journal of Laboratory Medicine,2014,35(14):1938-1940.
[10]RUBECA T,RAPI S,DEANDREA S,et al.Guidance for faecal occult blood testing:quantitative immunochemical method(FIT-HB)in colorectal cancer screening programmes[J].Epidemiologia&Prevenzione,2017,41(5/6suppl 1):1-32.
[11]中国合格评审国家认可委员会.CNAS-CL39医学实验室质量和能力认可准则在临床免疫学定性检验领域的应用说明[M].北京:中国计量出版社,2012.China National Accreditation Service for Conformity Assessment.CNAS-CL39Guidance on the Application of Accreditation Criteria for the Medical Laboratory Quality and Competence in the Field of Clinical Qualitative Immunology[M].Beijing:China Metrology Publishing House,2012.
[12]王萍,刘辉,张铁,等.体外模拟胃肠道消化环境对免疫法粪便隐血实验的影响[J].中华检验医学杂志,2017,40(4):294-297.WANG Ping,LIU Hui,ZHANG Tie,et al.Effect of in vitro gastrointestinal environment on immunochemical fecal occult blood test[J].Chinese Journal of Laboratory Medicine,2017,40(4):294-297.
[13]NISHIWAKI S,MAEDA M,YAMADA M,et al.Clinical efficacy of fecal occult blood test and colonoscopy for dasatinib-induced hemorrhagic colitis in CML patients[J].Blood,2017,129(1):126-128.
[14]张家超,薛国平,叶纪纲.粪便中血红蛋白和转铁蛋白联合检测在消化道出血诊断中的应用价值[J].实验与检验医学,2017,35(2):267-268,273.ZHANG Jiachao,XUE Guoping,YE Jigang.Application value of combined detection of hemoglobin and transferrin in feces in gastrointestinal tract bleeding[J].Experimental and Laboratory Medicine,2017,35(2):267-268,273.
[15]MULLER I,BRADE V,HAGEDORN H J,et al.Is serological testing a reliable tool in laboratory diagnosis of syphilis?Meta-analysis of eight external quality control surveys performed by the german infection serology proficiency testing program[J].Journal of Clinical Microbiology,2006,44(4):1335-1341.