隐球菌抗原检测试剂盒敏感性和特异性的实验室评价  

Laboratory evaluation of sensitivity and specificity of cryptococcal antigen rapid test

作　　者：张洁 董家丽 陈东科[3] ZHANG Jie;DONG Jia-li;CHEN Dong-ke(Department of Clinical Laboratory,People's Hospital of Yinan County,Yi'nan,Shandong 2763009 China;Medical Laboratory Center,Cangzhou People’s Hospital,Cangzhou,Hebei 061000,China;Laboratory Department of Beijing Hospital,National Center for Geriatrics,Institute of Geriatrics,Chinese Academy of Medical Sciences,Beijing 1007301 China)

机构地区：[1]沂南县人民医院检验科,山东沂南276300 [2]沧州市人民医院医学检验中心,河北沧州061000 [3]北京医院检验科,国家老年医学中心,中国医学科学院老年医学研究院,北京100730

出　　处：《中国热带医学》2021年第6期576-582,共7页China Tropical Medicine

摘　　要：目的用比对试剂评价待评价试剂,以了解待评价试剂的敏感性和特异性。方法选取隐球菌31株、隐球菌近缘菌36株及其他肺部感染常见菌种33株,共28属100株菌株作为检测对象,配置0.5麦氏(M)浓度菌液用于检测试剂的特异性,0.5 M阳性的菌株再以10倍连续稀释液作为敏感性检测浓度菌液,以2M和4M浓度菌液作为钩状效应的检测菌液,并以美国Immuno Mycologics公司(IMMY)生产的隐球菌抗原检测(胶体金免疫层析法)试剂盒作为比对试剂,比较南京黎明生物制品有限公司生产的隐球菌抗原检测(乳胶免疫层析法)试剂与IMMY试剂的一致性。结果在31株隐球菌属菌株中,检测阳性25株和检测阴性6株;在16株毛孢子菌属菌株中,检测阳性12株和检测阴性4株;1株Cutaneotrichosporon curvatum检测结果为阳性;52株肺部感染常见菌种的检测结果均为阴性;敏感性实验结果显示隐球菌最低检出限是1.0×1O^(2)CFU/mL;2М和4М浓度菌液均未出现钩状效应;对已知菌株检测的敏感性和特异性与IMMY试剂比对结果高度一致。结论结果表明,待评价试剂对隐球菌检测敏感性高,特异性检测结果显示存在一定的属内和属外交叉反应结果,实验中未发现有钩状效应。待评价试剂与比对试剂的检测结果高度一致。Objective The comparison reagents were used to evaluate the reagents to be evaluated in order to understand the sensitivity and specificity of the reagents to be evaluated.Methods 31 strains of Cryptococcus,36 strains of Cryptococcus parvum and 33 strains of common pulmonary infection strains belonging to 28 genera and 100 strains were selected as the detection objects.0.5 M concentration solution was used to detect the specificity of the reagents,and 10 times of 0.5 M continuous diluent positive strain as the sensitivity test concentration of bacterial solution.2 M and 4 M concentration solution was used as the hook effect detection solution,and IMMY kit was used as the comparison reagents to compare the consistency of the two reagents.Results Of the 31 strains of Cryptococcus,25 were positive and 6 were negative;among 16 strains of Trichosporon,12 were positive and 4 were negative;1 strain of Cutaneotrichosporon curvatum was positive;the results of 52 common strains of pulmonary infection were all negative;the lowest detection limit of Cryptococcus was 1.0×1O^(2)CFU/mL;the concentration of 2 M and 4 M had no hook effect;the sensitivity and specificity to known strains were highly consistent with the results of IMMY reagent comparison.Conclusion Reagents to be evaluated has high sensitivity,and the specific detection results showed that there are some intra-genus and extra-genus cross-reaction results,and no hook effect is found in the experiment.The test results of the reagents to be evaluated are highly consistent with those of the contrast reagents.

关 键 词：隐球菌荚膜多糖抗原 乳胶免疫层析法 敏感性 特异性 

分 类 号：R379.5[医药卫生—病原生物学]