基于CLSI EP12-A2文件要求的乙型肝炎五项定性检测性能验证  

Performance validation of 5-item qualitative detection of hepatitis B based on requirements of EP12-A2 CLSI file

作　　者：唐恩跃 何增品[2] 崔晓花[2] 杨永平[2] 熊秋霞[2] 

机构地区：[1]云南省保山市人民医院检验科,678000 [2]昆明医科大学第一附属医院检验科,昆明650032

出　　处：《国际检验医学杂志》2016年第24期3443-3444,3448,共3页International Journal of Laboratory Medicine

摘　　要：目的对昆明医科大学第一附属医院检验科免疫室酶联免疫吸附试验(ELISA)定性项目乙型肝炎(乙肝)五项进行性能验证。方法采用ELISA,通过稀释乙肝五项各项目强阳性标本得到临界值浓度(C50)并验证其是否正确;采用各个项目C50-20%^+20%浓度范围的重复性实验验证其结果是否包含C5~C95区间;用C50+20%浓度验证检测限;常规手工操作试验和TECAN全自动酶免检测两种方法检测10例阳性和10例阴性标本,对其结果进行方法学比较及分析。结果 5个项目C50验证正确;C50-20%^+20%浓度范围包含了C5~C95区间;检测限验证通过;5个项目两种方法检测结果一致性检验Kappa系数均为1。结论本实验室乙肝五项定性检测使用方法及试剂盒相关性能均验证合格,常规手工操作试验方法和TECAN全自动酶免检测方法两种方法学比较结果一致性较好。Objective To perform the performance verification of 5-item qualitative detection of enzyme linked immunosorbent assay（ELISA）in the immunology room of laboratory department of the First Affiliated Hospital of Kunming Medical University.Methods The ELISA method was adopted.The strong positive samples of hepatitis B 5items were diluted to the critical value concentration（C50）and its correction was verified;the repeated experiments with the C50-20%-＋20%concentration range for the various items were adopted to verify whether the results including the C5-C95interval;the detection limit was verified by using the C50 ＋20% concentration;10positive and 10 negative specimens were detected by the conventional manual operating test and TECAN fully automatic enzyme immunoassay detection,then the obtained results were performed the methodological comparison and analysis.Results The 5-item C50 verification was correct;the C50-20%-＋20% concentration range included the C5-C95interval;the verification of detection limit was passed;the Kappa coefficient of 5-item consistency test in the results detected by two methods was 1.Conclusion The application method of hepatitis B 5-item qualitative detection and related performance of reagent kit all are qualified by verification.The methodological comparison results of the routine manual operation test and TECAN fully automatic enzyme immunoassay display good consistency.

关 键 词：乙肝五项定性检测 性能验证 酶联免疫吸附试验 

分 类 号：R512.62[医药卫生—内科学]