中国输血杂志2018，Vol.31Issue(2)：110-113,4.DOI:10.13303/j.cjbt.issn.1004-549x.2018.02.004
ELISA试剂检测HBsAg不合格标本的假阳性率调查
Investigation of the false positive rate in the unqualified samples of HBsAg ELISA test
张巧琳 1释艳华 2魏超 3李维 1王露楠 4谢晓艳 1尹丹 1魏兰 1葛红卫 5韩卫 6潘彤 7方建华8
作者信息
- 1. 重庆市血液中心,重庆, 400000
- 2. 襄阳市中心血站
- 3. 沧州市中心血站
- 4. 卫生部临床检验中心
- 5. 北京市红十字血液中心
- 6. 河北省血液中心
- 7. 天津市血液中心
- 8. 河南省红十字血液中心
- 折叠
摘要
Abstract
Objective To evaluate the false positive rate in unqualified donors designated by the positive HBsAg ELISA screen test. Methods A total of 888 unqualified samples were acquired from 16 blood centers nation-wide, which were then processed by both Roche ECLIA and Abbott CLIA. The samples were defined as positive only when a dual-reactive result was confirmed while a dual-nonreactive result was considered negative. Neutralization tests by several blood centers with different ELISA test kits were performed for the samples presenting inconsistent results in the two tests mentioned prior. In our study, test results were compared among 6 laboratories and 3 types of reagents (Type 1, 2 and 3) . Reagent-dependent consistency was also analyzed based on the application of each reagent in 3 different labs. Results 301 of the 888 unqualified samples were confirmed negative, accounting for 33. 9％ of the total volume; No statistical significance were found in reagent-dependent consistency tests (P＞0. 05); Three of the six laboratories used two types of reagents, among which, two labs' results showed statistical significance between type 1 and type 2 reagent. (P＜0. 05) while the other with type 2 and 3 revealed otherwise(P＞0. 05); Reagent reliability tests were performed where the total chance of random false positive result by one reagent in 3 labs were calculated. No statistical significance was found comparing the chance where one reagent yields all falsepositive results in 3 labs (P＞0. 05) . However, statistical significance was presented when the standard was lower to random false-positive results in one or two laboratories for each reagent (P＜0. 05); The S /Co distribution of all-false-positive results of the three reagents were analyzed and difference was identified in P50 and interquartile spacing. Conclusion The falsepositive rate is reagent-dependent in ELISA tests, which also applies to the distribution of s /co statistics of false-positive samples. This may provide valuable reference for the strategy design of blood donor re-entry.关键词
乙肝表面抗原/假阳性率/酶联免疫吸附试验Key words
HBsAg/false positive rate/ELISA分类
医药卫生引用本文复制引用
张巧琳,释艳华,魏超,李维,王露楠,谢晓艳,尹丹,魏兰,葛红卫,韩卫,潘彤,方建华..ELISA试剂检测HBsAg不合格标本的假阳性率调查[J].中国输血杂志,2018,31(2):110-113,4.
