摘要
目的探讨酶联免疫吸附试验(ELISA)检测乙型肝炎病毒表面抗原(HBsAg)临界样本的复检范围。方法收集用ELISA初检HBsAg吸光度(A)值在0.07～2.00范围内的样本,用ELISA复检;初、复检结果不符和2次结果均在临界的样本,用微粒子酶免疫法(MEIA)进行复核,并用中和法做确认试验。统计分析结果,选择一个合适的样本复检范围。结果样本初检结果A值在0.070～0.104、0.105～0.300范围内,ELISA复检符合率分别为85.2%、56.9%;MEIA与ELISA复检结果的符合率分别为90.1%、93.9%。A值在0.301～0.500、0.501～1.000、1.001～1.500、1.501～2.000范围内,ELISA复检符合率依次为88.3%、93.8%、99.1%、99.2%,MEIA与ELISA复检结果的符合率为100%。确认试验和MEIA复检结果的符合率样本测定值(S)/阴性对照值(N)在1.50～1.99、2.00～5.00,分别为50.0%和92.7%,其他组均在97.1%以上。结论在操作规范化的实验室内,ELISA初检HBsAg复检范围宜选择样本A值在0.070～0.300范围内;大批量体检时,复检范围应放宽至0.070～0.500;乙肝标志物模式异常的样本也需复检。规定适宜的复检范围既能确保检测结果的准确性,又能避免人力和试剂等物品的浪费。
Objective To identify the retesting range of the hepatitis B surface antigen（HBsAg） borderline sample detected by enzyme-linked immunosorbent assay（ELISA）.Methods The HBsAg samples were selected by ELISA with absorbance（A） value ranged from 0.07 to 2.00,and were retested by ELISA.The unproper samples and samples in borderline in both tests were selected and detected by microparticle enzyme immunoassay（MEIA） and the results were confirmed by neutralization test.The retesting range was analyzed statistically and defined.Results For A value ranged from 0.070 to 0.104,the ELISA coincidence rate was 85.2%.For A value ranged from 0.105 to 0.300,the coincidence rate was 56.9%.The coincidence rates on MEIA and ELISA were 90.1% and 93.9%,respectively.For A value within 0.301-0.500,0.501-1.000,1.001-1.500 and 1.501-2.000,the ELISA coincidence rates were 88.3%,93.8%,99.1% and 99.2%,respectively.The MEIA and ELISA coincidence rates were all 100%.While sample measured value（S）/negative control value（N） range at 1.50-1.99 and 2.00-5.00,the coincidence rates on confirmatory test and MEIA were 50.0% and 92.7%.For other range,the coincidence rates were above 97.1%.Conclusions The A value of the retesting range by ELISA is considered appropriate from 0.070 to 0.300 under a standardized laboratory condition.For health examination,the range can be enlarged to 0.070-0.500.Samples with abnormal hepatitis B virus marker model should also be retested.The appropriate retesting range can assure the accuracy of the testing results and can avoid the waste of manpower and reagents.
出处
《检验医学》
CAS
北大核心
2010年第6期447-450,共4页
Laboratory Medicine
基金
上海市科委基础研究重点项目(08JC1417900)
关键词
乙型肝炎病毒表面抗原
临界样本
酶联免疫吸附试验
微粒子酶免疫法
确认试验
Hepatitis B surface antigen
Critical sample
Enzyme-linked immunosorbent assay
Microparticle enzyme immunoassay
Confirmatory test
