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丙型肝炎病毒分片段试剂对抗-HCV临界值附近标本的确认价值

The confirmed inspection and analysis of HCV Different Region ELISA KIT to anti-HCV near S/CO sample
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摘要 目的探讨丙型肝炎病毒(HCV)分片段(抗-HCV-C、抗-HCV-NS3、抗-HCV-NS4、抗-HCV-NS5)试剂对抗-HCV临界(CO)范围标本的确认价值。方法酶联免疫吸附法(ELISA)方法检测抗-HCV总抗体,结果为临界值(S/CO)或灰区状态(CO±10%)的可疑标本,分离血清后贮存于-29℃低温冰箱内,集中用丙型肝炎病毒(HCV)抗体分片段酶联免疫确认试剂,在全自动酶标分析仪上进行检测,收集可疑标本44例,其中抗-HCVCO±10%阳性24例及CO±10%阴性20例。同时收集抗-HCV总抗体S/CO值大于5.0的标本30例,健康对照标本20例。结果44例抗-HCVELISA总抗体检测S/CO值为灰区状态标本中,HCV分片段确认为阳性者为22.7%(10/44),可疑者为6.8%(3/44),阴性者为70.5%(31/44)。抗-HCVCO±10%阳性中的假阳性率为54.2%(13/24),抗-HCVCO±10%阴性中的假阴性率为5.0%(1/20)。30例抗-HCV检测S/CO值大于5.0的标本中,HCV分片段确认阳性者为80.0%(24/30),可疑者为13.3%(4/30),阴性者为6.7%(2/30);20例健康对照组HCV分片段确认试验均呈阴性反应。结论用HCV分片段酶联免疫确认试剂对抗-HCVELISA总抗体检测是较好的旁证试验,特别对不确定的灰区标本进一步的确认意义甚大,可降低抗-HCV在检测低危人群时所产生的假阳性及假阴性结果,提高临床丙型肝炎诊断的准确率,对血站安全用血、避免浪费血源有一定的实用价值,且操作简便,易于推广应用。 Objective To discuss the confirmed value of HCV Different Region ELISA KIT (ANTI-HCV-C, ANTI-HCV-NS3, ANTI-HCV-NS4, ANTI-HCV-NSS) to anti-HCV CO sample. Methods To inspect the general antibody of anti-HCV with ELISA, which is commonly used in clinic. The serum was separated from the suspicious samples, whose results were equal to S/CO or in the state of grey district ( CO±10% ), and stored in the refrigerator in -29℃ low temperature and concenratedly inspected by the HCV Different Region ELISA KIT on the Triturus,the enayme immuno-reactions automatic analyzer. We totally collected 44 suspicious samples,among which there were 24 anti- HCV positive,20 anti-HCV CO± 10% negative. Meanwhile we collected 30 samples whose S/CO of general antiboby was more than 5.0 and 20 ones which were healthy and could be compared with. Results In the 44 suspicious cases, whose S/CO was in the state of grey disrtict (CO± 10% ), the HCV Different Region Kit confirmed positive was 22. 7% (10/44), suspicious 6. 8% (3/44), negative 70.5%(31/44). The false positive rate of positive anti-HCV CO± 10% was 54.2%( 13/24 ) and the false negative rate of negative anti-HCV CO± 10% was 5.0%(1/20). In the 30 cases,whose S/CO of general antibody was more than 5.0, the HCV Different Region Kit confirmed positive was 80.0% (24/ 30 ), suspicious 13.3 % (4/30 ), negative 67 % (2/30). In 20 cases, which were from healthy people, the HCV Different Region Kit confirmed totally negative. Conclusion Using HCV Different Region Kit is a better evidence laboratory,especially for the uncertain samples,that is,it is very important for the " grey district"(CO±10%) samples to be further confirmed. It can reduce the false positive and false negative result which may emerge when anti HCV EIA inspects the dangerous groups and improve the accuracy of clinical HCV diagnosis. To blood station, it has certain practical value for the blood not only can be safely used, but also avoided wasting. The operation is simple and convenient, easily be spread and applied.
出处 《国际检验医学杂志》 CAS 2006年第9期792-793,803,共3页 International Journal of Laboratory Medicine
关键词 肝炎抗体 丙型 酶联免疫吸附测定 指示剂和试剂 参考值 Hepatitis C antibodies Enzyme-linked immunosorbent assay Indicators and reagents Reference values
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