丙型肝炎病毒抗体试剂检测结果的可信度分析  

Reliability of commercial anti-HCV diagnostic kits in China′s market

作　　者：谷金莲[1] 祁自柏[1] 王尊文[1] 张华远[1] 于洋[1] 扬振[1] 

机构地区：[1]中国药品生物制品检定所,北京100050

出　　处：《中华检验医学杂志》2005年第6期580-583,共4页Chinese Journal of Laboratory Medicine

基　　金：国家"十五"科技攻关基金资助(项目:2001BA705B06)

摘　　要：目的分析丙型肝炎病毒抗体试剂检测结果的可信度。方法利用研制第5套抗HCV国家参考品过程中所搜集到的283份样品,用国内2家和国外4家公司生产的6种抗HCV试剂检测。6种试剂检测结果不一致的样品,用HCVRIBA试剂和HCVRNAPCR试剂作进一步确证,对结果进行综合分析。结果6种抗HCV试剂阳性符合率均>93%,阴性符合率、总符合率均>96%。6种抗HCV试剂曾出现19份假阳性样品,国外的3种抗HCVEIA试剂(DS,M4,O3)所出现的4份假阳性样品其S/CO值均<3.8,化学发光试剂(OF)所出现的8份假阳性样品除1份S/CO值为7.57以外,其余7份亦均小于3.8。国内2种抗HCVEIA试剂假阳性样品S/CO值范围分布较广,9份样品S/CO值大于3.8,6份样品S/CO值在3.8和1.0之间。6种抗HCV试剂曾出现5份假阴性样品的S/CO值在0.42～0.98之间,大多数假阴性样品的S/CO值在0.50～0.98之间。结论美国CDC对美国市场所用抗HCVEIA试剂检测可信度的分析[1]适用于国内市场上进口的抗HCVEIA试剂。而国产抗HCVEIA试剂假阳性样品S/CO值范围分布较广,对于国产抗HCV试剂可信度的S/CO值界限不应机械的套用美国CDC规定。对于国内外抗HCVEIA试剂检测时S/CO值>0.5,<1.0的高值阴性样品应注意是否为漏检。Objective To analyze the reliability of commercial anti-HCV diagnostic kits in China′s market.Methods 283 samples ,which we collected from deferent places of China for preparing the national reference panal for anti-HCV diagnostic reagents, were detected with 4 imported anti-HCV kits and 2 domestic anti-HCV EIA kits. The result was confirmed with Chiron RIBA HCV 3.0 SIA and HCV RNA PCR kits. Results For all 6 kits, the sensibilities were more than 93% and the specifisities were more than 96%. Total 19 false positive samples were found.The S/CO values of 4 false positive samples, which were detected by 3 imported anti-HCV EIA kits, were below 3.8. 7 of 8 false positive samples detected by one chemiluminescence immunoassay kit have the S/CO values below 3.8. But 9 of 15 false positive samples detected by 2 domestic anti-HCV EIA kits have the S/CO values more than 3.8. 5 false negative samples were found and thier S/CO values were 0.42 to 0.98 ( most of them were betwin 0.50 to 0.98).Conclusion[KG*2]The guidline found by American CDC for anti-HCV diagnostic reagent kits in American′s market~ [1] applies to all licensed 3 imported anti-HCV EIA kits in China′s market. But for domestic anti-HCV EIA kits, the reliabilities were different each other. The samples with S/CO values 0.50~0.98 should be doubted whether them were false negative.

关 键 词：丙型肝炎病毒 检测结果 抗体试剂 可信度分析 S/CO值 EIA试剂 抗HCV试剂 美国CDC 结果不一致 阳性符合率 假阳性 RIBA 综合分析 化学发光 国内市场 假阴性 样品 出现 参考品 RNA PCR 国内外 国外 分布 国产 

分 类 号：R446.6[医药卫生—诊断学]