摘要
目的 了解国产抗HCV EIA试剂的质量情况。方法 用16种国产抗HCV EIA试剂盒和2种进口试剂对1426份来源于血站及医院的血清进行了检测,并对疑难样品用RIBA及PCR试剂进行了确证。对各种试剂的灵敏度,特异度及检测的抗体谱进行了分析。结果 目前国产试剂灵敏度不低于国外试剂,特异度尚有待于改进。国产试剂漏检及假阳性的主要原因为HCV NS3区抗原相对较弱,抗原纯度较低,用量不足,有待于改进。结论 国产抗HCV试剂灵敏度不低于国外试剂,特异度有待提高。
Objective To investigate the quality of domestic and - HCV EIA kits.Methods 1426 sera of blood donors and hepatitis patients coming from 9 provinces of China were detected by using 16 domestic anti - HCV EIA kits and 2 imported anti - HCV EIA kits. The suspeuous samples were confirmed with RIBA and PCR.The sensitivity and specificity of each kits were calculated and the ability of each kits to detect the anti - HCV core, NS3, NS4 and NS5 were also analyzed. Results The sensitivity of domestic anti -HCV EIA kits is equal to imported kits but the specificity of them is little lower than that kits.Conclution We found the activity and purity of HCV NS3 antigen used by domestic anti - HCV EIA kits should be improved.
出处
《中国预防医学杂志》
CAS
2001年第3期168-170,共3页
Chinese Preventive Medicine
基金
国家"九五"重点科技攻关基金资助(96-906-03-06)
