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广东省临床检验中心组织广州市九间三级甲等医院的免疫检验专家,抽样调查了九个有生产批文的试剂厂家出品的乙肝检测ELISA试剂。结果显示:不同厂家试剂的灵敏度相差1-5个稀释度,精密性为1.28~66.3%;九厂家试剂的平均特异性为89.4~100%、敏感性为75~94%、符合率为86.5~95.9%;五种品名试剂的平均特异性HBsAg98.8%、抗-HBs97.0%、HBeAg99.1%、抗-HBe96.2%、抗-HBc86.5%、平均敏感性HBsAg85.5%、抗-HBs78.6%、HBeAg90%、抗-HBe70.2%、抗-HBc93.1%,平均符合率HBsAg90%、抗-HBs89.9%、HBeAg95.1%、抗-HBe86.1%、抗HBc90.6%。
Guangdong Provincial Clinical Laboratory Center organized nine immunization test experts in three Grade A hospitals in Guangzhou to sample and survey nine hepatitis B detection ELISA reagents produced by nine reagent manufacturers with production approval. The results showed that the sensitivities of reagents from different manufacturers differed by 1-5 dilutions and the precision was 1.28-66.3%. The average specificity of the reagents of nine factories was 89.4-100% and the sensitivity was 75-94% , The coincidence rate was 86.5 ~ 95.9%. The average specific HBsAg98.8%, anti-HBs97.0%, HBeAg99.1%, anti-HBe96.2%, anti-HBc86.5 %, The average sensitivity of HBsAg85.5%, anti-HBs78.6%, HBeAg90%, anti-HBe70.2%, anti-HBc93.1%, the average coincidence rate of HBsAg90%, anti-HBs89.9%, HBeAg95.1 %, Anti-HBe86.1%, anti-HBc 90.6%.