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用组织培养、梯度离心纯化的呼吸道合胞病毒(RSV)作包被抗原,用辣根过氧化物酶(HRP)标记的抗人IgMu链单克隆抗体(McAb)作为酶标抗体(二抗),采用间接ELISA研制出了检测人血清中特异性抗RSVIgM抗体的试剂盒,用于RSV感染的早期诊断。对其进行质量检测的结果表明,特异性好,灵敏度达1:160,精密性CV值为13.3%,稳定性(37℃存放4天)变化率在20%以下。用此试剂盒检测正常人群,IgM阳性率为1.94%(12/620),住院婴幼儿和学龄前儿童的阳性检出率为6.5%(13/200)。
Respiratory syncytial virus (RSV) was purified by tissue culture and gradient centrifugation. The anti-human IgMu monoclonal antibody (McAb) labeled with horseradish peroxidase (HRP) was used as the ELISA antibody (secondary antibody) , A kit for detecting specific anti-RSVIgM antibodies in human serum was developed by indirect ELISA for the early diagnosis of RSV infection. The results of quality inspection showed that the specificity was good, the sensitivity was 1: 160, the CV value was 13.3%, and the stability (stored at 37 ℃ for 4 days) was less than 20%. With this kit, the positive rate of IgM was 1.94% (12/620). The positive rate of positive IgM in infants and preschool children was 6.5% (13/200).