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采用从人精浆中纯化的前列腺特异性抗原(PSA),经免疫、融合、筛选,得到两株抗PSA抗原的单克隆抗体1H7和2D1,并通过免疫组化法鉴定了抗体的特异性。将其配对建立的定量测定血清PSA的双抗体夹心ELISA法最低检出量为0.5μg/L,孔间平均变异系数为4.4%,批内平均变异系数为5.8%。35例正常男性血清PSA的范围(x±s)为(1.45±1.24)μg/L;11例前列腺癌患者血清PSA的范围(x±s)为(26±27.2)μg/L。与进口PSA-ELISA试剂盒检测的总符合率为83%。
Purified prostate specific antigen (PSA) from human seminal plasma was used for immunization, fusion and screening to obtain two anti-PSA antigen monoclonal antibodies 1H7 and 2D1. The specificity of the antibody was identified by immunohistochemistry. The minimal detectable amount of double antibody sandwich ELISA for the quantitative determination of serum PSA was 0.5 μg/L. The average coefficient of variation between wells was 4.4%, and the average intra-assay coefficient of variation was 5.8%. The range of serum PSA (x±s) in 35 normal men was (1.45±1.24) μg/L; the range of serum PSA (x±s) in 11 patients with prostate cancer was (26±27.2) μg. /L. The total compliance with the imported PSA-ELISA kit was 83%.