免疫测定用前列腺特异性抗原国家标准品的定值研究

目的：制备并标定免疫测定用前列腺特异性抗原国家标准品。方法：使用英国国家生物标准与检定所（NIBSC）来源的前列腺特异性抗原（PSA）国际标准品进行量值传递，使用化学发光法、酶联免疫法、时间分辨免疫荧光法3 种反应原理的8 种试剂盒进行联合标定，同时进行了均匀性和稳定性评价，对定值的不确定度做了分析和估计。结果：本次换批制备PSA 国家标准品定值为190 ng&#183;mL^-1；不确定度为&#177;27ng&#183;mL^-1；瓶间精密度为0.98%；4 ℃保存11 周，经t 检验直线斜率< t_0.95，6*S（b₁），样品稳定；37 ℃保存11 周，经t 检验直线斜率> t_0.95，6*S（b₁），样品中总前列腺特异性抗原（tPSA）显著降解，游离前列腺特异性抗原（fPSA）浓度显著升高。结论：本次换批制备的PSA 国家标准品定值过程合理，具有较好的均匀性和稳定性，适用于tPSA免疫检测相关试剂盒的产品研究及质量评价，该标准品高温条件保存不稳定，运输过程应保持冷链。

Objective: To prepare and calibrate the new batch of national standard material of prostate specific antigen (PSA)for immunoassay. Methods: PSA international standard material from National Institute for Biological Standards and Control(NIBSC)was used for value transfer,and eight kinds of kits included in three mechanisms, CLIA,ELISA and TRFIA were used for joint calibration. In addition,the homogeneity and stability were evaluated, the quantification uncertainty was analyzed and estimated at the same time. Results: The quantitawve value of the national standard material in this batch of PSA was 190 ng&#183;mL^-1,and the uncertainty was &#177;27 ng&#183;mL^-1. Precision between bottles was 0.98%. Stability test showed that it was stable after storage at 4℃ for 11 weeks with t-test straight slop < t_0.95,6*S(b₁),but unstable after storage at 37℃ for 11 weeks with t-test straight slop > t_0.95,6*S (b₁)。The results showed that the PSA in the sample was significantly degraded while the concentration of fPSA significantly increased Conclusion: The quantification process of this new batch of PSA national standard material is reasonable with good homogeneity and stability. It can meet the need of product research and quality evaluation of PSA kits. PSA national standard material is unstable when it was stored at an elevated temperature,so cold chain should be applied to its transportation.

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