Einarsson R, Lei J D, Ullrich A, Van Dalen A
BEKI Diagnostics, Bromma, Stockholm, Sweden.
Anticancer Res. 1999 Jul-Aug;19(4A):2743-7.
This paper describes an automated immunoassay for the measurement of TPS developed for the IMMULITE. The IMMULITE system is a fully automated continous random access analyzer, which uses enzyme-amplified chemiluminiscent as the detection system. The IMMULITE TPS assay is a sequential, two-site chemiluminiscent enzyme immunometric assay designed for the quantitative measurement of TPS in serum. The IMMULITE TPS assay covers a clinical concentration range of 20-2400 U/L, with a lower detection limit of 6 U/L. A serum method comparison (n = 340) to the TPS IRMA assay demonstrates a correlation coefficient of 0.961 and a slope of 1.04. Samples run on IMMULITE TPS assay exhibit linearity upon dilution where recovered values fall within 15% of the theoretical sample value. The intra-assay precision of the IMMULITE TPS assay ranged from 3.3-4.7%, while the interassay precision ranged from 3.9-6.0%. By using different methods (immunoradiometric assay vs chemiluminiscent enzyme-labeled immunometric assay, one-step procedure vs sequential two-step procedure, manual vs fully automated procedure) the two TPS tumor marker tests used in this study gave quite comparable determinations for the sera from the cancer patients.
本文介绍了一种为IMMULITE系统开发的用于检测TPS的自动化免疫测定法。IMMULITE系统是一台全自动连续随机进样分析仪，它采用酶放大化学发光作为检测系统。IMMULITE TPS测定法是一种序贯双位点化学发光酶免疫测定法，用于定量检测血清中的TPS。IMMULITE TPS测定法的临床浓度范围为20 - 2400 U/L，检测下限为6 U/L。与TPS免疫放射分析进行血清方法比较（n = 340），相关系数为0.961，斜率为1.04。在IMMULITE TPS测定法上运行的样品经稀释后呈线性，回收值在理论样品值的15%以内。IMMULITE TPS测定法的批内精密度范围为3.3 - 4.7%，批间精密度范围为3.9 - 6.0%。通过使用不同方法（免疫放射测定法与化学发光酶标记免疫测定法、一步法与序贯两步法、手动法与全自动法），本研究中使用的两种TPS肿瘤标志物检测方法对癌症患者血清的测定结果相当。
