Wheeler M J, D'Souza A, Matadeen J, Croos P
Department of Chemical Pathology, St. Thomas' Hospital, London, UK.
Clin Chem. 1996 Sep;42(9):1445-9.
A fully automated direct assay of testosterone has been developed for the Ciba Corning ACS:180 immunoassay system. We have evaluated this method and compared specimen results with those from the Diagnostic Products Corp. (DPC) and Medgenix direct assays and an in-house extraction assay. Accuracy of the method was assessed by measuring GC-MS-targeted serum pools. Within-assay im- precision was <6% and between-assay imprecision <9% over the concentration range examined. High concentrations of lipid caused an increase in the measured testosterone but other potential interferents were without effect. Recovery was quantitative but was affected by sex-hormone-binding globulin. The method was positively biased with respect to the DPC and Medgenix assays but negatively biased with the extraction assay. Measurement of the GC-MS-targeted serum pools showed the assay to overestimate recovery by approximately 13%. The ACS:180 assay is particularly attractive as a routine assay because it is fully automated, obtains the first result in only 15 min, and shows good assay performance.
已为Ciba Corning ACS:180免疫分析系统开发了一种全自动直接检测睾酮的方法。我们对该方法进行了评估，并将样本结果与诊断产品公司（DPC）、Medgenix直接检测法以及一种内部提取检测法的结果进行了比较。通过测量气相色谱-质谱靶向血清池评估了该方法的准确性。在所检测的浓度范围内，批内不精密度<6%，批间不精密度<9%。高浓度脂质会导致测得的睾酮增加，但其他潜在干扰物则无影响。回收率是定量的，但受性激素结合球蛋白的影响。该方法相对于DPC和Medgenix检测法呈正偏差，但相对于提取检测法呈负偏差。对气相色谱-质谱靶向血清池的测量表明，该检测法高估回收率约13%。ACS:180检测法作为一种常规检测法特别有吸引力，因为它是全自动的，仅需15分钟就能获得首个结果，并且检测性能良好。
