ARUP Institute for Clinical and Experimental Pathology, Salt Lake City, UT, United States.
Clin Chim Acta. 2010 Aug 5;411(15-16):1073-9. doi: 10.1016/j.cca.2010.03.041. Epub 2010 Apr 10.
Serum testosterone measurements have utility in diagnosis of clinical conditions characterized by both increased and decreased testosterone concentrations. Studies have indicated that testosterone immunoassays may give inaccurate results for women and children. We evaluated the performance of a second generation testosterone immunoassay from Roche Diagnostics.
Testo II performed on a Modular Analytics E 170 analyzer is an automated random access electrochemiluminometric assay. We evaluated limit of blank (LoB), imprecision, linearity, interference, and method comparison with liquid chromatography-tandem mass spectrometry assay (LC-MS/MS). Method comparison included the current generation Roche testosterone assay (Testo I) and the Access 2 testosterone chemiluminometric assay (Beckman Coulter). Results for men and women were analyzed for analytic concordance. The relative % differences of immunoassay compared to LC-MS/MS results were evaluated.
The LoB was 0.07nmol/l. Total imprecision was <6%. The assay was linear from 0.2 to 46.6nmol/l. Negative interference was observed for lipemia at concentrations >22.5g/l. Analytic concordance showed improved specificity for women. Comparison of results to LC-MS/MS indicated comparable performance with other immunoassays for men and improved performance for women, boys, and girls with mean differences of 0.5%, -0.7%, and 24.4%, respectively.
The Roche Testo II assay demonstrated excellent precision. Comparison to 2 other automated immunoassays showed comparable performance for men and improved performance for women and children. However, challenges still exist for quantifying testosterone concentrations <10.4nmol/l for men and <1.7nmol/l for women and children by immunoassay.
血清睾酮测量在诊断表现为睾酮浓度升高和降低的临床病症方面具有实用性。研究表明，睾酮免疫测定可能会为女性和儿童提供不准确的结果。我们评估了罗氏诊断公司的第二代睾酮免疫测定的性能。
罗氏诊断公司生产的 Modular Analytics E170 分析仪上的 Testo II 是一种自动化随机存取电化学发光免疫测定。我们评估了空白限（LoB）、不精密度、线性、干扰以及与液相色谱-串联质谱测定法（LC-MS/MS）的方法比较。方法比较包括当前一代罗氏睾酮测定法（Testo I）和贝克曼库尔特 Access2 睾酮化学发光免疫测定法（Beckman Coulter）。对男性和女性的结果进行了分析，以确定分析一致性。评估了免疫测定与 LC-MS/MS 结果的相对%差异。
LoB 为 0.07nmol/L。总不精密度<6%。该测定法在 0.2 至 46.6nmol/L 之间呈线性。在浓度>22.5g/L 时，脂血会产生负干扰。分析一致性表明，女性的特异性有所提高。与 LC-MS/MS 的结果比较表明，男性与其他免疫测定法具有可比性，而女性、男孩和女孩的性能有所提高，平均差异分别为 0.5%、-0.7%和 24.4%。
罗氏 Testo II 测定法显示出出色的精密度。与另外 2 种自动化免疫测定法的比较表明，男性的性能相当，女性和儿童的性能有所提高。然而，通过免疫测定法仍难以定量男性<10.4nmol/L 和女性和儿童<1.7nmol/L 的睾酮浓度。
Zotero 插件