免疫分析
医学
肌钙蛋白I
内科学
灵敏度(控制系统)
心脏病学
化学
心肌梗塞
免疫学
抗体
电子工程
工程类
作者
Giuseppe Lippi,Laura Pighi,Elisa Paviati,Davide Demonte,Simone De Nitto,Matteo Gelati,Martina Montagnana,Giorgio Gandini,Brandon Michael Henry,Giuseppe Lippi
标识
DOI:10.1515/cclm-2023-1448
摘要
Abstract Objectives The current study was designed to evaluate the analytical performance of the new Mindray highly sensitive cardiac troponin I (hs-cTnI) chemiluminescent immunoassay on Mindray CL-1200i, as a thorough validation of novel hs-cTnI methods is required before introduction into clinical practice. Methods The evaluation of the analytical performance of this hs-cTnI immunoassay encompassed the calculation of the limit of blank (LOB), limit of detection (LOD), functional sensitivity, imprecision, linearity, 99th percentile upper reference limit (URL) and concordance with another previously validated hs-cTnI chemiluminescent immunoassay. Results The LOB and LOD were 0.32 and 0.35 ng/L, whilst the functional sensitivity (expressed as cTnI value with <10 % imprecision), was 0.35 ng/L. The linearity was excellent throughout a wide range of clinically measurable values (r=1.00 between 0.8 and 9,726.9 ng/mL). The intra-assay, inter-assay and total imprecision were 1.1–1.3 %, 5.5–8.1 % and 5.6–8.2 %, respectively. The 99th percentile URL calculated using residual plasma from 246 ostensibly healthy blood donors was 9.2 ng/L (4.3 ng/L in women vs. 12.3 ng/L in men). The Spearman’s correlation between Mindray hs-cTnI and Access hs-TnI was 0.97, with mean bias of 7.2 % (95 % CI, 2.6–11.9 %). Conclusions Although we failed to confirm the very optimistic analytical characteristics previously reported for this method, our evaluation of the novel Mindray hs-cTnI immunoassay on CL-1200i demonstrated that the overall performance is comparable to that of other commercially available hs-cTnI techniques, making it a viable alternative to other methods.
科研通智能强力驱动
Strongly Powered by AbleSci AI