原文作者：Chiara Cosma a,b, Andrea Padoan a,b, Aldo Clerico c, Mario Plebani a,b,⁎
a Department of Medicine – DIMED, University of Padova, via Giustiniani 2, 35128 Padova, Italy
b Department of Laboratory Medicine, University-Hospital of Padova, via Giustiniani 2, 35128 Padova, Italy
c Scuola, Superiore Sant’Anna, Department of Laboratory Medicine, Fondazione G. Monasterio CNR – Regione Toscana, Via Giuseppe Moruzzi 1, 56124 Pisa, Italy
医院介绍：帕多瓦大学是欧洲最古老的顶级大学之一，建于1222年，帕多瓦大学是世界领先的研究型大学， 在意大利高校及研究机构国家评估署（ANVUR）至今发布两份报告中，连续被评为“拥有最高质量研究成果的大学”，大学学术文章引用量在欧洲顶级大学中位居的前10%。伽利略（Galileo Galilei）教授曾于1592-1610年在帕多瓦大学授课。
文章2019年4月9日发表于 Clinica Chimica Acta
Background : C-peptide and insulin are widely used in clinical practice for the diagnosis for several conditions, including hypoglycaemia and diabetes. However, the lack of method harmonization represents an important analytical limitation. Aims of this study were to evaluate new Mindray CL-2000i C-peptide and insulin methods for precision and comparability with Tosoh AIA-CL2400 and Siemens Immulite 2000 systems.
临床疾病诊断中常常会检测C肽和胰岛素，比如低血糖和糖尿病。由于方法学之间缺乏一致性，导致了严重的分析局限性。本研究的目的是评估迈瑞CL-2000i 机型C肽和胰岛素试剂盒的精密度，以及与东曹AIA-CL2400、西门子Immulite2000进行方法学比对。
Methods: Mindray CL-2000i precision was evaluated by the CLSI EP15-A3 protocol and compared with the manufacturer’s claimed values. A series of one hundred sixty-five specimens were used for comparing C-peptide and immunoreactive insulin (IRI) between Mindray CL-2000i, Tosoh AIA-CL2400 and Siemens Immulite 2000.
依据CLSI EP15-A3对迈瑞CL-2000i进行精密度的评估，并与厂家宣称的精密度指标进行比较。通过165个临床样本分析三个发光厂家：迈瑞CL-2000i, 东曹AIA-CL2400，西门子Immulite2000 ，C肽和胰岛素之间方法学的比对。
Results : Mindray CL-2000i repeatability results were 1.7% and 1.35% for C-peptide and 2.1% and 1.2% for IRI. Intermediate precisions were 2.6% and 1.4% for C-peptide and 4.6% and 2.3% for IRI. For C-peptide, Mindray CL-2000i performed similarly to Tosoh AIA-CL2400; for IRI a good agreement between Mindray C-2001 and Siemens Immulite 2000was found.
迈瑞CL-2000i C肽项目重复性结果分别为1.7%和1.35%。 胰岛素项目重复性结果分别为2.1% 和 1.2%。C肽项目中间精密度结果分别为 2.6%和1.4%，胰岛素项目中间精密度分别为4.6%和2.3%。迈瑞CL-2000i与东曹Tosoh AIA-CL2400的C肽值相似，迈瑞CL-2000i 与西门子Immulite 2000 胰岛素方法学比对一致性高。
Discussion：In this study, the precision characteristics of C-peptide and immunoreactive insulin (IRI) on the new Mindray CL-2000i analytical
system have been evaluated. Results showed that Mindray CL-2000i
presents a very low imprecision at each level evaluated, both for Cpeptide and IRI. Further, with the exception of IRI intermediate precision for level 1, all results were comparable to those reported by the manufacturer.
本研究评估了迈瑞CL-2000i C肽和胰岛素项目的精密度，测试结果表明迈瑞CL-2000i C肽和胰岛素都具有极好的精密度水平。此外， 除胰岛素浓度1中间精密度外，所有的精密度结果均与厂家宣称保持高度一致。
Comparability evaluations for C-peptide showed that Mindray CL2000i was more similar to Tosoh AIA-CL2400 than Siemens Immulite 2000. For IRI, Mindray CL-2000i showed equivalence with respect to Siemens Immulite 2000 (absence of proportional and constant bias).
C肽项目的方法学比对数据表明，迈瑞CL-2000i与东曹的AIA-CL2400方法学相对迈瑞与西门子Immulite方法学比对一致度更高。胰岛素项目方法学数据表明，迈瑞CL-2000i 与西门子Immulie 2000方法学相当（无斜率或者固定偏倚）。
For C-peptide, Bland Altman analysis of Mindray CL-2000i and Tosoh
AIA-CL2400 showed a bias (−4.0%) lower than the desirable bias derived
from the biological variation data (7.1%), demonstrating the clinically acceptable comparability of the two methods [11]. For IRI, the Bland Altman analysis of Mindray CL-2000i and Siemens Immulite 2000 revealed that bias was not statistical significant (95% CI: -11.9% to 3.6%), further supporting the Passing Bablok regression results.
迈瑞CL-2000i 与东曹CL2400 的C肽项目方法学拟合，通过 Bland Altman 分析得到的偏差（-4.0%）低于生物变异数据（7.1%），表明这两种方法的可比性在临床上是可以接受的。迈瑞CL-2000i 和西门子Immulite 2000胰岛素项目方法学拟合， 通过Bland Altman 分析表明偏差不具有显著统计学差异（95%CI:-11.9%-3.6%）, 进一步验证Passing Bablock 回归结果一致性。
Conclusions：Our results for the analytical performance support the routine use of the Mindray CL-2000i for monitoring C-peptide or IRI values during therapy, as the analytical accuracy is satisfactory. Overall, the data obtained highlight the need for further efforts to provide standardization/harmonization and result comparability between different commercially available immunoassays.
通过分析性能的数据表明：迈瑞CL-2000i 系统在C肽和胰岛素治疗监测的临床应用中结果准确性良好可正常使用。总之，性能评估数据进一步确认了方法学的一致性以及不同免疫测定方法结果之间的可比性。
译：王晶晶 来源： 迈瑞体外诊断