Analytical evaluation of the new Beckman Coulter Access high sensitivity cardiac troponin I immunoassay

被引:5
|
作者
Lippi, Giuseppe [3 ]
Ferrari, Anna [1 ]
Gandini, Giorgio [2 ]
Gelati, Matteo [1 ]
Lo Cascio, Claudia [1 ]
Salvagno, Gian Luca [1 ]
机构
[1] Univ Verona, Sect Clin Biochem, Verona, Italy
[2] Univ Hosp Verona, Serv Transfus Med, Verona, Italy
[3] Univ Hosp Verona, Sect Clin Biochem, Ple Scuro 10, I-37314 Verona, Italy
关键词
immunoassay; method evaluation; myocardial infarction; troponin; ACUTE CORONARY SYNDROME; 99TH PERCENTILE; ASSAY; GENERATION; IMPRECISION; PERFORMANCE; ELEVATION; COHORT;
D O I
10.1515/cclm-2017-0350
中图分类号
R446 [实验室诊断]; R-33 [实验医学、医学实验];
学科分类号
1001 ;
摘要
Background: This study was aimed to evaluate the analytical performance of the novel chemiluminescent and fully-automated Beckman Coulter Access hsTnI high-sensitivity immunoassay for measurement of cardiac troponin I (cTnI). Methods: The study, using lithium heparin samples, included assessment of limit of blank (LOB), limit of detection (LOD), functional sensitivity, linearity, imprecision (within run, between-run and total), calculation of 99th percentile upper reference limit (URL) in 175 healthy blood donors (mean age, 36 +/- 12 years; 47% women) and comparison with two other commercial cTnI immunoassays. Results: The LOB, LOD and functional sensitivity of Access hsTnI were 0.14, 0.34 and 1.35 ng/L, respectively. The within-run, between-run and total imprecision was 2.2%-2.9%, 4.6%-5.4%, and 5.4%-6.1%, respectively. The linearity was excellent in the range of cTnI values between 0.95 and 4195 ng/L (r = 1.00). The 99th percentile URL was 15.8 ng/L. Measurable cTnI values were found in 173/175 healthy subjects (98.9%). Good agreement of cTnI values was found with AccuTnI+3 (r = 0.97; mean bias, -9.3%), whereas less satisfactory agreement was found with Siemens Dimension Vista cTnI (r = 0.95; mean bias, -55%). Conclusions: The results of our evaluation of the Beckman Coulter Access hsTnI indicate that the analytical performance of this fully-automated immunoassay is excellent.
引用
收藏
页码:157 / 161
页数:5
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