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西门子 Atellica BRAHMS 与雅培 Architect BRAHMS 降钙素原检测试剂盒的比较。

Comparison of the Siemens Atellica BRAHMS and the Abbott Architect BRAHMS Procalcitonin Assays.

机构信息

Department of Pathology, Wexner Medical Center, The Ohio State University, Columbus, OH, USA.

Department of Pathology, Wexner Medical Center, The Ohio State University, Columbus, OH, USA

出版信息

Ann Clin Lab Sci. 2021 Mar;51(2):241-244.

PMID:33941564
Abstract

OBJECTIVE

In this study, we compared the Abbott Architect B.R.A.H.M.S procalcitonin (PCT) assay with the newly developed Siemens Atellica B.R.A.H.M.S PCT assay.

METHODS

Residual 45 lithium heparin plasma/serum specimens were randomly selected from routine hospital orders, and PCT was measured on both systems and compared with Passing-Bablok regression. Bias was evaluated using the Bland-Altman method. Concordance correlation was used for agreement evaluation at the clinically diagnostic cutoff of 0.10, 0.25, 0.50, and 2.00 ng/mL.

RESULTS

Weighted Deming regression analysis showed approximately 13% positive bias (Atellica PCT=1.13Architect PCT+0.02, =0.961). The Passing-Bablok regression analysis of the total sample range revealed approximately 12% positive bias of the Atellica PCT compared to the Architect PCT (Atellica PCT=1.12Architect PCT+0.02, =0.961). The Bland-Altman plot showed the agreement between Atellica and Architect PCT was on average 0.04±0.25 ng/mL in the clinically relevant range of 0.1-2.0 ng/mL. The concordance of both methods at the clinically diagnostic cutoff (0.1, 0.25, 0.5, 2.0 ng/mL) showed excellent overall agreement at each threshold (90-100%).

CONCLUSIONS

The Siemens Atellica B.R.A.H.M.S PCT assay showed good correlation with the established Abbott Architect B.R.A.H.M.S PCT assay. Therefore, this technique can be used in clinical routine with the same clinical interpretation.

摘要

目的

本研究比较了 Abbott Architect B.R.A.H.M.S 降钙素原(PCT)检测与新开发的 Siemens Atellica B.R.A.H.M.S PCT 检测。

方法

从常规医院医嘱中随机选择 45 份剩余的锂肝素血浆/血清标本,在两个系统上同时测量 PCT,并与 Passing-Bablok 回归进行比较。使用 Bland-Altman 法评估偏差。使用一致性相关系数评估在临床上诊断截止值 0.10、0.25、0.50 和 2.00ng/mL 时的一致性。

结果

加权 Deming 回归分析显示 Atellica PCT 存在约 13%的正偏倚(Atellica PCT=1.13Architect PCT+0.02,=0.961)。总样本范围内的 Passing-Bablok 回归分析显示,Atellica PCT 与 Architect PCT 相比存在约 12%的正偏倚(Atellica PCT=1.12Architect PCT+0.02,=0.961)。Bland-Altman 图显示,在临床上相关的 0.1-2.0ng/mL 范围内,Atellica 和 Architect PCT 之间的一致性平均为 0.04±0.25ng/mL。两种方法在临床上诊断截止值(0.1、0.25、0.5、2.0ng/mL)的一致性在每个阈值(90-100%)均显示出极好的总体一致性。

结论

Siemens Atellica B.R.A.H.M.S PCT 检测与已建立的 Abbott Architect B.R.A.H.M.S PCT 检测具有良好的相关性。因此,该技术可以在临床常规中使用,具有相同的临床解释。

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