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Cobas h232 即时检验 NT-proBNP 在初级保健中的准确性、用户友好性和实用性。

Accuracy, user-friendliness and usefulness of the Cobas h232 point-of-care test for NT-proBNP in primary care.

机构信息

Department of Public Health and Primary Care, KU Leuven, Leuven, Belgium.

Department of Clinical Biology, ZOL Genk Hospital, Genk, Belgium.

出版信息

J Clin Pathol. 2018 Jun;71(6):539-545. doi: 10.1136/jclinpath-2017-204746. Epub 2017 Dec 20.

Abstract

AIMS

N-terminal pro-B-type natriuretic peptide (NT-proBNP) has been shown to be useful for ruling out heart failure in primary care. In this study, we examined the accuracy of the Cobas h232 point-of-care (POC) instrument in primary care compared with an in-hospital measurement. Furthermore, we investigated the user-friendliness and usefulness of the POC device.

METHODS

Five general practitioner (GP) groups were asked to evaluate adult patients who were suspected of having heart failure and to test NT-proBNP with the Cobas h232. The samples were subsequently delivered to and analysed at a central hospital laboratory by the Cobas e602 using conventional transport and storage. Difference between the paired measurements was analysed using a percentage difference plot, and correlation was assessed using Passing-Bablok linear regression analysis. User-friendliness and usefulness were assessed using semistructured questionnaires.

RESULTS

Nineteen GPs studied 94 patients. Passing-Bablok analysis showed a slope of 1.05 (95% CI 1.00 to 1.11) (R=0.97). The percentage difference plot showed a mean difference of 15.7% (95% CI -46.0% to -77.4%). User-friendliness and usefulness had median scores of 4 or 5 on a five-point Likert scale. Eighteen out of 19 GPs confirmed that the device influenced their clinical practice. During the study, GPs' confidence in using NT-proBNP increased significantly from a mean score of 4.4 (95% CI 3.2 to 5.6) to 7.6 out of 10 (95% CI 7.1 to 8.2).

CONCLUSIONS

The Cobas h232 NT-proBNP POC test proved to be an accurate, user-friendly and useful test in primary care. Nearly all participating GPs were convinced that the test could benefit clinical decision making.

摘要

目的

已证实 N 末端脑利钠肽前体(NT-proBNP)可用于排除初级保健中心的心衰。本研究旨在比较 Cobas h232 即时检测(POC)仪器在初级保健中的准确性与院内检测。此外,我们还研究了 POC 设备的易用性和实用性。

方法

5 个全科医生(GP)小组被要求评估疑似心衰的成年患者,并使用 Cobas h232 检测 NT-proBNP。随后,由 GP 将样本送至中心医院实验室,采用常规运输和储存方式,由 Cobas e602 进行分析。采用百分比差异图分析配对测量之间的差异,采用 Passing-Bablok 线性回归分析评估相关性。采用半结构式问卷评估易用性和实用性。

结果

19 名 GP 研究了 94 名患者。Passing-Bablok 分析显示斜率为 1.05(95%CI 1.00 至 1.11)(R=0.97)。百分比差异图显示平均差异为 15.7%(95%CI -46.0% 至 -77.4%)。易用性和实用性的五分制量表中位数评分为 4 或 5。19 名 GP 中有 18 名确认该设备影响了他们的临床实践。在研究过程中,GP 使用 NT-proBNP 的信心从平均 4.4(95%CI 3.2 至 5.6)显著增加至 10 分制的 7.6(95%CI 7.1 至 8.2)。

结论

Cobas h232 NT-proBNP POC 检测在初级保健中被证实是一种准确、易用且实用的检测方法。几乎所有参与的 GP 都确信该检测有助于临床决策。

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