cobas h 232:全新現場診斷系統精準測定心臟及血栓標記

本翻譯僅作學術交流用,無商業意圖,請勿轉載,如有疑議問請來信

新推出的cobas h 232點護理分析儀在1329位急性冠狀動脈症候群、心衰竭和血栓病患者中進行測試,證明其對心臟和血栓標記(包括肌鈣蛋白T、肌酸激酶MB、心肌球蛋白、NT-proBNP和D-二聚體)的分析結果與實驗室方法及前一代設備具有良好的一致性,支援醫療現場的即時決策。

Multicentre analytical evaluation of a new point-of-care system for the determination of cardiac and thromboembolic markers

新型即時檢測系統在多中心分析評估心臟及血栓栓塞標誌物的研究

Bertsch T, Chapelle JP, Dempfle CE, Giannitsis E, Schwabs M, Zerback R. Multicentre analytical evaluation of a new point-of-care system for the determination of cardiac and thromboembolic markers. Clin Lab. 2010;56(1-2):37-49.

https://pubmed.ncbi.nlm.nih.gov/20380358/

Abstract

Background

The cobas h 232 point-of-care analyzer by Roche is the instrument successor of the Cardiac reader allowing the quantitative determination of troponin T, creatine kinase MB, myoglobin, NT-proBNP and D-dimer.

Methods

In this study 1329 patients with acute coronary syndromes, heart failure, thromboembolic or other diseases and 945 healthy donors were assessed. Comparisons versus central laboratory methods were carried out with 2379 samples from these individuals; out of these, 1591 samples gave quantitative results within the measuring range and were included in the evaluation.

Results

The point-of-care assays for creatine kinase MB, myoglobin, NT-proBNP and D-dimer were within a relative bias range of -5.9 to +6.9% compared to the laboratory assay. The troponin T assay showed a bias of -11.0% and after change of the calibration procedure of +1.9%. None of the five point-of-care assays had a relative difference between the new system and the precursor device that was higher than +5.0%. Within-series coefficients of variation of patient samples were found in a range from 4.8 to 14.8%. No significant interference was observed with lipemic, hemolytic and icteric blood or at different hematocrit values.

Conclusions

Due to its good analytical agreement with the laboratory methods and with its precursor device, the cobas h 232 system can be reliably used to support on-site decision making for cardiovascular patients in acute and non-acute settings.

摘要

背景

羅氏公司的 cobas h 232 即時檢測分析儀是 Cardiac reader 的後繼儀器,能夠定量測定肌鈣蛋白 T、肌酸激酶 MB、肌紅蛋白、NT-proBNP 和D-二聚體。

方法

本研究評估了1329名患有急性冠狀動脈綜合症、心力衰竭、血栓栓塞或其他疾病的患者及945名健康捐贈者。使用這些個體的2379個樣本進行與中央實驗室方法的比較;其中1591個樣本在測量範圍內給出定量結果,並納入評估。

結果

與實驗室分析相比,肌酸激酶 MB、肌紅蛋白、NT-proBNP 和D-二聚體的即時檢測偏差範圍在-5.9%到+6.9%之間。肌鈣蛋白 T 的檢測偏差為-11.0%,在更改校準程序後為+1.9%。五種即時檢測的結果與前代設備相比,差異均未超過+5.0%。患者樣本的系列內變異係數範圍在4.8%到14.8%之間。未發現脂血症、溶血和黃疸血或不同血球比容值對結果有顯著干擾。

結論

由於其與實驗室方法及前代設備有良好的分析一致性,cobas h 232 系統可以可靠地用於支持急性和非急性心血管患者的現場決策。