全新cobas h 232心臟和血栓栓塞標記物點護檢測系統的多中心分析評估

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cobas h 232點護分析儀,作為Cardiac reader的後續產品,成功進行了心肌損傷、心衰、血栓栓塞等疾病患者和健康捐獻者的分析評估。研究對1329名患者及945名健康捐獻者的2379個樣本進行了比較。結果顯示,該系統在創酸激酶MB、肌紅蛋白、NT-proBNP和D-二聚體檢測方面與實驗室方法具有良好的一致性。該系統可用於在急性及非急性情況下對心血管病患者進行現場決策支持。

多中心分析評估用於測定心臟和血栓栓塞標誌物的新型快速測試系統

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

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. PMID: 20380358.

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

羅氏的cobas h 232快速測試分析儀是Cardiac reader的後繼儀器,能定量測定肌鈣蛋白T、肌酸激酶MB、肌紅蛋白、NT-proBNP和D-二聚體。

方法

在這項研究中,對1329名患有急性冠狀動脈綜合徵、心衰、血栓栓塞性或其他疾病的患者以及945名健康捐獻者進行了評估。使用來自這些個體的2379個樣本與中央實驗室方法進行了比較;在這些樣本中,1591個樣本在測量範圍內給出了定量結果,並被納入評估。

結果

與實驗室分析相比,肌酸激酶MB、肌紅蛋白、NT-proBNP和D-二聚體的快速測試法偏差範圍在-5.9%到+6.9%之間。肌鈣蛋白T分析顯示出-11.0%的偏差,而在校準程序更改後為+1.9%。五種快速測試法中沒有一種在新系統與前代設備之間的相對差異高於+5.0%。患者樣本的系列內變異系數範圍在4.8%到14.8%之間。未觀察到與脂血、溶血和黃疸血液或不同的血液比容值有顯著的干擾。

結論

由於cobas h 232系統與實驗室方法和其前代設備具有良好的分析一致性,因此可以可靠地用於支持心血管病患者在急性和非急性設置中的現場決策。