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Clinical Chemistry and Laboratory Medicine (CCLM)

Published in Association with the European Federation of Clinical Chemistry and Laboratory Medicine (EFLM)

Editor-in-Chief: Plebani, Mario

Ed. by Gillery, Philippe / Lackner, Karl J. / Lippi, Giuseppe / Melichar, Bohuslav / Payne, Deborah A. / Schlattmann, Peter / Tate, Jillian R.


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Multicentre evaluation of a new point-of-care test for the determination of CK-MB in whole blood

Evangelos Giannitsis1 / Hannsjörg Baum2 / Thomas Bertsch3 / Martin Juchum4 / Margit Müller-Bardorff5 / Bo Jørgensen6 / Agathe Böhmer7 / Martina Rebmann8 / Jürgen Schäffler9 / Michael Schwab10 / Rainer Zerback11

1Abteilung für Kardiologie, Angiologie und Pulmonologie, Universitätsklinikum Heidelberg, Heidelberg, Germany

Present address: Institut für Laboratoriumsmedizin, Kliniken Ludwigsburg-Bietigheim, Ludwigsburg, Germany
2Institut für Klinische Chemie und Pathobiochemie, Klinikum rechts der Isar, München, Germany

3Institut für Klinische Chemie und Laboratoriumsmedizin, Klinikum Nürnberg, Nürnberg, Germany

4Abteilung für Innere Medizin, Bezirkskrankenhaus Hall in Tirol, Hall, Austria

5Medizinische Klinik II, Universitätsklinikum Schleswig-Holstein, Campus Lübeck, Lübeck, Germany

6Department of Clinical Biochemistry, Viborg-Kjellerup Hospital, Viborg, Denmark

7Research and Development Near Patient Testing, Roche Diagnostics GmbH, Mannheim, Germany

8Research and Development Near Patient Testing, Roche Diagnostics GmbH, Mannheim, Germany

9Research and Development Near Patient Testing, Roche Diagnostics GmbH, Mannheim, Germany

10Research and Development Near Patient Testing, Roche Diagnostics GmbH, Mannheim, Germany

11Research and Development Near Patient Testing, Roche Diagnostics GmbH, Mannheim, Germany

Corresponding author: Dr. Rainer Zerback, Roche Diagnostics GmbH, Evaluation Near Patient Testing (Dept. DXR-ED1), Sandhofer Straße 116, 68305 Mannheim, Germany Phone: +49-621-759-4191, Fax: +49-621-759-6259,

Citation Information: Clinical Chemistry and Laboratory Medicine. Volume 46, Issue 5, Pages 630–638, ISSN (Online) 14374331, ISSN (Print) 1434-6621, DOI: https://doi.org/10.1515/CCLM.2008.127, March 2008

Publication History

Received:
2007-11-28
Accepted:
2008-01-22
Published Online:
2008-03-10

Abstract

Background: The point-of-care (POC) test Roche CARDIAC CK-MB is a new assay which has been developed for the existing Roche Cardiac reader system.

Methods: We performed a multicentre evaluation at six sites to assess the analytical performance of the POC CK-MB assay and to compare it with a quantitative laboratory CK-MB assay.

Results: Within-series coefficients of variation (CV) resulting from 34 ten-fold measurements with patient samples ranged from 4.3% to 16.4%. Using quality control material, the mean CV values for day-to-day imprecision were 6.5% for the low level control and 8.4% for the high level control. Based upon 847 pairs of values, the mean relative bias of three independently calibrated lots of the POC CK-MB assay ranged from –6% to –11% in method comparisons with the lab CK-MB assay. The mean relative lot-to-lot differences of POC CK-MB were between –2% and +1%. No interference was observed with lipaemic blood (triglyceride concentrations up to 8.1 mmol/L), icteric blood (bilirubin concentrations up to 513 μmol/L), haemolytic blood (haemoglobin concentrations up to 0.12 mmol/L), biotin (up to 30 mg/L) and rheumatoid factor (up to 119 IU/mL), or with 53 standard or cardiological drugs even in toxic concentrations. There was no influence on the results by varying haematocrit values in the range from 21% to 54%. A slight interference with human anti-mouse antibodies type 2 was found. No significant influence on the results with POC CK-MB was found by using sample volumes between 135 and 165 μL. High CK-MB concentrations above the measuring range of POC CK-MB (1–40 μg/L) did not lead to false low results due to potential high-dose hook effect. No significant effect of sample age on recovery occurred up to a sample age of 24 h. No cross-reactivity was found between the POC CK-MB assay and either CK-MM or CK-BB. A substudy with healthy individuals confirmed the reference limits of 3.8 μg/L for females and 6.7 μg/L for males.

Conclusions: The POC CK-MB assay showed a very good analytical performance with an excellent concordance with the calibration and reference laboratory method. It should be therefore suitable for its intended use in POC settings.

Clin Chem Lab Med 2008;46:630–8.

Keywords: acute myocardial infarction; analytical performance; creatine kinase MB (CK-MB); multicentre evaluation; point-of-care testing

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