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Clinical Chemistry 44: 614-621, 1998;
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(Clinical Chemistry. 1998;44:614-621.)
© 1998 American Association for Clinical Chemistry, Inc.

Laboratory Management

Multicenter harmonization of common enzyme results by fresh patient-pool sera

Paul F. H. Franck1,a, Gerard Steen2, Arnold J. P. F. Lombarts1, John H. M. Souverijn3, and Robert K. A. van Wermeskerken4

1 Department of Clinical Chemistry, Leyenburg Hospital, P.O. Box 40551, 2504 LN, The Hague, The Netherlands.

2 Department of Clinical Chemistry, Rijnland Hospital, 2350 CC, Leiderdorp, The Netherlands.

3 Department of Clinical Chemistry, Leiden University Hospital, 2300 RC, Leiden, The Netherlands.

4 Department of Clinical Chemistry, Bronovo Hospital, 2597 AX, The Hague, The Netherlands.
a Author for correspondence. Fax (31) 703592158.

A region consisting of 19 clinical laboratories harmonized their calibration of seven common enzymes by using fresh patient-pool sera. One of the laboratories was chosen to act as Regional Reference Laboratory (RRL). This laboratory used internationally accepted (mostly IFCC) methods at 37 °C, with an intralaboratory CV <=2.5%. First, the reference ranges of the RRL were verified by analysis of a reference population and calculation of the results by a parametric method. Next, all laboratories, including the RRL, received six patient-pool sera and analyzed them at the same time on the same date. Enzyme calibration factors at each laboratory were converted on the basis of the slope, and occasionally the intercept, of regression analysis with the RRL and the individual laboratory. Before harmonization, the interlaboratory CVs varied from 16.9% to 61.6%. After harmonization, CVs decreased to between 5.0% and 9.5%. These results proved to be reproducible over a period of more than a year. Using internationally accepted inaccuracy and imprecision criteria, the achieved interlaboratory CVs permit the use of one set of reference ranges by all participating laboratories. Certified Reference Materials were analyzed, resulting in interlaboratory CVs as low as those achieved with patient-pool sera. These materials can act as commutable reference preparations, except for creatine kinase.




The following articles in journals at HighWire Press have cited this article:


Home page
 Clin. Chem.Home page
G. Cattozzo, E. Guerra, F. Ceriotti, C. Franzini, and on behalf of the Enzyme Working Group of the Itali
Commutable Calibrator with Value Assigned by the IFCC Reference Procedure to Harmonize Serum Lactate Dehydrogenase Activity Results Measured by 2 Different Methods
Clin. Chem., August 1, 2008; 54(8): 1349 - 1355.
[Abstract] [Full Text] [PDF]


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