The quest for comparability: Calibration 2000 |
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Authors: | Rob T P Jansen |
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Institution: | (1) St. Anna Hospital, P. O. Box 90, 5660 AB Geldrop, The Netherlands Tel.: +31-40-2891 866 Fax: +31-40-2854 945, NL |
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Abstract: | Most efforts in quality control have been focussed on the reduction of intralaboratory variation and the assessment of interlaboratory
variation. Over the last few years, the importance of bias in interlaboratory variation and intralaboratory shifts has become
clear. Small shifts can sometimes have a large impact on the number of treated patients, particularly in assays where cut
off values are used. For example in cholesterol, HDL-cholesterol, HbA1c and TSH assays. There is an obvious need for adequate
calibration material. However, the process of development of international primary reference materials and reference methods
takes time, and even if reference materials exist and are used by in vitro diagnostics manufacturers, there still remains
significant and clinically relevant interlaboratory variance and intralaboratory shifts, as is seen, e.g. in protein chemistry.
The harmonization of inter laboratory and intralaboratory results needs an impulse from professional organizations to convince
individual laboratories of the importance and significance of bias. This applies to all subdisciplines of laboratory medicine.
On the occasion of the 25th anniversary of the Foundation for External Quality Assessment (SKZL), a large interdisciplinary
harmonization project called Calibration 2000 was launched in The Netherlands The strategy and first results are reported
in this paper. The project aims at harmonization of laboratory data of several disciplines, using secondary calibration materials,
leading to common reference ranges throughout The Netherlands.
Received: 15 April 2000 · Accepted: 15 April 2000 |
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Keywords: | Quality assessment Bias Harmonization Calibration Laboratory medicine |
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