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Calibration of Technicon Chem 1 multitest analysers
J D van Suijlen1, B G Blijenberg, G J Boerma
1Department of Clinical Chemistry, Academic Hospital Rotterdam Dijkzigt, The Netherlands.
European Journal of Clinical Chemistry and Clinical Biochemistry : Journal of the Forum of European Clinical Chemistry Societies
|March 1, 1991
Summary
Multi-point calibration is essential for clinical chemistry analyzers. This study demonstrates that manufacturer calibration alone causes significant assay differences, necessitating adjustments for accurate intra-laboratory results.
Area of Science:
- Clinical Chemistry
- Laboratory Medicine
- Analytical Chemistry
Background:
- Two Technicon Chem 1 multitest clinical chemistry analyzers were evaluated.
- Initial manufacturer calibration revealed significant assay result differences between analyzers for 12 of 22 methods.
Purpose of the Study:
- To implement and evaluate an additional calibration procedure to minimize inter-analyzer differences.
- To assess the impact of multi-point calibration on assay accuracy and comparability to reference methods.
Main Methods:
- Utilized a procedure based on the NCCLS EP-9P protocol for method comparison.
- Employed four reference methods and routine laboratory methods for comparison.
- Performed multi-point calibration adjusting slope and intercept parameters.
Main Results:
- Significant biases in slope and intercept were identified for three methods when compared to reference methods.
- Fifteen of eighteen assays required slope and/or intercept corrections to maintain cumulative average patient data.
- Post-calibration adjustments led to significant differences between laboratory-measured values and manufacturer-assigned values for 10 of 13 methods.
Conclusions:
- Manufacturer calibration alone is insufficient for ensuring inter-analyzer comparability.
- The proposed multi-point calibration procedure significantly improves intra-laboratory comparability.
- This calibration approach should be integrated into multi-center evaluations of clinical chemistry analyzers.