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Validation of methods performance for routine biochemistry analytes at Cobas 6000 analyzer series module c501
Vesna Supak Smolcic1, Lidija Bilic-Zulle, Elizabeta Fisic
1Clinical Institute of Laboratory Diagnostics, Rijeka Clinical Hospital Center, Rijeka, Croatia. vesnasupak@gmail.com
Biochemia Medica
|December 6, 2011
Summary
The Cobas 6000 biochemistry analyzer demonstrates satisfactory precision and accuracy for most analytes, though some require method adjustments for routine clinical laboratory operation. Analytical validation confirmed its stability and performance for biochemical testing.
Area of Science:
- Clinical chemistry
- Analytical biochemistry
- Laboratory diagnostics
Background:
- The Cobas 6000 is a biochemistry analyzer used for spectrophotometric, immunoturbidimetric, and ion-selective determinations.
- This study focuses on the analytical validation of the Cobas 6000 for routine laboratory use.
Purpose of the Study:
- To perform analytical validation of the Cobas 6000 biochemistry analyzer.
- To assess method performance for routine operation, emphasizing accuracy, precision, and total error.
Main Methods:
- Validation of 30 analytes including metabolites, enzymes, trace elements, specific proteins, and electrolytes.
- Determination of within-run and between-run imprecision, inaccuracy, and total error.
- Method comparison with the Beckman Coulter AU640 analyzer using Passing-Bablok regression.
Main Results:
- Within-run CVs were below 5% for most analytes; between-run CVs were below 10%.
- Several analytes (total protein, albumin, calcium, sodium, chloride, IgA, IgM, HDL cholesterol) did not meet all required specifications for imprecision, inaccuracy, or total error.
- Method comparison revealed that many analytes require slope and intercept adjustments for complete accordance with the routine analyzer.
Conclusions:
- The Cobas 6000 analyzer exhibits satisfactory accuracy, precision, and stability for most biochemical analytes.
- Specific analytes require calibration adjustments (slope and intercept) to ensure complete accordance with the routine Beckman Coulter AU640 analyzer for reliable clinical laboratory results.
