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Multicentre evaluation of an enzymatic method for creatinine determination using a sensitive colour reagent
Summary
A new enzymatic colorimetric method accurately determines creatinine in serum and urine. This precise assay improves interlaboratory agreement, making it suitable for routine clinical chemistry diagnostics.
Area of Science:
- Clinical Chemistry
- Biochemical Assays
- Diagnostic Methods
Background:
- Accurate creatinine determination is crucial for diagnosing kidney function.
- Existing methods for creatinine measurement present challenges in precision and interlaboratory agreement.
Purpose of the Study:
- To evaluate a new enzymatic colorimetric method for creatinine determination.
- To assess the accuracy, precision, and interferences of the new method in serum and urine samples.
Main Methods:
- Enzymatic degradation of creatinine using creatininase, creatinase, and sarcosine oxidase.
- Quantification of hydrogen peroxide via a modified Trinder reaction.
- Evaluation across 16 clinical laboratories using manual and automated analyzers.
Main Results:
- Excellent within-run (0.9-4.6%) and between-day (2.8-6.4%) precision.
- Linear measuring range up to 1780 µmol/l (at 546 nm).
- High accuracy demonstrated through recovery studies and method comparisons; no significant interference from common factors, except calcium dobesilate and icteric samples.
Conclusions:
- The new enzymatic colorimetric test offers precise and specific creatinine measurement in serum and urine.
- It significantly enhances interlaboratory comparability compared to existing methods.
- The method is well-suited for routine clinical laboratory use.