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Analytical performance evaluation of different test systems on serum creatinine assay
Lina He1, Jinqi Yu2, Guang Han2
1The Second Clinical Medical College, Guangzhou University of Chinese Medicine, Guangzhou, China.
Journal of Clinical Laboratory Analysis
|December 27, 2021
Summary
Enzymatic kits for serum creatinine (SCr) measurement show comparable analytical performance. Both matched and open test systems provide accurate results, with the open system demonstrating superior interference handling for dobutamine.
Area of Science:
- Clinical Chemistry
- Diagnostic Assays
- Renal Function Testing
Background:
- Serum creatinine (SCr) is a key biomarker for assessing kidney function.
- Accurate SCr quantification is crucial for estimating glomerular filtration rate (GFR).
Purpose of the Study:
- To compare the analytical performance of different enzymatic serum creatinine test systems.
- To evaluate matched versus open test systems for SCr measurement.
Main Methods:
- Analytical performance evaluated per Clinical and Laboratory Standards Institute (CLSI) guidelines.
- Key parameters assessed: precision, accuracy, linearity, dilution, lower limit of measurement, and analytical interference.
- Comparison between matched and open test systems for SCr determination.
Main Results:
- Both test systems demonstrated good precision, accuracy, and linearity for SCr measurement.
- Accurate creatinine results were obtained with both systems in the presence of common interferents, except for specific drugs.
- The open test system exhibited enhanced anti-interference capabilities against dobutamine compared to the matched system.
Conclusions:
- The study offers guidance for clinical laboratories selecting SCr test systems.
- Provides a model for future comparative studies of different diagnostic test systems.
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