Evaluation of five routine glucose methods on an Olympus AU5400 analyzer using the CDC hexokinase reference method.

Area of Science:

• Clinical Chemistry
• Biotechnology
• Medical Diagnostics

Background:

• Serum glucose measurement is crucial in clinical diagnostics.
• Two primary methods, glucose oxidase (GOD) and hexokinase (HK), are widely used in China.
• Evaluation of commercial reagent kits against a reference standard is essential for quality control.

Purpose of the Study:

• To assess the performance of five commercially available glucose reagent kits.
• To compare these kits against the Center for Disease Control (CDC) hexokinase (HK) reference method.
• To determine the suitability of these glucose reagents for routine clinical laboratory use.

Main Methods:

• Five routine glucose detection methods were evaluated.
• Comparison was performed using the Clinical and Laboratory Standards Institute (CLSI) guideline EP9-A2.
• Methods were analyzed on an Olympus 5400 analyzer in an open-channel mode.

Main Results:

• All five evaluated glucose reagent kits demonstrated a high correlation (r > 0.9998) with the HK reference method.
• Minor positive biases were observed for Olympus-HK and Roche-GOD methods.
• Slight negative biases were noted for Biosino-HK, Osborne-GOD, and Baiding-GOD methods, all within acceptable clinical limits.

Conclusions:

• The evaluated glucose reagent kits, when used with matching calibrators, exhibit strong correlation and minimal bias compared to the reference method.
• All five commercial glucose reagents are deemed suitable for application in clinical laboratory settings.
• This study validates the reliability of these glucose testing kits for accurate patient diagnosis.