Background: The trueness of glucose monitors is commonly assessed using whole-blood samples and a clinical analyzer as a comparison method. In this study, the effect of specimen matrix on trueness of one clinical analyzer and one glucose monitor was compared with a gas chromatography-mass spectrometry (GC/MS) reference method, using split-sample comparison with capillary whole blood (CWB), venous whole blood (VWB), and plasma (PL).
Methods: CWB was analyzed by the glucose monitor and the GC/MS reference method. VWB was analyzed by the glucose monitor, clinical analyzer, and the GC/MS method. PL was analyzed by the clinical analyzer and the GC/MS reference method.
Results: For the glucose monitor, the bias was 0.4% and -18.2% for CWB and VWB, respectively. The clinical analyzer had a bias of -25.4% for VWB and -12.0% for PL and a proportional bias was detected in both specimens. Using the clinical analyzer as a comparison method, the glucose monitor had a proportional bias of -9.8%.
Conclusion: The trueness of clinical analyzers can be affected by the specimen matrix that needs to be assessed before they are used as comparison method to assess trueness of glucose monitors.