Key result
The INCLIX POCT method for HbA1c determination demonstrated a statistically significant correlation with the Olympus AU400 automated method (r = 0.871, p < 0.01), although a negative bias indicates a need for standardization.
Why the study?
The study was conducted to examine the analytical characteristics of the novel INCLIX POCT method for HbA1c determination to test its performance before introducing it into routine use.
Does the INCLIX POCT method accurately measure HbA1c compared to the automated Olympus AU400 method in blood samples?
Observational (n=44)
No
Does the INCLIX POCT method accurately measure HbA1c compared to the automated Olympus AU400 method in blood samples?
The INCLIX POCT method for HbA1c shows significant correlation with automated laboratory testing but exhibits a negative bias requiring standardization before routine use.
INCLIX POCT HbA1c needs larger validation; leaves open routine adoption versus laboratory methods.
Previous research suggests that point-of-care (POCT) determination of glycated hemoglobin (HbA1c) is a diagnostic test that can be an adequate alternative to measuring HbA1c in the laboratory. The main goal of this study was to examine the analytical characteristics of the novel INCLIX POCT method for HbA1c determination in order to test its performance before introducing this method into routine use. HbA1c is measured in a duplicate in 44 EDTA blood samples parallel on INCLIX POCT device (Sugitech, Inc.) and using automated turbidimetric immunoinhibition test on Olympus AU400 (Beckman Coulter). The within run imprecision was 7.58%, between runs imprecision was 6.63% and 6.22%, and day-to-day imprecision was 8.80% and 7.51%. Total laboratory imprecision was in agreement with those stated by the manufacturer. A statistically significant Pearson correlation coefficient was calculated (r = 0.871, P < 0.01; linear R2 = 0.757). Using Deming regression analysis, the following equation was obtained: y = - 1.80 + 1.304x. Our results indicate statistically significant correlation, linear relationship, and a significant degree of compatibility between the two analyzed methods. However, the negative bias of the HbA1c values determined on the POCT analyzer compared to the Olympus AU400 was confirmed, highlighting the need to standardize the INCLIX method.
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Milinković et al. (2022) conducted an observational in Diabetes (HbA1c determination) (n=44). INCLIX POCT method vs. Olympus AU400 automated method was evaluated on Method agreement (Pearson correlation coefficient) (r = 0.871, p=<0.01). The INCLIX POCT method for HbA1c determination demonstrated a statistically significant correlation with the Olympus AU400 automated method (r = 0.871, p < 0.01), although a negative bias indicates a need for standardization.
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