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Challenges in harmonizing immunoassays: The use of the Bland-Altman based harmonization algorithm
Wenqing Liu1, Xing Qi1, Huaguo Wang2
1Department of Medical Laboratory, The Affiliated Hospital, Southwest Medical University, Sichuan, PR China; Department of Experimental Medicine, Ziyang Central Hospital, Sichuan, PR China.
Background:
In this study, we compared the recently proposed Bland-Altman plot-based harmonization algorithm (BA-BHA) with the weighted Deming regression-based harmonization algorithm (WD-BHA) taken as an example in ISO 21151:2020, aiming to evaluate the effectiveness of BA-BHA and discuss the applicability of these two different harmonization algorithms.
Methods:
BA-BHA and WD-BHA were applied to 19 measurands on LiCA medical devices, Chemclin Diagnostics Co., Ltd. A panel of 80 patient sera were collected for each measurand and the effectiveness of BA-BHA and the applicability of the two different harmonization algorithms were specified according to the Bland-Altman (B-A) plot, curve estimation and the Passing-Bablok regression.
Results:
After harmonized with BA-BHA, the mean of the B-A plot for each measurand was close to zero, and the limits of agreement (LoAs) met the quality requirements. The distribution of the variations in the B-A plot was demonstrated approximately symmetric over the measuring interval. Furthermore, "0" was included in the 95% confidence interval of the intercept and "1" was included in the 95% confidence interval of the slope for the Passing-Bablok regression, indicating acceptable harmonization effects for all 19 measurands. In contrast, acceptable harmonization effects were achieved in only some of the 19 measurands.
Conclusion:
Acceptable harmonization effects can be achieved for various measurands by BA-BHA because both the mean and the distribution of percent differences in the B-A plot can be adjusted, which demonstrating BA-BHA with a more extensive applicability compared to WD-BHA.
