Wenqing Liu , Xing Qi , Huaguo Wang , Sheng Lin , Yan Zhang , Ping Zhu , Xiaoqin Gou , Xin Chang , Wenqing Chu , Jinbo Liu , Yuanbiao Guo
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引用次数: 0
Abstract
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.
期刊介绍：
The Official Journal of the International Federation of Clinical Chemistry and Laboratory Medicine (IFCC)
Clinica Chimica Acta is a high-quality journal which publishes original Research Communications in the field of clinical chemistry and laboratory medicine, defined as the diagnostic application of chemistry, biochemistry, immunochemistry, biochemical aspects of hematology, toxicology, and molecular biology to the study of human disease in body fluids and cells.
The objective of the journal is to publish novel information leading to a better understanding of biological mechanisms of human diseases, their prevention, diagnosis, and patient management. Reports of an applied clinical character are also welcome. Papers concerned with normal metabolic processes or with constituents of normal cells or body fluids, such as reports of experimental or clinical studies in animals, are only considered when they are clearly and directly relevant to human disease. Evaluation of commercial products have a low priority for publication, unless they are novel or represent a technological breakthrough. Studies dealing with effects of drugs and natural products and studies dealing with the redox status in various diseases are not within the journal''s scope. Development and evaluation of novel analytical methodologies where applicable to diagnostic clinical chemistry and laboratory medicine, including point-of-care testing, and topics on laboratory management and informatics will also be considered. Studies focused on emerging diagnostic technologies and (big) data analysis procedures including digitalization, mobile Health, and artificial Intelligence applied to Laboratory Medicine are also of interest.
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