Shitong Cheng , Dongliang Man , Zhiwei Zhou , Hui Kang
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引用次数: 0
Abstract
Objectives
China is promoting the mutual recognition of clinical laboratory test results to reduce redundant testing, provide more convenient medical services, and lower economic burdens. This study aimed to enhance the consistency of test results across laboratories using a linear transformation method, focusing on five representative biochemical parameters: ALP, CA, TBIL, TC, and TG.
Methods
Five ISO 15189 accredited laboratories participated in this study. We established inter-laboratory and intra-laboratory conversion relationships using patient sample comparisons and daily quality control (QC) data. These relationships were used to develop a web-based tool enabling real-time conversion and mutual recognition of laboratory test results.
Results
The study found that the linear transformation method effectively improved the consistency of test results. After three stages of conversion, most test results showed deviations within ±1/2 TEa when compared to a reference laboratory. However, some parameters in the low-value range exhibited less significant conversion effects, likely due to the sensitivity of percentage deviation measurements in this range.
Conclusions
The developed approach and web-based tool show potential for enhancing result consistency and facilitating mutual recognition across laboratories. Despite its effectiveness, the study's limitations, such as a small sample size and a narrow focus on five biochemical parameters, indicate the need for further research and broader application.
期刊介绍:
Practical Laboratory Medicine is a high-quality, peer-reviewed, international open-access journal publishing original research, new methods and critical evaluations, case reports and short papers in the fields of clinical chemistry and laboratory medicine. The objective of the journal is to provide practical information of immediate relevance to workers in clinical laboratories. The primary scope of the journal covers clinical chemistry, hematology, molecular biology and genetics relevant to laboratory medicine, microbiology, immunology, therapeutic drug monitoring and toxicology, laboratory management and informatics. We welcome papers which describe critical evaluations of biomarkers and their role in the diagnosis and treatment of clinically significant disease, validation of commercial and in-house IVD methods, method comparisons, interference reports, the development of new reagents and reference materials, reference range studies and regulatory compliance reports. Manuscripts describing the development of new methods applicable to laboratory medicine (including point-of-care testing) are particularly encouraged, even if preliminary or small scale.