Enhancing laboratory test consistency through linear transformation: A multi-center study

Area of Science:

• Clinical chemistry
• Laboratory medicine
• Medical diagnostics

Background:

• Mutual recognition of clinical laboratory test results is promoted in China to reduce redundancy, improve convenience, and lower costs.
• Ensuring consistency of test results across different laboratories is crucial for reliable medical services.

Purpose of the Study:

• To enhance the consistency of clinical laboratory test results across laboratories using a linear transformation method.
• To facilitate the mutual recognition of biochemical test results, focusing on ALP, CA, TBIL, TC, and TG.

Main Methods:

• Five ISO 15189 accredited laboratories participated in the study.
• Inter-laboratory and intra-laboratory conversion relationships were established using patient samples and quality control (QC) data.
• A web-based tool was developed for real-time conversion and mutual recognition of laboratory test results.

Main Results:

• The linear transformation method significantly improved the consistency of test results.
• After three conversion stages, most results showed deviations within ±1/2 TEa compared to a reference laboratory.
• Less significant conversion effects were observed for some low-value parameters due to measurement sensitivity.

Conclusions:

• The developed linear transformation approach and web tool can enhance result consistency and facilitate mutual recognition.
• The method shows potential for broader application in clinical laboratory settings.
• Further research is needed due to limitations such as small sample size and focus on limited parameters.