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An improved auto-generation system to obtain reference intervals for laboratory medicine
Hyung Hoi Kim1, Hae Sook Hong, Shine Young Kim
1Department of Laboratory Medicine and Biomedical Informatics, College of Medicine, Pusan National University, Busan, Korea.
A new integrated program standardizes clinical laboratory reference intervals using nonparametric methods and CLSI guidelines. This tool enhances the consistency and reliability of reference interval calculations, simplifying data analysis for diagnostic test manufacturers and laboratories.
Area of Science:
- Clinical laboratory science
- Biostatistics
- Diagnostic test development
Background:
- Reliable reference intervals are crucial for clinical laboratory testing, yet current methods for their calculation are often unsatisfactory.
- Existing statistical approaches for reference intervals are limited by data extraction and require multiple software programs, causing inconvenience.
Purpose of the Study:
- To develop an integrated program for standardized calculation of reference intervals.
- To improve the convenience and reliability of reference interval determination in clinical laboratories.
Main Methods:
- Developed an integrated program utilizing a nonparametric method aligned with Clinical and Laboratory Standards Institute (CLSI) guidelines.
- Incorporated a user-friendly grouping interface for customizable classification (age, gender, race, etc.) during reference interval calculation.
Main Results:
- The developed program was verified by comparing its calculated reference intervals with pre-existing data for 281 individuals across 8 areas.
- The results obtained from the new program perfectly matched the previously calculated reference intervals, confirming its accuracy.
Conclusions:
- The integrated program offers a convenient solution for calculating accurate reference intervals through continuous data inspection.
- This novel program is expected to significantly enhance the consistency and reliability of statistical data pertaining to reference intervals.
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