An improved auto-generation system to obtain reference intervals for laboratory medicine.

ABSTRACT

OBJECTIVES: Reference values are highly required parameters for all tests in the clinical laboratory, and the supplementary provision of reliable reference intervals is an important task for both clinical laboratories and diagnostic test manufacturers. Despite the progress that has been made in the conceptual aspects of reference intervals, in practice their use is still not completely satisfactory. Most of the laboratories have used various methods to calculate statistic-based reference intervals, and they have mainly focused on extracted data, yet its use is considerably limited. We had to deal with the inconvenience of using a number of programs (SPSS or SAS, MS Excel) in order to calculate the results of reference intervals. METHODS: In order to obtain standardized reference intervals, we developed an integrated program that can calculate, by a nonparametric method, reference intervals with using the Clinical and Laboratory Standards Institute (CLSI) processes as its guideline. We also developed a grouping interface that enables users to customize classification of each group (age, gender, blood group, race, etc) when calculating reference intervals. RESULTS: To verify the developed program, we compared the reference intervals of the current data on 281 persons for 8 total areas, and the reference intervals were was already calculated beforehand with by using this new program. As a result, both results perfectly matched. CONCLUSIONS: This integrated program will be convenience for calculating reasonable values through continual datainspection at an inspection lab for calculating reference intervals. The newly developed program will improve the consistency and reliability of the statistics on reference intervals.