[The investigation of reference intervals application status of the analytes in coagulation test].

OBJECTIVE

To investigate and analyze the reference interval application status of analytes in coagulation tests.

METHODS

Every laboratories attended 2012 external quality assessment program were received an internet questionnaire about the resource, grouping and ranges of analytes of coagulation test. By using Microsoft excel 2007 and SPSS 13.0 to analyze the submitted data and calculate the arithmetic averages, medians, maximum values, minimum values, and the 2.5% and 97.5% percentages after eliminating the outliers. The data of every analytes was divided into 4-5 subgroups by different kinds of reagents. Meanwhile, each subgroup was also conducted statistical analysis for further description.

RESULTS

There were 403 laboratories submitting the investigation questionnaire. The top three resources of reference intervals were reagent manufacturer instruction (56.33%-57.32%), calculated by laboratories themselves (15.25%-21.34%), and national guide to clinical laboratory procedures (19.11%-23.00%). Most laboratories did not conduct gender grouping in PT, INR and Fbg. The reference intervals conducted gender grouping had little difference from the medians. The median of lower and upper limits of analytes of coagulation test were as of follows: PT, male (10.3, 14.4) s, female (10.8, 14.4) s, totally (10.0, 14.0) s; INR, male, female and totally (0.80, 1.20); APTT, male (25.0, 40.0) s, female (24.5, 40.0) s, totally (23.0, 38.5) s; Fbg, male, female and totally (2.0, 4.0) g/L. Some of lower and upper limits of subgroups of analytes of coagulation test had significant statistical differences between each other. The distributions of the 2.5% and 97.5% percentages of difference reagent manufacturers were not same as others.

CONCLUSION

There were little differences between the arithmetic averages and medians of the lower and upper limits of PT, INR, APTT and Fbg, but the consistencies of the distributions of the 2.5% and 97.5% percentages were not very well. The resources of reference intervals had some major categories. We suggest establishing new reference intervals to apply most parts of China.