Abstract
Objective The authors aimed to explore methods to establish indirect reference intervals for PIVKA-II from hospital-stored data.Method 7623 patient specimens of the Renmin Hospital of Wuhan University were collected. Indirect reference intervals were established based on the hospital-stored data with four different methods, including the Hoffmann method (HM), revised Hoffmann method (HMCDF), E-M algorithm-based method (EMBCT), and a recent estimator (KOSMIC). According to CLSI C28-A3 guidelines, 369 healthy specimens were collected. The authors tested the difference between reference intervals of gender-specific and age-specific subgroups using Harris and Boyd's test. Finally, the averaging result of estimates was calculated according to how likely each model was.Results The indirect reference intervals of PIVKA-II based on LIS data were 0 to 35.30 mAU/mL (HM), 0 to 31.48 mAU/mL (HMCDF), 0 to 30.78 mAU/mL (EMBCT), 0 to 36.17 mAU/mL (KOSMIC) and 0 to 31.48 mAU/mL (averaging) respectively, and the reference intervals based on healthy group were 0 to 32 mAU/mL. Compared with HM, EMBCT and KOSMIC, HMCDF and the averaging result was closer to those of the health group. Significant difference was detected between gender-partitioned subgroups, and the reference upper limit in the female group was smaller than the male group.Conclusions The authors established the indirect reference intervals of PIVKA-II for the Wuhan population, which could be used to the clinical reference intervals. The framework proposed could help clinical laboratory set their reference intervals of test items.
Structural correspondence, indirect reference, and partial truth: phlogiston theory and Newtonian mechanics