Establishment of PIVKA-Ⅱ Reference Intervals From Hospital-stored Data: A Comparison Analysis

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.