Establishing the blood reference interval of pancreatic elastase-1: A prospective study.

Abstract

Pancreatic elastase-1 (PE-1) has been investigated in pancreatic disorders. However, the reference interval (RI) of PE-1 in blood remains unconfirmed. We aimed to establish the blood RI of PE-1 in an adult population. In this prospective cross-sectional study, we enrolled 400 adults who had received the whole-body physical check-up program between May 1, 2019 and November 20, 2019. The serum and plasma PE-1 levels were measured by latex turbidimetric immunoassay in different storage conditions (fresh, refrigerated, and frozen). The 95% and 99% RI of PE-1 were calculated according to the Clinical & Laboratory Standards Institute guidelines. The correlations between PE-1 and other parameters were analyzed using multivariable regression models. Ultimately, 38 patients with acute pancreatitis were prospectively recruited as the validation cohort. The PE-1 levels in fresh serum were highly correlated with those in refrigerated (R2 =0.998) or frozen (R2 =0.942) samples; however, plasma should not be suggested in frozen conditions (plasma vs serum: R2 =0.185). In the RI study population (202 male & 198 female participants), the median age was 52.6 (25-75% interquartile range: 43.1-61.0). The 95% and 99% RIs of PE-1 were 30.0-221.0 and 22.0-359.0ng/dL, respectively. Triglycerides (β=0.106, P=0.033), lipase (β=0.154, P=0.007), and CA19-9 (β=0.130, P=0.008) were independent factors associated with PE-1. In the pancreatitis validation cohort, with a cut-off value of 359.0ng/dL, the sensitivity and specificity were 100% and 99.8%, respectively. The RI of PE-1 established in this study can be used for further applications. Serum is the suggested form for frozen sample storage.