Establishing the blood reference interval of pancreatic elastase-1: A prospective study
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Su-Fen Chi1, Chia-Yeh Lai2, Wei-Ting Dong1
1Department of Pathology and Laboratory Medicine, Taichung Veterans General Hospital, Taichung, Taiwan.
Insights
This study establishes the blood reference interval (RI) for pancreatic elastase-1 (PE-1) in adults. Serum is recommended for frozen sample storage, with established RIs aiding further diagnostic applications.
Area of Science:
- Biochemistry
- Clinical Chemistry
- Pancreatic Physiology
Background:
- Pancreatic elastase-1 (PE-1) is crucial in pancreatic disorders.
- A confirmed blood reference interval (RI) for PE-1 is lacking.
- Establishing a reliable PE-1 RI is essential for clinical diagnostics.
Purpose of the Study:
- To establish the blood reference interval (RI) for pancreatic elastase-1 (PE-1) in an adult population.
- To evaluate the stability of PE-1 in serum and plasma under various storage conditions.
- To identify factors associated with PE-1 levels and validate its diagnostic utility in acute pancreatitis.
Main Methods:
- Prospective cross-sectional study of 400 adults.
- Measurement of serum and plasma PE-1 using latex turbidimetric immunoassay.
- Calculation of 95% and 99% RIs following CLSI guidelines.
- Multivariable regression analysis for associated factors and validation in 38 acute pancreatitis patients.
Main Results:
- High correlation of PE-1 levels in fresh, refrigerated, and frozen serum samples (R² ≥ 0.942).
- Plasma is not recommended for frozen storage (R² = 0.185 vs. serum).
- Established 95% RI: 30.0-221.0 ng/dL; 99% RI: 22.0-359.0 ng/dL.
- Triglycerides, lipase, and CA19-9 are independent factors associated with PE-1.
- Validation cohort showed 100% sensitivity and 99.8% specificity for acute pancreatitis using a 359.0 ng/dL cut-off.
Conclusions:
- The established PE-1 reference interval is suitable for clinical applications.
- Serum is the preferred sample type for frozen storage of PE-1.
- PE-1 measurement, with defined RIs, can aid in diagnosing pancreatic disorders like acute pancreatitis.
Background And Aim:
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.
Methods:
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.
Results:
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 22.0-359.0 ng/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 359.0 ng/dL, the sensitivity and specificity were 100% and 99.8%, respectively.
Conclusion:
The RI of PE-1 established in this study can be used for further applications. Serum is the suggested form for frozen sample storage.
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