Serum amylase and lipase levels in healthy volunteers assessed by multiple commercial analyzers: Variability with established reference values

Date
2021
Language
American English
Embargo Lift Date
Committee Members
Degree
Degree Year
Department
Grantor
Journal Title
Journal ISSN
Volume Title
Found At
Journal of Gastroenterology Research and Practice
Abstract

Background/Aims: Although serum pancreatic enzyme measurements for amylase and lipase are the most widely used biochemical tests for the diagnosis of pancreatitis, limitations for their interpretation of pancreatic disease do exist. An international reference method or an evidence-based cut-off value of serum pancreatic enzyme levels has not been established to facilitate standardization. Therefore, different analytic methods for serum pancreatic enzyme levels have verified their own Reference Ranges (RR) as normal values. The aim of this study is to evaluate the frequency of serum pancreatic enzyme values outside of the RR in healthy volunteers, using 5 different pancreatic enzyme analyzers to determine variability of values between analyzers.

Methods: Healthy volunteers were screened to exclude a history of pancreatic disease or pancreatic surgery, severe gastrointestinal disease, excess alcohol intake, tobacco use, amongst other conditions. Volunteers were prospectively enrolled and blood samples from a single draw were analyzed for serum pancreatic enzyme levels on five different automated chemistry analyzer platforms. Whether or not the results were within each analyzer's institutional RR was evaluated.

Results: Among screened healthy volunteers, 180 participants were enrolled who met the inclusion criteria. Serum amylase results were outside the RR in 8 (4.4%), 11 (7.2%), 19 (10.5%), 6 (3.3%) and 7 (3.9%) subjects, respectively, based on the 5 separate analyzers. Serum lipase results were not within the RR in 3 (1.7%), 20 (13.2%), 13 (7.2%), 1 (0.6%) and 2 (1.1%) subjects, respectively. Among all 22 (12.2%) subjects that were outliers of the serum amylase level, 10 (5.6%) of those subjects were outside of the RR for two or more analyzers. In contrast, among all 32 (17.8%) subjects who were outliers of serum lipase level, only four subjects (2.2%) were outside of the RR for two or more analyzers.

Conclusion: Although there was slight variability in test results for serum amylase and lipase between different commonly available testing systems in healthy subjects, no values exceeded three times the upper limit of normal. There was a small group of healthy volunteers that fell outside of the reference range on two or more analyzers. If there is clinical ambiguity due to an abnormal serum pancreatic enzyme, further diagnostic testing can be pursued. Standardization amongst pancreas enzyme analyzers with a unified reference methodology and standard would be beneficial.

Description
item.page.description.tableofcontents
item.page.relation.haspart
Cite As
Kumar V, Gromski MA, Kwon C, Zimmerman MK, McNulty GM, et al. Serum amylase and lipase levels in healthy volunteers assessed by multiple commercial analyzers: Variability with established reference values. Japanese J Gastroenterol Res. 2021; 1(3): 1011.
ISSN
Publisher
Series/Report
Sponsorship
Major
Extent
Identifier
Relation
Journal
Japanese Journal of Gastroenterology Research
Source
Publisher
Alternative Title
Type
Article
Number
Volume
Conference Dates
Conference Host
Conference Location
Conference Name
Conference Panel
Conference Secretariat Location
Version
Final published version
Full Text Available at
This item is under embargo {{howLong}}