PMID- 34498301
OWN - NLM
STAT- MEDLINE
DCOM- 20220328
LR  - 20220328
IS  - 1440-1746 (Electronic)
IS  - 0815-9319 (Linking)
VI  - 37
IP  - 1
DP  - 2022 Jan
TI  - Establishing the blood reference interval of pancreatic elastase-1: A prospective 
      study.
PG  - 117-123
LID - 10.1111/jgh.15685 [doi]
AB  - 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 (R(2)  = 0.998) or frozen (R(2) 
       = 0.942) samples; however, plasma should not be suggested in frozen conditions 
      (plasma vs serum: R(2)  = 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 (beta = 0.106, P = 0.033), lipase (beta = 0.154, 
      P = 0.007), and CA19-9 (beta = 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.
CI  - (c) 2021 Journal of Gastroenterology and Hepatology Foundation and John Wiley & 
      Sons Australia, Ltd.
FAU - Chi, Su-Fen
AU  - Chi SF
AD  - Department of Pathology and Laboratory Medicine, Taichung Veterans General 
      Hospital, Taichung, Taiwan.
FAU - Lai, Chia-Yeh
AU  - Lai CY
AD  - Division of Gastroenterology and Hepatology, Department of Internal Medicine, 
      Taichung Veterans General Hospital, Taichung, Taiwan.
FAU - Dong, Wei-Ting
AU  - Dong WT
AD  - Department of Pathology and Laboratory Medicine, Taichung Veterans General 
      Hospital, Taichung, Taiwan.
FAU - Wang, Jiunn-Min
AU  - Wang JM
AD  - Department of Pathology and Laboratory Medicine, Taichung Veterans General 
      Hospital, Taichung, Taiwan.
FAU - Wang, Ya-Yu
AU  - Wang YY
AD  - Division of Family Medicine, Taichung Veterans General Hospital, Taichung, 
      Taiwan.
FAU - Yang, Sheng-Shun
AU  - Yang SS
AUID- ORCID: 0000-0002-7665-0988
AD  - Division of Gastroenterology and Hepatology, Department of Internal Medicine, 
      Taichung Veterans General Hospital, Taichung, Taiwan.
AD  - School of Medicine, Chung Shan Medical University, Taichung, Taiwan.
AD  - Ph.D. Program in Translational Medicine, National Chung Hsing University, 
      Taichung, Taiwan.
AD  - Institute of Biomedical Sciences, National Chung Hsing University, Taichung, 
      Taiwan.
FAU - Lin, Jaw-Town
AU  - Lin JT
AUID- ORCID: 0000-0001-9368-6141
AD  - Digestive Medicine Center, China Medical University Hospital, Taichung, Taiwan.
FAU - Lee, Teng-Yu
AU  - Lee TY
AUID- ORCID: 0000-0002-4097-4315
AD  - Division of Gastroenterology and Hepatology, Department of Internal Medicine, 
      Taichung Veterans General Hospital, Taichung, Taiwan.
AD  - School of Medicine, Chung Shan Medical University, Taichung, Taiwan.
LA  - eng
GR  - MOST 109-2327-B-039-001/Ministry of Science and Technology, Taiwan/
GR  - DMR 109-215/China Medical University/
GR  - Medicare Product Inc./
GR  - TCVGH-1093302C/Biostatistics Task Force of Taichung Veterans General Hospital/
GR  - Clinical Informatics Research & Development Center of Taichung Veterans General 
      Hospital/
PT  - Journal Article
DEP - 20210929
PL  - Australia
TA  - J Gastroenterol Hepatol
JT  - Journal of gastroenterology and hepatology
JID - 8607909
RN  - EC 3.4.21.36 (Pancreatic Elastase)
SB  - IM
MH  - Acute Disease
MH  - Adult
MH  - Cross-Sectional Studies
MH  - Female
MH  - Humans
MH  - Male
MH  - Middle Aged
MH  - *Pancreatic Elastase/blood
MH  - *Pancreatitis/blood/diagnosis
MH  - Prospective Studies
MH  - Reference Values
MH  - Sensitivity and Specificity
OTO - NOTNLM
OT  - acute pancreatitis
OT  - biomarker
OT  - immunoreactive
OT  - pancreatic cancer
EDAT- 2021/09/10 06:00
MHDA- 2022/03/29 06:00
CRDT- 2021/09/09 07:06
PHST- 2021/08/02 00:00 [revised]
PHST- 2021/04/23 00:00 [received]
PHST- 2021/08/30 00:00 [accepted]
PHST- 2021/09/10 06:00 [pubmed]
PHST- 2022/03/29 06:00 [medline]
PHST- 2021/09/09 07:06 [entrez]
AID - 10.1111/jgh.15685 [doi]
PST - ppublish
SO  - J Gastroenterol Hepatol. 2022 Jan;37(1):117-123. doi: 10.1111/jgh.15685. Epub 
      2021 Sep 29.