Abstract
Although being the recommended laboratory test to diagnose acute pancreatitis, serum pancreatic lipase (LIP) is among the poorly standardized laboratory tests, and laboratory stakeholders often appear to not take enough care of the quality of its measurements. Here we discuss some important issues that, if not correctly managed and solved, make misdiagnosis of acute pancreatitis by using serum LIP a real possibility. First, the current unavailability of a suitable higher-order reference material to be used as common calibrator should be filled up to definitively improve the inter-method bias. Second, knowledge of the analytical characteristics that may explain the defective performance of LIP assays should be deepened. IVD manufacturers should be more explicit in providing this information, including description of their internal protocol for transferring LIP values from internal references to commercial calibrators. Third, recommended models for accurately estimating measurement uncertainty and reliably defining analytical performance specifications for LIP measurements should be applied. Finally, investments considering alternative options for measuring LIP (e.g., targeted to the development of automated LIP immunoassays) should be warranted. All involved stakeholders (standardization bodies, higher-order reference providers, in vitro diagnostics manufacturers, and laboratory professionals) should contribute to fill the existing gap.
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Research funding: None declared.
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Author contributions: All authors have accepted responsibility for the entire content of this manuscript and approved its submission.
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Competing interests: Authors state no conflict of interest.
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Informed consent: Not applicable.
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Ethical approval: Not applicable.
References
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© 2021 Walter de Gruyter GmbH, Berlin/Boston
Articles in the same Issue
- Frontmatter
- Editorials
- Optimizing effectiveness of COVID-19 vaccination: will laboratory stewardship play a role?
- Mathematical recalibration of total bile acids: comparing the incomparable?
- Reviews
- Could metabolomics drive the fate of COVID-19 pandemic? A narrative review on lights and shadows
- Low free-T3 serum levels and prognosis of COVID-19: systematic review and meta-analysis
- Opinion Paper
- Pancreatic lipase: why laboratory community does not take enough care of this clinically important test?
- General Clinical Chemistry and Laboratory Medicine
- The BACH project protocol: an international multicentre total Bile Acid Comparison and Harmonisation project and sub-study of the TURRIFIC randomised trial
- Comparability of 11 different equations for estimating LDL cholesterol on different analysers
- Streamlined three step total vitamin C analysis by HILIC-UV for laboratory testing
- Hematology and Coagulation
- Anti-phosphatidyl-serine/prothrombin antibodies (aPS/PT) in isolated lupus anticoagulant (LA): is their presence linked to dual test positivity?
- Cancer Diagnostics
- Consideration should be given to smoking, endometriosis, renal function (eGFR) and age when interpreting CA125 and HE4 in ovarian tumor diagnostics
- Monitoring the M-protein of multiple myeloma patients treated with a combination of monoclonal antibodies: the laboratory solution to eliminate interference
- Cardiovascular Diseases
- Identification of macrotroponin T: findings from a case report and non-reproducible troponin T results
- Diabetes
- Impact of optimizing pre-analytical phase on the diagnosis of gestational diabetes and related outcomes
- Infectious Diseases
- Daily monitoring of viral load measured as SARS-CoV-2 antigen and RNA in blood, IL-6, CRP and complement C3d predicts outcome in patients hospitalized with COVID-19
- Alternative detection of SARS-CoV-2 RNA by a new assay based on mass spectrometry
- Performance evaluation of an automated SARS-CoV-2 Ag test for the diagnosis of COVID-19 infection on nasopharyngeal swabs
- Predicting the protective humoral response to a SARS-CoV-2 mRNA vaccine
- Quantitative serological evaluation as a valuable tool in the COVID-19 vaccination campaign
- Letters to the Editors
- Effects of various pre-analytical conditions on blood-based biomarkers of Alzheimer’s disease
- Stability of lactate in venous blood gas and sodium fluoride-potassium oxalate plasma: a 6-year retrospective database analysis
- Validation of the Fujirebio Lumipulse G1200 aldosterone assay for measurements during adrenal venous sampling for primary hyperaldosteronism
- The new Roche Elecsys TSH assay conforms with current IFCC C-STFT standards
- Development of an inverse-PCR approach for characterization of the major BCR-ABL1 breakpoint sequences on genomic DNA: proof of concept
- Antiphospholipid antibodies quantification using ALBIA technology: how to define an optimal cutoff?
- Simultaneous occurrence of EDTA-dependent lymphoagglutination and agglutination of myeloid cells in a patient with chronic myelomonocytic leukemia
- NT-proBNP use in old patients and the impact of the selected threshold value: a big data analysis
- Congress Abstracts
- 53rd National Congress of the Italian Society of Clinical Biochemistry and Clinical Molecular Biology (SIBioC – Laboratory Medicine)
Articles in the same Issue
- Frontmatter
- Editorials
- Optimizing effectiveness of COVID-19 vaccination: will laboratory stewardship play a role?
- Mathematical recalibration of total bile acids: comparing the incomparable?
- Reviews
- Could metabolomics drive the fate of COVID-19 pandemic? A narrative review on lights and shadows
- Low free-T3 serum levels and prognosis of COVID-19: systematic review and meta-analysis
- Opinion Paper
- Pancreatic lipase: why laboratory community does not take enough care of this clinically important test?
- General Clinical Chemistry and Laboratory Medicine
- The BACH project protocol: an international multicentre total Bile Acid Comparison and Harmonisation project and sub-study of the TURRIFIC randomised trial
- Comparability of 11 different equations for estimating LDL cholesterol on different analysers
- Streamlined three step total vitamin C analysis by HILIC-UV for laboratory testing
- Hematology and Coagulation
- Anti-phosphatidyl-serine/prothrombin antibodies (aPS/PT) in isolated lupus anticoagulant (LA): is their presence linked to dual test positivity?
- Cancer Diagnostics
- Consideration should be given to smoking, endometriosis, renal function (eGFR) and age when interpreting CA125 and HE4 in ovarian tumor diagnostics
- Monitoring the M-protein of multiple myeloma patients treated with a combination of monoclonal antibodies: the laboratory solution to eliminate interference
- Cardiovascular Diseases
- Identification of macrotroponin T: findings from a case report and non-reproducible troponin T results
- Diabetes
- Impact of optimizing pre-analytical phase on the diagnosis of gestational diabetes and related outcomes
- Infectious Diseases
- Daily monitoring of viral load measured as SARS-CoV-2 antigen and RNA in blood, IL-6, CRP and complement C3d predicts outcome in patients hospitalized with COVID-19
- Alternative detection of SARS-CoV-2 RNA by a new assay based on mass spectrometry
- Performance evaluation of an automated SARS-CoV-2 Ag test for the diagnosis of COVID-19 infection on nasopharyngeal swabs
- Predicting the protective humoral response to a SARS-CoV-2 mRNA vaccine
- Quantitative serological evaluation as a valuable tool in the COVID-19 vaccination campaign
- Letters to the Editors
- Effects of various pre-analytical conditions on blood-based biomarkers of Alzheimer’s disease
- Stability of lactate in venous blood gas and sodium fluoride-potassium oxalate plasma: a 6-year retrospective database analysis
- Validation of the Fujirebio Lumipulse G1200 aldosterone assay for measurements during adrenal venous sampling for primary hyperaldosteronism
- The new Roche Elecsys TSH assay conforms with current IFCC C-STFT standards
- Development of an inverse-PCR approach for characterization of the major BCR-ABL1 breakpoint sequences on genomic DNA: proof of concept
- Antiphospholipid antibodies quantification using ALBIA technology: how to define an optimal cutoff?
- Simultaneous occurrence of EDTA-dependent lymphoagglutination and agglutination of myeloid cells in a patient with chronic myelomonocytic leukemia
- NT-proBNP use in old patients and the impact of the selected threshold value: a big data analysis
- Congress Abstracts
- 53rd National Congress of the Italian Society of Clinical Biochemistry and Clinical Molecular Biology (SIBioC – Laboratory Medicine)