Stability of ten serum tumor markers after one year of storage at −18°C
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Etienne Mondésert
,
David-Paul De Brauwere
Abstract
Objectives
The storage of serum tumor markers (STM) at −18 °C for one year has been a legal requirement in France since 1999, but has been abolished in 2022. This raises the question of the relevance of maintaining these biobanks in terms of conditions of storage. These should only be implemented after validation; in order to maintain the integrity of the biological sample and must be controlled over time according to the laboratoryʼs procedures. The aim of the study was to assess the suitability of storing 10 STMs by evaluating their stability after one year of storage at −18 °C.
Methods
A new immuno-enzymatic assay (A+1) was conducted on samples that had been stored at −18 °C for one year after an initial assay (A) of one of the following STMs: carcino-embryonic antigen (CEA), alpha-fetoprotein (AFP), carbohydrate antigen 125 (CA125), carbohydrate antigen 15-3 (CA15-3), carbohydrate antigen 19-9 (CA19-9), total (TPSA), and free (FPSA) prostate-specific antigen, calcitonin (CT), thyroglobulin (TG), and neuro-specific enolase (NSE). The results were confronted to four different permissible error sources.
Results
In total, 1148 A+1 assays were performed. A strong correlation between A+1 and A values was found for all analytes, but with a statistically significant reduction in the mean A+1 concentration compared to the mean A concentration in 7/10 STMs. The bias induced by conservation seems to be technically unsustainable if we rely on the repositories closest to the current analytical performances.
Conclusions
These results support the discontinuation of mandatory STM biobank storage at −18 °C, which requires considerable technical time and organizational effort.
Acknowledgments
We want to sincerely thank the technical staff, especially Ms. Laetitia Lillamand, for assisting and contributing to this study.
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Research ethics: Not applicable.
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Informed consent: Not applicable.
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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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Research funding: None declared.
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Data availability: The raw data can be obtained on request from the corresponding author.
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Articles in the same Issue
- Frontmatter
- Editorial
- Analytical performance specifications – moving from models to practical recommendations
- Opinion Papers
- What the Milan conference has taught us about analytical performance specification model definition and measurand allocation
- The role of analytical performance specifications in international guidelines and standards dealing with metrological traceability in laboratory medicine
- How clinical laboratories select and use Analytical Performance Specifications (APS) in Italy
- Outcome-based analytical performance specifications: current status and future challenges
- Analytical performance specifications based on biological variation data – considerations, strengths and limitations
- State-of-the-art model for derivation of analytical performance specifications: how to define the highest level of analytical performance technically achievable
- Analytical performance specifications for combined uncertainty budget in the implementation of metrological traceability
- When bias becomes part of imprecision: how to use analytical performance specifications to determine acceptability of lot-lot variation and other sources of possibly unacceptable bias
- Using analytical performance specifications in a medical laboratory
- Issues in assessing analytical performance specifications in healthcare systems assembling multiple laboratories and measuring systems
- Applying the Milan models to setting analytical performance specifications – considering all the information
- Guidelines and Recommendations
- Recommendations for blood sampling in emergency departments from the European Society for Emergency Medicine (EUSEM), European Society for Emergency Nursing (EuSEN), and European Federation of Clinical Chemistry and Laboratory Medicine (EFLM) Working Group for the Preanalytical Phase. Executive summary
- General Clinical Chemistry and Laboratory Medicine
- Assessment of accuracy of laboratory testing results, relative to peer group consensus values in external quality control, by bivariate z-score analysis: the example of D-Dimer
- The stability of 65 biochemistry analytes in plasma, serum, and whole blood
- Assessment of the 2023 European Kidney Function Consortium (EKFC) equations in a Chinese adult population
- In vitro, in vivo metabolism and quantification of the novel synthetic opioid N-piperidinyl etonitazene (etonitazepipne)
- Quantification of blood glial fibrillary acidic protein using a second-generation microfluidic assay. Validation and comparative analysis with two established assays
- Association of prehospital lactate levels with base excess in various emergencies – a retrospective study
- Reference Values and Biological Variations
- Stability of ten serum tumor markers after one year of storage at −18°C
- Variations in tumor growth, intra-individual biological variability, and the interpretation of changes
- Cancer Diagnostics
- N-linked glycosylation of the M-protein variable region: glycoproteogenomics reveals a new layer of personalized complexity in multiple myeloma
- Cardiovascular Diseases
- Reference intervals for high sensitivity cardiac troponin I and N-terminal pro-B-type natriuretic peptide in children and adolescents on the Siemens Atellica
- Infectious Diseases
- Fetal chronic hypoxia does not affect urinary presepsin levels in newborns at birth
- Letters to the Editor
- AWMF statement on medical services in laboratory diagnostics and pathology with regard to the IVDR
- An outline of measurement uncertainty of total protein in urine estimated according to the ISO Technical Specification 20914
- Early diagnosis of severe illness in an outpatient – the Sysmex XN’s neutrophil reactivity parameter
- Analytical and diagnostic performance of Theradiag i-Tracker assays on IDS-iSYS for infliximab and adalimumab therapeutic drug monitoring
- Improving the diagnosis of AATD with aid of serum protein electrophoresis: a prospective, multicentre, validation study
- Cerebrospinal fluid kappa free light chains in patients with tumefactive demyelination
- Diagnostic value of quantitative chemiluminescence immunoassay for anti-gp210 and anti-sp100 antibodies in primary biliary cholangitis
Articles in the same Issue
- Frontmatter
- Editorial
- Analytical performance specifications – moving from models to practical recommendations
- Opinion Papers
- What the Milan conference has taught us about analytical performance specification model definition and measurand allocation
- The role of analytical performance specifications in international guidelines and standards dealing with metrological traceability in laboratory medicine
- How clinical laboratories select and use Analytical Performance Specifications (APS) in Italy
- Outcome-based analytical performance specifications: current status and future challenges
- Analytical performance specifications based on biological variation data – considerations, strengths and limitations
- State-of-the-art model for derivation of analytical performance specifications: how to define the highest level of analytical performance technically achievable
- Analytical performance specifications for combined uncertainty budget in the implementation of metrological traceability
- When bias becomes part of imprecision: how to use analytical performance specifications to determine acceptability of lot-lot variation and other sources of possibly unacceptable bias
- Using analytical performance specifications in a medical laboratory
- Issues in assessing analytical performance specifications in healthcare systems assembling multiple laboratories and measuring systems
- Applying the Milan models to setting analytical performance specifications – considering all the information
- Guidelines and Recommendations
- Recommendations for blood sampling in emergency departments from the European Society for Emergency Medicine (EUSEM), European Society for Emergency Nursing (EuSEN), and European Federation of Clinical Chemistry and Laboratory Medicine (EFLM) Working Group for the Preanalytical Phase. Executive summary
- General Clinical Chemistry and Laboratory Medicine
- Assessment of accuracy of laboratory testing results, relative to peer group consensus values in external quality control, by bivariate z-score analysis: the example of D-Dimer
- The stability of 65 biochemistry analytes in plasma, serum, and whole blood
- Assessment of the 2023 European Kidney Function Consortium (EKFC) equations in a Chinese adult population
- In vitro, in vivo metabolism and quantification of the novel synthetic opioid N-piperidinyl etonitazene (etonitazepipne)
- Quantification of blood glial fibrillary acidic protein using a second-generation microfluidic assay. Validation and comparative analysis with two established assays
- Association of prehospital lactate levels with base excess in various emergencies – a retrospective study
- Reference Values and Biological Variations
- Stability of ten serum tumor markers after one year of storage at −18°C
- Variations in tumor growth, intra-individual biological variability, and the interpretation of changes
- Cancer Diagnostics
- N-linked glycosylation of the M-protein variable region: glycoproteogenomics reveals a new layer of personalized complexity in multiple myeloma
- Cardiovascular Diseases
- Reference intervals for high sensitivity cardiac troponin I and N-terminal pro-B-type natriuretic peptide in children and adolescents on the Siemens Atellica
- Infectious Diseases
- Fetal chronic hypoxia does not affect urinary presepsin levels in newborns at birth
- Letters to the Editor
- AWMF statement on medical services in laboratory diagnostics and pathology with regard to the IVDR
- An outline of measurement uncertainty of total protein in urine estimated according to the ISO Technical Specification 20914
- Early diagnosis of severe illness in an outpatient – the Sysmex XN’s neutrophil reactivity parameter
- Analytical and diagnostic performance of Theradiag i-Tracker assays on IDS-iSYS for infliximab and adalimumab therapeutic drug monitoring
- Improving the diagnosis of AATD with aid of serum protein electrophoresis: a prospective, multicentre, validation study
- Cerebrospinal fluid kappa free light chains in patients with tumefactive demyelination
- Diagnostic value of quantitative chemiluminescence immunoassay for anti-gp210 and anti-sp100 antibodies in primary biliary cholangitis
