Indirect method for validating transference of reference intervals
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Simon Lykkeboe
Abstract
Background:
Transference of reference intervals (RIs) from multicentre studies are often verified by use of a small number of samples from reference individuals or by the use of one serum sample (Serum X for NORIP RI). Despite recommended and appropriate methods, both have inconveniencies and drawbacks. Several attempts have been made to develop an indirect method, which uses historical data from the laboratory. These methods are retrospective relying on older test results. A near prospective method would be preferable for the laboratories introducing new methods or changing analytical platforms.
Methods:
We performed a data mining experiment using results from our laboratory information system covering patients from a large geographic area. Request patterns for patients with assumed healthy characteristics were identified and used to extract laboratory results for calculation of new RI by an indirect method. Calculated RI and confidence intervals (CIs) were compared to transferred NORIP RI verified by NFKK Reference Serum X.
Results:
We found that our indirect method and NFKK Reference Serum X in general produced similar results when verifying transference of RI. The method produces results for all stratifications. Only single stratifications and one analyte showed unexplained incongruences to the NORIP RI.
Conclusions:
Our results suggest using request patterns as a surrogate measure for good health status. This allows for a data mining method for validation of RI or validating their transference, which is likely to be applicable in countries with similar healthcare and laboratory information system.
Acknowledgments
The authors thank the staff at the Department of Clinical Biochemistry, Aalborg University Hospital, for valuable discussions and Professor Aase Handberg for critical reading of the manuscript.
Author contributions: All the authors have accepted responsibility for the entire content of this submitted manuscript and approved submission.
Research funding: None declared.
Employment or leadership: None declared.
Honorarium: None declared.
Competing interests: The funding organisation(s) played no role in the study design; in the collection, analysis, and interpretation of data; in the writing of the report; or in the decision to submit the report for publication.
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©2018 Walter de Gruyter GmbH, Berlin/Boston
Artikel in diesem Heft
- Frontmatter
- Editorial
- Analytical quality: an unfinished journey
- Reviews
- Update in diagnosis and management of primary aldosteronism
- Diagnosis biomarkers in acute intestinal ischemic injury: so close, yet so far
- Opinion Papers
- Irregular analytical errors in diagnostic testing – a novel concept
- A Black Swan in clinical laboratory practice: the analytical error due to interferences in immunoassay methods
- General Clinical Chemistry and Laboratory Medicine
- Reaching consensus on communication of critical laboratory results using a collective intelligence method
- Stability of routine biochemical analytes in whole blood and plasma/serum: focus on potassium stability from lithium heparin
- GFR estimation based on standardized creatinine and cystatin C: a European multicenter analysis in older adults
- Binding of bromocresol green and bromocresol purple to albumin in hemodialysis patients
- Interlaboratory variability of urinary iodine measurements
- The venous thromboembolic risk and the clot wave analysis: a useful relationship?
- Hematology and Coagulation
- Autovalidation and automation of the postanalytical phase of routine hematology and coagulation analyses in a university hospital laboratory
- Reference Values and Biological Variations
- Indirect method for validating transference of reference intervals
- Differences in levels of albumin, ALT, AST, γ-GT and creatinine in frail, moderately healthy and healthy elderly individuals
- Cancer Diagnostics
- Serum exosomal hnRNPH1 mRNA as a novel marker for hepatocellular carcinoma
- Intragenic hypomethylation of DNMT3A in patients with myelodysplastic syndrome
- Cardiovascular Diseases
- Evaluation of analytical performance of a new high-sensitivity immunoassay for cardiac troponin I
- MEF2C loss-of-function mutation associated with familial dilated cardiomyopathy
- Letter to the Editor
- Hyperuricemia does not seem to be an independent risk factor for coronary heart disease
- Reply to: Hyperuricemia does not seem to be an independent risk factor for coronary heart disease
- Preanalytics of ammonia: stability, transport and temperature of centrifugation
- Influence of delayed separation of plasma from whole blood on Cu, I, Mn, Se, and Zn plasma concentrations
- Copeptin as a diagnostic and prognostic biomarker in patients admitted to Emergency Department with syncope, presyncope and vertiginous syndrome
- Development of an internally controlled quantitative PCR to measure total cell-associated HIV-1 DNA in blood
- Selective changes in cholesterol metabolite levels in plasma of breast cancer patients after tumor removal
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Artikel in diesem Heft
- Frontmatter
- Editorial
- Analytical quality: an unfinished journey
- Reviews
- Update in diagnosis and management of primary aldosteronism
- Diagnosis biomarkers in acute intestinal ischemic injury: so close, yet so far
- Opinion Papers
- Irregular analytical errors in diagnostic testing – a novel concept
- A Black Swan in clinical laboratory practice: the analytical error due to interferences in immunoassay methods
- General Clinical Chemistry and Laboratory Medicine
- Reaching consensus on communication of critical laboratory results using a collective intelligence method
- Stability of routine biochemical analytes in whole blood and plasma/serum: focus on potassium stability from lithium heparin
- GFR estimation based on standardized creatinine and cystatin C: a European multicenter analysis in older adults
- Binding of bromocresol green and bromocresol purple to albumin in hemodialysis patients
- Interlaboratory variability of urinary iodine measurements
- The venous thromboembolic risk and the clot wave analysis: a useful relationship?
- Hematology and Coagulation
- Autovalidation and automation of the postanalytical phase of routine hematology and coagulation analyses in a university hospital laboratory
- Reference Values and Biological Variations
- Indirect method for validating transference of reference intervals
- Differences in levels of albumin, ALT, AST, γ-GT and creatinine in frail, moderately healthy and healthy elderly individuals
- Cancer Diagnostics
- Serum exosomal hnRNPH1 mRNA as a novel marker for hepatocellular carcinoma
- Intragenic hypomethylation of DNMT3A in patients with myelodysplastic syndrome
- Cardiovascular Diseases
- Evaluation of analytical performance of a new high-sensitivity immunoassay for cardiac troponin I
- MEF2C loss-of-function mutation associated with familial dilated cardiomyopathy
- Letter to the Editor
- Hyperuricemia does not seem to be an independent risk factor for coronary heart disease
- Reply to: Hyperuricemia does not seem to be an independent risk factor for coronary heart disease
- Preanalytics of ammonia: stability, transport and temperature of centrifugation
- Influence of delayed separation of plasma from whole blood on Cu, I, Mn, Se, and Zn plasma concentrations
- Copeptin as a diagnostic and prognostic biomarker in patients admitted to Emergency Department with syncope, presyncope and vertiginous syndrome
- Development of an internally controlled quantitative PCR to measure total cell-associated HIV-1 DNA in blood
- Selective changes in cholesterol metabolite levels in plasma of breast cancer patients after tumor removal
- Athletes beware before throwing towels to audiences
