Abstract
Background: Allowable total error is usually derived from data on biological variation or from state-of-the-art of measuring technology. Here we present a new principle for evaluating allowable total error when the concentration of the analyte (the measurand) is used for prediction: What are the predictive consequences of allowable total errors in terms of errors in the estimate of the hazard ratio (HR)?
Methods: We explored the effect of analytical measurement errors on Cox regression estimates of HR. Published data on Cox regression coefficients were used to illustrate the effect of measurement errors on predicting cardiovascular events or death based on serum concentration of cholesterol and on progression of chronic kidney disease to kidney failure based on serum concentrations of albumin, bicarbonate, calcium and phosphate, and urine albumin/creatinine-ratio.
Results: If the acceptable error in the estimate of the HR is 10%, allowable total errors in serum cholesterol, bicarbonate and phosphate are approximately the same as allowable total error based on biological variation, while allowable total error in serum albumin and calcium are a little larger than estimates based on biological variation.
Conclusions: Evaluating allowable total error from its effect on the estimate of HR is universally applicable to measurands used for prediction.
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 organization(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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©2016 by De Gruyter
Articles in the same Issue
- Frontmatter
- Editorials
- Laboratory analytical quality – the process continues
- Measurement uncertainty – a revised understanding of its calculation and use
- Review
- Substrate-zymography: a still worthwhile method for gelatinases analysis in biological samples
- Opinion Papers
- Is the combination of trueness and precision in one expression meaningful? On the use of total error and uncertainty in clinical chemistry
- The problem with total error models in establishing performance specifications and a simple remedy
- Measurement uncertainty for clinical laboratories – a revision of the concept
- Uncertainty in measurement and total error – are they so incompatible?
- General Clinical Chemistry and Laboratory Medicine
- Using the hazard ratio to evaluate allowable total error in predictive measurands
- Performance of electrolyte measurements assessed by a trueness verification program
- Analytical interference by monoclonal immunoglobulins on the direct bilirubin AU Beckman Coulter assay: the benefit of unsuspected diagnosis from spurious results
- Preliminary probe of quality indicators and quality specification in total testing process in 5753 laboratories in China
- Analytical and clinical evaluation of the new Fujirebio Lumipulse®G non-competitive assay for 25(OH)-vitamin D and three immunoassays for 25(OH)D in healthy subjects, osteoporotic patients, third trimester pregnant women, healthy African subjects, hemodialyzed and intensive care patients
- Patient-performed extraction of faecal calprotectin
- Comparison of the clinical utility of the Elia CTD Screen to indirect immunofluorescence on Hep-2 cells
- Reference Values and Biological Variations
- Sex-related differences in the association of ghrelin levels with obesity in adolescents
- Gestation specific reference intervals for thyroid function tests in pregnancy
- Cancer Diagnostics
- SOX17 promoter methylation in plasma circulating tumor DNA of patients with non-small cell lung cancer
- Dopamine concentration in blood platelets is elevated in patients with head and neck paragangliomas
- Letters to the Editor
- Cancer dynamics and the success of cancer screening programs
- Mother’s instinct – a rare case of multiple test interferences due to heterophile antibodies
- Sigma metric or defects per million opportunities (DPMO): the performance of clinical laboratories should be evaluated by the Sigma metrics at decimal level with DPMOs
- A national survey of preanalytical handling of oral glucose tolerance tests in pregnancy
- Updating pregnancy diabetes guidelines: is (y)our laboratory ready?
- Low serum bilirubin values are associated with pulmonary embolism in a case-control study
- Effect of Hb H on HbA1c measurements as measured by IFCC reference method and affinity HPLC
- Adipocytes in venipunctures cause falsely elevated S-100B serum values
- Earlier detection of sepsis by Candida parapsilosis using three-dimensional cytographic anomalies on the Mindray BC-6800 hematological analyzer
- Theranos phenomenon – part 4: Theranos at an International Conference
Articles in the same Issue
- Frontmatter
- Editorials
- Laboratory analytical quality – the process continues
- Measurement uncertainty – a revised understanding of its calculation and use
- Review
- Substrate-zymography: a still worthwhile method for gelatinases analysis in biological samples
- Opinion Papers
- Is the combination of trueness and precision in one expression meaningful? On the use of total error and uncertainty in clinical chemistry
- The problem with total error models in establishing performance specifications and a simple remedy
- Measurement uncertainty for clinical laboratories – a revision of the concept
- Uncertainty in measurement and total error – are they so incompatible?
- General Clinical Chemistry and Laboratory Medicine
- Using the hazard ratio to evaluate allowable total error in predictive measurands
- Performance of electrolyte measurements assessed by a trueness verification program
- Analytical interference by monoclonal immunoglobulins on the direct bilirubin AU Beckman Coulter assay: the benefit of unsuspected diagnosis from spurious results
- Preliminary probe of quality indicators and quality specification in total testing process in 5753 laboratories in China
- Analytical and clinical evaluation of the new Fujirebio Lumipulse®G non-competitive assay for 25(OH)-vitamin D and three immunoassays for 25(OH)D in healthy subjects, osteoporotic patients, third trimester pregnant women, healthy African subjects, hemodialyzed and intensive care patients
- Patient-performed extraction of faecal calprotectin
- Comparison of the clinical utility of the Elia CTD Screen to indirect immunofluorescence on Hep-2 cells
- Reference Values and Biological Variations
- Sex-related differences in the association of ghrelin levels with obesity in adolescents
- Gestation specific reference intervals for thyroid function tests in pregnancy
- Cancer Diagnostics
- SOX17 promoter methylation in plasma circulating tumor DNA of patients with non-small cell lung cancer
- Dopamine concentration in blood platelets is elevated in patients with head and neck paragangliomas
- Letters to the Editor
- Cancer dynamics and the success of cancer screening programs
- Mother’s instinct – a rare case of multiple test interferences due to heterophile antibodies
- Sigma metric or defects per million opportunities (DPMO): the performance of clinical laboratories should be evaluated by the Sigma metrics at decimal level with DPMOs
- A national survey of preanalytical handling of oral glucose tolerance tests in pregnancy
- Updating pregnancy diabetes guidelines: is (y)our laboratory ready?
- Low serum bilirubin values are associated with pulmonary embolism in a case-control study
- Effect of Hb H on HbA1c measurements as measured by IFCC reference method and affinity HPLC
- Adipocytes in venipunctures cause falsely elevated S-100B serum values
- Earlier detection of sepsis by Candida parapsilosis using three-dimensional cytographic anomalies on the Mindray BC-6800 hematological analyzer
- Theranos phenomenon – part 4: Theranos at an International Conference