Sharing reference intervals and monitoring patients across laboratories – findings from a likely commutable external quality assurance program
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Christopher J.L. Farrell
,
Graham R.D. Jones
,
Peter Graham
Abstract
Objectives
Laboratory results are increasingly interpreted against common reference intervals (CRIs), published clinical decision limits, or previous results for the same patient performed at different laboratories. However, there are no established systems to determine whether current analytical performance justifies these interpretations. We analysed data from a likely commutable external quality assurance program (EQA) to assess these interpretations.
Methods
The use of CRIs was assessed by evaluating instrument group medians against minimum specifications for bias. The use of clinical decision limits was assessed using specifications from professional bodies, and the monitoring of patients by testing at different laboratories was assessed by comparing all-laboratory imprecision to within-subject biological variation.
Results
Five of the 18 analytes with Australasian CRIs did not meet specification for all instrument groups. Among these, calcium and magnesium failed for one instrument group out of seven, while bicarbonate, chloride, and lipase failed for two instrument groups. Of the 18 analytes reviewed currently without CRIs in Australasia, 10 candidates were identified. Among analytes with clinical decision limits, i.e. lipids, glucose, and vitamin D, only triglycerides met both bias and imprecision specifications, while vitamin D met the imprecision specification. Monitoring patients by testing at different laboratories was supported for 15 of the 46 (33 %) analyte-method principles groups that met minimum imprecision specifications.
Conclusions
Analysis of data from commutable EQA programs can provide a mechanism for monitoring whether analytical performance justifies the interpretations made in contemporary laboratory practice. EQA providers should establish systems for routinely providing this information to the laboratory community.
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Research ethics: Not applicable.
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Informed consent: Not applicable.
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Author contributions: The authors have accepted responsibility for the entire content of this manuscript and approved its submission.
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Competing interests: The authors state no conflict of interest.
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Research funding: None declared.
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Data availability: Not applicable.
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Supplementary Material
This article contains supplementary material (https://doi.org/10.1515/cclm-2024-0041).
© 2024 Walter de Gruyter GmbH, Berlin/Boston
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Artikel in diesem Heft
- Frontmatter
- Editorial
- Six years of progress – highlights from the IFCC Emerging Technologies Division
- IFCC Papers
- Skin in the game: a review of single-cell and spatial transcriptomics in dermatological research
- Bilirubin measurements in neonates: uniform neonatal treatment can only be achieved by improved standardization
- Validation and verification framework and data integration of biosensors and in vitro diagnostic devices: a position statement of the IFCC Committee on Mobile Health and Bioengineering in Laboratory Medicine (C-MBHLM) and the IFCC Scientific Division
- Linearity assessment: deviation from linearity and residual of linear regression approaches
- HTA model for laboratory medicine technologies: overview of approaches adopted in some international agencies
- Considerations for applying emerging technologies in paediatric laboratory medicine
- A global perspective on the status of clinical metabolomics in laboratory medicine – a survey by the IFCC metabolomics working group
- The LEAP checklist for laboratory evaluation and analytical performance characteristics reporting of clinical measurement procedures
- General Clinical Chemistry and Laboratory Medicine
- Assessing post-analytical phase harmonization in European laboratories: a survey promoted by the EFLM Working Group on Harmonization
- Potential medical impact of unrecognized in vitro hypokalemia due to hemolysis: a case series
- Quantification of circulating alpha-1-antitrypsin polymers associated with different SERPINA1 genotypes
- Targeted ultra performance liquid chromatography tandem mass spectrometry procedures for the diagnosis of inborn errors of metabolism: validation through ERNDIM external quality assessment schemes
- Improving protocols for α-synuclein seed amplification assays: analysis of preanalytical and analytical variables and identification of candidate parameters for seed quantification
- Evaluation of analytical performance of AQUIOS CL flow cytometer and method comparison with bead-based flow cytometry methods
- IgG and kappa free light chain CSF/serum indices: evaluating intrathecal immunoglobulin production in HIV infection in comparison with multiple sclerosis
- Reference Values and Biological Variations
- Reference intervals of circulating secretoneurin concentrations determined in a large cohort of community dwellers: the HUNT study
- Sharing reference intervals and monitoring patients across laboratories – findings from a likely commutable external quality assurance program
- Verification of bile acid determination method and establishing reference intervals for biochemical and haematological parameters in third-trimester pregnant women
- Confounding factors of the expression of mTBI biomarkers, S100B, GFAP and UCH-L1 in an aging population
- Cancer Diagnostics
- Exploring evolutionary trajectories in ovarian cancer patients by longitudinal analysis of ctDNA
- Diabetes
- Evaluation of effects from hemoglobin variants on HbA1c measurements by different methods
- Letters to the Editor
- Are there any reasons to use three levels of quality control materials instead of two and if so, what are the arguments?
- Issues for standardization of neonatal bilirubinemia: a case of delayed phototherapy initiation
- The routine coagulation assays plasma stability – in the wake of the new European Federation of Clinical Chemistry and Laboratory Medicine (EFLM) biological variability database
- Improving HCV diagnosis following a false-negative anti-HCV result
