Abstract
Objectives
Our study aimed to determine the usefulness of duplicate testing in identifying irregular analytical errors and subsequent prevention of patient mismanagement.
Methods
In our laboratory, all requests for Na+, Ca2+, alkaline phosphatase (ALP), and high-sensitivity cardiac-troponin-I (hs-cTnI) are run in duplicate. Data from four separate weeks for Na+ (n=21,649), Ca2+ (n=14,803) and ALP (n=19,698); and a full year for hs-cTnI (n=17,036) were gathered. For each test, pre-defined limits for differences between duplicates were used to identify erroneous results (Fliers). We further characterised a subset of such fliers as “critical errors”, where duplicates fell on opposing sides of a reference/decision making threshold. The costs/benefits of running these tests in duplicate were then considered in light of increased number of tests analysed by this approach.
Results
For Na+, 0.03 % of duplicates met our flier defining criteria, and 0.01 % of specimens were considered critical errors. For Ca2+ requests, 4.58 % of results met our flier defining criteria and 0.84 % were critical errors. For ALP, 0.22 % of results were fliers, and 0.01 % were critical errors. For hs-cTnI, 1.58 % of results were classified as fliers, whilst 0.14 % were classified as a critical error. Depending on the test in question, running all analyses in duplicate increased annual costs by as little as €1,100 (for sodium), and as much as €48,000 (for hs-cTnI).
Conclusions
Duplicate testing is effective at identifying and mitigating irregular laboratory errors, and is best suited for assays predisposed to such error, where costs are minimal, and clinical significance of an incorrect result can justify the practice.
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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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© 2023 Walter de Gruyter GmbH, Berlin/Boston
Artikel in diesem Heft
- Frontmatter
- Editorial
- Value-based laboratory medicine: the time is now
- Review
- Cardiovascular risk evaluation in pregnancy: focus on cardiac specific biomarkers
- Opinion Papers
- From volume to value: a watershed moment for the clinical laboratory
- APS calculator: a data-driven tool for setting outcome-based analytical performance specifications for measurement uncertainty using specific clinical requirements and population data
- Guidelines and Recommendations
- Analytical interference of intravascular contrast agents with clinical laboratory tests: a joint guideline by the ESUR Contrast Media Safety Committee and the Preanalytical Phase Working Group of the EFLM Science Committee
- Genetics and Molecular Diagnostics
- Specifications of qPCR based epigenetic immune cell quantification
- General Clinical Chemistry and Laboratory Medicine
- An appraisal of the practice of duplicate testing for the detection of irregular analytical errors
- Machine learning-based nonlinear regression-adjusted real-time quality control modeling: a multi-center study
- The effect of ratios upon improving patient-based real-time quality control (PBRTQC) performance
- Diagnostic sample transport via pneumatic tube systems: data logger and their algorithms are sensitive to transport effects
- Ambulatory human chorionic gonadotrophin (hCG) testing: a verification of two hCG point of care devices
- Monitoring patients with celiac disease on gluten free diet: different outcomes comparing three tissue transglutaminase IgA assays
- Verification, implementation and harmonization of automated chemiluminescent immunoassays for MPO- and PR3-ANCA detection
- Performance evaluation of a novel platelet count parameter, hybrid platelet count, on the BC-780 automated hematology analyzer
- Reference Values and Biological Variations
- Pediatric reference intervals for serum neurofilament light and glial fibrillary acidic protein using the Canadian Laboratory Initiative on Pediatric Reference Intervals (CALIPER) cohort
- Biological variation of serum neopterin concentrations in apparently healthy individuals
- Short-term biological variation of serum tryptase
- Cancer Diagnostics
- Quantification of the lung cancer tumor marker CYFRA 21-1 using protein precipitation, immunoaffinity bottom-up LC-MS/MS
- Cardiovascular Diseases
- Prognostic significance of chronic myocardial injury diagnosed by three different cardiac troponin assays in patients admitted with suspected acute coronary syndrome
- Deep learning-based NT-proBNP prediction from the ECG for risk assessment in the community
- Diabetes
- Innovations in HbA1c analysis: finding the balance between speed and accuracy. An investigation of a potential new Secondary Reference Measurement Procedure for the IFCC
- Precise glucose measurement in sodium fluoride-citrate plasma affects estimates of prevalence in diabetes and prediabetes
- Infectious Diseases
- Urinary phenotyping of SARS-CoV-2 infection connects clinical diagnostics with metabolomics and uncovers impaired NAD+ pathway and SIRT1 activation
- Letters to the Editor
- Analytical performance specifications for measurement uncertainty in therapeutic monitoring of immunosuppressive drugs
- Capillary blood collection tubes containing serum separator gel result in lower measurements of oestradiol and total testosterone
- Re.: Louise Guillaume et al. Biological variation of CA 15-3, CA 125 and HE 4 on lithium heparinate plasma in apparently healthy Caucasian volunteers. Clin Chem Lab Med 2023;61(7):1319–1326; https://doi.org/10.1515/cclm-2022-0966
- A comparison of cannabidiol (CBD) concentrations in venous vs. fingertip-capillary blood
- Identification of sulfamethoxazole’s residues in sulfamethoxazole induced kidney stones by mass spectrometry
- Impact of different preservation methods on urinary red blood cell counts
- Diagnosis of IRAK-4-deficiency by flow cytometric measurement of IκB-α degradation
Artikel in diesem Heft
- Frontmatter
- Editorial
- Value-based laboratory medicine: the time is now
- Review
- Cardiovascular risk evaluation in pregnancy: focus on cardiac specific biomarkers
- Opinion Papers
- From volume to value: a watershed moment for the clinical laboratory
- APS calculator: a data-driven tool for setting outcome-based analytical performance specifications for measurement uncertainty using specific clinical requirements and population data
- Guidelines and Recommendations
- Analytical interference of intravascular contrast agents with clinical laboratory tests: a joint guideline by the ESUR Contrast Media Safety Committee and the Preanalytical Phase Working Group of the EFLM Science Committee
- Genetics and Molecular Diagnostics
- Specifications of qPCR based epigenetic immune cell quantification
- General Clinical Chemistry and Laboratory Medicine
- An appraisal of the practice of duplicate testing for the detection of irregular analytical errors
- Machine learning-based nonlinear regression-adjusted real-time quality control modeling: a multi-center study
- The effect of ratios upon improving patient-based real-time quality control (PBRTQC) performance
- Diagnostic sample transport via pneumatic tube systems: data logger and their algorithms are sensitive to transport effects
- Ambulatory human chorionic gonadotrophin (hCG) testing: a verification of two hCG point of care devices
- Monitoring patients with celiac disease on gluten free diet: different outcomes comparing three tissue transglutaminase IgA assays
- Verification, implementation and harmonization of automated chemiluminescent immunoassays for MPO- and PR3-ANCA detection
- Performance evaluation of a novel platelet count parameter, hybrid platelet count, on the BC-780 automated hematology analyzer
- Reference Values and Biological Variations
- Pediatric reference intervals for serum neurofilament light and glial fibrillary acidic protein using the Canadian Laboratory Initiative on Pediatric Reference Intervals (CALIPER) cohort
- Biological variation of serum neopterin concentrations in apparently healthy individuals
- Short-term biological variation of serum tryptase
- Cancer Diagnostics
- Quantification of the lung cancer tumor marker CYFRA 21-1 using protein precipitation, immunoaffinity bottom-up LC-MS/MS
- Cardiovascular Diseases
- Prognostic significance of chronic myocardial injury diagnosed by three different cardiac troponin assays in patients admitted with suspected acute coronary syndrome
- Deep learning-based NT-proBNP prediction from the ECG for risk assessment in the community
- Diabetes
- Innovations in HbA1c analysis: finding the balance between speed and accuracy. An investigation of a potential new Secondary Reference Measurement Procedure for the IFCC
- Precise glucose measurement in sodium fluoride-citrate plasma affects estimates of prevalence in diabetes and prediabetes
- Infectious Diseases
- Urinary phenotyping of SARS-CoV-2 infection connects clinical diagnostics with metabolomics and uncovers impaired NAD+ pathway and SIRT1 activation
- Letters to the Editor
- Analytical performance specifications for measurement uncertainty in therapeutic monitoring of immunosuppressive drugs
- Capillary blood collection tubes containing serum separator gel result in lower measurements of oestradiol and total testosterone
- Re.: Louise Guillaume et al. Biological variation of CA 15-3, CA 125 and HE 4 on lithium heparinate plasma in apparently healthy Caucasian volunteers. Clin Chem Lab Med 2023;61(7):1319–1326; https://doi.org/10.1515/cclm-2022-0966
- A comparison of cannabidiol (CBD) concentrations in venous vs. fingertip-capillary blood
- Identification of sulfamethoxazole’s residues in sulfamethoxazole induced kidney stones by mass spectrometry
- Impact of different preservation methods on urinary red blood cell counts
- Diagnosis of IRAK-4-deficiency by flow cytometric measurement of IκB-α degradation