Long-term stability of laboratory tests and practical implications for quality management
-
Sofie K. Van Houcke
,
Tom Fiers
Abstract
Background: Long-term stability of analytical performance is required for adequate patient management. We investigated the use of patient data to document test stability, and the relevance of observed instabilities on a surrogate medical outcome. We used multiyear patient and internal quality control (IQC) data from two laboratories for tests to monitor chronic kidney and thyroid disease.
Methods: We plotted moving means of the 50th percentiles of stratified patient data and of the daily IQC means. We evaluated observed instabilities based on goals inferred from the analytes’ biological variation and investigated their effect on classification of results against reference intervals.
Results: Patient and IQC data generally matched well, except for analytes, for which other than analytical variation sources prevailed. Analytical instabilities were predominantly due to reagent/calibrator lot changes, however, for immunoassays also to within-lot instabilities, urging frequent recalibrations. The relevance of biased results on medical decisions ranged from negligible to very pronounced, indicating the need for assessment of analytical performance in relation to quality goals inferred from biological variation.
Conclusions: Patient percentiles offer great potential to assess/monitor the medium- to long-term analytical stability of a test within certain constraints. Differences in analytical quality between assays can significantly affect medical outcome.
We are indebted to D. Stöckl (STT-Consulting) for giving statistical advice and to B. Neckebroek for his assistance in standardizing the data and developing a Java-based application for data processing.
Conflict of interest statement
Authors’ conflict of interest disclosure: The authors stated that there are no conflicts of interest regarding the publication of this article.
Research funding: None declared.
Employment or leadership: None declared.
Honorarium: None declared.
References
1. Arbor Research Collaborative for Health. Dialysis Outcomes and Practice Patterns Study. Available from: http://www.dopps.org. Accessed on 10 November, 2012.Suche in Google Scholar
2. Okosieme OE, Belludi G, Spittle K, Kadiyala R, Richards J. Adequacy of thyroid hormone replacement in a general population. QJM 2011;104:395–401.http://gateway.webofknowledge.com/gateway/Gateway.cgi?GWVersion=2&SrcApp=PARTNER_APP&SrcAuth=LinksAMR&KeyUT=000289838200004&DestLinkType=FullRecord&DestApp=ALL_WOS&UsrCustomerID=b7bc2757938ac7a7a821505f8243d9f310.1093/qjmed/hcq222Suche in Google Scholar PubMed
3. Centers for Disease Control and Prevention. National Health and Nutrition Examination Survey. Available from: http://www.cdc.gov/nchs/nhanes/about_nhanes.htm. Accessed on 10 November, 2012.Suche in Google Scholar
4. Miller WG, Erek A, Cunningham TD, Oladipo O, Scott MG, Johnson RE. Commutability limitations influence quality control results with different reagent lots. Clin Chem 2011;57:76–83.10.1373/clinchem.2010.148106Suche in Google Scholar PubMed
5. Kazmierczak SC. Laboratory quality control: using patient data to assess analytical performance. Clin Chem Lab Med 2003;41:617–27.10.1515/CCLM.2003.093Suche in Google Scholar PubMed
6. Zweig MH, Robertson EA. Lot-to-lot variation in three thyroid-related radioimmunoassay kits. Clin Chem 1980;26:646–8.10.1093/clinchem/26.5.0646Suche in Google Scholar PubMed
7. Lott JA, Smith DA, Mitchell LC, Moeschberger ML. Use of medians and “average of normals” of patients’ data for assessment of long-term analytical stability. Clin Chem 1996;42:888–92.10.1093/clinchem/42.6.888Suche in Google Scholar PubMed
8. Stepman HC, Stöckl D, Stove V, Fiers T, Couck P, Gorus F, et al. Long-term stability of clinical laboratory data-sodium as benchmark. Clin Chem 2011;57:1616–7.http://gateway.webofknowledge.com/gateway/Gateway.cgi?GWVersion=2&SrcApp=PARTNER_APP&SrcAuth=LinksAMR&KeyUT=000296606100023&DestLinkType=FullRecord&DestApp=ALL_WOS&UsrCustomerID=b7bc2757938ac7a7a821505f8243d9f310.1373/clinchem.2011.168195Suche in Google Scholar PubMed
9. Westgard QC. Biological variation database, and quality specifications for imprecision, bias and total error (desirable and minimum). The 2012 update. Available from: http://www.westgard.com/biodatabase-2012-update.htm. Accessed on 10 November, 2012.Suche in Google Scholar
10. Klee GG. Tolerance limits for short-term analytical bias and analytical imprecision derived from clinical assay specificity. Clin Chem 1993;39:1514–8.10.1093/clinchem/39.7.1514Suche in Google Scholar PubMed
11. Stöckl D, Baadenhuijsen H, Fraser CG, Libeer JC, Petersen PH, Ricós C. Desirable routine analytical goals for quantities assayed in serum. Discussion paper from the members of the external quality assessment (EQA) Working Group A on analytical goals in laboratory medicine. Eur J Clin Chem Clin Biochem 1995;33:157–69.Suche in Google Scholar
12. Gallaher MP, Rivers Mobley L, Klee GG, Schryver P. National Institute of Standards and Technology. The impact of calibration error in medical decision making. Planning report 04–1. NIST, 2004.Suche in Google Scholar
13. Paxton A. CAP today. Minting QC and efficiency gains with middleware. Available from: http://www.cap.org/apps/cap.portal?_nfpb=true&cntvwrPtlt_actionOverride=%2Fportlets%2FcontentViewer%2Fshow&_windowLabel=cntvwrPtlt&cntvwrPtlt[actionForm.contentReference}=cap_today%2F0611%2F0611h_minting_qc.html&_state=maximized&_pageLabel=cntvwr. Accessed on 10 November, 2012.Suche in Google Scholar
©2013 by Walter de Gruyter Berlin Boston
Artikel in diesem Heft
- Letters to the Editor
- Evaluation of a novel room temperature RNA storage tube for use in a real-time quantitative PCR assay
- Evaluation of the Universal Master Mix (STAT-NAT DNA-Mix) for reliable molecular testing
- HbA1c: performance of the Sebia Capillarys 2 Flex Piercing
- A case of monoclonal gammopathy of undetermined significance (MGUS): type IgD-lambda
- Evidence-based use of serum protein electrophoresis in laboratory medicine
- Plasma volume shifts during multiday racing
- Structured handoff at shift change in a clinical laboratory increases patient safety
- Instrument-dependent interference of Howell-Jolly bodies in reticulocyte enumeration
- Reply to Gore et al.: Plasma volume shift during multiday racing
- Recommendations for appropriate serum electrophoresis requests: the Italian approach
- Masthead
- Masthead
- Editorials
- Biomarkers for sepsis: an unfinished journey
- Laboratory demand management of repetitive testing – time for harmonisation and an evidenced based approach
- Reviews
- Non-invasive prenatal diagnostics of aneuploidy using next-generation DNA sequencing technologies, and clinical considerations
- The diagnostic utility of brain natriuretic peptide in heart failure patients presenting with acute dyspnea: a meta-analysis
- Opinion Paper
- Opinion paper on innovative approach of biomarkers for infectious diseases and sepsis management in the emergency department
- Genetics and Molecular Diagnostics
- Microarray with LNA-probes for genotyping of polymorphic variants of Gilbert’s syndrome gene UGT1A1(TA)n
- Selection of the optimal manual method of cell free fetal DNA isolation from maternal plasma
- A multiplex assay to rapidly exclude HLA-DQ2.5 and HLA-DQ8 expression in patients at risk for celiac disease
- Low cost biosensor-based molecular differential diagnosis of α-thalassemia (Southeast Asia deletion)
- General Clinical Chemistry and Laboratory Medicine
- Managing laboratory test ordering through test frequency filtering
- Critical review of laboratory investigations in clinical practice guidelines: proposals for the description of investigation
- Long-term stability of laboratory tests and practical implications for quality management
- Coffee consumption, serum γ-glutamyltransferase, and glucose tolerance status in middle-aged Japanese men
- Biological variation and prognosis usefulness of new biomarkers in liver transplantation
- Switching between parathormone (PTH) assays: the impact on the diagnosis of renal osteodystrophy
- A comparison between two different in vitro basophil activation tests for gluten- and cow’s milk protein sensitivity in irritable bowel syndrome (IBS)-like patients
- A proficiency testing program of hemoglobin analysis in prevention and control of severe hemoglobinopathies in Thailand
- Advancing haemostasis automation – successful implementation of robotic centrifugation and sample processing in a tertiary service hospital
- ADAM12s and PP13 as first trimester screening markers for adverse pregnancy outcome
- Analysis of serous body fluids using the CELL-DYN Sapphire hematology analyzer
- Cancer Diagnostics
- Association and prognostic value of serum inflammation markers in patients with leukoplakia and oral cavity cancer
- Do laboratories follow heart failure recommendations and guidelines and did we improve? The CARdiac MArker Guideline Uptake in Europe (CARMAGUE)
- Cardiovascular Diseases
- Additional diagnostic and prognostic value of copeptin ultra-sensitive for diagnosis of non-ST-elevation myocardial infarction in older patients presenting to the emergency department1)
- Moderate elevations of high-sensitivity cardiac troponin I and B-type natriuretic peptide in chronic hemodialysis patients are associated with mortality
Artikel in diesem Heft
- Letters to the Editor
- Evaluation of a novel room temperature RNA storage tube for use in a real-time quantitative PCR assay
- Evaluation of the Universal Master Mix (STAT-NAT DNA-Mix) for reliable molecular testing
- HbA1c: performance of the Sebia Capillarys 2 Flex Piercing
- A case of monoclonal gammopathy of undetermined significance (MGUS): type IgD-lambda
- Evidence-based use of serum protein electrophoresis in laboratory medicine
- Plasma volume shifts during multiday racing
- Structured handoff at shift change in a clinical laboratory increases patient safety
- Instrument-dependent interference of Howell-Jolly bodies in reticulocyte enumeration
- Reply to Gore et al.: Plasma volume shift during multiday racing
- Recommendations for appropriate serum electrophoresis requests: the Italian approach
- Masthead
- Masthead
- Editorials
- Biomarkers for sepsis: an unfinished journey
- Laboratory demand management of repetitive testing – time for harmonisation and an evidenced based approach
- Reviews
- Non-invasive prenatal diagnostics of aneuploidy using next-generation DNA sequencing technologies, and clinical considerations
- The diagnostic utility of brain natriuretic peptide in heart failure patients presenting with acute dyspnea: a meta-analysis
- Opinion Paper
- Opinion paper on innovative approach of biomarkers for infectious diseases and sepsis management in the emergency department
- Genetics and Molecular Diagnostics
- Microarray with LNA-probes for genotyping of polymorphic variants of Gilbert’s syndrome gene UGT1A1(TA)n
- Selection of the optimal manual method of cell free fetal DNA isolation from maternal plasma
- A multiplex assay to rapidly exclude HLA-DQ2.5 and HLA-DQ8 expression in patients at risk for celiac disease
- Low cost biosensor-based molecular differential diagnosis of α-thalassemia (Southeast Asia deletion)
- General Clinical Chemistry and Laboratory Medicine
- Managing laboratory test ordering through test frequency filtering
- Critical review of laboratory investigations in clinical practice guidelines: proposals for the description of investigation
- Long-term stability of laboratory tests and practical implications for quality management
- Coffee consumption, serum γ-glutamyltransferase, and glucose tolerance status in middle-aged Japanese men
- Biological variation and prognosis usefulness of new biomarkers in liver transplantation
- Switching between parathormone (PTH) assays: the impact on the diagnosis of renal osteodystrophy
- A comparison between two different in vitro basophil activation tests for gluten- and cow’s milk protein sensitivity in irritable bowel syndrome (IBS)-like patients
- A proficiency testing program of hemoglobin analysis in prevention and control of severe hemoglobinopathies in Thailand
- Advancing haemostasis automation – successful implementation of robotic centrifugation and sample processing in a tertiary service hospital
- ADAM12s and PP13 as first trimester screening markers for adverse pregnancy outcome
- Analysis of serous body fluids using the CELL-DYN Sapphire hematology analyzer
- Cancer Diagnostics
- Association and prognostic value of serum inflammation markers in patients with leukoplakia and oral cavity cancer
- Do laboratories follow heart failure recommendations and guidelines and did we improve? The CARdiac MArker Guideline Uptake in Europe (CARMAGUE)
- Cardiovascular Diseases
- Additional diagnostic and prognostic value of copeptin ultra-sensitive for diagnosis of non-ST-elevation myocardial infarction in older patients presenting to the emergency department1)
- Moderate elevations of high-sensitivity cardiac troponin I and B-type natriuretic peptide in chronic hemodialysis patients are associated with mortality
