Startseite An appraisal of the practice of duplicate testing for the detection of irregular analytical errors
Artikel
Lizenziert
Nicht lizenziert Erfordert eine Authentifizierung

An appraisal of the practice of duplicate testing for the detection of irregular analytical errors

  • Alastair D. Green und Graham R. Lee EMAIL logo
Veröffentlicht/Copyright: 10. November 2023
Veröffentlichen auch Sie bei De Gruyter Brill
Manuskript einreichen Informationen für Autor*innen
Clinical Chemistry and Laboratory Medicine (CCLM)
Aus der Zeitschrift Clinical Chemistry and Laboratory Medicine (CCLM) Band 62 Heft 4

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.

Keywords: duplicate testing; duplicate analysis; irregular errors
Corresponding author: Dr. Graham R. Lee, Department of Clinical Biochemistry and Diagnostic Endocrinology, Mater Misericordiae University Hospital, Eccles Street. Dublin 7, Dublin, Ireland, Phone: +353 (1) 803 2423, E-mail:

  1. Research ethics: Not applicable.

  2. Informed consent: Not applicable.

  3. Author contributions: All authors have accepted responsibility for the entire content of this manuscript and approved its submission.

  4. Competing interests: Authors state no conflict of interest.

  5. Research funding: None declared.

References

1. Schultze, AE, Irizarry, AR. Recognizing and reducing analytical errors and sources of variation in clinical pathology data in safety assessment studies. Toxicol Pathol 2016;45:281–7. https://doi.org/10.1177/0192623316672945.Suche in Google Scholar PubMed

2. Wauthier, L, Plebani, M, Favresse, J. Interferences in immunoassays: review and practical algorithm. Clin Chem Lab Med 2022;60:808–20. https://doi.org/10.1515/cclm-2021-1288.Suche in Google Scholar PubMed

3. Vogeser, M, Seger, C. Irregular analytical errors in diagnostic testing – a novel concept. Clin Chem Lab Med 2018;56:386–96. https://doi.org/10.1515/cclm-2017-0454.Suche in Google Scholar PubMed

4. Bonini, P, Plebani, M, Ceriotti, F, Rubboli, F. Errors in laboratory medicine. Clin Chem 2002;48:691–8. https://doi.org/10.1093/clinchem/48.5.691.Suche in Google Scholar

5. Hammerling, JA. A review of medical errors in laboratory diagnostics and where we are today. Lab Med 2012;43:41–4. https://doi.org/10.1309/lm6er9wjr1ihqauy.Suche in Google Scholar

6. Aita, A, Sciacovelli, L, Plebani, M. Laboratory-related errors: you cannot manage what you don’t measure. You manage what you know and measure. Diagnosis (Berl) 2017;4:193–5. https://doi.org/10.1515/dx-2017-0038.Suche in Google Scholar PubMed

7. De Grande, LAC, Goossens, K, Van Uytfanghe, K, Stockl, D, Theinpont, LM. The Empower project – a new way of assessing and monitoring test comparability and stability. Clin Chem Lab Med 2015;53:1197–204. https://doi.org/10.1515/cclm-2014-0959.Suche in Google Scholar PubMed

8. Neubig, S, Grotevendt, A, Kallner, A, Nauck, M, Petersmann, A. Analytical robustness of nine common assays: frequency of outliers and extreme differences identified by a large number of duplicate measurements. Biochem Med 2017;27:192–8. https://doi.org/10.11613/bm.2017.021.Suche in Google Scholar

9. Sana, N, Moiz, B, Raheem, A. Clinical significance of repeat testing of critical results in a haematology laboratory. Int J Lab Hematol 2020;42:e132–4. https://doi.org/10.1111/ijlh.13166.Suche in Google Scholar PubMed

10. Chima, HS, Ramarajan, V, Bhansali, D. Is it necessary to repeat critical values in the laboratory? Today’s technology may have the answers. Lab Med 2009;40:453–7. https://doi.org/10.1309/lmmy883okbzqqbku.Suche in Google Scholar

11. Lehman, CM, Howanitz, PJ, Souers, R, Karcher, DS. Utility of repeat testing of critical values: a Q-probes analysis of 86 clinical laboratories. Arch Pathol Lab Med 2014;138:788–93. https://doi.org/10.5858/arpa.2013-0140-cp.Suche in Google Scholar PubMed

12. McIntosh, E, Andrews, PJ. Is sodium chloride worth its salt? Crit Care 2014;17:150. https://doi.org/10.1186/cc12732.Suche in Google Scholar PubMed PubMed Central

13. Braun, MM, Barstow, CH, Pyzocha, NJ. Diagnosis and management of sodium disorders: hyponatremia and hypernatremia. Am Fam Physician 2015;91:299–307.Suche in Google Scholar

14. George, JC, Zafar, W, Bucaloiu, ID, Chang, AR. Risk factors and outcomes of rapid correction of severe hyponatremia. Clin J Am Soc Nephrol 2018;13:984–92. https://doi.org/10.2215/cjn.13061117.Suche in Google Scholar

15. Ruppe, MD. Medications that affect calcium. Endocr Pract 2011;17(1 Suppl):S26–30. https://doi.org/10.4158/ep10281.ra.Suche in Google Scholar PubMed

16. Bazydlo, LAL, Needham, M, Harris, NS. Calcium, magnesium and phosphate. Lab Med 2014;45:e44–50. https://doi.org/10.1309/lmglmz8ciymfnogx.Suche in Google Scholar

17. Epstein, E, Kiechle, FL, Artiss, JD, Zak, B. The clinical use of alkaline phosphatase enzymes. Clin Lab Med 1986;6:491–505. https://doi.org/10.1016/s0272-2712(18)30795-9.Suche in Google Scholar

18. Vogelsang, H, Hamwi, H, Ferenci, P. Elevated liver isoenzymes of alkaline phosphatase and disease activity in patients with crohn’s disease. Digestion 1996;57:11–15. https://doi.org/10.1159/000201306.Suche in Google Scholar PubMed

19. Sharma, U, Pal, D, Prasad, R. Alkaline phosphatase: an overview. Indian J Clin Biochem 2014;29:269–78. https://doi.org/10.1007/s12291-013-0408-y.Suche in Google Scholar PubMed PubMed Central

20. Lee, GR, Browne, TCA, Guest, B, Khan, I, Murphy, E, McGorrian, C, et al.. Transitioning high sensitivity cardiac troponin I (hs-cTnI) into routine diagnostic use: more than just a sensitivity issue. Pract Lab Med 2016;4:62–75. https://doi.org/10.1016/j.plabm.2016.01.001.Suche in Google Scholar PubMed PubMed Central

21. Ungerer, JPJ, Pretorius, CJ, Dimeski, G, O’Rourke, PK, Tyack, SA. Falsely elevated troponin I results due to outliers indicate a lack of analytical robustness. Ann Clin Biochem 2010;47:242–7. https://doi.org/10.1258/acb.2010.010012.Suche in Google Scholar PubMed

22. Jaffe, AS. Troponin-past, present, and future. Curr Probl Cardiol 2012;37:209–28. https://doi.org/10.1016/j.cpcardiol.2012.02.002.Suche in Google Scholar PubMed

23. Sawyer, N, Blennerhassett, J, Lambert, R, Sheehan, P, Vasikaran, SD. Outliers affecting cardiac troponin I measurement: comparison of a new high sensitivity assay with a contemporary assay on the Abbott ARCHITECT analyser. Ann Clin Biochem 2014;51:476–84. https://doi.org/10.1177/0004563213499737.Suche in Google Scholar PubMed

24. Okyay, K, Yıldırır, A. The preanalytical and analytical factors responsible for false-positive cardiac troponins. Anatol J Cardiol 2015;15:264–5. https://doi.org/10.5152/akd.2015.6006.Suche in Google Scholar PubMed PubMed Central

25. Favresse, J, Bayart, JL, Gruson, D, Bernardini, S, Clerico, A, Perrone, M. The underestimated issue of non reproducible cardiac troponin I and T results: case series 2 and systematic review of the literature. Clin Chem Lab Med 2020;59:1201–11. https://doi.org/10.1515/cclm-2020-1564.Suche in Google Scholar PubMed

26. Nevraumont, A, Deltombe, M, Favresse, J, Guillaume, L, Chapelle, V, Twerenbold, R, et al.. Interferences with cardiac biomarker assays: understanding the clinical impact. Eur Heart J 2022;43:2286–8. https://doi.org/10.1093/eurheartj/ehab924.Suche in Google Scholar PubMed

27. Favresse, J, Bayart, JL, Gruson, D, Bernardini, S, Clerico, A, Perrone, M. The underestimated issue of non-reproducible cardiac troponin I and T results: case series and systematic review of the literature. Clin Chem Lab Med 2021;59:1201–11. https://doi.org/10.1515/cclm-2020-1564.Suche in Google Scholar

28. Panteghini, M, Ceriotti, F, Jones, G, Oosterhuis, W, Plebani, M, Sandberg, S, et al., Task Force on Performance Specifications in Laboratory Medicine of the European Federation of Clinical Chemistry and Laboratory Medicine (EFLM). Strategies to define performance specifications in laboratory medicine: 3 years on from the milan strategic conference. Clin Chem Lab Med 2017;55:1849–56. https://doi.org/10.1515/cclm-2017-0772.Suche in Google Scholar PubMed

29. Diaz-Garzon, J, Fernandez-Calle, P, Sandberg, S, Özcürümez, M, Bartlett, WA, Coskun, A, et al.. European Federation of Clinical Chemistry and Laboratory Medicine (EFLM) Working Group on Biological Variation and Task Group for the Biological Variation Database. Biological variation of cardiac troponins in health and disease: a systematic review and meta-analysis. Clin Chem 2021;67:256–64. https://doi.org/10.1093/clinchem/hvaa261.Suche in Google Scholar PubMed

30. Aarsand, AK, Fernandez-Calle, P, Webster, C, Coskun, A, Gonzales-Lao, E, Diaz-Garzon, J, et al.. The EFLM biological variation database. https://biologicalvariation.eu/ [Accessed 16 Jun 2022].Suche in Google Scholar

31. Braga, F, Panteghini, M. Performance specifications for measurement uncertainty of common biochemical measurands according to Milan models. Clin Chem Lab Med 2021;59:1362–8. https://doi.org/10.1515/cclm-2021-0170.Suche in Google Scholar PubMed

Received: 2022-08-13
Accepted: 2023-10-17
Published Online: 2023-11-10
Published in Print: 2024-03-25

© 2023 Walter de Gruyter GmbH, Berlin/Boston

Artikel in diesem Heft

  1. Frontmatter
  2. Editorial
  3. Value-based laboratory medicine: the time is now
  4. Review
  5. Cardiovascular risk evaluation in pregnancy: focus on cardiac specific biomarkers
  6. Opinion Papers
  7. From volume to value: a watershed moment for the clinical laboratory
  8. APS calculator: a data-driven tool for setting outcome-based analytical performance specifications for measurement uncertainty using specific clinical requirements and population data
  9. Guidelines and Recommendations
  10. 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
  11. Genetics and Molecular Diagnostics
  12. Specifications of qPCR based epigenetic immune cell quantification
  13. General Clinical Chemistry and Laboratory Medicine
  14. An appraisal of the practice of duplicate testing for the detection of irregular analytical errors
  15. Machine learning-based nonlinear regression-adjusted real-time quality control modeling: a multi-center study
  16. The effect of ratios upon improving patient-based real-time quality control (PBRTQC) performance
  17. Diagnostic sample transport via pneumatic tube systems: data logger and their algorithms are sensitive to transport effects
  18. Ambulatory human chorionic gonadotrophin (hCG) testing: a verification of two hCG point of care devices
  19. Monitoring patients with celiac disease on gluten free diet: different outcomes comparing three tissue transglutaminase IgA assays
  20. Verification, implementation and harmonization of automated chemiluminescent immunoassays for MPO- and PR3-ANCA detection
  21. Performance evaluation of a novel platelet count parameter, hybrid platelet count, on the BC-780 automated hematology analyzer
  22. Reference Values and Biological Variations
  23. Pediatric reference intervals for serum neurofilament light and glial fibrillary acidic protein using the Canadian Laboratory Initiative on Pediatric Reference Intervals (CALIPER) cohort
  24. Biological variation of serum neopterin concentrations in apparently healthy individuals
  25. Short-term biological variation of serum tryptase
  26. Cancer Diagnostics
  27. Quantification of the lung cancer tumor marker CYFRA 21-1 using protein precipitation, immunoaffinity bottom-up LC-MS/MS
  28. Cardiovascular Diseases
  29. Prognostic significance of chronic myocardial injury diagnosed by three different cardiac troponin assays in patients admitted with suspected acute coronary syndrome
  30. Deep learning-based NT-proBNP prediction from the ECG for risk assessment in the community
  31. Diabetes
  32. Innovations in HbA1c analysis: finding the balance between speed and accuracy. An investigation of a potential new Secondary Reference Measurement Procedure for the IFCC
  33. Precise glucose measurement in sodium fluoride-citrate plasma affects estimates of prevalence in diabetes and prediabetes
  34. Infectious Diseases
  35. Urinary phenotyping of SARS-CoV-2 infection connects clinical diagnostics with metabolomics and uncovers impaired NAD+ pathway and SIRT1 activation
  36. Letters to the Editor
  37. Analytical performance specifications for measurement uncertainty in therapeutic monitoring of immunosuppressive drugs
  38. Capillary blood collection tubes containing serum separator gel result in lower measurements of oestradiol and total testosterone
  39. 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
  40. A comparison of cannabidiol (CBD) concentrations in venous vs. fingertip-capillary blood
  41. Identification of sulfamethoxazole’s residues in sulfamethoxazole induced kidney stones by mass spectrometry
  42. Impact of different preservation methods on urinary red blood cell counts
  43. Diagnosis of IRAK-4-deficiency by flow cytometric measurement of IκB-α degradation
https://doi.org/10.1515/cclm-2022-0605
Schlagwörter für diesen Artikel
duplicate testing; duplicate analysis; irregular errors

Artikel in diesem Heft

  1. Frontmatter
  2. Editorial
  3. Value-based laboratory medicine: the time is now
  4. Review
  5. Cardiovascular risk evaluation in pregnancy: focus on cardiac specific biomarkers
  6. Opinion Papers
  7. From volume to value: a watershed moment for the clinical laboratory
  8. APS calculator: a data-driven tool for setting outcome-based analytical performance specifications for measurement uncertainty using specific clinical requirements and population data
  9. Guidelines and Recommendations
  10. 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
  11. Genetics and Molecular Diagnostics
  12. Specifications of qPCR based epigenetic immune cell quantification
  13. General Clinical Chemistry and Laboratory Medicine
  14. An appraisal of the practice of duplicate testing for the detection of irregular analytical errors
  15. Machine learning-based nonlinear regression-adjusted real-time quality control modeling: a multi-center study
  16. The effect of ratios upon improving patient-based real-time quality control (PBRTQC) performance
  17. Diagnostic sample transport via pneumatic tube systems: data logger and their algorithms are sensitive to transport effects
  18. Ambulatory human chorionic gonadotrophin (hCG) testing: a verification of two hCG point of care devices
  19. Monitoring patients with celiac disease on gluten free diet: different outcomes comparing three tissue transglutaminase IgA assays
  20. Verification, implementation and harmonization of automated chemiluminescent immunoassays for MPO- and PR3-ANCA detection
  21. Performance evaluation of a novel platelet count parameter, hybrid platelet count, on the BC-780 automated hematology analyzer
  22. Reference Values and Biological Variations
  23. Pediatric reference intervals for serum neurofilament light and glial fibrillary acidic protein using the Canadian Laboratory Initiative on Pediatric Reference Intervals (CALIPER) cohort
  24. Biological variation of serum neopterin concentrations in apparently healthy individuals
  25. Short-term biological variation of serum tryptase
  26. Cancer Diagnostics
  27. Quantification of the lung cancer tumor marker CYFRA 21-1 using protein precipitation, immunoaffinity bottom-up LC-MS/MS
  28. Cardiovascular Diseases
  29. Prognostic significance of chronic myocardial injury diagnosed by three different cardiac troponin assays in patients admitted with suspected acute coronary syndrome
  30. Deep learning-based NT-proBNP prediction from the ECG for risk assessment in the community
  31. Diabetes
  32. Innovations in HbA1c analysis: finding the balance between speed and accuracy. An investigation of a potential new Secondary Reference Measurement Procedure for the IFCC
  33. Precise glucose measurement in sodium fluoride-citrate plasma affects estimates of prevalence in diabetes and prediabetes
  34. Infectious Diseases
  35. Urinary phenotyping of SARS-CoV-2 infection connects clinical diagnostics with metabolomics and uncovers impaired NAD+ pathway and SIRT1 activation
  36. Letters to the Editor
  37. Analytical performance specifications for measurement uncertainty in therapeutic monitoring of immunosuppressive drugs
  38. Capillary blood collection tubes containing serum separator gel result in lower measurements of oestradiol and total testosterone
  39. 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
  40. A comparison of cannabidiol (CBD) concentrations in venous vs. fingertip-capillary blood
  41. Identification of sulfamethoxazole’s residues in sulfamethoxazole induced kidney stones by mass spectrometry
  42. Impact of different preservation methods on urinary red blood cell counts
  43. Diagnosis of IRAK-4-deficiency by flow cytometric measurement of IκB-α degradation
Jetzt anmelden und 20% sparen
Institutioneller Zugang
Wie funktioniert Authentifizierung?
Haben Sie eine Idee, wie wir unsere Website verbessern können?
Bitte schreiben Sie uns.
© 2025 De Gruyter Brill
Heruntergeladen am 8.10.2025 von https://www.degruyterbrill.com/document/doi/10.1515/cclm-2022-0605/html
Button zum nach oben scrollen