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External quality assessment of serum indices: Spanish SEQC-ML program

  • Rubén Gómez Rioja ORCID logo EMAIL logo , Monserrat Ventura , María Antonia Llopis , Josep Miquel Bauça , Andrea Caballero Garralda , Mercedes Ibarz ORCID logo , Debora Martinez , Carolina Gómez , Paloma Salas Gómez-Pablos , Isabel García del Pino , Jose Delgado , Juan Jose Puente and Iciar Marzana
Published/Copyright: October 21, 2021
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Clinical Chemistry and Laboratory Medicine (CCLM)
From the journal Clinical Chemistry and Laboratory Medicine (CCLM) Volume 60 Issue 1

Abstract

Objectives

Serum indices included in clinical chemistry instruments are widely used by laboratories to assess the quality of samples. Instruments that report quantitative results allow an evaluation of their diagnostic performance in a similar way to other biochemical tests. The Spanish Society of Laboratory Medicine (SEQC-ML) launched a monthly External Quality program of serum indices in 2018 using three lyophilized materials of simultaneous annual distribution. We present the results of the first three years of the program.

Methods

The use of four different quality control materials with different concentrations in three alternate months allows an annual evaluation of the participant’s accuracy. Assigned values are established by consensus among homogeneous groups, considering necessary at least 10 participants for a comparison at instrument level. The average percentage difference results per instrument allow the assessment of bias among groups.

Results

The imprecision of the three indices ranges between 3 and 9%, with no major differences among instruments. Significant differences were observed in all indices among instruments with more than 10 participants (Roche Cobas, Abbott Architect, Abbott Alinity and Siemens Advia). The 90th percentile of the distribution of percentage differences was used as the analytical performance specification (APS). An improvement in performance was observed in the first three years of the program, probably due to the learning curve effect. In 2020, APS of 7.8, 12.2 and 9.7% were proposed for hemolytic, icteric and lipemic indices, respectively.

Conclusions

Serum indices have a great impact on the quality and the reliability of laboratory test results. Participation in proficiency testing programs for serum indices is helpful to encourage harmonization among providers and laboratories.

Keywords: external quality assessment (EQA); hemolysis; icterus; lipemia; proficiency testing scheme; serum indices
Corresponding author: Rubén Gómez Rioja, Laboratory Medicine, La Paz – Cantoblanco – Carlos III University Hospital, Madrid, Spain, E-mail:

Acknowledgments

The design and maintenance of the Quality Assurance Schemes of the Spanish Society of Laboratory Medicine (SEQC ML) is carried out by the Programs Committee, composed by: Ma Carmen Perich Alsina (President); Beatriz Boned Juliani; Sandra Bullich Marín; Marià Cortés Rius; Pilar Fernández Calle; Rubén Gómez Rioja; Ma Antonia Llopis Díaz; Cecília Martínez Bru; Francisco Ramón Bauzá; Ángel Salas García; Margarida Simon Palmada; Montserrat Ventura Alemany.

  1. Research funding: None declared.

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

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

  4. Informed consent: Not applicable.

  5. Ethical approval: Not applicable.

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Received: 2021-07-11
Accepted: 2021-09-24
Published Online: 2021-10-21
Published in Print: 2022-01-26

© 2021 Walter de Gruyter GmbH, Berlin/Boston

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  2. Editorials
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https://doi.org/10.1515/cclm-2021-0786
Keywords for this article
external quality assessment (EQA); hemolysis; icterus; lipemia; proficiency testing scheme; serum indices

Articles in the same Issue

  1. Frontmatter
  2. Editorials
  3. EU health policy is on the brink of a spectacular own-goal that will harm patients and hamper innovation
  4. Theranos revisited: the trial and lessons learned
  5. Reviews
  6. Review and evolution of guidelines for diagnosis of COVID-19 vaccine induced thrombotic thrombocytopenia (VITT)
  7. High-sensitivity cardiac troponins in pediatric population
  8. Opinion Papers
  9. Implementation of the new EU IVD regulation – urgent initiatives are needed to avert impending crisis
  10. Exploration of novel biomarkers for hypertensive disorders of pregnancy by comprehensive analysis of peptide fragments in blood: their potential and technologies supporting quantification
  11. General Clinical Chemistry and Laboratory Medicine
  12. Total lab automation: sample stability of clinical chemistry parameters in an automated storage and retrieval module
  13. Instability of corticotropin during long-term storage – myth or reality?
  14. External quality assessment of serum indices: Spanish SEQC-ML program
  15. Comparison of two LC-MS/MS methods for the quantification of 24,25-dihydroxyvitamin D3 in patients and external quality assurance samples
  16. Isotope dilution LC-MS/MS quantification of the cystic fibrosis transmembrane conductance regulator (CFTR) modulators ivacaftor, lumacaftor, tezacaftor, elexacaftor, and their major metabolites in human serum
  17. Hematology and Coagulation
  18. The development of autoverification system of lymphocyte subset assays on the flow cytometry platform
  19. Cancer Diagnostics
  20. Comparison of the QuikRead go® point-of-care faecal immunochemical test for haemoglobin with the FOB Gold Wide® laboratory analyser to diagnose colorectal cancer in symptomatic patients
  21. Evaluation of circulating Dickkopf-1 as a prognostic biomarker in ovarian cancer patients
  22. Cardiovascular Diseases
  23. Soluble CD40 ligand and outcome in patients with coronary artery disease undergoing percutaneous coronary intervention
  24. Diabetes
  25. Lot variation and inter-device differences contribute to poor analytical performance of the DCA Vantage™ HbA1c POCT instrument in a true clinical setting
  26. Infectious Diseases
  27. Lipase elevation in serum of COVID-19 patients: frequency, extent of increase and clinical value
  28. Acknowledgment
  29. Acknowledgment
  30. Letters to the Editors
  31. Presepsin value predicts the risk of developing severe/critical COVID-19 illness: results of a pooled analysis
  32. Measuring accuracy of the neutralizing activity of COVID-19 convalescent plasma
  33. Evaluation of reference intervals for classical and alternative pathway functional complement assays
  34. Reference values for plasma neurofilament light chain in healthy Chinese children
  35. Cerebrospinal fluid neurogranin in Alzheimer’s disease studies: are immunoassay results interchangeable?
  36. Pepsin pretreatment corrects underestimation of 25-hydroxyvitamin D measurement by an automated immunoassay in subjects with high vitamin D binding protein levels
  37. A conspicuous reduced plasma creatinine: the first presenting sign of Waldenstrom macroglobulinemia
  38. Effect of non-linearity on rheumatoid factor assay in Beckman system IMMAGE800
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