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Within-subject biological variation estimates using an indirect data mining strategy. Spanish multicenter pilot study (BiVaBiDa)

  • Fernando Marqués-García EMAIL logo , Ana Nieto-Librero , Nerea González-García , Purificación Galindo-Villardón , Luisa María Martínez-Sánchez , Xavier Tejedor-Ganduxé , Beatriz Boned , María Muñoz-Calero , Jose-Vicente García-Lario , Elisabet González-Lao , Ricardo González-Tarancón , M. Pilar Fernández-Fernández , Maria Carmen Perich , Margarida Simón , Jorge Díaz-Garzón and Pilar Fernández-Calle
Published/Copyright: August 29, 2022
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Clinical Chemistry and Laboratory Medicine (CCLM)
From the journal Clinical Chemistry and Laboratory Medicine (CCLM) Volume 60 Issue 11

Abstract

Objectives

The estimates of biological variation (BV) have traditionally been determined using direct methods, which present limitations. In response to this issue, two papers have been published addressing these limitations by employing indirect methods. Here, we present a new procedure, based on indirect methods that analyses data collected within a multicenter pilot study. Using this method, we obtain CVI estimates and calculate confidence intervals (CI), using the EFLM-BVD CVI estimates as gold standard for comparison.

Methods

Data were collected over a 18-month period for 7 measurands, from 3 Spanish hospitals; inclusion criteria: patients 18–75 years with more than two determinations. For each measurand, four different strategies were carried out based on the coefficient of variation ratio (rCoeV) and based on the use of the bootstrap method (OS1, RS2 and RS3). RS2 and RS3 use symmetry reference change value (RCV) to clean database.

Results

RS2 and RS3 had the best correlation for the CVI estimates with respect to EFLM-BVD. RS2 used the symmetric RCV value without eliminating outliers, while RS3 combined RCV and outliers. When using the rCoeV and OS1 strategies, an overestimation of the CVI value was obtained.

Conclusions

Our study presents a new strategy for obtaining robust CVI estimates using an indirect method together with the value of symmetric RCV to select the target population. The CVI estimates obtained show a good correlation with those published in the EFLM-BVD database. Furthermore, our strategy can resolve some of the limitations encountered when using direct methods such as calculating confidence intervals.

Keywords: biological variation; data mining; indirect method; reference change value
Corresponding author: Fernando Marqués-García, PhD, Clinical Biochemistry Department, Metropolitan North Clinical Laboratory (LUMN), Germans Trias i Pujol Universitary Hospital, Badalona, Barcelona, Spain; and Spanish Society of Laboratory Medicine (SEQC), Analytical Quality Commission, Barcelona, Spain, Phone: +34934651200, E-mail:

  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: This protocol was approved by the Institutional Ethical Review board of Germans Trias i Pujol University Hospital (PI-21-034) in agreement with the World Medical Association Declaration of Helsinki, the Spanish law, and by the Ethical Board/Regional Ethics Committee of each Center.

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Supplementary Material

The online version of this article offers supplementary material (https://doi.org/10.1515/cclm-2021-0863).

Received: 2021-08-02
Accepted: 2022-08-16
Published Online: 2022-08-29
Published in Print: 2022-10-26

© 2022 Walter de Gruyter GmbH, Berlin/Boston

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https://doi.org/10.1515/cclm-2021-0863
Keywords for this article
biological variation; data mining; indirect method; reference change value

Articles in the same Issue

  1. Frontmatter
  2. Editorial
  3. Measuring FGF23 in clinical practice: dream or reality?
  4. Reviews
  5. Fibroblast growth factor 23: translating analytical improvement into clinical effectiveness for tertiary prevention in chronic kidney disease
  6. Pursuing appropriateness of laboratory tests: a 15-year experience in an academic medical institution
  7. General Clinical Chemistry and Laboratory Medicine
  8. Moving average quality control of routine chemistry and hematology parameters – a toolbox for implementation
  9. Practical application of European biological variation combined with Westgard Sigma Rules in internal quality control
  10. Total bilirubin assay differences may cause inconsistent treatment decisions in neonatal hyperbilirubinaemia
  11. Early predictors of abnormal MRI patterns in asphyxiated infants: S100B protein urine levels
  12. Interlaboratory comparison study of immunosuppressant analysis using a fully automated LC-MS/MS system
  13. Analytical evaluation and bioclinical validation of new aldosterone and renin immunoassays
  14. Improving clinical performance of urine sediment analysis by implementation of intelligent verification criteria
  15. Clinical evaluation of the OC-Sensor Pledia calprotectin assay
  16. Serous body fluid evaluation using the new automated haematology analyser Mindray BC-6800Plus
  17. Analysis of cryoproteins with a focus on cryofibrinogen: a study on 103 patients
  18. Reference Values and Biological Variations
  19. Within-subject biological variation estimates using an indirect data mining strategy. Spanish multicenter pilot study (BiVaBiDa)
  20. Short-term biological variation of serum glial fibrillary acidic protein
  21. Reference ranges for GDF-15, and risk factors associated with GDF-15, in a large general population cohort
  22. Serum GFAP – reference interval and preanalytical properties in Danish adults
  23. Determination of pediatric reference limits for 10 commonly measured autoantibodies
  24. Hematology and Coagulation
  25. Arterial and venous blood sampling is equally applicable for coagulation and fibrinolysis analyses
  26. Infectious Diseases
  27. Free urinary sialic acid levels may be elevated in patients with pneumococcal sepsis
  28. Letters to the Editor
  29. Thyroid stimulating hormone: biased estimate of allowable bias
  30. Letter to the Editor relating to Clin Chem Lab Med 2022;60(9):1365–72
  31. Reply to the Letter of Sun et al. [1] relating to Clin Chem Lab Med 2022;60(9):1365–72
  32. Prognostic significance of smudge cell percentage in chronic lymphocytic leukemia. Facts or artifacts? Methodological considerations and literature review
  33. Detection of a monoclonal component after pediatric liver transplantation: a case report
  34. Reporting magnesium critical results: clinical impact on pregnant women and neonates
  35. Congress Abstracts
  36. 54th National Congress of the Italian Society of Clinical Biochemistry and Clinical Molecular Biology (SIBioC – Laboratory Medicine)
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