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Striving for a pragmatic contribution of biomarkers results to lifelong health care

  • Simona Ferraro EMAIL logo , Cristina Cereda , Gianvincenzo Zuccotti , Santica Marcovina , Mario Plebani ORCID logo and Elia Mario Biganzoli EMAIL logo
Published/Copyright: February 17, 2023
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Clinical Chemistry and Laboratory Medicine (CCLM)
From the journal Clinical Chemistry and Laboratory Medicine (CCLM) Volume 61 Issue 8

Abstract

Background

The increased role of preventive medicine in healthcare and the rapid technological advancements, have deeply changed the landscape of laboratory medicine. In particular, increased investments in newborn screening tests and policies have been observed. Aim of this paper is to characterize how laboratory professionals engaged in clinical chemistry or newborn screening, in collaboration with experts in econometric, bioinformatics, and biostatistics may address a pragmatic use of laboratory results in the decision-making process oriented toward improvement of health care outcomes.

Content

The effectiveness of biomarkers on healthcare depends on several factors such as analytical performance, prevalence of the disease, integration of the test within the diagnostic algorithm, associated costs, and social/economic impact of false positive and false negative results. Cost-effectiveness analysis needs to be performed and reliability achieved, by overcoming analytical pitfalls and by improving interpretative criteria. These are challenging issues common to clinical chemistry and newborn screening tests. Following the experience in clinical chemistry, one of the main issues to be approached in newborn screening tests, is the lack of harmonization of results obtained by different methods and the limited healthcare effectiveness.

Summary

The focus on prevention is a crucial opportunity for laboratory medicine to change how to approach the effectiveness of biomarkers on healthcare. The consolidation within clinical laboratories of professionals with different technical and methodological expertise coupled with the need to produce and manage large sets of data, require the cooperation of professionals from other disciplines to characterize the impact of the tests on epidemiological outcomes for health care policy making process.

Keywords: biomarkers; clinical chemistry; effectiveness; harmonization; healthcare; newborn screening; prevention
Corresponding authors: Simona Ferraro, Department of Pediatrics, Center of Functional Genomics and Rare Diseases, Buzzi Children’s Hospital, Milan, Italy, E-mail: ; and Elia Mario Biganzoli, Department of Biomedical and Clinical Sciences L. Sacco, Medical Statistics Unit, “Luigi Sacco” University Hospital, University of Milan, Milan, Italy, E-mail:
Mario Plebani and Elia Mario Biganzoli contributed equally to this work.

  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: 2022-12-21
Accepted: 2023-02-07
Published Online: 2023-02-17
Published in Print: 2023-07-26

© 2023 Walter de Gruyter GmbH, Berlin/Boston

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https://doi.org/10.1515/cclm-2022-1294
Keywords for this article
biomarkers; clinical chemistry; effectiveness; harmonization; healthcare; newborn screening; prevention

Articles in the same Issue

  1. Frontmatter
  2. Editorial
  3. Addressing standardized definitions of post-COVID and long-COVID
  4. Reviews
  5. The chitinases as biomarkers in immune-mediate diseases
  6. Pitfalls in the diagnosis of hematuria
  7. Opinion Papers
  8. Remote decentralized clinical trials: a new opportunity for laboratory medicine
  9. Striving for a pragmatic contribution of biomarkers results to lifelong health care
  10. IFCC Paper
  11. External quality assessment practices in medical laboratories: an IFCC global survey of member societies
  12. Guidelines and Recommendations
  13. Antibody-mediated interferences affecting cardiac troponin assays: recommendations from the IFCC Committee on Clinical Applications of Cardiac Biomarkers
  14. General Clinical Chemistry and Laboratory Medicine
  15. Evaluation of four automated clinical analyzers for the determination of total 25(OH)D in comparison to a certified LC-MS/MS
  16. Standard −20 °C freezer storage protocols may cause substantial plasma renin cryoactivation
  17. Lower accuracy of testosterone, cortisol, and free T4 measurements using automated immunoassays in people undergoing hemodialysis
  18. Multicenter study to compare the diagnostic performance of CLIA vs. FEIA transglutaminase IgA assays for the diagnosis of celiac disease
  19. Imprecision remains to be improved in the measurement of serum cystatin C with heterogeneous systems
  20. Analytical validation of the modified Westergren method on the automated erythrocyte sedimentation rate analyzer CUBE 30 touch
  21. Reference Values and Biological Variations
  22. Systematic review and meta-analysis of within-subject and between-subject biological variation data of coagulation and fibrinolytic measurands
  23. Biological variation estimates for spot urine analytes and analyte/creatinine ratios in 33 healthy subjects
  24. Short-term biological variation of plasma uracil in a Caucasian healthy population
  25. Cardiovascular Diseases
  26. Elevated Hemolysis Index is associated with higher risk of cardiovascular diseases
  27. Infectious Diseases
  28. Clinical assessment of SNIBE Maglumi SARS-CoV-2 antigen fully-automated chemiluminescent immunoassay
  29. Pre-analytical considerations in the development of a prototype SARS-CoV-2 antigen ARCHITECT automated immunoassay
  30. SARS CoV-2 spike protein-guided exosome isolation facilitates detection of potential miRNA biomarkers in COVID-19 infections
  31. Monocyte distribution width alterations and cytokine storm are modulated by circulating histones
  32. Letters to the Editor
  33. Letter to the Editor regarding the article by Wayne J. Dimech et al. Time to address quality control processes applied to antibody testing for infectious diseases. Clin Chem Lab Med 2023; 61(2):205–212
  34. Response to Tony Badrick regarding “Letter to the Editor regarding the article by Wayne J. Dimech et al. Time to address quality control processes applied to antibody testing for infectious diseases. Clin Chem Lab Med 2023; 61(2):205–212 by”
  35. Monocyte distribution width (MDW) as a reliable biomarker for urosepsis
  36. A consistency analysis of common biochemical tests in arterial blood and venous blood of critically ill patients
  37. Test results comparison: is the S-Monovette® Lithium-Heparin Gel+ a suitable replacement for the S-Monovette® Lithium-Heparin Gel on Alinity Abbott®?
  38. Analytical performance of Abbott’s ARCHITECT and Alinity TSH-receptor antibody (TRAb) assays
  39. Cis-AB showing discrepant results across different automated and manual methods: a case report and review of the literature
  40. A graphical tool to investigate method validation
  41. Live lab-monitor; a customizable HTML-based and systems independent, real-time laboratory overview screen
  42. Congress Abstracts
  43. 61st National Congress of the Hungarian Society of Laboratory Medicine
  44. 9th Annual Meeting of the Austrian Society for Laboratory Medicine and Clinical Chemistry (ÖGLMKC)
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