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The total testing process harmonization: the case study of SARS-CoV-2 serological tests

  • Alessandra Colombini , Carla Divieto , Rossella Tomaiuolo ORCID logo EMAIL logo , Leonardo Mortati , Jessica Petiti , Chiara Di Resta and Giuseppe Banfi
Published/Copyright: August 4, 2023
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Clinical Chemistry and Laboratory Medicine (CCLM)
From the journal Clinical Chemistry and Laboratory Medicine (CCLM) Volume 61 Issue 12

Abstract

The total testing process harmonization is central to laboratory medicine, leading to the laboratory test’s effectiveness. In this opinion paper the five phases of the TTP are analyzed, describing, and summarizing the critical issues that emerged in each phase of the TTP with the SARS-CoV-2 serological tests that have affected their effectiveness. Testing and screening the population was essential for defining seropositivity and, thus, driving public health policies in the management of the COVID-19 pandemic. However, the many differences in terminology, the unit of measurement, reference ranges and parameters for interpreting results make analytical results difficult to compare, leading to the general confusion that affects or completely precludes the comparability of data. Starting from these considerations related to SARS-CoV-2 serological tests, through interdisciplinary work, the authors have highlighted the most critical points and formulated proposals to make total testing process harmonization effective, positively impacting the diagnostic effectiveness of laboratory tests.

Keywords: harmonization; SARS-CoV-2 serological tests; total testing process
Corresponding author: Rossella Tomaiuolo, IRCCS Istituto Ortopedico Galeazzi, Milan, Italy; and Vita-Salute San Raffaele University, 20132 Milan, Italy, E-mail:

Funding source: Ministero della Salute

Award Identifier / Grant number: COVID-2020-12371619

  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: The study was funded by Ministero della Salute (COVID-2020-12371619).

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Received: 2023-04-06
Accepted: 2023-07-19
Published Online: 2023-08-04
Published in Print: 2023-11-27

© 2023 Walter de Gruyter GmbH, Berlin/Boston

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https://doi.org/10.1515/cclm-2023-0353
Keywords for this article
harmonization; SARS-CoV-2 serological tests; total testing process

Articles in the same Issue

  1. Frontmatter
  2. Editorial
  3. Adherence to recommendations and clinical practice guidelines: not an easy task
  4. Reviews
  5. Comparison of interferon-gamma production between TB1 and TB2 tubes of QuantiFERON-TB Gold Plus: a meta-analysis
  6. Review on adherence of the literature to official recommendations on albuminuria harmonization and standardization
  7. Opinion Paper
  8. The total testing process harmonization: the case study of SARS-CoV-2 serological tests
  9. IFCC Paper
  10. Quality standards and internal quality control practices in medical laboratories: an IFCC global survey of member societies
  11. Guidelines and Recommendations
  12. Toolkit for emerging technologies in laboratory medicine
  13. Recommendations for the study of monoclonal gammopathies in the clinical laboratory. A consensus of the Spanish Society of Laboratory Medicine and the Spanish Society of Hematology and Hemotherapy. Part I: Update on laboratory tests for the study of monoclonal gammopathies
  14. Recommendations for the study of monoclonal gammopathies in the clinical laboratory. A consensus of the Spanish Society of Laboratory Medicine and the Spanish Society of Hematology and Hemotherapy. Part II: Methodological and clinical recommendations for the diagnosis and follow-up of monoclonal gammopathies
  15. Genetics and Molecular Diagnostics
  16. The MBL2 genotype relates to COVID-19 severity and may help to select the optimal therapy
  17. General Clinical Chemistry and Laboratory Medicine
  18. The stability of C-peptide and insulin in plasma and serum samples under different storage conditions
  19. Self-sampling of blood using a topper and pediatric tubes; a prospective feasibility study for PSA analysis using 120 prostate cancer patients
  20. Albumin determined by bromocresol green leads to erroneous results in routine evaluation of patients with chronic kidney disease
  21. Uncertainty in measurement and the renal tubular reabsorption of phosphate
  22. Urine transfer devices may impact urinary particle results: a pre-analytical study
  23. Analytical and clinical validation of a blood progranulin ELISA in frontotemporal dementias
  24. Early changes in S100B maternal blood levels can predict fetal intrauterine growth restriction
  25. Reference Values and Biological Variations
  26. Interpreting two TSH results from the same patient
  27. Cancer Diagnostics
  28. Integrated plasma and exosome long noncoding RNA profiling is promising for diagnosing non-small cell lung cancer
  29. Diagnostic accuracy of extended HPV DNA genotyping and its application for risk-based cervical cancer screening strategy
  30. Infectious Diseases
  31. Performance evaluation of SARS-CoV-2 antigen detection in the post-pandemic era: multi-laboratory assessment
  32. Serum sPD-L1 levels are elevated in patients with viral diseases, bacterial sepsis or in patients with impaired renal function compared to healthy blood donors
  33. Letters to the Editor
  34. Results of the first survey of the EFLM Task Force Preparation of Labs for Emergencies (TF-PLE)
  35. Thrombocytopenia and hyperinflammation are induced by extracellular histones circulating in blood
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  41. Laboratory medicine unveiling an unusual cause of D-lactic acidosis as the trigger of decompensation of a rare inborn error of metabolism
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