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.
Funding source: Ministero della Salute
Award Identifier / Grant number: COVID-2020-12371619
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Research ethics: Not applicable.
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Informed consent: Not applicable.
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Author contributions: All authors have accepted responsibility for the entire content of this manuscript and approved its submission.
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Competing interests: Authors state no conflict of interest.
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Research funding: The study was funded by Ministero della Salute (COVID-2020-12371619).
References
1. Plebani, M. Harmonization in laboratory medicine: the complete picture. Clin Chem Lab Med 2013;51:741–51. https://doi.org/10.1515/cclm-2013-0075.Search in Google Scholar PubMed
2. Tate, JR, Johnson, R, Barth, J, Panteghini, M. Harmonization of laboratory testing – current achievements and future strategies. Clin Chim Acta 2014;432:4–7. https://doi.org/10.1016/j.cca.2013.08.021.Search in Google Scholar PubMed
3. http://www.clsi.org/source/custom/termsall.cfm?Section=Harmonized_Terminology_Database [Accessed 29 Jun 2023].Search in Google Scholar
4. Plebani, M, Panteghini, M. Promoting clinical and laboratory interaction by harmonization. Clin Chim Acta 2014;432:15–21. https://doi.org/10.1016/j.cca.2013.09.051.Search in Google Scholar PubMed
5. Zaninotto, M, Graziani, MS, Plebani, M. The harmonization issue in laboratory medicine: the commitment of CCLM. Clin Chem Lab Med 2023;61:721–31.10.1515/cclm-2022-1111Search in Google Scholar PubMed
6. Clinical and Laboratory Standards Institute (CLSI). Harmonized terminology database; 2023. Available from: http://www.clsi.org/source/custom/termsall.cfm?Section=Harmonized_Terminology_Database.Search in Google Scholar
7. Greenberg, N. Update on current concepts and meanings in laboratory medicine — standardization, traceability and harmonization. Clin Chim Acta 2014;432:49–54. https://doi.org/10.1016/j.cca.2013.12.045.Search in Google Scholar PubMed
8. BIPM, IEC, et al.. International vocabulary of metrology | basic and general concepts and associated terms (VIM). In: Joint Committee for Guides in Metrology, 3rd ed.; 2012.Search in Google Scholar
9. ISO 15198:2004 – Clinical laboratory medicine—In vitro diagnostic medical devices—Validation of user quality control procedures by the manufacturer.Search in Google Scholar
10. Lippi, G, Banfi, G, Church, S, Cornes, M, De Carli, G, Grankvist, K, et al.. Preanalytical quality improvement. In pursuit of harmony, on behalf of European federation for clinical chemistry and laboratory medicine (EFLM) working group for preanalytical phase (WG-PRE). Clin Chem Lab Med 2015;53:357–70. https://doi.org/10.1515/cclm-2014-1051.Search in Google Scholar PubMed
11. Simundic, AM, Cornes, MP, Grankvist, K, Lippi, G, Nybo, M, Ceriotti, F, et al.. Colour coding for blood collection tube closures – a call for harmonisation. Clin Chem Lab Med 2015;53:371–6. https://doi.org/10.1515/cclm-2014-0927.Search in Google Scholar PubMed
12. Plebani, M, Graziani, MS, Tate, JR. Harmonization in laboratory medicine: blowin’ in the wind. Clin Chem Lab Med 2018;56:1559–62. https://doi.org/10.1515/cclm-2018-0594.Search in Google Scholar PubMed
13. Karger, AB, Brien, JD, Christen, JM, Dhakal, S, Kemp, TJ, Klein, SL, et al.. The serological sciences network (SeroNet) for COVID-19: depth and breadth of serology assays and plans for assay harmonization. mSphere 2022;7:e0019322. https://doi.org/10.1128/msphere.00193-22.Search in Google Scholar PubMed PubMed Central
14. Coskun, A, Unsal, I, Serteser, M, Inal, T. Six sigma as a quality management tool: evaluation of performance in laboratory medicine. In: Coskun, A. editor Quality Management and Six Sigma [Internet]. Sciyo; 2010. http://www.intechopen.com/books/quality-management-and-six-sigma/six-sigma-as-a-quality-management-tool-evaluation-of-performance-in-laboratory-medicine [Accessed 15 Jun 2023].10.5772/9928Search in Google Scholar
15. Plebani, M. The detection and prevention of errors in laboratory medicine. Ann Clin Biochem 2010;47:101. https://doi.org/10.1258/acb.2009.009222.Search in Google Scholar PubMed
16. Neogi, S, Mehndiratta, M, Gupta, S, Puri, D. Pre-analytical phase in clinical chemistry laboratory. J Clin Sci Res 2016;5:171. https://doi.org/10.15380/2277-5706.jcsr.15.062.Search in Google Scholar
17. https://www.cdc.gov/coronavirus/2019-ncov/lab/resources/antibody-tests.html [Accessed 15 Jun 2023].Search in Google Scholar
18. Di Resta, C, Ferrari, D, Viganò, M, Moro, M, Sabetta, E, Minerva, M, et al.. The gender impact assessment among healthcare workers in the SARS-CoV-2 vaccination-an analysis of serological response and side effects. Vaccines 2021;9:522. https://doi.org/10.3390/vaccines9050522.Search in Google Scholar PubMed PubMed Central
19. Lustig, Y, Sapir, E, Regev-Yochay, G, Cohen, C, Fluss, R, Olmer, L, et al.. BNT162b2 COVID-19 vaccine and correlates of humoral immune responses and dynamics: a prospective, single-centre, longitudinal cohort study in health-care workers. Lancet Respir Med 2021;9:999–1009. https://doi.org/10.1016/s2213-2600(21)00220-4.Search in Google Scholar
20. Alexopoulos, H, Trougakos, IP, Dimopoulos, MA, Terpos, E. Clinical usefulness of testing for severe acute respiratory syndrome coronavirus 2 antibodies. Eur J Intern Med 2022;S0953-6205:00393–4.Search in Google Scholar
21. van den Hoogen, LL, Smits, G, van Hagen, CCE, Wong, D, Vos, ERA, van Boven, M, et al.. Seropositivity to Nucleoprotein to detect mild and asymptomatic SARS-CoV-2 infections: a complementary tool to detect breakthrough infections after COVID-19 vaccination? Vaccine 2022;40:2251–7. https://doi.org/10.1016/j.vaccine.2022.03.009.Search in Google Scholar PubMed PubMed Central
22. From the American Association of Neurological Surgeons (AANS), American Society of Neuroradiology (ASNR), Cardiovascular and Interventional Radiology Society of Europe (CIRSE), Canadian Interventional Radiology Association (CIRA), Congress of Neurological Surgeons (CNS), European Society of Minimally Invasive Neurological Therapy (ESMINT), et al.. Multisociety consensus quality improvement revised consensus statement for endovascular therapy of acute ischemic stroke. Int J Stroke 2018;13:612–32. https://doi.org/10.3174/ajnr.a5638.Search in Google Scholar PubMed PubMed Central
23. Ferrari, D, Ambrosi, A, Di Resta, C, Tomaiuolo, R, Locatelli, M, Banfi, G. Evaluation of antibody titer kinetics and SARS-CoV-2 infections in a large cohort of healthcare professionals ten months after administration of the BNT162b2 vaccine. J Immunol Methods 2022;506:113293. https://doi.org/10.1016/j.jim.2022.113293.Search in Google Scholar PubMed PubMed Central
24. Colombini, A, Viganò, M, Tomaiuolo, R, Di Resta, C, Corea, F, Sabetta, E, et al.. Exploratory assessment of serological tests to determine antibody titer against SARS-CoV-2: appropriateness and limits. J Clin Lab Anal 2022;36:e24363. https://doi.org/10.1002/jcla.24363.Search in Google Scholar PubMed PubMed Central
25. Tan, W, Zhao, X, Ma, X, Wang, W, Niu, P, Xu, W, et al.. A novel coronavirus genome identified in a cluster of pneumonia cases – Wuhan, China 2019–2020. China CDC Wkly 2020;2:61–2. https://doi.org/10.46234/ccdcw2020.017.Search in Google Scholar
26. Lima-Oliveira, G, Volanski, W, Lippi, G, Picheth, G, Guidi, GC. Pre-analytical phase management: a review of the procedures from patient preparation to laboratory analysis. Scand J Clin Lab Invest 2017;77:153–63. https://doi.org/10.1080/00365513.2017.1295317.Search in Google Scholar PubMed
27. Cadamuro, J, Baird, G, Baumann, G, Bolenius, K, Cornes, M, Ibarz, M, et al.. Preanalytical quality improvement – an interdisciplinary journey, on behalf of the European federation for clinical chemistry and laboratory medicine (EFLM) working group for preanalytical phase (WG-PRE). Clin Chem Lab Med 2022;60:662–8. https://doi.org/10.1515/cclm-2022-0117.Search in Google Scholar PubMed
28. Kim, J, Sung, H, Lee, H, Kim, JS, Shin, S, Jeong, S, et al.. Clinical performance of rapid and point-of-care antigen tests for SARS-CoV-2 variants of concern: a living systematic review and meta-analysis. Viruses 2022;14:1479. https://doi.org/10.3390/v14071479.Search in Google Scholar PubMed PubMed Central
29. Pinilla, YT, Heinzel, C, Caminada, LF, Consolaro, D, Esen, M, Kremsner, PG, et al.. SARS-CoV-2 antibodies are persisting in saliva for more than 15 Months after infection and become strongly boosted after vaccination. Front Immunol 2021;12:798859. https://doi.org/10.3389/fimmu.2021.798859.Search in Google Scholar PubMed PubMed Central
30. Jarius, S, Pache, F, Körtvelyessy, P, Jelčić, I, Stettner, M, Franciotta, D, et al.. Cerebrospinal fluid findings in COVID-19: a multicenter study of 150 lumbar punctures in 127 patients. J Neuroinflammation 2022;19:19. https://doi.org/10.1186/s12974-021-02339-0.Search in Google Scholar PubMed PubMed Central
31. Sonntag, O. Quality in the analytical phase. Biochem Med 2010;20:147–53. https://doi.org/10.11613/bm.2010.017.Search in Google Scholar
32. JCGM 200. International vocabulary of metrology – basic and general concepts and associated terms, 3rd ed. VIM; 2012.Search in Google Scholar
33. Knezevic, I, Mattiuzzo, G, Page, M, Minor, P, Griffiths, E, Nuebling, M, et al.. WHO International Standard for evaluation of the antibody response to COVID-19 vaccines: call for urgent action by the scientific community. Lancet Microbe 2022;3:e235–40. https://doi.org/10.1016/s2666-5247(21)00266-4.Search in Google Scholar PubMed PubMed Central
34. Ferrari, D, Clementi, N, Spanò, SM, Albitar-Nehme, S, Ranno, S, Colombini, A, et al.. Harmonization of six quantitative SARS-CoV-2 serological assays using sera of vaccinated subjects. Clin Chim Acta 2021;522:144–51. https://doi.org/10.1016/j.cca.2021.08.024.Search in Google Scholar PubMed PubMed Central
35. Plebani, M, Lippi, G. Standardization and harmonization in laboratory medicine: not only for clinical chemistry measurands. Clin Chem Lab Med 2022;61:185–7. https://doi.org/10.1515/cclm-2022-1122.Search in Google Scholar PubMed
36. Tomaiuolo, R, Restelli, U, Faggiano, FC, Di Resta, C, Al Bitar Nehme, S, Giuliani, F, et al.. Health technology assessment to employ COVID-19 serological tests as companion diagnostics in the vaccination campaign against SARS-CoV-2. Clin Chem Lab Med 2022;60:1463–77. https://doi.org/10.1515/cclm-2022-0262.Search in Google Scholar PubMed
37. Podolsky, E, Hudek, N, McCudden, C, Presseau, J, Yanikomeroglu, S, Brouwers, M, et al.. Choosing which in-hospital laboratory tests to target for intervention: a scoping review. Clin Chem Lab Med 2023;61:388–401. https://doi.org/10.1515/cclm-2022-0910.Search in Google Scholar PubMed PubMed Central
38. Landaas, EJ, Baird, GS, Hansen, RN, Flum, DR, Sullivan, SD. Integrating formal technology assessment into an integrated healthcare delivery system: smart innovation. Int J Technol Assess Health Care 2020;36:58–63. https://doi.org/10.1017/s0266462319003465.Search in Google Scholar PubMed
39. Hayden, JA, Kwan, SW, Valji, K. Implementation of rapid cortisol during adrenal vein sampling. Hypertension 2014;63:e88. https://doi.org/10.1161/hypertensionaha.113.03064.Search in Google Scholar
40. Armbruster, D, Miller, RR. The Joint Committee for Traceability in Laboratory Medicine (JCTLM): a global approach to promote the standardisation of clinical laboratory test results. Clin Biochem Rev 2007;28:105–13.Search in Google Scholar
41. Mi, W, Josephs, RD, Melanson, JE, Dai, X, Wang, Y, Zhai, R, et al.. PAWG pilot study on quantification of SARS-CoV-2 monoclonal antibody – Part 1. Metrologia 2022;59:08001. https://doi.org/10.1088/0026-1394/59/1a/08001.Search in Google Scholar
42. Tomaiuolo, R, Derrico, P, Ritrovato, M, Locatelli, M, Milella, F, Restelli, U, et al.. COVIDIAGNOSTIX: health technology assessment of serological tests for SARS-CoV-2 infection. Int J Technol Assess Health Care 2021;37:e87. https://doi.org/10.1017/s0266462321000441.Search in Google Scholar PubMed
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