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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

  • Tony Badrick EMAIL logo

Corresponding author: Tony Badrick, RCPA Quality Assurance Programs, St Leonards, Sydney, Australia, 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: Not applicable.

References

1. Dimech, WJ, Vincini, GA, Plebani, M, Lippi, G, Nichols, JH, Sonntag, O. Time to address quality control processes applied to antibody testing for infectious diseases. Clin Chem Lab Med 2022;61:205–12. https://doi.org/10.1515/cclm-2022-0986.Search in Google Scholar PubMed

2. Stenman, U. Immunoassay standardization: is it possible, who is responsible, who is capable? Clin Chem 2001;47:815820. https://doi.org/10.1093/clinchem/47.5.815.Search in Google Scholar

3. Vesper, HW, Thienpont, LM. Traceability in laboratory medicine. Clin Chem 2009;55:1067–75. https://doi.org/10.1373/clinchem.2008.107052.Search in Google Scholar PubMed

4. Patel, N. Why the CDC botched its coronavirus testing. In: MIT technology review; 2020. Available from: https://www.technologyreview.com/2020/03/05/905484/why-the-cdc-botched-its-coronavirus-testing/ [Accessed 13 Feb 2023].Search in Google Scholar

5. Duong, YT, Wright, CG, Justman, J. Antibody testing for coronavirus disease 2019: not ready for prime time. BMJ 2020;370:1–2. https://doi.org/10.1136/bmj.m2655.Search in Google Scholar PubMed PubMed Central

6. Algeciras-Schimnich, A, Bruns, DE, Boyd, JC, Bryant, SC, la Fortune, KA, Grebe, SKG. Failure of current laboratory protocols to detect lot-to-lot reagent differences: findings and possible solutions. Clin Chem 2013;59:1187–94. https://doi.org/10.1373/clinchem.2013.205070.Search in Google Scholar PubMed

7. Kinns, H, Pitkin, S, Housley, D, Freedman, DB. Internal quality control: best practice. J Clin Pathol 2013;66:1027–32. https://doi.org/10.1136/jclinpath-2013-201661.Search in Google Scholar PubMed

8. Badrick, T, Parvin, C. Letter to the Editor on article Dimech W, Karakaltsas M, Vincini G. Comparison of four methods of establishing control limits for monitoring quality controls in infectious disease serology testing. Clin Chem Lab Med 2018;56:1970–8.10.1515/cclm-2018-0351Search in Google Scholar PubMed

9. CLSI. Statistical quality control for quantitative measurement procedures: principles and definitions. In: CLSI Guideline C24, 4th ed. Wayne, PA, USA: CLSI; 2016.Search in Google Scholar

Received: 2023-02-01
Accepted: 2023-02-10
Published Online: 2023-03-06
Published in Print: 2023-07-26

© 2023 Walter de Gruyter GmbH, Berlin/Boston

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