Skip to content
Licensed Unlicensed Requires Authentication Published by De Gruyter August 11, 2023

Six Sigma driven QC in antibody testing for infectious diseases

  • Mohamed Mokhtar Khelil EMAIL logo

Corresponding author: Mohamed Mokhtar Khelil, Medical Laboratory Scientist, Clinical Immunology and Clinical Molecular Biology Laboratory, Pasteur Institute of Algeria, Annexe of M'SILA, Alger, Algeria, E-mail:

Acknowledgments

I would like to thank MECHATI SARA for her help in preparing the figures.

  1. Research ethics: The local Institutional Review Board deemed the study exempt from review.

  2. Informed consent: Informed consent was obtained from all individuals included in this study.

  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: None declared.

References

1. 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. Clin Chem Lab Med 2019; Clin Chem Lab Med 2019;57:e71–2.Search in Google Scholar

2. Badrick, T. 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):205–12. Clin Chem Lab Med 2023;61:135–6.10.1515/cclm-2023-0118Search in Google Scholar PubMed

3. Schochetman, G. AIDS testing: a comprehensive guide to technical, medical, social, legal, and management issues. New York; Berlin: Springer-Verl; 1994.10.1007/978-1-4612-0867-9Search in Google Scholar

4. Paul, WE. Fundamental immunology. Philadelphia: Wolters Kluwer/Lippincott Williams & Wilkins; 2008.Search in Google Scholar

5. Green, GA, Carey, RN, Westgard, JO, Carten, T, Shablesky, L, Achord, D, et al.. Quality control for qualitative assays: quantitative QC procedure designed to assure analytical quality required for an ELISA of hepatitis B surface antigen. Clin Chem 1997;43:1618–21. https://doi.org/10.1093/clinchem/43.9.1618.Search in Google Scholar

6. 14:00-17:00. ISO 15189:2022 [Internet]. ISO. Available from https://www.iso.org/fr/standard/76677.html [accessed 25 May 2023].Search in Google Scholar

7. Kudlac, J, Hanan, S, McKee, GL. Development of quality control procedures for the human immunodeficiency virus type 1 antibody enzyme-linked immunosorbent assay. J Clin Microbiol 1989;27:1303–6. https://doi.org/10.1128/jcm.27.6.1303-1306.1989.Search in Google Scholar PubMed PubMed Central

8. Westgard, JO, Westgard, SA. Six sigma quality management system and design of risk-based statistical quality control. Clin Lab Med 2017;37:85–96. https://doi.org/10.1016/j.cll.2016.09.008.Search in Google Scholar PubMed

9. CLSI C24-Ed4. Statistical quality control for quantitative measurement procedures: principles and definitions, 4th ed. Wayne (PA): Clinical and Laboratory Standards Institute; 2016.Search in Google Scholar

10. Azimzadeh, A, Van Regenmortel, MHV. Antibody affinity measurements. J Mol Recogn 1990;3:108–16. https://doi.org/10.1002/jmr.300030304.Search in Google Scholar PubMed

Received: 2023-05-25
Accepted: 2023-07-20
Published Online: 2023-08-11
Published in Print: 2024-01-26

© 2023 Walter de Gruyter GmbH, Berlin/Boston

Downloaded on 9.5.2024 from https://www.degruyter.com/document/doi/10.1515/cclm-2023-0552/html
Scroll to top button