Keywords
HIV antibodies
serologic tests
laboratories, clinical
How to Cite
Abstract
The use of internal quality control (IQC) has contributed significantly to improving the analytical phase in clinical laboratories, ensuring greater reliability of results used in clinical decision-making. This study aimed to monitor and evaluate overall performance of laboratories in determining the optimal IQC dilution in the HIV immunoblot assay across different batches distributed between 2022 and 2025. This is an observational, descriptive, retrospective study assessing laboratory performance within a quality control program. During the study period, the Internal Quality Control Program of the Adolfo Lutz Institute produced ten batches of HIV IQC, each composed of four samples with distinct concentrations of anti-HIV antibodies for use in the rapid immunoblot assay. Participating laboratories were instructed to establish, as IQC, the highest dilution that maintained the HIV-1 positivity criterion. The accuracy rate was 91% in 2022 and ranged between 70% and 80% in subsequent years, with no evidence of a consistent temporal trend. The systematic incorporation of critical samples into quality control programs may represent an effective strategy for identifying analytical biases and promoting continuous improvement in laboratory performance.
References
1. Price CP, St John A. The role of laboratory medicine in value-based healthcare. J Appl Lab Med. 2020; 5(6):1408-10. https://doi.org/10.1093/jalm/jfaa136.
2. Plebani M. The journey to pre-analytical quality. Clin Chem Lab Med. 2025; 63(7):1237-38. https://doi.org/10.1515/cclm-2025-0057.
3. Sciacovelli L, Padoan A, Aita A, Basso D, Plebani M. Quality indicators in laboratory medicine: state-of-the-art, quality specifications and future strategies. Clin Chem Lab Med. 2023; 61(4):688-95. https://doi.org/10.1515/cclm-2022-1143.
4. Gray JJ, Wreghitt TG, McKee TA, McIntyre P, Roth CE, Smith DJ, et al. Internal quality assurance in a clinical virology laboratory. I. Internal quality assessment. J Clin Pathol. 1995; 48(2):168-73. https://doi.org/10.1136/jcp.48.2.168.
5. Witte DL, VanNess SA, Angstadt DS, Pennell BJ. Errors, mistakes, blunders, outliers, or unacceptable results: how many? Clin Chem. 1997; 43(8):1352-56. https://doi.org/10.1093/clinchem/43.8.1352.
6. Kinns H, Pitkin S, Housley D, Freedman DB. Internal quality control: best practice. J Clin Pathol. 2013; 66(12):1027-32. https://doi.org/10.1136/jclinpath-2013-201661.
7. Plebani M. Quality in laboratory medicine: 50 years on. Clin Biochem. 2017; 50(3):101-04. https://doi.org/10.1016/j.clinbiochem.2016.10.007.
8. Castejon MJ, Oliveira EL. Boas práticas de fabricação para a produção do material de referência para ensaios sorológicos no Instituto Adolfo Lutz. Bol Epidemiol Paul. 2024; 21:e41429. https://doi.org/10.57148/bepa.2024.v.21.41429.
9. Plebani M. Quality indicators: an evolving target for laboratory medicine. Clin Chem Lab Med. 2025; 63(10):1889-90. https://doi.org/10.1515/cclm-2025-0674.
10. Lippi G, Jackson B, Plebani M. Improving diagnosis in health care: laboratory medicine. Diagnosis (Berl). 2025;12(4):570-77. https://doi.org/10.1515/dx-2025-0052.
11. Castejon MJ, Yamashiro R, Oliveira CAF, Ueda M. Implementation of a strategy for improving the serological diagnosis of HIV/AIDS by introducing the internal quality control. Rev Inst Adolfo Lutz. 2010; 69(2):157-64. https://doi.org/10.53393/rial.2010.v69.32650.
12. Castejon MJ, Yamashiro R, Oliveira CC, Granato D, Oliveira CAF, Ueda M. Study on the stability of internal quality control sera for HIV/AIDS immunodiagnostic tests. J Bras Patol Med Lab. 2014; 50(1):36-45. https://doi.org/10.1590/S1676-24442014000100005.
13. Castejon MJ, Yamashiro R, Oliveira CC, Olivieri JC, Oliveira CAF, Ueda M. Homogeneity study of the internal quality control sera for immunodiagnosis of HIV/AIDS. J Bras Patol Med Lab. 2014; 50(1):46-52. https://doi.org/10.1590/S1676-24442014000100006.
14. Ministério da Saúde (BR). Portaria SVS/MS n. 29, de 17 de dezembro de 2013. Aprova o Manual técnico para o diagnóstico da infecção pelo HIV em adultos e crianças e dá outras providências. Brasília; Diário Oficial da União. 18 dez 2013. Seção 1; 245.
15. Castejon MJ, Yamashiro R, Oliveira EL, Silveira EPR, Oliveira CAF. Manual do participante – controle de qualidade interno (CQI) em ensaios de imunoblot rápido HIV e de quimioluminescência anti-treponêmico. São Paulo, Instituto Adolfo Lutz. 2016; p.20. [Acesso em: 3 fev. 2026] Disponível em: https://pesquisa.bvsalud.org/portal/resource/pt/ses-33099.
16. Castejon MJ, Yamashiro R, Oliveira EL, Fazioli RA. Manual do participante - controle de qualidade interno para o ensaio de imunoblot rápido para HIV. 2022; p.8. [Acesso em: 3 fev. 2026] Disponível em: https://pesquisa.bvsalud.org/portal/resource/pt/biblio-1381909.
17. Castejon MJ, Madureira KCR, Rossi MB, Oliveira EL, Gallo JF, Yamashiro R et al. Monitoramento da estabilidade do controle de qualidade interno para ensaios sorológicos de HIV/aids. Bol Epidemiol Paul. 2024; 21:e40675. https://doi.org/10.57148/bepa.2024.v.21.40675.
18. Wilson EB. Probable inference, the law of succession, and statistical inference. Amer. Statistical Association. 1927; 22 (158): 209-12. (1927). https://doi.org/10.2307/2276774.
19. Berlitz FA. Controle da qualidade no laboratório clínico: alinhando melhoria de processos, confiabilidade e segurança do paciente. J Bras Patol Med Lab. 2010; 46(5):353-63. https://doi.org/10.1590/S1676-24442010000500003.
20. Plebani M, Sciacovelli L, Marinova M, Marcuccitti J, Chiozza ML. Quality indicators in laboratory medicine: a fundamental tool for quality and patient safety. Clin Biochem. 2013; 46(13-14):1170-4. https://doi.org/10.1016/j.clinbiochem.2012.11.028.
21. Galli C, Plebani M. Quality controls for serology: an unfinished agenda. Clin Chem Lab Med. 2020; 58(8):1169-70. https://doi.org/10.1515/cclm-2020-0304.
22. Plebani M. Value-based laboratory medicine: the time is now. Clin Chem Lab Med 2024; 62(4):579-80. https://doi.org/10.1515/cclm-2023-1095.
23. Dimech WJ, Vincini GA, Cabuang LM, Wieringa M. Does a change in quality control results influence the sensitivity of an anti-HCV test? Clin Chem Lab Med. 2020; 58(8):1372-80. https://doi.org/10.1515/cclm-2020-0031.
24. Badrick T, Fortun M, Vayanos Z, Bernard M, Dufour P, Souied L, et al. Quality control for serological testing. Clin Chim Acta. 2025; 564:119905. https://doi.org/10.1016/j.cca.2024.119905.
25. Vieira KF, Shitara ES, Mendes ME, Sumita NM. A utilidade dos indicadores da qualidade no gerenciamento de laboratórios clínicos. Bras Patol Med Lab. 2011; 47(3):201-10. https://doi.org/10.1590/S1676-24442011000300002.
26. Altman DG. Practical statistics for medical research. London: Chapman & Hall/CRC; 1991.
27. Oliveira CA, Mendes ME. Gestão da fase analítica do laboratório: como assegurar a qualidade na prática. 1.ed. - Rio de Janeiro: ControlLab, 2010 https://so.controllab.com/pdf/gestao_fase_analitica_vol1.pdf
28. Plebani M, Astion ML, Barth JH, Chen W, Galoro CAO, Escuer MI, et al. Harmonization of quality indicators in laboratory medicine. A preliminary consensus. Clin Chem Lab Med. 2014; 52(7): 951–8. https://doi.org/10.1515/cclm-2014-0142.
29. Ricós C, Fernandez-Calle P, Perich C, Westgard JO. Internal quality control - past, present and future trends. Adv Lab Med. 2022; 3(3):243-62. https://doi.org/10.1515/almed-2022-0029
30. Jesus LG, Bonichini PCG, Oliveira FA, Miranda CL, Castro AB. Padronização do controle de qualidade interno e procedimentos de validação de insumos utilizados em rotina de testes sorológicos. Rev. Multi. Saúde. 2025; 6(1):27-37. https://doi.org/10.1016/j.htct.2024.09.1606.
31. Dimech W. The Standardization and control of serology and nucleic a testing for infectious diseases. Clin Microbiol Rev. 2021; 34(4):e0003521. https://doi.org/: 10.1128/CMR.00035-21.
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