[Impact of the analitycal quality for the infectious serology]

Gisela Cortés-Rivera1

  • 1Laboratorios LICON S.A., Subdirección de Línea, Sistemas de Control de la Calidad. Tlalnepantla, Estado de México, México.

Insights

Quality assurance in clinical laboratory testing for infectious markers is crucial for reliable results. Implementing robust quality management systems and adhering to international guidelines ensures accurate detection and patient safety.

Area of Science:

  • Clinical Laboratory Science
  • Medical Diagnostics
  • Public Health

Context:

  • The scope of quality assurance has expanded significantly, particularly in analytical testing for infectious disease markers within clinical laboratories and blood banks.
  • Official Mexican standards mandate the assurance of result quality for these tests.
  • International guidelines for good practices are recommended for compliance.

Purpose:

  • To highlight the importance and application of quality assurance in the analytical phase of infectious marker screening.
  • To emphasize the integration of quality management systems with regulatory requirements and international best practices.
  • To underscore the benefits of robust quality assurance in clinical laboratory diagnostics.

Summary:

  • Quality assurance in infectious marker testing involves meticulous material selection, statistical analysis, and appropriate tools, all within a comprehensive quality management system.
  • Adherence to official standards and international guidelines is essential for ensuring the reliability of laboratory results.
  • Monitoring key indicators and implementing corrective actions are vital for reducing risks associated with diagnostic testing.

Impact:

  • Enhances the reliability and clinical utility of results from infectious marker screening.
  • Reduces the risk of adverse outcomes for patients and blood donors.
  • Promotes a higher standard of care in clinical laboratories and blood banking services through systematic quality management.