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Standardization activities for harmonization of test results.

F Dati1, B Brand

  • 1DiaSys Diagnostic Systems, Scientific Affairs, Alte Strasse 9, D-65558, Holzheim, Germany. dati@de.tuv.com

Clinica Chimica Acta; International Journal of Clinical Chemistry
|June 8, 2000
PubMed
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International efforts focus on standardizing laboratory tests for renal damage markers. This ensures reliable disease management through quality-controlled assays and consistent reference values.

Area of Science:

  • Clinical Chemistry
  • Laboratory Medicine
  • Nephrology

Background:

  • Advancements in laboratory assays for urinary proteins (e.g., albumin, beta(2)-microglobulin) aid in detecting renal damage and function.
  • New applications and technologies for known markers present analytical and interpretative challenges for laboratories and clinicians.

Purpose of the Study:

  • To highlight the necessity of international standardization for renal function and damage marker assays.
  • To emphasize the role of quality management, guidelines, and reference materials in improving laboratory testing.

Main Methods:

  • Development of comprehensive quality management measures by international societies.
  • Establishment of uniform guidelines for optimal test utilization.
  • Creation of standardized methods, reference materials, and reference ranges/cut-off values.

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Main Results:

  • International standardization activities are underway to harmonize disease management strategies.
  • Focus on producing and evaluating appropriate reference materials for calibrating diagnostic systems.
  • Aim to establish reliable reference ranges and cut-off values for specific analytes.

Conclusions:

  • International standardization is crucial for harmonized disease management.
  • Reliable laboratory testing, based on quality and value, enhances patient care.
  • Standardized methods and reference materials ensure consistent and accurate diagnostic outcomes.