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Quality management and international standardization programs for protein immunoassays
1Behring Diagnostics GmbH, AG, Marburg, Germany.
Anticancer Research
|July 1, 1997
Summary
Quality management is crucial for numerous immunoassays. International standardization programs and reference materials ensure comparable and reliable laboratory test results for improved clinical use.
Area of Science:
- Clinical Chemistry
- Laboratory Medicine
- Biotechnology
Background:
- The proliferation of immunoassays for protein and tumor marker detection necessitates robust quality management.
- Ensuring the comparability of laboratory test results across different systems is a significant challenge.
Purpose of the Study:
- To highlight the importance of international standardization programs for immunoassays.
- To emphasize the role of reference materials in quality management for laboratory tests.
Main Methods:
- Development and implementation of international standardization programs.
- Establishment of consensus/reference methods.
- Creation and certification of reference materials with defined characteristics.
Main Results:
- Internationally accepted reference materials facilitate result harmonization across diverse test systems.
- Standardization efforts improve the overall quality and clinical utility of immunoassay results.
Conclusions:
- Comprehensive quality management, including standardization and reference materials, is essential for modern immunoassays.
- Harmonized laboratory test results enhance diagnostic accuracy and patient care.