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Factor VIII assays. Assessment of variables
J T Brandt1, D A Triplett, K Musgrave
1Department of Pathology, Ohio State University, Columbus 43210.
Archives of Pathology & Laboratory Medicine
|January 1, 1988
Summary
Standardizing reference plasma and choosing proper reagents improve the accuracy and reproducibility of Factor VIII assays, addressing common interlaboratory result variations.
Area of Science:
- Clinical Chemistry
- Hematology
- Laboratory Medicine
Background:
- Factor VIII assays are crucial for diagnosing and managing bleeding disorders.
- Interlaboratory proficiency studies reveal significant variability in current Factor VIII assay results.
- This inconsistency poses challenges for accurate patient diagnosis and treatment.
Purpose of the Study:
- To identify key variables impacting the performance of the one-stage Factor VIII assay.
- To propose strategies for enhancing the accuracy and reproducibility of Factor VIII testing.
- To reduce interlaboratory variations in coagulation factor assay results.
Main Methods:
- A workshop was convened by the College of American Pathologists' Coagulation Resource Committee.
- Experts analyzed factors influencing the one-stage Factor VIII assay.
- Potential sources of variability in reagents, reference standards, and instrumentation were examined.
Main Results:
- Uniform standardization of reference plasma samples is critical for improving assay accuracy.
- Careful selection of reagents and instruments significantly enhances assay reproducibility.
- Addressing these variables can mitigate the persistent problems of result variation.
Conclusions:
- Standardization of reference materials and optimized reagent/instrument selection are essential.
- Implementing these improvements will lead to more consistent and reliable interlaboratory Factor VIII assay results.
- Enhanced assay performance will improve diagnostic confidence and patient care.