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Reference values and methods comparison of a new testosterone assay on the AxSYM system
M González-Sagrado1, F J Martín-Gil, S López-Hernández
1Division of Biochemistry, Laboratory of Clinical Chemistry, University Hospital Del Río Hortega, Valladolid, Spain.
Clinical Biochemistry
|July 29, 2000
Summary
The Abbott AxSYM Testosterone assay shows good agreement with other methods, establishing reliable reference ranges for both men and women. This validation supports its use in clinical diagnostics.
Area of Science:
- Clinical Chemistry
- Immunoassay Technology
- Endocrinology
Background:
- Accurate testosterone measurement is crucial for diagnosing various endocrine disorders.
- Validation of new diagnostic assays is essential for reliable clinical laboratory practice.
Purpose of the Study:
- To establish reference values for the Abbott AxSYM Testosterone assay.
- To compare the performance of the AxSYM Testosterone assay against established methods (ACS-180 and Elecsys).
Main Methods:
- Reference values were determined using a population of 45 women and 30 men.
- Method comparison involved analyzing 132 samples (AxSYM vs. ACS-180) and 30 samples (AxSYM vs. Elecsys).
- Statistical analyses included Pearson and intraclass concordance coefficients and Passing-Bablock regression.
Main Results:
- Established reference ranges: 0.9-3.1 nmol/L (females) and 1.0-30.2 nmol/L (males).
- Good agreement was observed between AxSYM and ACS-180 (r=0.961) and between AxSYM and Elecsys (r=0.935).
- Slightly lower agreement was noted for female samples compared to the overall group.
Conclusions:
- The Abbott AxSYM Testosterone assay provides reference ranges consistent with existing methodologies.
- The assay demonstrates acceptable agreement with both classical and modern testosterone testing platforms.