1. Reference values and methods comparison of a new testosterone assay on the AxSYM system
- Author
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Nuria Fernández-García, María Luisa Arranz-Peña, Francisco Javier Martín-Gil, Silvia López-Hernández, Ana María Olmos-Linares, and Manuel González-Sagrado
- Subjects
Adult ,Male ,medicine.medical_specialty ,Adolescent ,Concordance ,Statistics as Topic ,Clinical Biochemistry ,Population ,Blood Donors ,Reference range ,Statistics, Nonparametric ,Immunoenzyme Techniques ,Reference Values ,medicine ,Humans ,Testosterone ,Child ,education ,Gynecology ,Analysis of Variance ,education.field_of_study ,Obstetrics ,business.industry ,Testosterone (patch) ,General Medicine ,Middle Aged ,Method comparison ,Evaluation Studies as Topic ,Reference values ,Female ,business ,Design Validation ,Slightly worse - Abstract
Objectives: We have contributed to the Design Validation Protocol of the new Abbott AxSYM Testosterone assay with a study on reference values and methods comparison. Design and methods: For reference values a population of 45 women and 30 men was tested. In methods comparison, 132 samples for the AxSYM vs. ACS-180, and 30 for the AxSYM vs. Elecsys were used. Pearson and intraclass concordance coefficients and Passing-Bablock test were performed for overall group, men and women. Results: Reference values were 0.9 ‐3.1 (females) and 1.0 ‐30.2 nmol/L (males). Globally, a good agreement between methods in both the AxSYM vs. ACS-180 (slope: 0.88, y-intercept: 0.67, r 5 0.961) and the AxSYM vs. Elecsys (slope: 1.08, y-intercept: 0.31, r 5 0.935) studies was found. Slightly worse results were observed for women. Conclusions: The reference range of testosterone by the AxSYM system matches with those published for other methods. An acceptable agreement between the AxSYM Testosterone assay and both a classical (ACS-180) and a more recent (Elecsys) methodology was observed. Copyright © 2000 The Canadian Society of Clinical Chemists
- Published
- 2000