Reference values and methods comparison of a new testosterone assay on the AxSYM system.
OBJECTIVE
We have contributed to the Design Validation Protocol of the new Abbott AxSYM Testosterone assay with a study on reference values and methods comparison.


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 = 0.961) and the AxSYM vs. Elecsys (slope: 1.08, y-intercept: 0.31, r = 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.
González-Sagrado
M
M
Division of Biochemistry, Laboratory of Clinical Chemistry, University Hospital Del Río Hortega, Valladolid, Spain.
Martín-Gil
F J
FJ
López-Hernández
S
S
Fernández-García
N
N
Olmos-Linares
A
A
Arranz-Peña
M L
ML
D000293:Adolescent; D000328:Adult; D000704:Analysis of Variance; D001782:Blood Donors; D002648:Child; D005069:Evaluation Studies as Topic; D005260:Female; D006801:Humans; D007124:Immunoenzyme Techniques / Q000295:instrumentation / Q000706:statistics & numerical data; D008297:Male; D008875:Middle Aged; D012016:Reference Values; D013223:Statistics as Topic; D018709:Statistics, Nonparametric; D013739:Testosterone / Q000097:blood*
D013739:Testosterone