Performance characteristics of the AxSYM D-dimer assay.
BACKGROUND
D-dimer testing is used to exclude thromboembolic disease in outpatients suspected of having deep venous thrombosis and pulmonary embolism.


METHODS
We evaluated 4 D-dimer assays for imprecision and method comparison and evaluated the AxSYM method for interference, linearity, and reference interval. Method comparison testing was performed using the following methods: Abbott AxSYM, bioMérieux mini VIDAS, Diagnostica Stago STA Compact, and Biosite Triage Meter Plus.


RESULTS
Total CVs for all methods ranged from 3.7% for the STA Compact to 17.3% for the Triage Meter. The AxSYM showed good agreement with the other methods with slopes ranging from 1.17 to 1.22 by Passing-Bablok regression and correlation coefficients >or=0.96. Interference from hemolysis, icterus, and lipemia had <7% deviation from the intended D-dimer concentration. Linearity had <or=11.5% deviation from target values.


CONCLUSIONS
The AxSYM D-dimer assay provides a precise, rapid, and user-friendly method for D-dimer testing with good correlation to other methods.
La'ulu
Sonia L
SL
ARUP Institute for Clinical and Experimental Pathology, Salt Lake City, UT, United States.
Dominguez
Camille M
CM
Roberts
William L
WL
D019963:Clinical Chemistry Tests; D005338:Fibrin Fibrinogen Degradation Products / Q000032:analysis*; D006801:Humans; D015203:Reproducibility of Results
D005338:Fibrin Fibrinogen Degradation Products; C036309:fibrin fragment D