Performance characteristics of the AxSYM D-dimer assay

Area of Science:

• Clinical Chemistry
• Hematology
• Diagnostic Assays

Background:

• D-dimer testing is crucial for ruling out thromboembolic disease in outpatients.
• Deep venous thrombosis and pulmonary embolism are common concerns in emergency settings.

Purpose of the Study:

• To evaluate the performance of four D-dimer assays.
• Specifically, to assess the Abbott AxSYM D-dimer assay's precision, method comparison, interference, linearity, and reference interval.

Main Methods:

• Four D-dimer assays were evaluated: Abbott AxSYM, bioMérieux mini VIDAS, Diagnostica Stago STA Compact, and Biosite Triage Meter Plus.
• Imprecision and method comparison were assessed for all assays.
• The AxSYM method underwent further evaluation for interference, linearity, and reference interval determination.

Main Results:

• Overall coefficients of variation (CVs) ranged from 3.7% to 17.3% across methods.
• The AxSYM assay demonstrated good agreement with other methods (correlation coefficients >=0.96).
• AxSYM showed minimal interference (<7% deviation) from common substances and acceptable linearity (<11.5% deviation).

Conclusions:

• The Abbott AxSYM D-dimer assay is a precise and rapid testing method.
• It is user-friendly and exhibits good correlation with other D-dimer assays.
• AxSYM is a reliable option for D-dimer testing in clinical practice.