Diagnostic Sensitivity

Elevated D-dimer levels, as a result of fibrin formation, occur in various other conditions than venous thrombotic events (VTE). Therefore, the clinician needs to be aware of the fact, that although D-dimer determination is very sensitive, it does not represent a specific measurand for VTE management.

Diagnostic Sensitivity: DiaSys vs Competitor

The diagnostic sensitivity of this parameter is of major importance, since it represents the rate of correctly classified positive cases. Any falsely negative classified result is critical and associated with high risks for the affected individual.

With a sensitivity of 98% DiaSys D-Dimer FS fulfills and even exceeds international requirements for diagnostic sensitivity: ≥ 95% (FDA), ≥ 97% (CLSI)

Another important term in the context of D-dimer determination is specificity. This value is defined by the rate of correctly classified negative cases. Although this measurand is not as critical as sensitivity, due to fact that no individual with VTE is overseen, high specificity rates minimize the number of false positive cases and reduces additional costs for time-consuming confirmation procedures.

Cutoff
[µg FEU/mL]
Sensitivity
[%]
Specificity
[%]
DiaSys0.59880.5
Competitor A0.599.345.8
Competitor B0.59842.7
Competitor C0.510042.1
Competitor D0.597-
Competitor E0.5599.437.8
Competitor F0.510035
Competitor G0.29564