Results of this test should always be interpreted in
conjunction with the patient's medical history, clinical presentation,
and other findings. DVT clinical diagnosis should not be based on the
result of Innovance® D-dimer alone.
D-dimer levels can be elevated
in many clinical circumstances, especially in hospitalized patients.
D-dimer should not be used as an aid for exclusion of venous thrombosis
or pulmonary embolism in pediatric patients in any circumstance and
adult patients with6-8:
• Therapeutic dose anticoagulant administered for >24 hours before D-dimer is measured
• Thrombosis distal to the knee only
• Fibrinolytic therapy within previous seven days
• Upper extremity thrombosis
•
D-dimer levels may be falsely negative if the elapsed time between
thrombosis onset and D-dimer measurement is sufficient such that D-dimer
has been cleared from the circulation.
The following conditions are associated with an increase in D-dimer concentrations, even in the absence of venous thrombosis:
• Aortic aneurysm
• Trauma or surgery within previous four weeks
• Disseminated malignancies
• Disseminated intravascular coagulation
• Sickle cell disease
• Sepsis, severe infections, pneumonia, severe skin infections
• Liver cirrhosis
• Pregnancy
Also note6:
•
Patient samples may contain heterophilic antibodies (eg, human
antimouse antibodies [HAMA] and rheumatoid factors) that could react in
immunoassays to yield falsely elevated results. This assay has been
designed to minimize interference from heterophilic antibodies.
Nevertheless, complete elimination of this interference from all patient
specimens cannot be guaranteed.
• Patients with subsegmental/peripheral PE or distal DVT may have a normal Innovance® D-dimer result.9,10
• Exclusionary claim of PE in patients with high PTP scores has not been established.
