Innovance D-dimer

On Sept. 11, 2009, the Coagulation Laboratory on the South Campus will be using a new reagent for reporting the D-dimer assay. The INNOVANCE D-Dimer assay from Siemens Healthcare Diagnostics will replace the current Advanced D-Dimer reagent. This change will allow for the following:

• Consistent cut-off of 0.50 mg/L FEU between instruments
• Minimal susceptibility to interfering substances
• Higher specificity
• Validated high sensitivity and negative predictive value
• Fast turn-around time
• Excellent precision

In a multicenter study using INNOVANCE D-Dimer at a clinical cut-off of 0.50 mg/L FEU, the Negative Predictive Value of 98 percent was established for ED patients with clinically suspected VTE evaluated using the Wells Pretest Probability Model and diagnosed by standard objective tests. At this cut off, the Sensitivity and Specificity for this method were found to be 97 percent and 42 percent respectively.

The INNOVANCE D-Dimer assay is intended for use as an aid in the diagnosis of venous thromboembolism (VTE) [deep vein thrombosis (DVT) or pulmonary embolism (PE)].

With this new method, the following will be reported out with patient results for the South Campus only (CMP lab has different methodology):

Patient result: _____mg/L FEU

Reference Range: ≤0.59 mg/L FEU

Clinical Cut off: 0.50 mg/L FEU

A very low percentage of patients with DVT may yield D-dimer results below the cut-off of 0.50 mg/L FEU. This is known to be more prevalent in patients with distal DVT.

Please Note: Results of D-dimer assays should always be interpreted in conjunction with the patient's medical history, clinical presentation and other findings.

Questions may be directed to Dr. Phil Stoffel at ext. 2825.