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Triage® D-Dimer Test: Product Info

Aids in the assessment and evaluation of patients suspected of having disseminated intravascular coagulation (DIC) and thromboembolic events including pulmonary embolism (PE) and deep venous thrombosis (DVT).

  • Uses highly sensitive, quantitative immunoassay technology.1
  • Utilizes the 3B6 D-dimer antibody, which has demonstrated high clinical specificity for PE and DVT.2,3
  • Correlates with ELISA and other immunoassay methods.1,5
  • Delivers quantitative results in approximately 15 minutes in the lab or at the point-of-care.
  • Performed on the Triage Meters; the Triage System is widely adopted by over 3,500 hospitals worldwide.

The Immunoassay Technology Advantage

The Triage D-Dimer Test is a fluorescence immunoassay that quickly provides accurate, quantitative D-dimer results.

  • D-dimer assays are known to have varied sensitivity for detecting D-dimer.2,3
  • Enzyme-linked immunosorbent assays (ELISA) are known for their high sensitivity in patients with suspected PE and DVT.4
  • ELISA assays are distinguishable from latex agglutination tests due to the presence of capture and detection antibodies, forming a sandwich immunoassay, yielding higher sensitivity.3
  • The Triage D-Dimer Test uses highly sensitive sandwich immunoassay technology to capture and detect D-dimer.1
  • The Triage D-Dimer Test, a fluorescent immunoassay (FIA), directly measures the fluorescent signal that is proportionate to the analyte present in the sample.1

Lateral Flow Sandwich Immunoassay

3B6 Antibody

Measurement of D-dimer is useful in evaluating patients suspected of PE, DVT and DIC, yet not all D-dimer tests are able to detect D-dimer the same way.

  • Antibody specificity plays a significant role in distinguishing D-dimer from other Fibrin Degradation Products (FDPs).2
  • The Triage D-Dimer Test utilizes the 3B6 monoclonal antibody that is highly specific to cross-linked D-dimer.1,2,3

The ability to distinguish D-dimer from other FDPs, is achieved with the 3B6 antibody, which detects the cross-linked epitope of D-dimer.
Plasmin derived FDPs may be detected
in addition to D-dimer, resulting in an
erroneously elevated result
The 3B6 antibody detects only
cross-linked FDPs (D-dimer) for accurate
measurement of the sample

The Performance You Expect

The Triage D-Dimer Test has a correlation coefficient of 0.92 (r value) to the Stratus CS® D-dimer method (Passing-Bablok regression).1.

    
Slope Intercept ng/mL Correlation Coefficient
0.999 -85.89 r = 0.92



    
Slope Intercept ng/mL Correlation Coefficient
1.330 -204.36 r = 0.962

Per this analysis, a 400 ng/ml upper limit of normal for the Triage D-Dimer Test compares favorably with the VIDAS D-dimer assay cut-off of 500 ng/mL.5

The Utility and Speed You Need

The Triage D-Dimer Test

  • Aids in the assessment and evaluation of patients suspected of having DIC and thromboembolic events including PE and DVT.
  • Provides critical results quickly to clinicians
    • Uses whole blood; eliminating centrifugation time
    • Delivers results in approximately 15 minutes using the Triage Meters
  • Designed for the point-of-care, yet aids in laboratory testing compliance
    • Easy to use
    • Does not require reagent reconstitution
    • Uses multiple on-board controls in the meter, software and Test Device to ensure acceptable performance

The Triage D-Dimer Test

  • Uses highly sensitive immunoassay technology and the highly specific 3B6 antibody for D-dimer2,3
  • Correlates with the VIDAS ELISA D-dimer and other immunoassay systems1,5
  • Aids in the assessment and evaluation of patients suspected of having DIC and thromboembolic events including PE and DVT.
  • Quickly provides lab-quality results in approximately 15 minutes

To learn more about the Triage D-Dimer Test, the Triage System and the entire Biosite® rapid diagnostics portfolio, please call us today at 888-BIOSITE (246-7483), email us at custservice@biosite.com, or send us a Product Information Request.

References