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Test Code D-Dimer (TVC) D-Dimer (TVC)

Important Note

This test should only be ordered by TVC 1st Care Providers or after consult with pathologist regarding the option for alternative testing. All other D-Dimer testing please see D Dimer

Additional Codes

Cerner

NextGen

D-Dimer (TVC)

D-Dimer (TVC)

Useful For

The Quidel Triage D-dimer Test is used as an aid in the assessment and evaluation of patients suspected of having disseminated intravascular coagulation (DIC) and thromboembolic events, including pulmonary embolism (PE).

Methodology

The Quidel Triage D-Dimer Test is a single use fluorescence immunoassay to be used with the Quidel Triage Meters for the quantitative determination of cross-linked fibrin degradation products containing D-dimer in EDTA anticoagulated whole blood and plasma specimens. The Triage D-Dimer Test utilizes the 3B6 monoclonal antibody which is highly specific to cross-linked D-dimer.

Patient Preparation

Standard venipuncture techniques.

Collection Instructions

Whole blood collected in K2 EDTA tube.

Avoid short draws – Fill tube 90% full – within 10% of draw line.

Specimen Requirements

Preferred Volume

approximately 250μL of K2 EDTA whole blood from at least a 90% filled tube

Minimum Volume

approximately 250μL of K2 EDTA whole blood from at least a 90% filled tube

Container

K2 EDTA tube

or

 

Stability

Whole blood ≤ 24 hrs at room temperature (20 oC - 24 oC)

Rejection Criteria
  • Clotted
  • Hemolyzed
  • Any specimen besides K2 EDTA specimens
  • Tubes that are not at least 90% full

Result Reporting and Reference Values

Reference Range

<600 ng/mL

  • The D-dimer values are presented in units of mass (ng/mL) of D-dimer, also known as D-dimer Units (D-DU). There are no international standards for D-dimer and different assays use antibodies with differing specificities for D-dimer and other fibrin degradation products, therefore results are not interchangeable between methods.
  • The expected value of less than 600 ng/mL represent the 95th percentile of apparently healthy individuals. The 90th percentile of measurements is less than 400 ng/mL.
  • A normal D-Dimer result of <400 ng/mL D-DU can be used as an aid in the exclusion of acute pulmonary embolism (PE) or deep vein thrombosis (DVT) per literature study reviews when there is a low or moderate pretest probability.

Critical Ranges

None

Reflex Testing

None

Limitations

  • The result of the test should be evaluated in the context of all the clinical and laboratory data available. In those instances where the laboratory result does not agree with the clinical evaluation, additional tests should be performed accordingly.
  • There is a possibility for interference by human anti-mouse antibodies (HAMA) in the sample. The test has been formulated to minimize this interference; however, specimens from patients who have been routinely exposed to animals or to animal serum products may contain heterophile antibodies which may cause erroneous results.
  • Hemoglobin (up to 500 mg/dL), lipids (triolein up to 3,000 mg/dL), bilirubin (up to 15 mg/dL), fibrinogen (up to 1 mg/mL), fragment D (up to 20 µg/mL) or fragment E (up to 20 µg/mL) added to EDTA anticoagulated plasma containing D-dimer did not interfere with the recovery of D-dimer. These substances failed to produce a positive response in a sample that did not contain the analyte of interest. However, severely hemolyzed specimens should be avoided whenever possible. When a sample appears to be severely hemolyzed, another specimen should be obtained and tested. The hematocrit was varied between 30% and 55% with no significant effect on the recovery of D-dimer. RA factor has not been tested.