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Test Code DDITT D-Dimer, Plasma

Useful For

Excluding the diagnosis of acute pulmonary embolism or deep vein thrombosis, particularly when results of a sensitive D-dimer assay are combined with clinical information, including pretest disease probability(1-4)


Diagnosis of intravascular coagulation and fibrinolysis, also known as disseminated intravascular coagulation, especially when combined with clinical information and other laboratory test data (eg, platelet count, assays of clottable fibrinogen and soluble fibrin monomer complex, and clotting time assays-prothrombin time and activated partial thromboplastin time)(5)

Method Name

Immunoassay Turbidimetric

Reporting Name

D-Dimer, P

Specimen Type

Plasma Na Cit

Specimen Required

Specimen Type: Platelet-poor plasma

Collection Container/Tube: Light-blue top (3.2% sodium citrate)

Submission Container/Tube: Plastic vial

Specimen Volume: 1 mL

Collection Instructions: Spin down, remove plasma and spin plasma again.

Additional Information: Double-centrifuged specimen is critical for accurate results as platelet contamination may cause spurious results.

Specimen Minimum Volume

0.5 mL

Specimen Stability Information

Specimen Type Temperature Time
Plasma Na Cit Frozen (preferred) 90 days
  Ambient  4 hours

Reject Due To


Mild OK; Gross reject


Mild OK; Gross OK


Mild OK; Gross OK



Clinical Information

The specific degradation of fibrin (ie, fibrinolysis) is the reactive mechanism responding to the formation of fibrin. Plasmin is the fibrinolytic enzyme derived from inactive plasminogen. Plasminogen is converted into plasmin by plasminogen activators. The main plasminogen activators are tissue plasminogen activator (tPA) and pro-urokinase, which is activated into urokinase (UK) by, among others, the contact system of coagulation.


In the bloodstream, plasmin is rapidly and specifically neutralized by alpha 2-antiplasmin, thereby restricting its fibrinogenolytic activity and localizes the fibrinolysis on the fibrin clot. On the fibrin clot, plasmin degrades fibrin into various products (ie, D-dimers). Antibodies specific for these products, which do not recognize fibrinogen, have been developed. The presence of these various fibrin degradation products, among which D-dimer is the terminal product, is the proof that the fibrinolytic system is in action in response to coagulation activation.


Elevated D-dimer levels are found in association with disseminated intravascular coagulation (DIC), pulmonary embolism (PE), deep vein thrombosis (DVT), trauma, and bleeding. D-dimer may also be increased in association with pregnancy, liver disease, malignancy, inflammation, or a chronic hypercoagulable state.

Reference Values

≤500 ng/mL Fibrinogen Equivalent Units (FEU)

D-dimer values ≤500 ng/mL FEU may be used in conjunction with clinical pretest probability to exclude deep vein thrombosis (DVT) and pulmonary embolism (PE).


A normal D-dimer result less than or equal to 500 ng/mL fibrinogen equivalent units (FEU) on the IL D-Dimer HS500 kit has a negative predictive value of approximately 100% (range 97%-100%) and is FDA approved for the exclusion of acute pulmonary embolism (PE) and deep vein thrombosis (DVT) when there is low or moderate pretest probability for PE or DVT.


D-dimer concentrations increase with age and, thus, the specificity for DVT and PE exclusion decreases with age. For DVT or PE exclusion, in addition to clinical pretest probability, age-adjusted D-dimer cutoffs are suggested for patients more than 50 years of age.


Recent evidence suggests using clinical pretest probability and age-adjusted cutoffs to improve the performance of D-dimer testing in patients greater than 50 years of age. In recent studies, when compared to a fixed D-dimer cutoff, age adjusted D-dimer cutoff values (calculated as follows: age [years] x 10 ng/mL) resulted in equivalent outcomes and no additional false negative findings.(7-8)


Increased D-dimer values are abnormal but do not indicate a specific disease state. D-dimer values may be increased as a result of:

-Clinical or subclinical disseminated intravascular coagulation/intravascular coagulation and fibrinolysis

-Other conditions associated with increased activation of the procoagulant and fibrinolytic mechanisms such as recent surgery, active or recent bleeding, hematomas, trauma, or thromboembolism

-Association with pregnancy, liver disease, inflammation, malignancy, or hypercoagulable (procoagulant) states


The degree of D-dimer increase does not definitely correlate with the clinical severity of associated disease states.


D-dimer results on the ACL TOP coagulation analyzer are not affected by rheumatoid factor up to 1,400 IU/mL.


The monoclonal antibody (MA-8D3) used in the latex reagent has major specificity for the D-dimer domain of cross-linked fibrin degradation products (FDP). A low cross-reactivity to FDP was seen with plasma samples spiked with purified fragments D and E above 10 mcg/mL.


Specimens from patients who have received preparation of mouse monoclonal antibody for diagnosis or therapy may contain human antimouse antibody (HAMA). The presence of HAMA may cause an overestimation of results in immunoassays that utilize mouse monoclonal antibodies. The reaction buffer contains a blocking agent against HAMA to minimize this interference on the assay results.

Method Description

HemosIL D-Dimer HS 500 kit on the ACL TOP is a latex enhanced turbidimetric immunoassay.(Package insert: HemosIL D-Dimer HS500)

Day(s) and Time(s) Performed

Monday through Sunday; Continuously

Analytic Time

Same day/1 day

Specimen Retention Time

1 day

Performing Laboratory

Mayo Medical Laboratories in Rochester

Test Classification

This test has been cleared or approved by the U.S. Food and Drug Administration and is used per manufacturer's instructions. Performance characteristics were verified by Mayo Clinic in a manner consistent with CLIA requirements.

CPT Code Information


LOINC Code Information

Test ID Test Order Name Order LOINC Value
DDITT D-Dimer, P In Process


Result ID Test Result Name Result LOINC Value
DDITT D-Dimer, P In Process