D-Dimer determinations aid in the quantitative assessment and evaluation of patients presenting with clinical symptoms of venous thromboembolism (VTE) including severely evolving disseminated intravascular coagulation, pulmonary embolism and deep vein thrombosis. Values at or below the upper limit of a healthy reference population are highly predictive of exclusion of VTE as a cause of symptoms (1,2,3,4).
From a population of 244 individuals, the IB10 sphingotest® D-Dimer test was used to determine the concentration upper reference limit of D-Dimer. This population included apparently healthy individuals. The 95th percentile upper reference limit, using lithium heparin as anticoagulant, is 446.8 FEU ng/mL. The IB10 sphingotest® D-Dimer reports results in FEU ng/mL. It is comonly accepted that 1 D-DU is equal to 2 FEU.
Each laboratory should establish a reference range that represents the patient population that is to be evaluated at their facility.
Whole Blood vs. Plasma Comparison
All our assays correlate with r=0.9. For more detailed information please read the IFUs or connect with our sales representatives.
|Sample Type||Lithium-Heparin or Citrate Whole Blood and Plasma Samples|
|Time to Result||20 minutes|
|Measuring Range||100 - 4,000 FEU ng/mL|
|Limit of Detection||100 FEU ng/mL|
|No High Dose Hook Effect||up to 40,000 FEU ng/mL|
|Analyte Stability for IB10 Measurement||24 hours for whole blood|
IB10 sphingotest® D-Dimer is a rapid point-of-care (POC) immunoassay for the quantitative in vitro determination of crosslinked fibrin degradation products containing D-Dimer in Lithium-Heparin or Citrate whole blood or plasma.
(1) Riley RS et al. Widely Used Types and Clinical Applications of D-Dimer Assay. Lab Med. 2016 May;47(2):90-102.
(2) Song J et al. Analytical and clinical performance of a new point of care LABGEOIB D-dimer test for diagnosis of venous thromboembolism. Ann Clin Lab Sci. 2014 Summer;44(3):254-61.
(3) Price CP et al. Point-of-Care Testing for D-Dimer in the Diagnosis of Venous Thromboembolism in Primary Care: A Narrative Review. Cardiol Ther 2020.
(4) Kyrle PA et al. Deep vein thrombosis. Lancet. 2005 Mar 26-Apr 1;365(9465):1163-74.