Inverness Medical Innovations

Clearview

• Clearview - HCG
• Clearview - EASY HCG
• Clearview - Exact Strep A
• Clearview - hCG Combo
• Clearview - RSV
• Clearview - EASY LH
• Clearview - Exact Influenza A&B
• Clearview - Careplan VpH Glove
• Clearview IM
• Clearview - Chlamydia MF
• Clearview - D-dimer
• Clearview - H.pylori
• Clearview - FOB
• Clearview - TB ELISA
• Clearview - Malaria
• Clearview Exact PBP2a

About D-dimer

 

What is D-dimer

 

D-dimer is the smallest breakdown product of clot dissolution. The coagulation cascade culminates in the conversion of fibrinogen into fibrin and the development of an insoluble fibrin clot. Complementary to the coagulation cascade is the process known as fibrinolysis. This is the body’s defence mechanism against the permanent occlusion of blood vessels, breaking down fibrin clots in order to restore blood flow. Plasmin degrades the fibrin network of the clot releasing a number of fibrin degredation products. D-dimer is the smallest plasmin-resistant molecular unit of all the fibrin degradation products. D-dimer is present in the circulation as part of the normal wound healing process, however it is invaluable as a diagnostic marker for thrombotic conditions such as Disseminated Intravascular Coagulation (DIC) and as an aid to the rule-out of Deep Vein Thrombosis (DVT) and Pulmonary Embolism (PE).

 

The 3B6 Antibody

 

The monoclonal antibody unique to the D-dimer epitope is DD-3B6/22, more commonly known as 3B6. The Clearview Simplify D-dimer test uses 3B6 which is highly specific for D-dimer and does not cross-react with other fibrin degradation molecules. This gives Clearview Simplify D-dimer high specificity for D-dimer and aids the safe-rule out of patients.

 

DVT and PE Rule-Out Algorithms

 

Clinical diagnosis should not be based on the result of the Clearview Simplify D-dimer test alone. The full clinical context of the patient should be included when making a diagnostic decision taking into account the clinical signs and other relevant info such as the Wells PTP score or equivalent².

 

Clinical Information

 

Clearview Simplify D-dimer 100% sensitive* in a 120 Outpatient Study with Suspected DVT³

 

 

 

Clearview Simplify D-dimer 100% sensitive* in a 527 Outpatient Study with Symptomatic PE⁴

 

 

 

 

Further studies demonstrate that Clearview Simplify D-dimer rapid diagnostic test can be used as an aid to rule-out of VTE when used in conjunction with validated diagnostic algorithms.^{5, 6}

 

The use of validated diagnostic algorithms, such as Wells, in combination with D-dimer testing have been determined as safe with a post test probability of an event of less than 1%.⁷

 

References

 

1. Kline JA, Wells PS. Methodology for a rapid protocol to rule out pulmonary embolism in the emergency department. Ann Emerg Med 2003 Aug;42(2):266-75.
   
2. Wells PS, Anderson DR et al. Evaluation of D-Dimer in the diagnosis of suspected deep-vein thrombosis. N Engl J Med 2003;349:1227-35.
   
3. Cini M, Legnani C, Cavallaroni et al. A new rapid bedside assay for D-dimer measurement (Simplify D-dimer) in the diagnostic work-up for deep vein thrombosis. J Thromb Haemost 2003;1:2681-3.
   
4. Toulon P, Meynlad O. D-dimer testing in patients with suspected pulmonary embolism. Performance of a new rapid semi-quantitative solid-phase immunochromatography assay (Simplify D-dimer) and comparison with two automated quantitative assays. Blood 2003; 102:1b-514b: Abstract no. 4149.
   
5. Kline JA, Runyon MS, Webb WB et al. Prospective Study of the Diagnostic Accuracy of the Simplify D-dimer Assay for Pulmonary Embolism in Emergency Department Patients.
   
6. Subramaniam, RM, Heath R, Cox K et al. Does an immunochromatographic D-dimer exclude acute lowerlimb deep venous thrombosis? Emerg Med Australas 2006;18:457-463.
   
7. Wells PS, Owen C, Doucette S et al. Does this Patient have Deep Vein Thombosis? JAMA 2006;295:199-206.