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RAPID D-dimer
Registration Certificate: № RZN 2023/19 155
A lateral flow immunoassay for semi-quantitative detection of D-dimer in human plasma
The Current Diagnostic Landscape
Venous thromboembolism (VTE) ranks 3rd in the structure of mortality from vascular diseases.
In conditions where clinical examination is unreliable and instrumental studies are difficult to access, D-dimer becomes an objective indicator. Since the marker level rises instantly upon fibrin breakdown, the test allows for the detection of active thrombosis even if clinical manifestations are minimal. This provides a clinical basis for the physician to initiate further investigations (CT angiography/Vascular Ultrasound/Duplex Scanning) and therapy in a timely manner.
In conditions where clinical examination is unreliable and instrumental studies are difficult to access, D-dimer becomes an objective indicator. Since the marker level rises instantly upon fibrin breakdown, the test allows for the detection of active thrombosis even if clinical manifestations are minimal. This provides a clinical basis for the physician to initiate further investigations (CT angiography/Vascular Ultrasound/Duplex Scanning) and therapy in a timely manner.
Clinical Impact & Benefits
01
EXCLUDING THROMBOSIS
If the test result is within the normal range (< 250 ng/ml), the physician can confidently rule out the presence of a thrombus. This eliminates the need for CT angiography/Ultrasound/Duplex scanning and prevents the prescription of unnecessary medications.
02
RISK ASSESSMENT
The semi-quantitative test format allows for the assessment of disease severity.
03
MONITORING HIGH-RISK GROUPS
The test enables monitoring of patients following surgical interventions, trauma, or burns, as well as those with atrial fibrillation.
Key Advantages
Reduces the number of unnecessary instrumental examinations
D-dimer is a dynamic marker, allowing for the assessment of treatment efficacy
Diagnostic coverage for all areas, including remote and hard-to-reach regions
No additional equipment required; room temperature storage simplifies logistics
Semi-quantitative results enable the assessment of patient condition severity
Rapid diagnostics within 20 minutes
Technical Specifications
Time to Result:
20 minutes
Analytical Sensitivity / Limit of Detection (LoD):
100 ng/mL
Diagnostic Specificity:
≥99%
Reproducibility:
100%
Semi-quantitative test with a color scale
Interpretation
NEGATIVE RESULT
Only the control line “C” appears in the test window. No coloration of the test line “T” occurs.
POSITIVE RESULT
Two colored lines appear.
The color intensity in the test line area (T) varies depending on the D-dimer concentration in the sample and must be compared with the standard lines of the color scale on the Control Card.
The color intensity in the test line area (T) varies depending on the D-dimer concentration in the sample and must be compared with the standard lines of the color scale on the Control Card.
INVALID RESULT
No colored line appears in the control area (C), regardless of the presence or absence of a line in the test area (T).
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