Roche Cobas D-Dimer T.Q. 2Gen Human D-Dimer – Immunoturbidimetric Method – 100 Tests Kit
The Roche Tina-quant D-Dimer Gen.2 kit is an in vitro diagnostic solution for professional use, designed for the quantitative determination of fibrin degradation products (D-Dimer and X-oligomers) in human plasma. Developed for seamless integration into automated cobas c analyzers, this assay delivers rapid, accurate measurement with high analytical sensitivity, serving as an essential diagnostic aid for monitoring coagulation status.
🎯 Technology: Particle-enhanced immunoturbidimetric assay using latex particles coated with anti-human D-Dimer monoclonal antibodies (F(ab’)2 fragments).
🧪 Sample Matrix: Human plasma (collected with Sodium Citrate, Li-Heparin, or EDTA K2/K3).
⏱️ Fast Workflow: Automated 2-Point End protocol completed in approximately 10 minutes of reaction time.
📊 Reliability: Measuring range from 0.15 to 9.00 µg FEU/mL with analytical sensitivity (LoD) of 0.15 µg FEU/mL and no hook effect up to 220 µg FEU/mL.
📦 Kit: Ready-to-use cobas c pack cassette suitable for performing 100 total tests.
Roche Cobas D-Dimer T.Q. II Gen
REF: 04912551190|SKU: 106633|BRAND: Roche
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Particle-enhanced immunoturbidimetric assay
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Human Plasma (Citrate, Li-Heparin, EDTA)
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2-Point End Reaction (10 Minutes)
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cobas c pack kit for 100 Tests
Scientific Description
The Roche Tina-quant D-Dimer Gen.2 (D-DI2) reagent constitutes an in vitro diagnostic aid for the quantitative immunological determination of fibrin degradation products (D-Dimer and X-oligomers) in human plasma on automated Roche/Hitachi cobas c 311 and cobas c 501/502 platforms. D-Dimer measurement is used as an aid in detecting intravascular coagulation and for ruling out deep vein thrombosis (DVT) and pulmonary embolism (PE) in conjunction with clinical probability assessment.
The test principle is based on a latex particle-enhanced immunoturbidimetric assay. Uniformly sized latex particles are coated with monoclonal F(ab’)2 antibody fragments directed against the D-Dimer epitope. The formation of antigen/antibody complexes causes an increase in turbidity, measured photometrically at 800 nm using a 2-point end protocol. The increase in absorbance is directly proportional to the concentration of D-Dimer epitopes present in the sample, expressed in fibrinogen equivalent units (FEU).
Quick Execution Protocol
- Load the cobas c pack cassette into the automated analyzer (cobas c 311 or cobas c 501/502), ensuring proper mixing of the reagent prior to placement.
- Prepare plasma samples collected in standard coagulation tubes containing sodium citrate (1+9 ratio), Li-Heparin, or EDTA (K2 or K3). Centrifuge samples containing precipitates prior to analysis.
- The analyzer automatically pipettes and dispenses 5.0 µL of sample, 90 µL of reagent R1 (TRIS/HCl buffer pH 8.2), and 90 µL of starter reagent R3 (0.12% latex particle suspension).
- Incubate at system-controlled temperature for the established reaction time (10 minutes) with photometric measurement of absorbance change.
- Process results expressed in µg FEU/mL via the stored calibration curve (Spline method using D-Dimer Gen.2 Calibrator Set) and verify data validity using dedicated quality controls (D-Dimer Gen.2 Control I/II).
Platform Technical Specifications
| Analyzed Parameter | Analytical Specifications & Methodological Performance |
|---|---|
| Measuring Range | 0.15 – 9.00 µg FEU/mL (extendable via automatic rerun function by a factor of 2.4) |
| Limits of Detection (CLSI EP17-A) | Limit of Blank (LoB): 0.08 µg FEU/mL | Limit of Detection (LoD): 0.15 µg FEU/mL |
| Expected Cut-off Value | < 0.50 µg FEU/mL (fibrinogen equivalent units) |
| Intra-assay Precision (Repeatability) | CV % on plasma: 0.3% – 2.9% (assessed across concentrations between 0.41 and 3.75 µg FEU/mL) |
| Inter-assay Precision (Intermediate) | CV % on plasma: 1.3% – 4.7% |
| Methodological Traceability | Standardized against the Asserachrom D-Dimer reference method |
| Endogenous Substance Interference | No interference up to Icterus (I ≤ 60 conjugated, I ≤ 30 unconjugated), Hemolysis (H ≤ 500), Lipemia (L ≤ 1000), Heparin (≤ 100 IU/mL), Rheumatic Factors (≤ 100 IU/mL) |
| High Dose Hook Effect | No false results up to D-Dimer concentrations of 220 µg FEU/mL |
| Reagent Stability | Storage at 2-8°C until expiration date. On-board stability: 12 weeks on cobas c systems |
| Compatible Platforms | cobas c 311, cobas c 501, cobas c 502 |
Technical opinion: The Roche Tina-quant D-Dimer Gen.2 reagent represents a reliable quantitative test for automated D-Dimer analysis in plasma matrices. Its high affinity toward high molecular weight fragments (X-oligomers) and long on-board stability ensure efficient workflow management in high-throughput analytical routines. Strong resistance to key endogenous and heparin interferences provides robust analytical support in clinical coagulation routine. Solution intended exclusively for professional use within Clinical Analysis Laboratories, Clinics, and Nursing Homes.
BIOLAB Diagnostici Technical Team – Laboratory Division
