High-Sensitivity Chemiluminescence Immunoassay for Fibrin Degradation Product Quantification
The D-Dimer CLIA Reagent is a bulk chemiluminescence immunoassay kit for the quantitative measurement of D-Dimer — the fibrin degradation product that serves as the primary laboratory marker for thrombotic disorders including deep vein thrombosis (DVT) and pulmonary embolism (PE). The assay uses an acridinium ester (AE) chemiluminescent label and magnetic bead capture for high-sensitivity detection.
Formulated for integration with AE-platform chemiluminescence analyzers, the reagent completes the full assay cycle in 5 minutes. With CV ≤3.3% and S/N exceeding 11,500 at the upper calibrator, this reagent provides the analytical performance required for clinical decision-making at the VTE exclusion threshold.
Analytical and workflow advantages designed for high-throughput clinical laboratory deployment.
Three-step protocol completes in 5 minutes: sample dilution → magnetic bead incubation (no wash) → AE-label incubation + wash → RLU read. Ideal for emergency and acute-care settings.
RLU signal of 1,766,286 at 10 ng/mL vs. blank of 153 — yielding an S/N exceeding 11,500. Chemiluminescence AE platform provides superior sensitivity versus colorimetric methods.
Within-run CV ≤3.3% at both 5 ng/mL and 0.5 ng/mL (n=10 replicates). Consistent RLU output demonstrates robust reagent formulation and minimal lot-to-lot variation.
Linear across 0.1–10 ng/mL covering the full clinically relevant D-Dimer range from baseline to markedly elevated thrombotic states, with proportional dilution recovery.
Accelerated stability testing at 37°C for 7 days shows signal deviation within ±15% for both reagents and lyophilized calibrators — supporting ambient-temperature shipping windows.
Formulated for direct integration with AE (acridinium ester) chemiluminescence analyzers. Magnetic bead capture format provides efficient separation and high-throughput compatibility.
All data generated using Sekbio D-Dimer Ra/Rb/Rd reagent on AE chemiluminescence platform.
Six calibrators spanning 0–10 ng/mL demonstrate robust chemiluminescent dose-response. The blank (0 ng/mL) produces a mean RLU of 153, with S/N exceeding 11,500 at the upper calibrator.
| Calibrator (ng/mL) | Run 1 — RLU | Run 2 — RLU | Run 3 — RLU | Avg. RLU | S/N vs. Blank |
|---|---|---|---|---|---|
| 0 — Blank | 123 | 221 | 115 | 153 | 1.00 |
| 0.1 | 20,634 | 19,953 | 19,065 | 19,884 | 129.96 |
| 0.5 | 99,683 | 99,699 | 103,438 | 100,940 | 659.74 |
| 2.5 | 484,100 | 491,194 | 489,341 | 488,212 | 3,190.93 |
| 5 | 993,216 | 969,501 | 980,593 | 981,103 | 6,412.44 |
| 10 | 1,813,690 | 1,748,119 | 1,737,050 | 1,766,286 | 11,544.36 |
| RLU = Relative Light Units; S/N = Signal-to-Noise ratio vs. blank. | |||||
Serial dilutions from 10 ng/mL demonstrate proportional RLU reduction with excellent back-calculated concentration recovery across the analytical range.
| Expected (ng/mL) | Dilution Ratio | Avg. RLU | Back-Calculated (ng/mL) |
|---|---|---|---|
| 10.00 | 1.0 | 1,777,501 | 10.00 |
| 8.02 | 0.8 | 1,500,248 | 8.21 |
| 6.04 | 0.6 | 1,127,234 | 5.96 |
| 4.06 | 0.4 | 727,193 | 3.72 |
| 2.08 | 0.2 | 346,387 | 1.73 |
| 0.10 | 0.0 | 19,132 | 0.10 |
| Serial dilutions of the 10 ng/mL calibrator. Back-calculated concentrations derived from calibration curve. | |||
Ten replicates at 5 ng/mL and 0.5 ng/mL demonstrate within-run CV ≤3.3% — well within IVD precision acceptance criteria of ≤10%.
| Nominal Conc. (ng/mL) | Replicates (n) | Mean Conc. (ng/mL) | SD | CV (%) |
|---|---|---|---|---|
| 5 | 10 | 4.97 | 0.16 | 3.25% |
| 0.5 | 10 | 0.49 | 0.02 | 3.10% |
| Acceptance criterion: CV ≤ 10% (IVD industry standard). | ||||
The D-Dimer CLIA reagent is validated for multiple clinical and OEM manufacturing applications.
Quantitative D-Dimer measurement for ruling out venous thromboembolism (DVT, PE) in combination with clinical pre-test probability scoring (Wells, Geneva).
5-minute turnaround supports urgent triage decisions in emergency departments. Magnetic bead format enables rapid automated processing on AE-platform analyzers.
D-Dimer Ra/Rb/Rd reagent components available for licensed chemiluminescence analyzer manufacturers. ISO 13485-compliant supply with consistent lot performance.
Quantitative fibrin degradation product measurement for thrombosis biomarker studies, anticoagulation monitoring, and disseminated intravascular coagulation (DIC) research.
Request the full technical datasheet, bulk reagent specifications, or discuss OEM supply and analyzer integration with our team.