KariéraTlačové správyCOVID-19
  1. Siemens Healthineers Slovakia
  2. Laboratórna diagnostika
  3. Hemostasis testing portfolio
  4. Hemostasis assays
  5. INNOVANCE D-Dimer 2.0 assay

INNOVANCE D-Dimer 2.0 assayDesigned for confidence in DVT/PE assessment

INNOVANCE D-Dimer 2.0 assay is intended for DVT/PE exclusion in outpatients with suspected DVT/PE in conjunction with clinical pretest probability assessment. In addition, it is intended as an aid in the diagnosis and monitoring of DIC and other hypercoagulable states.1

INNOVANCE D-Dimer 2.0 reagent, buffer, and diluent vials.

Benefits

Confidence in D-dimer testing goes beyond the result itself. The assay combines robust analytical performance and clinical validation with efficient laboratory workflows to support confident DVT/PE exclusion in routine practice. Designed for today's laboratories, it helps deliver consistent results, streamline operations, and maintain continuity across clinical pathways.

Illustration of a blood drop and test tube representing D-dimer testing and analytical confidence.

INNOVANCE D-Dimer 2.0 assay provides a dependable analytical foundation for routine practice, helping laboratories deliver consistent results across sites, shifts, and challenging samples.

  • Deliver consistent analytical performance across laboratories, analyzer systems, reagent lots, and routine testing conditions.
  • Support timely reporting of challenging samples through a broad measuring range, automated redilution, and low susceptibility to common interferences.
  • Monitor performance where clinical decisions are made with quality controls positioned around the validated DVT/PE decision threshold.
  • Support confident assessment of low D-dimer concentrations with analytical sensitivity designed for measurements near the clinical decision threshold.
Illustration of a healthcare professional with a medical checklist representing clinical confidence in D-dimer testing.

Prospective clinical validation and a rigorously established decision threshold provide an evidence-based foundation for confident DVT/PE exclusion in routine practice.

  • Support evidence-based DVT/PE exclusion with multicenter clinical validation in more than 2,500 consecutive outpatients.
  • Apply a clinically validated decision threshold established according to CLSI H59 recommendations.
  • Support multiple clinical applications with evidence for DVT/PE exclusion and for DIC evaluation where indicated.1
  •  Promote consistent interpretation through alignment with international D-dimer standardization efforts.
Illustration of a gear with arrows, a dollar sign, and test tube representing operational efficiency in D-dimer testing.

INNOVANCE D-Dimer 2.0 assay is designed to simplify daily operation through ready-to-use components, automated workflow steps, and continuous availability.

  • Deliver rapid turnaround with fast testing times.
  • Reduce hands-on effort using ready-to-use liquid reagents and controls.
  • Maintain continuous laboratory operation through long lot and onboard stability and automated workflow steps.
  • Keep results flowing with automated redilution and dependable reporting across the measuring range.
Illustration of hands holding a dollar sign representing resource and cost efficiency in D-dimer testing.

INNOVANCE D-Dimer 2.0 assay helps laboratories use resources more efficiently through optimized kit design, simplified handling, and reduced waste.

  • Reduce laboratory waste through optimized packaging and low solid and liquid waste generation.
  • Get more value from every kit with balanced reagent utilization and ready-to-use reagents and controls.
  • Simplify logistics and handling through an integrated kit configuration designed for efficient routine laboratory operation.
  • Extend resource efficiency beyond the laboratory by supporting DVT/PE exclusion that can help avoid unnecessary diagnostic work-up and direct hospital resources where they are needed.
Resource confidence

INNOVANCE D-Dimer 2.0 assay supports a seamless transition through demonstrated comparability, continuity of clinical practice, and familiar laboratory workflows.

  • Transition with confidence backed by extensive analytical verification and practice-oriented validation.
  • Preserve established clinical pathways through demonstrated agreement with defined D-dimer assays and continuity at the clinical decision threshold.
  • Maintain familiar laboratory workflows with a similar assay structure compared to INNOVANCE D-Dimer assay and straightforward implementation.
  • Reduce implementation effort through continuity of clinical interpretation and routine laboratory processes.
Illustration of a blood drop and test tube representing D-dimer testing and analytical confidence.

INNOVANCE D-Dimer 2.0 assay provides a dependable analytical foundation for routine practice, helping laboratories deliver consistent results across sites, shifts, and challenging samples.

  • Deliver consistent analytical performance across laboratories, analyzer systems, reagent lots, and routine testing conditions.
  • Support timely reporting of challenging samples through a broad measuring range, automated redilution, and low susceptibility to common interferences.
  • Monitor performance where clinical decisions are made with quality controls positioned around the validated DVT/PE decision threshold.
  • Support confident assessment of low D-dimer concentrations with analytical sensitivity designed for measurements near the clinical decision threshold.

Clinical Use

Patient in a hospital bed with a healthcare professional monitoring medical equipment.

DVT/PE exclusion

Support the exclusion of deep vein thrombosis (DVT) and pulmonary embolism (PE) in conjunction with a clinical pretest probability assessment model for outpatients suspected of DVT/PE.

Patient speaking with a healthcare professional during a clinical consultation.

Disseminated intravascular coagulation (DIC)1

Support the diagnosis and monitoring of patients at risk of, or with signs of, disseminated intravascular coagulation (DIC) and other hypercoagulable states.1

Older woman talking with others while seated at a table.

Population-specific interpretation

Support clinical interpretation with a validated clinical decision threshold and, where available, additional interpretation tools such as age-adjusted cutoff guidance.

Technical Details

Clinical application

Analytical performance

Workflow and operation

Kit configuration

Clinical decision threshold

0.5 mg/L FEU (500 ng/mL FEU)

Reference interval (90th percentile)

0.488 mg/L FEU

Negative predictive value (NPV)

99.8% (PE) / 99.6% (DVT)

Diagnostic sensitivity

99.0% (PE) / 97.4% (DVT)

Diagnostic specificity

57.3% (PE) / 48.0% (DVT)

Clinical validation

DVT/PE exclusion study followed to CLSI H59-A

Technical Specifications

 

Technical specifications indicated for use on CN-3000/6000 Systems. Assay performance figures may from country to country as well as with the system application of the respective assay. The values listed above are provided as examples only.

Measuring interval

0.19–80 mg/L FEU (automated re-dilution); initial: 0.19–7.5 mg/L FEU

Limit of detection (LoD)

0.0353 mg/L FEU

Limit of quantitation (LoQ)

0.1270 mg/L FEU

Repeatability

≤3.1% CV across three reagent lots

Within-device precision

≤3.9% CV across three reagent lots

Reproducibility

≤5.26% CV across three systems

Interference testing

Evaluated for hemoglobin, bilirubin, lipids, HAMA, rheumatoid factor, six other endogenous substances, and >40 drugs and medications

HAMA

901 ng/mL

Rheumatoid factor

2141 IU/mL

 

Technical specifications indicated for use on CN-3000/6000 Systems. Assay performance figures may from country to country as well as with the system application of the respective assay. The values listed above are provided as examples only.

Time to first result (at push of the start button)

Approximately 8 minutes when using the normal mode, micro mode, or for STAT samples; 1 minute between consecutive results

STAT samples

7:56 minutes (micro mode)

Sample type

Citrated plasma, fresh or frozen

Re-dilution

Automated

Stability once opened

Reagents and controls: 1 month at 2-8°C

Reagent onboard stability

120 hours with reagent cap; 12 days2 / 100 hours in original vials

Control onboard stability

12 days2 / 24 hours in original vials

 

Technical specifications indicated for use on CN-3000/6000 Systems. Assay performance figures may from country to country as well as with the system application of the respective assay. The values listed above are provided as examples only.

Reagent kit

Set of three vials of reagent, sample diluent and buffer, and 1 × Calibrator

Reagent formulation

Liquid, ready to use

Reagent capacity

51 tests per vial

Controls

Liquid, ready to use; three control levels available in separate kits

QC levels required

Two control levels

Control frequency

Once per day or per local requirements

Calibrator

Human plasma-based, automatic preparation of calibration curve

Sample diluent

Additionally available separately (optional)

 

Technical specifications indicated for use on CN-3000/6000 Systems. Assay performance figures may from country to country as well as with the system application of the respective assay. The values listed above are provided as examples only.

Evidence

Confidence backed by rigorous validation

INNOVANCE D-Dimer 2.0 assay underwent an extensive analytical verification and prospective clinical validation program designed to demonstrate reproducible performance under the conditions laboratories encounter every day.

Performance demonstrated under routine testing conditions

Performance was evaluated across multiple reagent lots, analyzer systems, instruments, laboratories, and countries, with studies spanning the measuring range up to 80 mg/L FEU to support reproducible performance in routine laboratory practice.

Robustness tested under challenging conditions

Precision was evaluated according to CLSI EP05-A3, while interference testing was conducted according to CLSI EP07 and included more than 50 endogenous and therapeutically relevant endogenous and exogenous substances to assess assay robustness under routine testing conditions.

Extensive validation designed to reflect clinical practice

The clinical cutoff was separately derived and validated following CLSI H59-A, with more than 2,500 consecutive outpatients across 22 clinical sites and three-month follow-up providing a representative evidence base for DVT/PE exclusion.

Strong clinical performance for DVT/PE exclusion

At the validated cutoff of 0.5 mg/L FEU, the assay demonstrated an NPV of 99.8% for PE and 99.6% for DVT, with specificity of 57.3% and 48.0%, respectively.

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1
The products/features/applications mentioned here are not commercially available in all countries and are subject to local regulations. Their future availability cannot be guaranteed. Not available for sale in the U.S.
2
When combined with 2–8°C storage; 8 hours on board per day for reagents or 2 hours on board per day for controls combined with stability in the refrigerator with closed reagents vials.
The products/features (mentioned herein) are not commercially available in all countries. Due to regulatory reasons, their future availability cannot be guaranteed. Please contact your local Siemens Healthineers organization for further details.
CN-3000/6000 Systems refer to Automated Blood Coagulation Analyzer CN-3000 and Automated Blood Coagulation Analyzer CN-6000.
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