INNOVANCE PFA-200 System1
Fast and reliable platelet dysfunction detection
INNOVANCE PFA-200 System
The INNOVANCE® PFA-200 System1 provides automated assessment for inherited, acquired, or drug-induced platelet dysfunction. It measures the process of primary hemostasis and aids in the rapid detection of platelet dysfunction. Through flow technology, the system provides a realistic hemodynamic environment for the measurement of primary hemostasis.
- Screens platelet function in patients with impaired primary hemostasis, such as von Willebrand disease2
- Provides excellent sensitivity for congenital platelet dysfunction, such as Glanzmann thrombasthenia
- Verifies efficacy of desmopressin acetate (DDAVP) therapy in presurgical patients3
- Assesses platelet dysfunction caused by aspirin
- Evaluates platelet dysfunction in multiple clinical settings, such as presurgical screening, high-risk pregnancy and menorrhagia
- Detects platelet P2Y12-receptor blockades in patients undergoing therapy with P2Y12-receptor antagonists
Features & Benefits
Simple, rapid, qualitative, and precise automated assessment of platelet function
The INNOVANCE® PFA-200 System1 provides simple, rapid, qualitative, and precise automated assessment of platelet function and supports clinically relevant decision-making processes effecting therapies. The system quickly measures platelet plug formation in a small whole blood sample (800 μL) and reports a ”closure time” in 5-8 minutes.
Comprehensive bleeding risk assessment
The INNOVANCE PFA-200 System’s unique technology simulates in vitro hemodynamic conditions of platelet adhesion and aggregation in a vascular lesion, providing rapid detection of acquired, inherited, or drug-induced platelet dysfunction in multiple clinical settings. Combining the INNOVANCE PFA® P2Y test1, the Dade® PFA Collagen/EPI Test Cartridge, and the Dade PFA Collagen/ADP Test Cartridge provides a comprehensive, cost-effective preoperative bleeding risk solution.
- Simple 3-step process requires minimal pipetting and hands-on time
- Results from one 800 μL sample of blood
- One cut-off for P2Y samples in 3.2 and 3.8% buffered sodium
- Preoperative screening results in 5-8 minutes
Detects inherited, acquired, and drug-induced platelet dysfunction
In combination with traditional coagulation screening tests such as prothrombin time and activated partial thromboplastin time, the INNOVANCE PFA-200 System provides excellent sensitivity to functional defects of hemostasis.
- Accurate detection of acquired, inherited, or drug-induced platelet dysfunction under high-shear stress
- Sensitive to quantitative and qualitative abnormalities of VWD in both plasma and platelets
- Simple, rapid, semi-quantitative, and precise assessment of platelet function
- Software supports closure curve4 illustrations for use in scientific studies
Reliable detection of aspirin-induced platelet dysfunction
The INNOVANCE PFA-200 System assesses whether doses are sufficient to induce platelet dysfunction. While other analyzers only detect the inhibition of platelet aggregation, the INNOVANCE PFA-200 System accurately measures the ability of aspirin to prevent platelet plug formation.
Effective monitoring of pre-surgical therapy
Several “screening tests” fail to detect a number of mild bleeding disorders that could cause substantial bleeding. The INNOVANCE PFA-200 System, however, can reliably identify patients with a bleeding risk due to platelet function deficiency. With the INNOVANCE PFA-200 System, most patients with prolonged Col/ADP Closure Times manifest abnormalities in primary hemostasis that could place them at risk during surgery.
- The Dade PFA Collagen/EPI Test Cartridge provides effective assessment of pre-surgical therapy with desmopressin (DDAVP)
- Several clinical studies suggest that the PFA closure time (CT) with both the Dade PFA Collagen/EPI and Dade PFA Collagen/ADP Test Cartridges becomes measurably shorter following infusion of DDAVP
- Shorter closure times indicate improved platelet function and may indicate improvement in bleeding symptoms and transfusion needs
Safe and efficient testing
- No special sample collection requirements–only a small volume of citrated whole blood is needed (800 μL)
- All PFA tests can be run from one patient sample tube
- All biological material remains in the test cartridge. This feature minimizes operator/blood contact for improved safety and consistency, avoiding instrument contamination and facilitating safe biohazard disposal
- Blood samples are stable for up to 4 hours after collection
- Built-in quality control program reduces risk of reporting false results
- Password/access levels protect sensitive patient data and provide enhanced traceability records
Assays
Dade® PFA Collagen/EPI Test Cartridge
Dade PFA Collagen/ADP Test Cartridge
INNOVANCE® PFA P2Y1
Technical Specifications
| Dimensions | 37.3 cm x 25.6 cm x 37.4 cm (W x D x H) |
| Weight | 10.0 kg |
| Principle | High-shear force dynamic flow system |
| Measuring channel | Single measuring channel |
| Incubation category | Two incubation wells |
| Incubation temperature | 37.9 °C ± 1.0 °C |
| Incubation warm up-time | <15 minutes (room to operating temperature) |
| Trigger solution | Illuminated trigger solution viewing area |
| Sample Handling: | |
| Type of sample | Citrated whole blood |
| Sample mechanism | Manual pipette dispensing (800 μL) |
| Bar-code identification | Optional external bar-code reader for sample identification |
| Reagent Handling: | |
| Type | Single disposable self-contained test cartridge |
| Reagent recognition | Positive optical-coding reagent cartridge identification |
| Additional reagent | Trigger solution |
| Throughput: | |
| Single test | Dade PFA Collagen/EPI Test Cartridge, Dade PFA Collagen/ADP Test Cartridge, or INNOVANCE® PFA P2Y1: 6 tests/hour |
| Duplicate test | Dade PFA Collagen/EPI Test Cartridge, Dade PFA Collagen/ADP Test Cartridge, or INNOVANCE PFA P2Y1: 10 tests/hour |
| Software: | |
| Interface | Color LCD touchscreen |
| Host connection | Uni-directional, external RS-232 DB-9 port or ethernet network |
| Sample ID | Maximum 20 numeric characters |
| Stored patient results, control results, and maintenance events | Last 1,200 results |
| Software update | USB flash drive |
| USB port | Software updates, printer, barcode scanner, and result export |
| Closure curve4 | Displayed on screen, printed as PDF, and exported to USB memory stick |
| Quality control | Built-in |
| Password/access levels | Yes |
| Onboard help | Yes |
| Instrumentation status | Clear status messages (red, yellow, and green) |
| Computer/Printer | |
| Workstation | Built-in PC |
| Display | Built-in touchscreen |
| Printer | Built-in 24 character-wide thermal printer, sound level printing 47 dB(A) |
| Printer paper | 61.9 mm wide thermal paper roll with standard 5-year readable life |
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1Not available for sale in the U.S. Product availability varies by country.
2Koscielny J, Ziemer S, Radtke H, et al. A practical concept for preoperative identification of patients with impaired primary hemostasis. Clin Appl Thromb Hemost. 2004;10:195-204.
3Koscielny J, von Tempelhoff GF, Ziemer S, et al. A practical concept for preoperative management of patients with impaired primary hemostasis. Clin Appl Thromb Hemost. 2004;10:155-66.
4For research use only. Not for use in diagnostic procedures
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 organization for further details.