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INNOVANCE PFA-200 System1

Fast and reliable platelet dysfunction detection

INNOVANCE PFA-200 System

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.

INNOVANCE PFA-200 System

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
INNOVANCE PFA-200 System

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
INNOVANCE PFA-200 System

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.

INNOVANCE PFA-200 System

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
INNOVANCE PFA-200 System

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

Display

Display

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

1 Not 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 Healthineers organization for further details.