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| Pharmanetics Inc Cardiovascular Division 5301
Departure Drive Phone: (800) 247-4234 |
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| INSTRUMENT | TEST MENU |
Thrombolytic Assessment System (TAS) / Rapidpoint
Coag |
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| Rapidpoint Accent |
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CORPORATE DESCRIPTION: PharmaNetics, Inc. develops, manufactures and markets rapid turnaround diagnostics to assess blood clot formation and dissolution. The company develops tests based on its proprietary, dry chemistry Thrombolytic Assessment System for its principal target market of managing powerful new drug compounds, some of which may have narrow therapeutic ranges, as well as for monitoring routine anticoagulants. The company's therapeutic diagnostics are used to monitor the effect of antithrombotic agents in the treatment of angina, myocardial infarction, stroke, deep venous thrombosis, and pulmonary and arterial emboli.
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Size:
Width: 152 mm (6.0 inches)
Height: 100 mm (3.9 inches)
Length: 265 mm (10.5 inches)
Weight: 1.9 kg (4.25 pounds)
Data Transfer Capability: RS 232 Serial Port for printer / computer interface and for software upgrades
Specifications: (No response)
Test Menu:
(ISI » 1.0) (Heparin Management Test)CPT codes:
Test Methodology: Photomechanical
Units in which test result is reported: Clotting times in seconds, International Normalized Ratio (INR) and % Quick for PT
Sample Volume: » 35 µL
Time to result: 1- 5 minutes depending on test type
CLIA Classification: Moderate complexity
Other:
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Size:
Width:
236.3 mm (9.30 in.)
Height: 297.0 mm (11.69 in.)
Depth:
Closed 240.4 mm (9.47 in.)
Open (w Rapidpoint Coag) 430.5 mm (16.95
in.)
Weight: 4 kg. (8 lb. 8 oz.)
Data Transfer Capability: RS 232 Serial Port
Specifications:
Power:
Overvoltage Categories II
Internal Power Supply:
Input: 100 - 240 VAC ±
10% 50-60
Hz Single Phase
Output: 7.1 VDC
Fuse: T2.5 A. 250 V
Ambient Temp. Range: 18-32°C (65-90°F)
Test Menu:
(Heparin Management Test)CPT codes: No response
Test Methodology:
The Rapidpoint Accent together with the Rapidpoint™ Coag monitors the impedance of the movement of small paramagnetic iron oxide particles (PIOP) in a flat capillary chamber. When whole blood is added to a test card, sample is drawn into the test chamber, dry reagent is re-dissolved and the PIOP begin to move in an oscillating magnetic field. As a blood clot begins to form the movement of the PIOP is slowed. Finally the clot entraps the particles and movement stops. This movement is monitored by a photodetector. The operator is alerted that the test is complete and the results are simultaneously displayed on the Rapidpoint Accent's screen and stored in the Rapidpoint Coag's internal memory.
Heparin Management Test (HMT) card monitors clotting capabilities of a patient's blood during heparin therapy.
The Heparin Titration Test (HTT) card is used to predict a patient's response to known concentrations of heparin prior to the initiation of heparin therapy. It can be use to calculate recommended dosages of heparin required to achieve a specific HMT value.
The Protamine Response Test (PRT) card is used during heparin therapy and prior to heparin reversal. The PRT result, along with the last maintenance HMT, is used to calculate the dosage of protamine recommended to neutralize the heparin in the patient's blood.Units in which test result is reported:
Sample Volume: » 35 µL
Time to result: Variable depending on test type and patient status.
CLIA Classification: Moderate complexity
Other:
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Ecarin
Clotting Time (ECT) Test Card CPT Code: n/a The ECT is designed
to monitor the anticoagulation effects of the direct thrombin inhibitor
Refludan®, r-hirudin. The
ECT test card is available under a Humanitarian Device Exemption (HDE,
h-990012) from the US FDA. The ECT is designed
for use with the Rapidpoint Coag during Cardiopulmonary Bypass Graft (CABG)
procedures in patients diagnosed with Heparin Induced Thrombocytopenia
(HIT) type II to determine the anticoagulant effects of recombinant
hirudin (r-hirudin). The ECT test card is
designed to measure therapeutic levels (0-3.0µg/mL to higher levels
(3.0-5.0 µg/mL) of r-hirudin in citrated whole blood. Each test requires
approximately 35µL of
citrated whole blood. More information can be found at http://www.pharmanetics.com/product_ECT.html |
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Last updated: 09/15/2003
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