Products - see text links below
See text links below


Pharmanetics has received an Humanitarian Device Exemption (HDE) for its Ecarin Clotting Time (ECT) test card from U.S. FDA www.fda.gov/cdrh/ode/h990012sum.html . The ECT HDE makes the test card available for monitoring the anticoagulation activity of r-hirudin (Refludan® <www.refludan.com>, Aventis Pharma) in patients with Heparin Induced Thrombocytopenia (HIT) undergoing Cardiopulmonary Bypass (CPB) procedures.


 The LHMT is designed to accurately monitor low to moderate levels of unfractionated heparin and can be used in interventional cardiac procedures such as angiography, Percutaneous Transluminal Coronary Angioplasty (PTCA), and stent implants. The LHMT measures heparin concentration from .25 to 3.0 U/mL. This represents a range above the aPTT and below that of the Heparin Management Test (HMT). Each test uses 35mL of citrated whole blood or non-citrated whole blood. The procedure for the LHMT test card is identical to the other tests Pharmanetics offers. As with the other test cards, simple, bi-level, liquid quality controls are available for the LHMT


NewAccent™ and the Heparin Management Panel (HMP)

Accent™ and the Heparin Management Panel (HMP)The Rapidpoint Accent is an accessory to the TAS / Rapidpoint Coag Analyzer. When used in conjunction with the TAS / Rapidpoint Coag and the Heparin Management Panel, its intended use is to generate information on heparin management.

The Rapidpoint Accent is designed for use in operating suites where cardiac bypass graft (CABG) procedures are performed. It can also be used during other procedures where heparin management is necessary. The Rapidpoint Coag automatically sends results to the Rapidpoint Accent and the Rapidpoint Accent processes these results, in combination with patient data, to calculate heparin concentrations and provide recommended dosing information.

The Rapidpoint Accent is a small, compact instrument with an easy-to-read, lighted, 8.1-inch diagonal, touch-operated screen. It contains a hard disk the size of a credit card where the Rapidpoint Accent software is installed. The Rapidpoint Accent is housed in a portable, lightweight frame with a platform in front of the screen for the Rapidpoint Coag. (See picture at left.) The Rapidpoint Coag is connected to the Accent System through a serial port located in a recess at the front of the Rapidpoint Accent. The Rapidpoint Accent provides a power connection to the Rapidpoint Coag, and has a built-in printer.

The Heparin Management Panel is composed of two test cards: the Heparin Titration Test (HTT) card and the Protamine Response Test (PRT) card. The HTT contains a known amount of heparin and is used with the Rapidpoint Accent to predict a patient's response to heparin.

The PRT contains a known amount of protamine sulfate. The result of the PRT in combination with the last Heparin Management Test (HMT) result allows the Rapidpoint Accent to determine how much protamine sulfate to give the patient to neutralize circulating heparin.

The Rapidpoint Accent system procedure is as follows. Patient data including patient ID, gender, height and weight are entered into the Rapidpoint Accent. A base line HMT and a HTT are run before the patient receives heparin. These test results are used to construct a titration curve that is used to calculate a patient's response to heparin and the amount of heparin required to achieve a target HMT or a target heparin concentration.

After heparin administration has begun, maintenance HMT tests are run to monitor coagulation. The maintenance HMT results are used with the HTT titration curve to calculate the amount of heparin required to maintain the target HMT or heparin concentration.

Prior to heparin reversal, a PRT is performed. The results of the PRT are combined with the last maintenance HMT to construct a titration curve that is used to calculate the dosage of protamine required to neutralize the heparin in the patient's blood. HMTs are performed following protamine administration to determine a return to baseline and hemostatic potential
TAS Result Acquisition System (TRAQS™)

The EQC test card is designed to validate that the Rapidpoint Coag is operating within prescribed guidelines. The EQC is meant to augment, not replace, the existing bi-level, liquid quality controls offered for the Rapidpoint Coag. The EQC test is performed just like the other test cards. The card is swiped through the analyzer's card reader. The card is then inserted into the analyzer's test well and the operator follows the prompts on the analyzer's LCD display. The analyzer will stimulate the paramagnetic iron oxide particles (PIOP) in the EQC test card to move in the oscillating magnetic field thus simulating the same kind of action as in the testing of an actual patient sample. The EQC test card automatically performs three levels quality control.

Version 4.1 software revision is required to operate EQC™.

4.1 Software Revision

The 4.10 revision of the Rapidpoint Coag operating software significantly enhances the already considerable features of the analyzer. Among the new feature of 4.10 are:

  • Addition of Electronic Quality Control
  • Provide a "battery low" indicator
  • Extend maximum Quality Control Lockout / Warning time (more that 24 hours)
  • Display a running timer during the HMT and LHMT
  • Ability for customer defined Prothrombin Time ISI value
  • Provisions to perform 3 new, upcoming assays (pending FDA review and clearance)
  • Allow interface with the Accent‘ (pending FDA review and clearance)
  • Provide for Quick % measure of Prothrombin Time (German language version only)

Analyzers shipped after July 1st, 1999 will have the 4.1 revision preloaded. Customers with earlier versions of Rapidpoint Coag software interested in upgrading should contact their local distribution representative or Pharmanetics, Inc.

 


The Rapidpoint Coag is a solid state, microprocessor controlled system for monitoring coagulation and fibrinolysis using a small drop of whole blood, plasma or quality control material. Weighing just over 4 pounds, the analyzer is flexible enough for use in a variety of testing environments including the clinical laboratory, OR, Cath Lab, ICU, CCU, dialysis, and outpatient clinics.

Rapidpoint Coag analyzer features include:

  • 1000 result internal memory
  • AC / DC power operation
  • Alpha-numeric key pad
  • Patient identification
  • Operator access / identification
  • Quality control warning / lockout
  • RS232 serial port
  • Normal and Quality Control Range Check

The Rapidpoint Coag stores each test result with date and time, patient identification, operator identification, test name and lot number automatically. Precise pipetting of reagents or samples and manual timing skills are not required with the Rapidpoint Coag test cards. The QC lockout feature insures that quality control has been performed and meets specific performance criteria before patient samples can be processed. The RS232 serial port allows for printer or PC interface.

 

Prothrombin Time (PT)

CVDI offers a variety of PT tests to meet a wide range of testing needs including:

  • PT (ISI approx. 1.6)
  • PT-ONE™ (ISI approx.1.0)
  • PT-NC™ (ISI approx.1.0) - for “finger stick” or non-citrated samples

 

activated Partial Thromboplastin Time (aPTT)

The Rapidpoint Coag aPTT test card is to be used with the Rapidpoint Coag analyzer and is intended for the determination of the activated Partial Thromboplastin Time of citrated whole blood or plasma.

 

Heparin Management Test (HMT)

The Rapidpoint Coag HMT is an alternative to the Activated Clotting Time (ACT). The HMT card together with the Rapidpoint Coag analyzer is intended for rapid monitoring of the effects of moderate to high heparin levels (1 to 10 U/mL) on coagulation. The HMT, unlike the ACT, uses a much smaller sample (35µl vs. 2.0mL), utilizes either citrated or non-citrated whole blood and is unaffected by hypothermia and hemodilution. Studies by independent trial examiners also indicate that the HMT is less affected by Aprotinin than the ACT.

 

Quality Control

PharmaNetics offers liquid, bi-level Quality Controls for each of its tests. These are simple, single use controls which eliminate the measurement of diluent and lengthy equilibration time. Each control vial contains lyophilized material in a glass ampoule suspended in pre-measured diluent. To use the PharmaNetics' TAS Quality Controls the operator simply crushes the ampoule containing the lyophilized material and shakes the vial for 30 seconds. The control is then ready to use immediately.

Site map PharmaNetics, manufacturer of a platform for point of care monitoring of whole blood coagulation.