CLIA-waved. FDA-cleared. CRMLN-certified. CE-marked. Professional use only.
The CardioChek PA is a fast, portable and accurate whole blood test system. The CardioChek PA test system includes an analyzer, MEMo Chip and test strips. This system is intended for in vitro diagnostic use to test whole blood. Using this system, a health care professional can quickly measure various blood components with a small sample size.
The CardioChek PA test system is capable of monitoring for diabetes and other disease states and lipid screening. The CardioChek PA uses reflectance photometry for testing. It reads color changes that occur on a test strip after blood is placed on the test strip.
The CardioChek PA System is the simplest, fastest and most user-friendly method to accurately determine lipid values at point of care. While the CardioChek PA System is CLIA-waived for use by self-trained or minimally-trained users, users are urged to learn proper techniques.
The CardioChek PA System, properly used, produces lipid results that typically meet the accuracy guidelines established by the National Cholesterol Education Program (NCEP) of the National Institutes of Health (NIH).
Moreover, PTS Panels Lipid Test accuracy is generally comparable to the accuracy of equivalent analyzers, as reported in various proficiency surveys.
The accuracy and precision of all CardioChek and PTS Panels products are detailed in Technical Documentation.
Medical Professionals and Clinical Laboratories are invited to evaluate the CardioChek PA System themselves against comparable methods to determine the accuracy and precision suitability for their situation.
CardioChek PA Technology
The underlying technology of the CardioChek PA System employs innovative concepts to emulate the complex chemical analysis, sample preparation and measurement methods of clinical labs in a simple format suitable for untrained operators.
Operating Principle
A precise volume of whole blood is dispensed on to the application window of a PTS Panels Test Strip that has been inserted into a CardioChek PA analyzer. Red cells and other non-plasma components are removed from the plasma. The plasma reacts in a precisely controlled manner with a series of chemically impregnated membranes, ultimately producing a color change in the final membrane layer. The analyzer measures the color intensity from the color spectral profile and compares to lot-specific calibration information contained in the MEMo Chip to calculate an accurate result. The analyzer then displays the result, simultaneously triggers a printout (if the dedicated printer is attached), and stores the test information in memory for later recall.
CardioChek PA Analyzer
The CardioChek PA is a state-of-the-art, hand-held, battery-operated, software-driven reflectance spectrophotometer.
PTS Panels Test Strips
PTS Panels Test Strips are composed of several layers of reagent-impregnated membranes sandwiched together in a plastic carrier. Each membrane layer performs specific functions to process and facilitate chemical reactions. The dry phase chemistry membranes are typically stable at room temperatures for 18 to 24 months.
MEMo Chip
MEMo Chips are individualized for each lot of PTS Panels Test Strips and contain calibration settings, expiration dating and other information that calibrates the CardioChek PA analyzer to every strip it “reads.” A MEMo Chip is packaged with every vial of strips to ensure accurate calibration specific to each lot of strips.
Benefits of CardioChek PA Technology
- Accurate. Factory calibrated with MEMo Chip
Fast.
- Results in approximately 1-2 minutes*
- Versatile. Ability to test multiple-test panels or individual tests
- Convenient. Small sample (15-40µL, fingerstick or venous (EDTA or heparin))
- Reliable. No moving parts
- Easy, simple. Stick finger > collect sample > dispense sample > read results
CLIA-Waived.*
- Stable. Room temperature strip storage 18-24 months (no refrigeration required*)
Portable. Test anywhere, any time (pocket-size, battery-operated)
Inexpensive.
- Profitable. Covered by most US payors for medically-indicated testing
- Memory. Stores last 30 tests for recall
- Printer and Computer Connectivity.
*Creatinine requires refrigeration, provides test results in 8 minutes, and is not CLIA-Waived.