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Silver CardioChek PA Analyzer

New Silver CardioChek PA analyzes 4 cholesterol types using SINGLE BLOOD DROPusing single-panel (total, triglycerides, hdl, ldl, glucose) or multi-panel test strips (Cardiochek test strips & supplies are sold separately)

$699.00/meter**


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CardioChek Products Improvement Program

  • Scope - This is a continuous program of sequential improvements to the CardioChek System which includes both the meter and the test strips.
  • Phase 1 – this phase was completed throughout 2010. The system improvements included a reformulation of the strip chemistry to yield better precision and accuracy; improved meter calibration and optimal curve setting for reference value accuracy
    •  
  • Phase 3 – Meter focused effort to improve the meter optical detection system such that meter precision is improved and meter to meter variance is diminished.
  • Quantifying the improvement is through clinical evaluations and health screening site based studies showing the correlation relationship (bias) to the reference laboratory value and the reproducibility of results (precision). The sum of bias and precision is the Total Analytical Error (TAE).

    • Clinical Performance Verification of the CardioChek System - Phase 1 Outcome

    Lee Springer, BSMT(ASCP),
    Robert Murphy, BS, Margo Enright, BS,
    Frank LaDuca, Ph.D.
    Clinical and Technical Affairs Polymer Technology Systems, Inc. April 2010

    Executive Summary:
     

    Following the completion of the process improvements and internal validation a four site comparison employing a total of 141 matched patient specimens was conducted using the CardioChek Lipid Panel and an analysis of the lipid components of cholesterol, HDL and triglycerides in a reference laboratory (Quest Diagnostics, Olympus AU Chemistry Analyzer). Bias and precision were determined across the four sites. The data confirms that use of the POCT CardioChek system for patient care and wellness screening properly categorizes patients for health risk assessment. These multi site evaluations demonstrate the performance verification of the CardioChek lipid system and illustrate the clinical efficacy of the CardioChek in a screening environment.
     
    CardioChek Component Process Improvement Summary
    Meter
    Establish a three point meter calibration process to improve reflectance precision
    Fortify Mechanical and Optical Systems
    Formulary
    Improve buffering to enhance stability to improve precision over time
    Improve membrane impregnation process for improved inter-lot precision
    MEMo chip correlation
    Re-confirm the internal secondary lab reference certification to the CRMLN standard
    Re-confirm CardioChek certification to the CRMLN standard
    Expand donor pool and dynamic range for correlation settings of the MEMo chip
    Maintain tightened Total System Error limits for all production runs


     


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  • Phase 2 – currently underway with incremental improvements due in early 2011. Strip focused effort which include a replacement blood separation membrane system and a refined reaction membrane formulary for improved precision and accuracy.