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The CardioChek PA System, properly used, produces lipid results that meet the accuracy guidelines established by the National Cholesterol Education Program (NCEP) of the National Institutes of Health (NIH).
Total Analytical Error
The generally accepted standard for quality of a result from any test method relates to the difference between the result obtained and the reference value. That difference is referred to as "Total Analytical Error," which is a measure of both accuracy of the system (i.e., the bias of the system, or how close the average of a series of results are to the reference value) and precision (i.e., the reproducibility of the system, or how close a series of results on the same sample are to each other).
The National Institutes of Health (NIH), through its National Cholesterol Education Program (NCEP), has established test protocols and guidelines for acceptable deviation from "truth," or the NRS/Chol (the National Reference System for Cholesterol) reference value. These guidelines state that Total Analytical Error (TAE) should be within the following limits from reference when these test protocols are followed:
PTS Total Cholesterol and HDL Cholesterol are CRMLN certified as of 2011.
CRMLN Chol & HDL certified
Because variability and system error are present in all commercial methods for determining lipid concentration, determining the reference value can be difficult. The reference value is typically defined as the result given by the standard methods established by the Centers for Disease Control and Prevention (CDC) for lipid analyses.
CRMLN Reference Labs
The CDC established reference laboratories in the US ("Cholesterol Reference Method Laboratory Network" [CRMLN]) to evaluate and certify manufacturers’ lipid products against reference standards. For a link to the CRMLN website, click here.
For additional information about accuracy and precision, please refer to the documents and technical publications provided below.
Technical Bulletin, POC Lipid Panels: Do They Measure Up?
Technical Bulletin, CRMLN Brochure
Evaluation, Jupiter Medical Center
Evaluation, White County Medical Center
2011 CardioChek Clinical Evaluations
2010 Clinical Performance Verification Summary
Accuracy and Precision in Point-of-Care Lipid Testing
Accuracy of the CardioChek PA and the Cholestech LDX Systems Compared to CRMLN Determinations
Performance of the CardioChek PA and Cholestech LDX Compared to Clinical Lab Tests
Performance Characteristics of the PTS PANELS Lipid Panel Test Strips
Understanding the Impact of Design and Analytical Errors in POCT Research
Accurate Health Risk Classification for Heart Disease using Point of Care Testing
Medical professionals and clinical laboratories are invited to evaluate the CardioChek PA system against their current methods. Please contact PTS Customer Service for a current evaluation protocol.
Polymer Technology Systems, Inc.7736 Zionsville Road | Indianapolis, IN | 46268 | USA
We develop and manufacture diagnostic tests for chronic diseases such as heart disease, diabetes, and other related medical conditions. Our products are distributed in more than 100 countries. More Contact Info
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