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Performance Standards

NCEP

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).

 



NCEP Guidelines for Total Analytical Error

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:

CRMLN

PTS Total Cholesterol and HDL Cholesterol are CRMLN certified as of 2011.  

icon CRMLN Chol & HDL certified

 

Reference Value

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.

icon Technical Bulletin, POC Lipid Panels: Do They Measure Up?

 

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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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