Certifying instrument performance for lipid testing

CLIENTS: Beckman, Abbott, Siemens and others


Internationally, there is an ongoing effort to standardize tests that most directly influence clinical decision-making. This places instrument manufacturers under increasing pressure to document traceability of their methods to defined bases of accuracy. Although compliance for certification programs is voluntary, it has become a prerequisite for maintaining a competitive position in the marketplace and instilling confidence in clinicians who rely on the test results for making decisions aligned with established guidelines, such as in lipid management.


As a member of the Cholesterol Reference Method Laboratory Network (CRMLN), CEQAL is one of the few labs in the world entrusted to provide the analytical support for administering the CDC’s Manufacturer Certification Program for Total Cholesterol, HDL Cholesterol and LDL Cholesterol. Instruments that meet the defined level of performance are issued a Certificate of Traceability documenting that their method is traceable to a defined base of reference, in this case the National Reference System for Cholesterol. This information is then published online and available to the public through the CDC. Visit the CDC online to learn more about the Manufacturer Certification Program.


“I can't tell you how much I appreciate CEQAL sticking with us during the certification processes for Total Cholesterol and HDL. I can't imagine any other lab or person taking the time, trouble, and effort you have.”