Did you know?
By participating in Oneworld Accuracy’s CHOL726 (Certification - Total Cholesterol) program, you are also participating in the CDC Lipids Standardization Program. Your laboratory’s performance will be compared directly to reference results as determined by a CRMLN (Cholesterol Reference Method Laboratory Network) laboratory, and you will be graded based on the ability to meet precision and accuracy limit specifications as determined by CDC.
If the participant is successful in the test event, a Certificate of Traceability will be granted by CRMLN, as the laboratory has documented traceability to the National Reference System for Cholesterol, by direct comparison with the cholesterol reference method as performed by a CRMLN laboratory. This certificate is valid for 6 months after the issue date.
Participating in a standardization program means patients’ results can be interpreted using clinical guidelines issued by the National Cholesterol Education Program (NCEP), as your laboratory’s method is comparable to the reference method(s) used to determine clinical decision points.
Source: https://www.cdc.gov/labstandards/crmln.html
CRMLN Laboratory
Oneworld Accuracy currently works with Erasmus MC (University Medical Center Rotterdam), a CRMLN member laboratory, to provide us with reference results determined by the Abell-Kendall method. It must be noted that a CRMLN laboratory has already passed a rigorous certification process as determined by CDC and they are subjected to more stringent analytical performance goals (<= 1% for bias and imprecision, for Total Cholesterol) than clinical laboratories testing patient samples.
Program Basics
There are two test events distributed during the year, and 6 samples are provided per test event. Participants are required to test for Total Cholesterol for each of the 6 samples in duplicate, for 3 days consecutively. Samples are human serum procured from donors and have not been modified in any manner, ensuring commutability.
Evaluation Basics
The current precision and accuracy limits are <=3%, for Total Cholesterol. After evaluation, each participant will receive a comprehensive performance report which includes the following analyses:
Bias (absolute and percentage) compared to the Abell-Kendall (AK) method
Regression analysis between the participant’s method and the AK method
t-test for determining significant bias with the AK method
Bias plot
Within and between method outlier determination
A Certificate of Traceability will only be granted after the laboratory has satisfied the pre-determined precision and accuracy limits.
Please contact Oneworld Accuracy Support (support@1wa.org) for additional information, or for instructions to enroll. All laboratories are welcome to join.
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