Clinical Laboratory Certification Program
In 1985, the National Cholesterol Education Program (NCEP) began an unprecedented campaign to educate the medical community and the general public about risk factors for coronary artery disease. To identify persons at risk for coronary artery disease, NCEP recommended initial classification using the medical decision points of 200 milligrams/deciliter (mg/dL) and 240 mg/dL (5.17 millimole/liter [mmol/L] and 6.21 mmol/L) for total cholesterol (1). Proper classification of a patient's risk based on these medical decision points requires reliable and standardized cholesterol measurements. Therefore, NCEP also developed recommendations for accuracy and precision (2). The Centers for Disease Control and Prevention (CDC) established the CRMLN (see Manufacturer Certification Program) to aid manufacturers in calibration. In addition to the manufacturer certification program, the CRMLN developed a total cholesterol certification program for clinical laboratories.
Since 1990, clinical laboratories have been able to evaluate their diagnostic system for measuring total cholesterol. This program was developed particularly for laboratories that use analytic systems that have not been certified by the manufacturer or those that consist of components from different manufacturers (e.g. an instrument from one manufacturer and reagents and calibrators from another manufacturer). However, any laboratory may participate in the certification program. The CRMLN provides physicians with a list of clinical laboratories that have been certified through this program.
Certification Protocol for Clinical Laboratories
[PDF - 291 KB]
Certified Analytical Systems
Analytical Systems Certified for Total Cholesterol
[PDF - 91 KB]
Analytical Systems Certified for HDL Cholesterol
[PDF - 76 KB]
Analytical Systems Certified for LDL Cholesterol
[PDF - 37 KB]
As with the manufacturer certification program, the evaluation for clinical laboratories is based on analysis of fresh serum samples. Clinical laboratories analyze 6 fresh samples that are distributed over a specific concentration range. Certificates of Traceability are issued to clinical laboratories that have bias from the reference method ≤ 3% and a coefficient of variation (CV) ≤ 3%. These certificates are valid for six months.
- National Institutes of Health. Report of the Expert Panel on Detection, Evaluation, and Treatment of High Blood Cholesterol in Adults. Bethesda, MD: National Institutes of Health, 1989. NIH publication no: 89-2925.
- National Institutes of Health. Recommendations for improving cholesterol measurement: a report from the Laboratory Standardization Panel of the National Cholesterol Education Program. Bethesda, MD: National Institutes of Health, 1990. NIH publication no: 90-2964.
Use of trade names is for identification only and does not constitute endorsement by the CDC or the U.S. Department of Health and Human Services.