Lipids Standardization Program

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The Lipids Standardization Program (LSP) monitors the accuracy of research and clinical laboratories over time. LSP ensures the analytical accuracy and precision of measurements performed in research studies and routine clinical laboratories by providing blinded standards (LSP samples) traceable to the CDC Reference Laboratory for measuring total cholesterol (TC), glycerides (TG), high-density lipoprotein cholesterol (HDL-C), apolipoprotein A-I (apo A-I), and apolipoprotein B (apo B). The LSP is unique among external quality-control systems (EQAS) because it provides a way to establish, assess, and improve the analytical accuracy and precision measurements over time.

LSP participants (clinical and research laboratories) report their measurement results from the LSP samples to CDC where results are evaluated. Those participants meeting defined performance criteria for accuracy and precision receive a certificate of performance and are considered CDC-certified.

Flowchart showing LSP standardization process

LSP monitors the accuracy and precision of its laboratory participants over time by collecting weekly measurement results from sera provided to them. It uses statistical procedures to evaluate measurement accuracy and precision over a period of three months, and issues quarterly reports to its participants.

LSP participants analyze three sera samples provided to them weekly, for 12 weeks. Participants are unaware of each sample’s lipids concentrations. These samples must be included in routine analytical runs, along with clinical samples. Participants receive new sets of blinded reference serum samples to be analyzed every 12 weeks (four sets per year), and report measurement results to CDC.

CDC provides participants with a statistical report that evaluates the accuracy and precision of their analyses. CDC issues a certificate of accuracy and precision if established analytical performance criteria are met.

If performance criteria are not met, the participant should take appropriate corrective actions before proceeding with subsequent surveys. Guidelines and instructions are provided to all participants about conducting measurements and using the LSP Laboratory Data Collection System on our secure website.

The LSP program uses unaltered, high quality pooled sera for evaluating the analytical performance of its laboratory participants. These sera are very similar to regular patient samples.

Reference values for TC, TG, HDL-C are assigned by the CDC Lipids Reference Laboratory. Reference values for apo A-I, and apo B are assigned outside of CDC, by the Northwest Lipid Metabolism and Diabetes Research Laboratories (NWLMDRL).

LSP is a unique program, because it evaluates measurement accuracy and precision over a period of three months. Other programs, such as External Quality Assessment/Proficiency Testing Program (EQA/PT), assess analytical measurement performance at a particular point in time without taking previous measurement results into account.

Please contact us at cdclsp@cdc.gov to request an application packet and submit the completed application for approval.

Criteria for Acceptable Performance for the
CDC Lipids Standardization Program (expressed in mg/dL)

Criteria for Acceptable Performance for the
CDC Lipids Standardization Program (expressed in mg/dL)
Analyte	Concentration Range	Maximum Allowable Bias	Maximum Allowable Standard Deviation
HDL-C	<40.0 ≥40.0	0.05 (RV) 0.05 (RV)	1.7 0.04 (RV)
TC	100-149.9 > 149.9	0.03 (RV) 0.03 (RV)	4.0 0.03
TG	0.0-88.0 > 88-176.0 > 176.0-220.0 > 220	9 10 11 0.05 (RV)	7 8 10 0.05 (RV)

Criteria for Acceptable Performance for the
CDC Lipids Standardization Program (expressed in mmol/L)

Criteria for Acceptable Performance for the
CDC Lipids Standardization Program (expressed in mmol/L)
Analyte	Concentration Range	Maximum Allowable Bias	Maximum Allowable Standard Deviation
HDL-C (mmol/L)	<1.03 ≥1.03	0.05 (RV) 0.05 (RV)	0.0440 0.04 (RV)
TC (mmol/L)	2.586-3.877 > 3.877	0.03 (RV) 0.03 (RV)	0.103 0.03 (RV)
TG (mmol/L)	0.00-0.994 > 0.994-1.989 > 1.989-2.486 > 2.486	0.102 0.113 0.124 0.05 (RV)	0.079 0.090 0.113 0.05 (RV)

There are no established criteria for acceptable performance for apolipoproteins A-I and B.

TC: Total Cholesterol
HDL-C: High Density Lipoprotein Cholesterol
TG: Total Glycerides

Disclaimer

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.

Lipids Standardization Program

Criteria for Acceptable Performance for the CDC Lipids Standardization Program (expressed in mg/dL)

Criteria for Acceptable Performance for the CDC Lipids Standardization Program (expressed in mmol/L)

Disclaimer

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Criteria for Acceptable Performance for the
CDC Lipids Standardization Program (expressed in mg/dL)

Criteria for Acceptable Performance for the
CDC Lipids Standardization Program (expressed in mmol/L)