CVD Reference Laboratory

At a glance

  • CDC performs reference measurement procedures for total cholesterol, total glycerides, HDL-Cholesterol and LDL-cholesterol.
  • The procedures are highly accurate, precise, and within analytical performance criteria established for Cholesterol Reference Method Laboratory Network Member Laboratories.
Male and female scientists in laboratory

CDC CVD Clinical Reference Laboratory (CRL)

Clinical decision points are derived from tests standardized to CDC's reference methods. So, CDC is ensuring that test results obtained for the same biomarker, but using different measurement procedures, can be compared to the same decision points.

The type of reference procedure used by CDC are:

  • LDL-cholesterol: Ultracentrifugation
  • HDL-cholesterol: Ultracentrifugation
  • Total cholesterol: Abell Kendall
  • Total glycerides: Mass spectrometry–based
  • Total cholesterol: Mass spectrometry–base

Spotlight‎

CDC's Clinical Reference Laboratory (CRL), which provides reference measurement services to the CDC's Clinical Standardization Programs (CSP), has received accreditation by the American Association for Laboratory Accreditation (A2LA), as a Calibration Laboratory, in accordance with the recognized International Standards ISO/IEC 17025:2017 General requirements for the competence of testing and calibration laboratories and ISO 15195:2018 Requirements for the competence of calibration laboratories using reference measurement procedures. The CDC CRL accreditation demonstrates technical competence as defined in the scope of accreditation for A2LA and the operation of a laboratory quality management system.


(A2LA Cert. No. 6909.01) 02/07/2024

Laboratory best practices

All CDC methods meet requirements necessary to avoid imprecision and bias and are calibrated to the National Institute Standards and Technology (NIST) standard reference materials. The Joint Committee for Traceability in Laboratory medicine (JCTLM) recognizes and lists CDC reference methods in its database.

To meet increasing demands for reference performed by mass spectrometry, CDC maintains reference procedures based on isotope dilution gas chromatography for total cholesterol and total glycerides.

CDC assigns target values to reference materials used in CRMLN and LSP Standardization Programs. CDC collaborates with NIST and other domestic and international organizations to assign target values to reference materials and trueness controls. CDC also provides reference measurement services to organizations and laboratories worldwide to improve the accuracy and reliability of cholesterol and other lipid measurements.

Contact the CRL team

E-mail: cdclsp@cdc.gov

  • Edwards S, Stribling S, Pyatt S, Kimberly M. Reference measurement procedure for total glycerides by isotope dilution GC-MS. Clin Chem. 2012 58(4):768-776
  • Handbook of Lipoprotein Testing, 2nd Edition. Washington DC: AACC Press 2001
  • Edwards S, Kimberly M, Pyatt S, Stribling S, Dobbin K, Myers G. Proposed serum cholesterol reference measurement procedure by gas chromatography-isotope dilution mass spectrometry. Clin Chem. 2011 Apr; 57(4):614-22
  • Cooper G et al. Interlaboratory testing of the transferability of a candidate reference method for total cholesterol in serum. Clin. Chem., 1986, 32, 921-929