CDC Clinical Standardization Programs

Presentation Number: SH02-7
Date of Presentation: April 2nd, 2017

Uliana Danilenko*, Julianne Cook Botelho, Krista Poynter, Ashley Ribera, Otoe Sugahara and Hubert W Vesper
Centers for Disease Control and Prevention, Atlanta, GA


Research and patient care highly relies on accurate and reliable laboratory tests. Problems with accuracy and overall performance of tests were described by research and professional organizations. Inaccurate measurements can lead to incorrect and inconsistent diagnosis, treatment, and prevention of diseases. CDC’s Clinical Standardization Programs evaluate laboratory tests to ensure that testing on patients is accurate and reliable across methods, time, and location.

CDC’s Clinical Standardization Programs use internationally recognized reference methods and reference materials to assess analytical test performance. The analytes included in its programs are total cholesterol (TC), total glycerides (TG), HDL-cholesterol, LDL-cholesterol, testosterone (T), estradiol (E2), and total 25-hydroxyvitamin D (25OHD). These programs use well-established procedures and criteria to evaluate and certify the analytical performance of tests. Participation in these programs is voluntary. Currently, over 198 participants are enrolled (88 are assay manufacturers and 110 laboratories).

The recently started programs for hormones already show profound improvements in accuracy among participants while the long-standing programs for blood lipids show that highly accurate measurements are maintained over decades. For T and E2, the among laboratory bias has decreased from 16.5% in 2007 to 4.4% in 2015 and from 59.2% in 2012 to 13.7% in 2015, respectively. Similar improvements in calibration have been observed in 25OHD. Data from participants in the CDC Lipids Standardization Program collected over the past 10 years show that the majority of TC measurements performed in research and patient care are consistently well within the recommended bias limits of +/-3%. Similar consistencies are made for TG, HDL-C and LDL-C.

Laboratory tests standardized by CDC are able to use common reference ranges and clinical decision points. This facilitates the effective implementation of clinical guidelines and saves cost for patient care. In examples, the annual cost savings attributed to standardized lipid measurements through CDC Standardization Programs over 20 years was estimated to be approximately $7.6 billion (Hoerger TJ Prev Chronic Dis 2011).

CDC is expanding its programs by including free testosterone, SHBG, both free and total thyroid hormones thyroxine (T4) and triiodothyronine (T3), parathyroid hormone (PTH), as well as glucose. Furthermore, it increases its services by providing new sets of reference samples to participants to better evaluate the analytical test performance and to better monitor the accuracy of research studies.

CDC Clinical Standardization Programs ensure that laboratory results in research and patient care are accurate, reliable, and continue to meet the needs defined by stakeholders such as The Partnership for Accurate Testing of Hormones (PATH).


Nothing to Disclose: UD, JCB, KP, AR, OS, HWV