What do CDC CSPs Offer?

CDC Clinical Standardization Programs (CDC CSPs) provide comprehensive assistance to various stakeholders worldwide.

Reference Laboratory Services

Our clinical reference laboratories continuously manage 10 highly accurate, specific reference measurement procedures for chronic disease biomarkers. We are developing new reference methods for high-priority biomarkers. Through these reference measurement procedures, we help laboratories and organizations with the following:

Assigning reference values to calibration and other reference materials
Developing reference materials
Conducting studies to assess the quality of reference materials
Developing new and improving existing laboratory methods
Establishing reference laboratory capacities globally

*We are the only laboratory in the United States that is continuously managing these reference measurement procedures.

Certification Programs

CDC Clinical Standardization Programs (CSPs) assess the analytical performance of new and established laboratory tests in patient care, public health, and clinical research globally. We do this through continuous certification programs and special, focused laboratory studies.

We help laboratories and test manufacturers through the following:

Offering certification programs for chronic disease biomarkers
Performing focused interlaboratory comparison studies for biomarkers of high clinical interest
Conducting performance assessment studies of testing devices in laboratories
Providing single-donor materials with reference information for clinical laboratory self-assessment

Monitoring Programs

We provide critical data by monitoring the accuracy and precision of laboratory tests used in patient care and research through:

Administering accuracy-based monitoring programs
Supporting external quality assurance–proficiency testing program providers
Helping researchers and public health officials in monitoring laboratories that do clinical and epidemiological studies

Accuracy-based Monitoring Programs (AMP) for Testosterone and Total 25-Hydroxyvitamin D

Lipids Standardization Program

Quality Control and Orientation Materials

CDC CSPs offer quality-control study materials and sample sets for more detailed method verification and characterization for total 25-hydroxyvitamin D, total testosterone, and estradiol. We also offer measurement data on additional steroid hormone levels (17α-hydroxyprogesterone, 17α-hydroxyprogesterone [17-OHP], androstenedione, progesterone, testosterone, estrone, 17β-estradiol, estrone sulfate, and dehydroepiandrosterone sulfate) and 24,25-dihydroxyvitamin D. Customization is available on request.

New Reference Methods, Programs, and Focus Areas

Parathyroid hormones
Lipoprotein(a)
Free, unbound testosterone
Point-of-care testing devices

For more information on new activities, email: standardization@cdc.gov.

Outreach, Capacity Building, and Education

CDC CSPs share knowledge and expertise with public and private groups to build laboratory capacity, educate them about the status of analytical performance of biomarker testing, and convey the importance of accurate and reliable laboratory tests in patient care and public health.

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