Why Participate?

Tailored to Your Needs

CDC Clinical Standardization Programs (CSPs) are open to anybody interested in assessing, verifying, or improving the quality of biomarker testing. This includes those working to create new tests and those interested in developing or strengthening capacity for chronic disease biomarker testing in their laboratory.

Decorative image, two scientists working in a lab
  • Our certification programs are typically used by test manufacturers and those developing or managing laboratory tests.
  • Our monitoring programs help laboratories conduct routine testing, tracking the accuracy of their measurements over time.

Our customized activities include the following:

  • Using specific quality-control samples for researchers to monitor the accuracy and reliability of measurements taken in their studies
  • Using individualized panels of samples (up to 120 different individual donor samples) for laboratories to gain information about the analytical performance or verify the calibration of their test

Which Program Fits Best?

Although CDC CSPs offer varied programs and options to assess the quality of laboratory tests, only those tests that successfully pass the certification programs are considered as standardized.

Not every test or laboratory is standardized. Standardized and nonstandardized tests are used in patient care. To find out if your test is standardized, check the lists of certified participants below the table.

The following table provides more details about our programs and options to help you choose the one that works best for you.

Table 1 – CDC Clinical Standardization Programs

Table 1 – CDC Clinical Standardization Programs
Program Specimen type Frequency of measurements by participant Biomarker concentration range Parameters assessed Reports CDC provides
Certification programs Single donor Depending on the program: Quarterly (10 samples), Biannual (20 samples), or Annual (40 samples) Analytical measurement range Bias, Precision, or Individual sample bias Certification report
Monitoring programs Single donor and pooled specimens Weekly: (1 sample/week) 3 different concentrations Bias, Precision, or Trend over time Quarterly performance Report
Study quality-control processes Pooled specimens or single donors, depending on specific needs As defined by study principal investigator. Typically, one quality-control process per analytical run (2–4 samples). 2–4 as defined by principal investigator Bias, Precision, Trend over time, or As defined by principal investigator Evaluation report available upon request
Individual donor panels Single donors Typically, once (1-120 samples) Typically, analytical measurement range, as defined by participant As defined by participant Evaluation report available upon request

Certification Programs List of Certified Participants

Cardiovascular Disease Biomarker Standardization Program

Hormones Standardization Program for Testosterone and Estradiol (HoSt-TT; HoSt-E2)

Vitamin D Standardization Certification Program (VDSCP)

Thyroid Hormone Standardization Program

Parathyroid Hormone Standardization Program

Monitoring Programs Participants within Performance Criteria