What to know
- Our certification programs are used by test manufacturers and those developing or managing laboratory tests.
- Our monitoring programs help routine and research laboratories with tracking the accuracy of their measurements over time.
Choosing the best program for your needs
CDC offers a variety of programs to assess the quality of laboratory tests.
- Certification Programs - assess the analytical performance of new and established laboratory tests in patient care, public health, and clinical research globally.
- Monitoring Programs - monitor the accuracy and precision of laboratory tests used in patient care and research.
Our customized support activities include:
- 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 learn about the analytical performance or verify the calibration of their test.
Which program fits best?
See Table 1 – CDC Clinical Standardization Programs
The following table provides more details about our programs and options to help you choose the one that works best for you.
| 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 |
Not every test or laboratory is standardized. Both 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.
Resources
Certification programs list of certified participants
Cardiovascular Disease Biomarker Standardization Program
- Cholesterol Reference Method Laboratory Network List of Certified Manufacturers
- Cholesterol Reference Method Laboratory Network List of Certified Clinical Laboratories
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