About Clinical Standardization Programs

Key points

  • Our mission is to improve the diagnosis, treatment, and prevention of selected diseases by standardizing clinical laboratory measurements.
  • We are working to create measurement results with the same analytical accuracy and precision to simplify comparison among them.
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Overview

CDC's Clinical Standardization Programs (CSPs) improve the accuracy and reliability of laboratory tests for key chronic biomarkers, such as those for diabetes, cancer, and kidney, bone, heart, and thyroid disease.

In the United States around 14 billion laboratory tests are performed each year in more than 266,000 Clinical Laboratory Improvement Amendments-certified laboratories.

The problem

Laboratory tests used in patient care and public health are not always accurate and reliable enough for making medical or public health decisions. For instance, different laboratories' tests on the same patient blood sample have shown different vitamin D levels.

According to a National Academy of Medicine report, different laboratories could reach different conclusions about vitamin D levels for the same patient. Similar observations were made about tests for other chronic disease biomarkers.

The solution

CDC can help laboratories and test manufacturers improve their analytical performance through standardization.

Laboratory standardization means test results have the same analytical accuracy and precision, no matter the measurement system, laboratory, or time of the test.

Standardized tests help health care providers and public health professionals to make evidence-based clinical decisions more easily. Laboratory standardization allows them to:

  • Apply evidence-based clinical practice guidelines with confidence
  • Put patient-care research findings into practice effectively
  • Exchange laboratory test data across health care systems
  • Save costs to the health care system.

CDC collaborates with laboratories, test and assay manufacturers, professional groups, and others to ensure tests meet clinical and public health needs.

Spotlight‎

CDC's Clinical Reference Laboratory (CRL), which provides reference measurement services to the CDC's Clinical Standardization Programs (CSP), is accredited by the American Association for Laboratory Accreditation (A2LA) as a Calibration Laboratory, in accordance with International Standards ISO/IEC 17025:2017 and ISO 15195:2018 (A2LA Accreditation Cert. No. 6909.01)