Key points
- Standardization is a continuous activity to ensure different laboratories will give the same result on the same sample, no matter the technology used.
- CDC CSPs make certain that the accuracy, precision, and other relevant analytical performance parameters of a laboratory test are improved and maintained to meet clinical needs.
How it works
People often use a special calibration weight to adjust a scale, or "standardize" it, to give the same weight as other scales.
Similarly, CDC works to ensure that certain laboratory tests give the same result for a given biomarker, no matter which laboratory test is used to measure it.
But body fluids, and the laboratory procedures and technologies used to measure biomarkers in them, are very complex. So, CDC Clinical Standardization Programs (CSPs) use several special procedures, not just one, to ensure that laboratories obtain the same result.
Clinical Tests: Accuracy is Vital
CDC Clinical Standardization Programs give laboratories a point of reference.
CDC uses highly accurate, specific, and precise laboratory methods, known as reference measurement procedures, to assign reference values to a body fluid, such as serum. These body fluids are called reference materials.
CDC makes reference materials available that are like the patient samples measured in health care and public health settings. Laboratories and test manufacturers can use the materials to check and adjust their tests, or "standardize" their test to the CDC CSPs.
This process makes sure the same test result is obtained from one patient sample, regardless of which laboratory does the test.
Did you know?
Harmonization means aligning individual patient results to the agreed-upon standard.
Standardization means aligning individual patient results to an unambiguous standard.
Thyroid stimulating hormone (TSH) is made up of many different proteins that are not well defined, so researchers agree to harmonize tests by using a standard preparation with a mix of TSH proteins. In contrast, cholesterol and glucose are well-defined compounds for which laboratory tests are standardized.
Both harmonization and standardization aim for the same outcome: laboratory test results that are comparable across technologies, time, and location.
Improving the quality of tests
Tests used in patient care and public health need to be accurate and reliable, so CDC works with laboratories and test manufacturers to make sure they are
- Specific — measure only the biomarker they are supposed to measure,
- Sensitive — able to measure small amounts or large amounts of biomarkers, depending on the needed information,
- Rugged — able to work and operate at low or high temperatures, and
- Consistent — perform the same way everywhere, every day.
To accomplish all this, CDC uses a range of reference materials, statistical procedures, and protocols. We also give participants in our programs detailed reports that they can us to assess the quality of their test, spot potential problems, and address them effectively.
Enhancing clinical research
In addition to laboratory tests used in patient care and public health, CDC supports laboratory tests used in clinical research. Data from research laboratories need to be accurate and reliable to support better diagnosis, treatment, and prevention strategies.
Clinical laboratories count on CDC's Reference Laboratory and Clinical Standardization Programs for reliable, independent, and impartial benchmarks:
- To provide reference measurements
- To monitor the accuracy of tests over time
- To help improve tests in patient care and clinical research
- To support the development of clinical reference intervals and other tools in patient care and public health.