What is Standardization?
Standardization is a continuous activity to ensure the same test performed by different laboratories will give the same result on the same patient sample, no matter what technology is used. CDC Clinical Standardization Programs (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 use special calibration weights to check and adjust scales. In other words, they standardize their scales. As a result, all those scales will display the same weight of an item.
The same principle applies to standardizing biomarker measurements in blood or other body fluids. However, blood and other body fluids are complex liquids. The procedures and technologies to measure biomarkers in them are very complicated. Therefore, a single action, like using a special weight, is not enough for standardization. CDC CSPs apply several special procedures to ensure that laboratories obtain the same result for a given biomarker no matter which laboratory test is used to measure it.
CDC CSPs use highly accurate, specific, and precise laboratory methods known as reference measurement procedures to assign reference values to a body fluid, such as serum. These serums are often referred to as reference materials. In patient care and public health settings, patient samples are measured; therefore, CDC CSPs make available reference materials that are like patient samples. CDC CSPs offer these materials to laboratories and test manufacturers so they can check and adjust their tests. By doing so, the laboratories standardize their test to the CDC CSPs. As a result, the same test result from one patient sample is obtained regardless of which of those laboratories does the test.
To make sure that clinical tests for cholesterol and other health markers are accurate, scientists compare their measurements to something with a known value — a point of reference. This is like using a known weight to check the accuracy of your scale.
CDC Clinical Standardization Programs give laboratories a point of reference. We achieve this through reference materials and procedures.
Because laboratory tests used in patient care are complicated, CDC CSPs help to calibrate them correctly. This process is called establishing metrological traceability. While calibration is a large focus of CDC CSPs, it is just one of the many services we provide.
Tests used in patient care and public health not only need to be accurate, but they also need to be reliable:
- Specific — measure only the biomarker they are supposed to measure
- Sufficiently 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
- Consistent — perform the same way everywhere, every day
CDC CSPs work with laboratories and test manufacturers to make sure their tests are accurate and reliable. To accomplish all this, CDC CSPs use a range of reference materials, statistical procedures, and protocols. We share findings in detailed reports so participants can correctly assess the quality of their test, spot potential problems, and address them effectively.
From Patient Care and Public Health to Clinical Research
In addition to laboratory tests used in patient care and public health, CDC CSPs support laboratory tests used in clinical research. Data from research laboratories need to be accurate and reliable to support better diagnosis, treatment, and prevention strategies.
As an example, consider measurement of thyroid stimulating hormone (TSH). TSH is made up of many different proteins that are not well defined. Therefore, in a research setting there is general agreement to use a standard preparation with a mix of these TSH proteins. Harmonization means aligning individual patient results to the agreed-upon standard.
In contrast to thyroid stimulating hormone, cholesterol and glucose are well-defined compounds for which laboratory tests are standardized. Standardization means aligning individual patient results to an unambiguous standard.
Both harmonization and standardization aim for the same outcome: laboratory test results that are comparable across technologies, time, and location.
CDC CSPs use reference materials, established protocols, and evaluation criteria from the clinical and medical communities. We provide detailed reports and help interpret the data on request.
We monitor laboratory measurement performance to help patients benefit from manufacturers’ improvements. Accuracy and precision matter when it comes to laboratory tests for people’s health.
In short, 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