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Biomarker Introduction
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Introduction


When you shop at the grocery store for produce, and the clerk weighs your purchase, you expect that the scale will accurately and reliably measure what you selected.

When you stop at a local gas station to fuel your car, you expect that the pump will accurately and reliably measure the amount of fuel purchased.

When you go your health care provider’s clinical laboratory to have your blood drawn and tested for cholesterol, kidney functioning, liver profile and other chronic diseases, you expect that the test results will be accurate and reliable.

Grocery store scales and fuel pumps are tested and certified to assure that you will get the same result no matter which grocery scale or fuel pump you use.

Clinical laboratory tests do NOT go through a similar process and are not automatically standardized. Consequently, test results can vary from one laboratory to the next. Testing equipment varies by manufacturer and within the same equipment, laboratory testing procedures can vary, resulting in unreliable test results. Test results can also vary over time in the same clinic if equipment or procedures are changed.

Standardization or assuring harmonization across clinical laboratories is the only way to assure accurate and reliable test results for the highest possible quality of patient care (screening, diagnosis and treatment) and research results which can be relied upon to provide reference points for early diagnosis and treatment.


Cardiovascular Biomarker Standardization – What’s that?


Clinical tests are routinely used in clinical trials to test new drugs and to diagnose and track pharmaceutical and behavioral treatment progress for cardiovascular disease. Over the past 50 years, CDC’s Lipid Standardization Program (LSP) has provided quality assurance of cholesterol testing for national and international laboratories that participate in clinical trials. CDC Clinical Chemistry Branch sends reference materials to these laboratories so they can test and adjust (standardize) the lipid values they get from their testing procedures. This standardization process assures uniformity in test results across labs, minimizing variability in clinical trial outcomes.

Since the 1950‘s when lipid test standardization began at CDC, many new clinical tests have been developed for cardiovascular disease. Many of these cardiovascular laboratory tests, such as troponin I, B-naturetic peptide, C-reactive protein, have no reference point or value against which diagnoses can be reliably made. In other words, they are not standardized. Limited funding has affected the development of reference standards for these tests and prohibited delivery of materials to laboratories needed to maintain reference standards.

In June of 2011, the Cardiovascular Biomarker Standardization Steering Committee (CBSSC), a task force of clinical chemists from universities and private sector laboratories hosted by NACDD and the LSP, met in Atlanta to outline strategic steps towards advancing standardization of laboratory tests for cardiovascular disease. A recent report from the Institute of Medicine (IOM), Evaluation of Biomarkers and Surrogate Endpoints in Chronic Disease, has reinforced the need for standardization and the work of the CBSSC.

A cost benefit study sponsored by NACDD and conducted by economists from the Research Triangle Institute was completed in January of 2011. It concluded that the LSP, and a related program the Cholesterol Reference Method Laboratory Network (CRMLN)), showed that standardized cholesterol measuring benefits attributable to these programs prevented or postponed more than 111,000 deaths and saved 1.35 million life-years in 2000 and saved between $338 million and $7.6 billion.


"Standardization is the holy grail of clinical chemistry.”
- Neil Greenberg, PhD, Member CBSSC