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Problems without Standardized Laboratory Test Results
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Why Are Standardized Laboratory Test Results Important?

Health care and public health practitioners rely nearly every day on the results of biochemical laboratory assays to diagnose and treat patients with cardiovascular and other chronic diseases, establish population-based health and health risk profiles, build research agendas, and conduct medical and epidemiological research. These laboratory test results inform program and policy interventions designed to reduce the impact of cardiovascular disease and other chronic diseases.

For example, commonly used tests like serum creatinine (a test to measure the level of the waste product [creatinine] in your blood tells how well your kidneys are functioning), microalbumin (when the kidneys are damaged, small amounts of albumin leak into the urine), high-sensitivity C-reactive protein (CRP) (a "marker" for inflammation is linked to increased risk of heart disease, heart attack, stroke, and peripheral arterial disease), and troponin I (tests blood to measure levels of cardiac enzymes in blood that indicate heart muscle damage) are used to establish clinical treatment protocols, treatment plans, and in research studies.

Now suppose that the reliability of these tests was in question and that timely and thorough application of laboratory standards were not being met. - - - The basis for many clinical research, and program evaluation activities conducted by health care providers, public health practitioners, and basic science researchers would fall into question.

Did you know that the use of cardiovascular biomarker tests that are not standardized could lead to:

  1. unreliable test results in clinical trials when multiple laboratories are participating (The resultant variability can have a significant impact on clinical trial outcomes.);
  2. public health epidemiological investigations launched on faulty science;
  3. unjustifiable, expensive clinical chemistry dependent research;
  4. misleading public health planning and evaluation data;
  5. needless and costly programs and policies; and .
  6. most importantly, some people will be treated needlessly, others will not be treated who should have been (false positive and false negative clinical lab test results).

What Can Be Done To Improve Standardization of Blood Tests?

Many laboratory tests used today have no reference point. Budget limitations have affected the availability of reference standards and the timeliness with which they are delivered to labs. The reference materials (blood samples) needed to standardize laboratory tests are either not readily available or not available at all. Without reference materials laboratory testing often proceeds without proper standardization.

Underfunded laboratory standardization also affects research schedules and outcomes in both government and private sector funded research laboratories. Research studies on tight grant program timelines need to proceed on schedule to stay within budget. Principal investigators (PI) who manage clinical studies that collect blood and urine sample data can fall behind schedule while waiting for reference materials. These PIs run the risk of depleting research funds before a study can be fully conducted without reference materials or simply proceed with the study without the assurance of test accuracy. Additionally, clinical laboratories are sometimes required to proceed using laboratory tests that are not properly standardized, in order to provide timely diagnosis and treatment information to medical clinics and their patients. The value of public health program evaluation studies can also be compromised by substandard laboratory practices.

In summary, standard values used to make clinical and research decisions are needed to establish generally accepted clinical treatment protocols, to obtain reliable conclusions from multi-centered trials, and for evaluating public health program and policy outcomes.

  • Funding should be made available for the research needed to establish generally accepted clinical treatment protocols;
  • Reference materials and methods should be readily available so clinical trials can proceed in a timely manner; and
  • All clinical trials that rely on blood testing should be required to undergo standardizing procedures to assure comparability of test outcomes across laboratories and over time.
Most importantly, standardized clinical laboratory tests assure the highest possible accuracy and reliability of test outcomes for the best possible patient care.