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Assessment of laboratory tests for plasma homocysteine--selected laboratories, July-September 1998
Insights
Elevated homocysteine (Hcy) is linked to vascular diseases. A CDC study found significant interlaboratory variation in Hcy testing, indicating a need for improved analytic precision and consistency among labs.
Area of Science:
- Clinical Chemistry
- Public Health
- Cardiovascular Research
Background:
- Cardiovascular diseases are the leading cause of death in the US.
- Elevated plasma homocysteine (Hcy) is an independent risk factor for vascular diseases.
- The role of Hcy in atherosclerosis and the clinical utility of population-wide screening remain debated.
Purpose of the Study:
- To assess interlaboratory and intralaboratory variation in homocysteine (Hcy) analysis.
- To evaluate the current status of Hcy testing methods in clinical laboratories.
Main Methods:
- A study was conducted by the CDC involving selected laboratories.
- Data on interlaboratory and intralaboratory variation for Hcy analysis were collected and analyzed.
- The study period was July-September 1998.
Main Results:
- Findings indicate significant variation among laboratories in Hcy analysis.
- Analytic precision needs improvement.
- There is a need to decrease analytic differences among laboratories performing Hcy tests.
Conclusions:
- The study highlights the need for standardization and improved quality control in Hcy testing.
- Current interlaboratory variability may impact the reliability of Hcy measurements in clinical practice.
- Further efforts are required to enhance the accuracy and consistency of Hcy assays.
Abstract:
Cardiovascular disease, including coronary heart disease and stroke, is the leading cause of death in the United States. Elevated plasma homocysteine (Hcy), generally defined as fasting plasma Hcy levels >15 micromol/L, is an independent risk factor for vascular diseases (1,2). It is unknown whether Hcy is a cause of or a marker for atherosclerosis. A recent statement by the Nutrition Committee of the American Heart Association concluded that until results of clinical trials are available, population-wide Hcy screening is not recommended (3). However, Hcy tests are used in the clinical setting and information on interlaboratory variation, on method variation, is limited. To assess the status of interlaboratory and intralaboratory variation for Hcy analysis, CDC conducted a study of selected laboratories during July-September 1998. This report summarizes findings from the study, which indicates a need to improve analytic precision and to decrease analytic differences among laboratories (4).