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Clinical chemistry reagents intended to be used in the performance of quantitative chemical analysis of body fluids (typically plasma or urine) to determine the total (i.e., the sum of protein bound, oxidized and reduced) level of homocysteine. Homocysteine (Hcy) is a sulfur-containing amino acid that is a metabolic intermediary derived from the essential sulfur containing amino acid methionine. The clinical significance of total Hcy levels are is related to a variety of conditions (vitamin B deficiency, renal diseases, genetic defects, drug consumption, age, general health status); high levels of total Hcy may be indicators of atherosclerosis and of other cardiovascular diseases. The tests are also used in the diagnosis and treatment of patients with hyperhomocysteinemia and homocystinuria.
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