Liquid-Stable Enzymatic Kit Determines Blood Lithium Levels

The new assay provides improved reagent stability at a reduced cost per test.

The assay is accurate and precise, and offers an extended reportable range of 0.1-3.0 mmole/L lithium that will reduce the need for retesting elevated patient samples. There is no significant interference from indigenous ions and other substances including hemoglobin, bilirubin, triglycerides, and ascorbic acid. The assay can be applied to most common clinical chemistry analyzers and application parameters are available.

The assay was developed by Diazyme Laboratories (La Jolla, CA, USA), a division of General Atomics. The U.S. Food and Drug Administration (FDA; Rockville, MD, USA) granted Diazyme 510(k) clearance to market the test kit. "Diazyme's new enzymatic lithium assay provides a convenient and cost effective test method which will benefit laboratories, physicians, and the patients they care for," said Dr. Chong Yuan, managing director of Diazyme Laboratories.

Diazyme Laboratories uses its enzyme platform technologies to develop low cost and uniform diagnostic products for clinical and research uses. Products include diagnostic blood tests for liver disease, cardiac markers, diabetes, renal disease, and electrolytes.

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Diazyme Laboratories
U.S. Food and Drug Administration