Diazyme Laboratories has announced that the FDA has granted Diazyme 510(k) clearance to market its liquid stable enzymatic lithium test kit for the quantitative determination of lithium levels in blood samples.
The new Diazyme lithium assay provides improved reagent stability at a reduced cost per test. The assay offers an extended reportable range of 0.1-3.0 mmole/L lithium, which reduces the need for re-testing elevated patient samples. The method also demonstrates no significant interference from indigenous ions and other interfering substances including hemoglobin, bilirubin, triglycerides, and ascorbic acid. The assay can be applied to most common clinical chemistry analyzers, and application parameters are available.
Lithium has remained a first line treatment for the past fifty years and is considered by many physicians to be one of the corner stones for treating mode and affective disorders. Highly effective Lithium has been shown to be successful in improving both the manic and depressive symptoms in up to as many as 70 to 80% of these types of patients and is considered the drug of choice for reduction of suicide risk in bipolar illness.
"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.
Source: Marketwire
