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Synthetic Macrocycle Complex (SMC)

Synthetic Macrocycle (SMC) technology is associated with the development of novel organic macrycyclic compounds and electronic readers that determine quantitative levels of therapeutic drugs, such as lithium blood levels. These hand-held readers and their associated proprietary reagents unlock new potential in both professional and consumer markets, particularly in therapeutic drug monitoring. An example of a product based on this technology is the Lithium CheckSystem; the product was licensed to another organization in 2008.

The Lithium Check System is an in vitro diagnostic device, intended for the accurate and precise measurement of lithium levels in less than 3 minutes with finger-stick whole blood samples. Measurements of lithium are used to assure that the proper drug dosage is administered in the treatment of patients with mental disturbances, such as manic depressive illness (bipolar disorder).

The system consists of three key components: the Blood Cell Separator, Lithium Reagent and the Photometric Reader. The Blood Cell Separator, referred to as the Separator, is a sample preparation aid to in vitro diagnostic testing systems, where a precise, micro-volume sample of serum or plasma is acquired from whole blood, serum or an EDTA-plasma specimen. This is achieved through the attraction and capture of blood cells from a whole blood specimen by a membrane impregnated with agents designed to bind to both red and white blood cells. The residual liquid continues to flow laterally to the tip of the membrane at which time the bulb pipette that has been inserted into the designated hole in the Separator, fills to the pipette's fixed volume and is ready to use.

The precise volume (0.2 µl) of cell-free sample that is captured using the Separator is introduced to the second key component of the system, the lithium reagent. The lithium reagent is a colorimetric reagent whose active ingredient is a porphyrin compound that is highly specific and sensitive to lithium. Absorbance of light at 510 nm is decreased by the lithium concentration, and is linear from 0.1 to 2.0 mEq/L of lithium.

The third key component of the system is the photometric reader.   It is designed to measure the absorbance of light at 510 nm of a solution contained in a cuvette and report concentrations from 0.1 to 2.0 mEq/L of lithium on the reader's display system.   Lithium results greater than 2.0 mEq/L are reported as " >2.0mEq/L ".
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