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For in vitro diagnostic use with the CARESIDE Analyzer to quantitatively measure GGT from anti-coagulated whole blood, plasma, or serum specimens to aid in the diagnosis and treatment of liver diseases such as alcoholic cirrhosis and primary and secondary liver tumors.

CARESIDE® GGT cartridges are used with the CARESIDE Analyze® to measure GGT activity in anti-coagulated whole blood, plasma or serum specimens. The CARESIDE GGT cartridge, a single use disposable in vitro diagnostic test cartridge, aids in specimen separation and delivers a measured volume of plasma or serum to a dry film to initiate the measurement of GGT activity. The patented film cartridge contains all reagents necessary to measure GGT activity. Each CARESIDE® GGT cartridge consists of a GGT-specific multi-layer reagent film mounted in a plastic base with a hinged lid. The user introduces the anti-coagulated whole blood, serum. or plasma specimen into the cartridge sample well, closes the lid and inserts the cartridge into the CARESIDE Analyzer. Once loaded, the CARESIDE Analyzer scans the cartridge barcode, brings the cartridge and the contained specimen to 37℃, and spins the cartridge to move the sample from the sample deposition well into the cartridge channels and chambers. As the cartridge continues to spin, the blood cells are separated from the plasma/serum and the cells accumulate in the separation well. Approximately 8.5 microliters of plasma (or serum, as applicable) remain in the metering passage. Any excess sample flows into an overflow well. The plasma (or serum, as applicable) is automatically dispensed onto the multi-layer reagent film. The spreading and substrate layer distributes the GGT containing specimen uniformly. The GGT in the specimen reacts with the substrate L-y-glutamyl-p-nitroanilide to release p-nitroaniline resulting in a change in film color. The rate of change of color intensity, as measured by the amount of reflected light at 425 nanometers, directly relates to the specimen GGT activity. As the cartridges spin, photodiodes measure reflectance of light emitted by wavelengthspecific light emitting diodes (LEDs) over a fixed time period. The instrument uses the reflectance measurements and the lot-specific standard curve to calculate GGT activity.

For in-vitro diagnostic use. For the quantitative determination of gamma glutamyltransferase in serum.

The method is based on the reaction wherein gamyl glutamyltransferase catalyzes the transfer of the glutamyl group from L-g-glutamyl-3-carboxy-4-nitroanilide to glycylglycine with the formation of g-glutamylglycylglycine and 5-amino-2-nitrobenzoate. The rate of increase of 5-amino-2-nitrobenzene, which absorbs light at 405 nM. is proportional to the gamma glutamyltransferase activity in the sample.