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This assay is for the qualitative determination of galactose-1-phosphate uridyl transferase activity in dried blood spot samples using the Bio-Rad CODA Analyzer. Measurements of GALT are used in the diagnosis and treatment of the hereditary disease galactosemia (disorder of galactose metabolism) in infants.

For in vitro diagnostic use only.

The CODA GALT assay utilizes dried blood spot samples (DBS) eluted in a medium containing B-nicotinamide adenine dinucleotide phosphate (NADP), galactose-1-phosphate, uridine-5diphosphoglucose (UDPG), and a tetrazolium salt. During the manual elution step, GALT present in the specimen converts galactose-1-phosphate to glucose-1-phosphate, with the eventual reduction of NADP to NADPH.

After elution, the samples are placed on the CODA instrument and an aliquot of the eluate is transferred to a microwell. The optical density (OD) is read, then Enzyme Reagent is added.

During the incubation that follows, the Enzyme Reagent converts NADPH generated by GALT and endogenous red cell enzymes to NADP, and the tetrazolium salt to a colored formazan dye which is detected at 570 nm. The OD is read again and the difference between the two OD readings is determined. GALT activity, in units/g hemoglobin or units/liter blood, is calculated from the difference in signal between the two absorbance readings. A unit is defined as the quantity of GALT that catalyzes the formation of 1 micromole of UDP galactose per gram of hemoglobin or per Liter blood per hour at 37℃. An external calibrator is not necessary because enzyme activity is measured directly with substrates in excess.

The CODA instrument is an integrated immunoassay analyzer intended for the automation of microplate based assays for in vitro diagnostic use.

Acceptance Criteria and Device Performance Study

1. Table of Acceptance Criteria and Reported Device Performance

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