US 11,214,821 B2Granted

Reagents and methods of use with automated analyzers for obtaining a specific gravity index for urine

AssigneeVision Diagnostics, Inc.

InventorJerry W. Denney

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Abstract

Reagents and methods for using automated laboratory equipment to determine whether the specific gravity of a urine sample is out of normal range as an indication of adulteration. The sodium (Na+) and potassium (K+) normally found in a urine sample can be used as markers. A sodium-potassium dependent β-galactosidase can be utilized with o-nitrophenylgalactoside (o-NPG) which is cleaved into o-nitrophenol, which turns the sample yellow. The sample can be analyzed by spectrophotometry methods utilized in most clinical analyzers at a pre-determined primary wavelength to obtain a Specific gravity Index (SGI). Measurements of the SGI that are outside a known normal range can indicate that the sample integrity has been compromised.

Claims17

Dependent claims

An assay method for spectrophotometrically analyzing a urine sample with a clinical analyzer, the assay method comprising:

combining the urine sample with a liquid reagent comprising β-galactosidase and o-nitrophenylgalactoside that react with sodium and potassium in the urine sample to form o-nitrophenol in a reacted urine sample at a rate that is proportional to the combined molar concentration of sodium and potassium in the urine sample, wherein the clinical analyzer is programmed to correlate the rate of formation of o-nitrophenol in the reacted urine sample to a Total Sodium and Potassium Value that is equivalent to the combined molar concentration of the sodium and potassium in the urine sample;
wherein the clinical analyzer is further programmed to,
analyze the reacted urine sample spectrophotometrically for a period of time to obtain a measure of the rate of increase in light absorbance corresponding to the rate of formation of o-nitrophenol in the reacted urine sample;
convert the measure of the rate of increase in light absorbance to an amount of o-nitrophenol formed in the reacted urine sample;
and
correlate the rate of formation of o-nitrophenol to the corresponding Total Sodium and Potassium Value for the urine sample.

3 more elements

Dependencies are inferred from the claim text.

Facts

Application: 15/651,334Filed 17 Jul 2017 · us provisional application
Priority: 18 Jul 2016
Published: US 2018/0127799 A110 May 2018
Granted: 4 Jan 2022
Term ends: Not estimatedThe source records don’t support an estimate.

Classification5 codes

C12Q 1/34
Measuring or testing processes involving enzymes, nucleic acids or microorganisms ; Compositions therefor; Processes of preparing such…
G01N 33/94
Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing:…
G01N 2333/938
Acting on glycosyl compounds: acting on beta-galactose-glycoside bonds, e.g. beta-galactosidase
C12Q
Measuring or testing processes involving enzymes, nucleic acids or microorganisms

Family

Application62/363,421Us provisional application · filed 18 Jul 2016
US 2018/0127799 A1Pre-grant publication · published 10 May 2018
US 11,214,821 B2This patent

From the US filing history. Foreign family members aren’t listed.

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