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US 11,079,320 B2Granted
Methods of characterizing a urine sample
AssigneeGenotox Laboratories
InventorsNicholas D. Laude, William S. Edgemond, Keqin Gregg
Life of this patent
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Abstract
This disclosure relates to methods of characterizing a urine sample from a subject.
Claims28
A method of characterizing a urine sample from a subject, the method comprising:
- (a) providing a urine sample from a subject;
- (b) determining one or more of the light absorption, luminescence, phosphorescence, fluorescence, and chemiluminescence of the urine sample at two or more wavelengths of light;
- (c) applying one or more eigenvectors derived from a principle component algorithm to a standardized dataset derived from the determined light absorption, luminescence, phosphorescence, fluorescence, and chemiluminescence of the urine sample to generate a Urine Characterization Index (UCI) comprising one or more values for corresponding principle component(s);
- and
- (d) characterizing a urine sample as a natural urine sample, based on the UCI;
- (e) enriching the characterized urine sample for mammalian cells, if present;
- (f) isolating any genomic DNA from the enriched sample of step (e) to form an isolated genomic DNA test sample;
- (g) adding to the isolated genomic DNA test sample of step (f) a control DNA to form a control sample or adding the control DNA to the enriched sample of step (e) and then isolating the DNA to form a control sample;
- (h) performing an assay to determine the genotype of at least 6 single nucleotide polymorphisms (SNPs) in the isolated genomic DNA test sample of (f) or the control sample of step (g);
- (i) comparing the genotype of the at least 6 SNPs in the isolated genomic DNA test sample of step (f) or the control sample of step (g) with the genotype of the at least 6 SNPs in a control cell sample from the subject;
- and
- (j) further identifying a characterized urine sample having a detectable level of the control DNA and having the same genotype of the at least 6 SNPs in the isolated genomic DNA test sample of step (f) or the control sample of step (g) as the genotype of the at least 6 SNPs in the control cell sample as originating from the subject, or identifying a characterized urine sample having a detectable level of the control DNA and not having the same genotype of the at least 6 SNPs in the isolated genomic DNA test sample of step (f) or the control sample of step (g) as the genotype of the at least 6 SNPs in the control cell sample as not originating from the subject.
9 more elements
A method of characterizing a urine sample from a subject, the method comprising:
- (a) providing a urine sample collected from a subject;
- (b) determining the absorbance at a first wavelength (A1) and the absorbance at a second wavelength (A2) of the urine sample, wherein the first wavelength is from about 230 nm to 250 nm, and the second wavelength is from about 260 nm to 340 nm;
- (c) applying an algorithm to the determined A1 and the determined A2 to generate a Urine Characterization Score (UCS), wherein the algorithm includes a ratio of the determined A1 to the determined A2;
- and
- (d) characterizing a urine sample as a natural urine sample, based on the UCS;
- (e) enriching the characterized urine sample for mammalian cells, if present;
- (f) isolating any genomic DNA from the enriched sample of step (e) to form an isolated genomic DNA test sample;
- (g) adding to the isolated genomic DNA test sample of step (f) a control DNA to form a control sample or adding the control DNA to the enriched sample of step (e) and then isolating the DNA to form a control sample;
- (h) performing an assay to determine the genotype of at least 6 single nucleotide polymorphisms (SNPs) in the isolated genomic DNA test sample of (f) or the control sample of step (g);
- (i) comparing the genotype of the at least 6 SNPs in the isolated genomic DNA test sample of step (f) or the control sample of step (g) with the genotype of the at least 6 SNPs in a control cell sample from the subject;
- and
- (j) further identifying a characterized urine sample having a detectable level of the control DNA and having the same genotype of the at least 6 SNPs in the isolated genomic DNA test sample of step (f) or the control sample of step (g) as the genotype of the at least 6 SNPs in the control cell sample as originating from the subject, or identifying a characterized urine sample having a detectable level of the control DNA and not having the same genotype of the at least 6 SNPs in the isolated genomic DNA test sample of step (f) or the control sample of step (g) as the genotype of the at least 6 SNPs in the control cell sample as not originating from the subject.
9 more elements
Dependencies are inferred from the claim text.