# US 8,771,962 B2 · Health test for a broad spectrum of health problems > Agents: this data is available as JSON from the patentgrep API and MCP server — see https://patentgrep.com/llms.txt - Number: US 8,771,962 B2 - Document ID: US8771962B2 - Status: Granted - Kind: B2 - Application number: 13/122,130 - Filed: 2009-10-02 - Published: 2011-10-13 - Granted: 2014-07-08 - Earliest claimed: 2008-10-02 - Applicants: Sarka O. Southern - Inventors: Sarka O. Southern - Web page: https://patentgrep.com/patent/US8771962B2 ## CPC - G01N 33/6893: {related to diseases not provided for elsewhere} - G01N 33/528: {Atypical element structures, e.g. gloves, rods, tampons, toilet paper} - G01N 2800/30: Psychoses; Psychiatry - G01N 2800/60: Complex ways of combining multiple protein biomarkers for diagnosis - G01N 2800/7004: Stress - G01N: INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES (measuring or testing apparatus or processes other than immunoassay, involving enzymes or microorganisms C12M, C12Q) ## Abstract Provided herein are methods and devices for the detection of conditions or disorders by detecting altered levels of stress response pathway biomarkers. Also provided are methods and reagents for identifying panels of biomarkers associated with a condition or disorder. ## Claims ### Claim 1 A method for detecting a condition or disorder associated with a stress response in a subject, comprising: (i) obtaining from the subject a biological sample comprising an adequate whole cell count comprising whole salivary cells, wherein the cells contain biomarkers; (ii) determining that a control sample contains an adequate whole cell count; and (iii) measuring levels of stress response (SR) biomarkers in a panel, wherein detection of an altered level of at least one SR biomarker in the biological sample, as compared to the control sample is indicative of a condition or disorder associated with a stress response, thereby detecting the condition or disorder in the subject. ### Claim 2 (depends on 1) The method of claim 1, wherein the at least one stress response biomarker is selected from the group consisting of aldose reductase, apoptosis signal-regulating kinase 1, aquaporin 5, beta-endorphin, betaine GABA transporter, caspase recruitment domain protein 9, caspase 8, cyclin D, cyclooxygenase 2, cytochrome P450, cytochrome c, c-fos, c-jun, epidermal growth factor receptor, ferritin, glucocorticoid receptor, glucose regulated protein 58, glucose regulated protein 75, glutathione S-transferase p, GroEL, heat shock protein 25/27, heat shock protein 40, heat shock protein 60, heat shock protein 70, heat shock protein 90, heat shock transcription factor-1, heme oxygenase-1, interleukin 1β, interleukin 6, interleukin 8, interleukin 10, interleukin 12, laminin, leptin receptor, matrix metalloproteinase 9, metallothionein, Mek-1, Mekk-1, inducible nitric oxide synthase, peripheral benzodiazepine receptor, p38 MAPK, salivary alpha amylase, SAPK, serotonin, serotonin receptor, substance P, superoxide dismutase Mn, superoxide dismutase Cu/Zn, superoxide dismutase EC, transforming growth factor β, tumor suppressor p53, and vasoactive intestinal peptide. ### Claim 3 (depends on 2) The method of claim 2, wherein the at least one stress biomarker is associated with dehydration. ### Claim 4 (depends on 2) The method of claim 2, wherein the at least one stress biomarker is associated with AIDS progression. ### Claim 5 (depends on 2) The method of claim 2, wherein the levels of the at least one biomarker are detected by analysis of biomarker protein or nucleic acid in the sample comprising the salivary cells. ### Claim 6 (depends on 5) The method of claim 5, wherein the analysis of biomarker protein includes detection with an antibody. ### Claim 7 (depends on 6) The method of claim 6, wherein the salivary cells are lysed prior to analysis with the antibody. ### Claim 8 (depends on 6) The method of claim 6, wherein the analysis is by ELISA. ### Claim 9 (depends on 1) The method of claim 1, wherein the sample comprising the salivary cells is analyzed on microscope slide. ### Claim 10 (depends on 5) The method of claim 5, wherein the analysis of biomarker nucleic acid comprises isolation of salivary cell nucleic acid. ### Claim 11 (depends on 10) The method of claim 10, wherein the biomarker nucleic acid is detected in the isolated salivary cell nucleic acid by nucleic acid hybridization or PCR amplification. ### Claim 12 (depends on 1) The method of claim 1, wherein the levels of the biomarkers are detected using a device, comprising: (a) a disposable module for uptake of a test sample and reagent storage, wherein the module comprises reagents for assaying for at least one stress response biomarker; and (b) a reusable module for signal detection and result display; wherein the reusable module displays a signal that indicates the presence of the at least one stress response biomarker in the test sample, thereby detecting the condition or disorder in the subject. ### Claim 13 (depends on 1) The method of claim 1, wherein the condition or disorder is dehydration or traumatic brain injury (TBI). ### Claim 14 (depends on 1) The method of claim 1, wherein the salivary cells are collected using an oral brush. ### Claim 15 (depends on 1) The method of claim 1, wherein the control sample comprises at least one of epithelial cells or leukocytes. ### Claim 16 (depends on 1) The method of claim 1, wherein the control sample comprises viable cells. ### Claim 17 (depends on 1) The method of claim 1, wherein the adequate cell count is approximately 5×105 cells/ml or greater.