Technical field of the invention

The present invention relates to systems and methods for obtaining test results from a body sample.

Background of the invention

Based on age, gender, genetic background, and lifestyle, people generally have health problems and chronic illnesses at different points in their lives. Knowledge about an individual person's or animal's physiological and/or medical state is key for both the individual self, the pet owner and to his/her/its health care provider in order to identify issues before they start, and to prevent them from occurring.

Regular health exams and tests can help find problems before they start. However, only few people and pet owners attend regular checkups with his/her health care provider. This is due to several factors, such as opening hours at the health care provider, discretion, embarrassment, and consultancy costs.

Especially when it comes to sexually transmitted diseases including chlamydia, gonorrhea, and herpes, people do not like such information to be a part of their medical record. Furthermore, some people and pet owners are only interested in monitoring their or the pet's physiological state, e.g. to analyze if specific exercise and change in eating habits has an effect - without involving his/her health care provider.

It is therefore desirable to provide a method for obtaining information about an individual person's or pet's physiological and/or medical state without having to attend regular checkups with his/her health care provider. At the same time, it is problematic for the laboratories to optimize the runtime of equipment at an analyzing unit, since they are unaware of how many samples that arrive from day to day. Hence, there is a need for a system that can solve both problems at the same time.

Summary of the invention

The inventor of the present invention has developed a method and a system for obtaining test results from a body sample with the possibility of staying anonymous during the entire process. The tests of the body sample are tests for biomarkers for an individual person's or pet's physiological and/or medical state.

A first aspect relates to a method for obtaining test results from a body sample comprising the steps of:

- providing a container adapted for holding a body sample, the container comprising a unique identification code;

- retrieving, by an application executing on a mobile/handheld computing device, the unique identification code by invoking a scanning function of the mobile/handheld computing device, wherein the application executing on the mobile/handheld computing device associates the unique identification code with a number of possible body sample tests;

- selecting, by the application executing on the mobile/handheld computing device, one or more body sample tests from the number of possible body sample tests;

- transmitting by the mobile/handheld computing device said selection of one or more body sample tests associated with the unique identification code to a server at a network location and/or to a database at an analyzing unit;

- positioning a body sample within the container;

- sending/transporting the container to an analyzing unit; - receiving the container at the analyzing unit;

- retrieving the unique identification code from the container by invoking a scanning function of an identification code reader at the analyzing unit;

- retrieving information on which body sample tests to perform on the body sample within the container from a server at a network location and/or from a database at the analyzing unit using the unique identification code;

- performing one or more body sample tests on the body sample within the container;

- associating the one or more body sample test results on the body sample within the container with the unique identification code, and storing them on a server at a network location and/or on a database;

- retrieving information from a server at a network location and/or from a database on the one or more body sample test results on body sample within the container with the application executing on the mobile/handheld computing device using the unique identification code.

The term body sample embraces, but is not confined to urine, saliva, breath, hair, fingernails, buccal cells, oral fluids, stool, skin, sweat, nasal fluids, mucous, semen, vaginal secretions, blood, ocular fluids, eye swabs, and earwax.

In one or more embodiments, the body sample is selected from the group consisting of urine, saliva, breath, hair, fingernails, buccal cells, oral fluids, stool, skin, sweat, nasal fluids, mucous, semen, vaginal secretions, blood, ocular fluids, eye swabs, and earwax.

In one or more embodiments, the body sample is selected from the group consisting of blood and urine.

In the present context, a unique identification code is a code representing a unique identification of the container adapted for holding a body sample, such as an encrypted serial number (e.g. Electronic Product Code). The identification code may include product (container) serial number, model number, batch number, manufacturing date, expiry date, price, country of sale/distribution, and other product identity related information that identifies or relates to the product.

The code may be in the form of a one-dimensional barcode, a two- dimensional barcode, a QR code, or combinations of a one-dimensional barcode and/or a two-dimensional barcode and/or a QR code.

The code may also be in the form of an RFID chip/tag (Radio-frequency identification).

The code, which is machine-readable by an electronic reader/scanner, is retrieved by an application executing on a mobile/handheld computing device, by invoking a scanning function of the mobile/handheld computing device. Hence, the mobile/handheld computing device (e.g. a smartphone) comprises an identification code reader/scanner (e.g. the camera of the smartphone).

The application executing on the mobile/handheld computing device associates the unique identification code with a number of possible body sample tests. The user is thereby able to select a number of different tests of his/her body sample. The possible tests on body sample are tests for body biomarkers for an individual person's or pet's physiological and/or medical state, such as oxidative stress, antioxidant and inflammatory biomarkers.

Whereas the analysis of oxidative stress, antioxidant and inflammatory biomarkers is often performed primarily using blood specimens, the present invention employs urine specimens that can be obtained non-invasively by a less skilled individual and with less risk of exposure to blood-borne pathogens. Furthermore, the levels of some of the biomarkers can be substantially altered for blood samples by release of constituents of red blood cells in hemolyzed specimens, or by the ex vivo oxidation of precursors (e.g. unsaturated lipids) upon exposure of blood to air.

Tests performed on urine for a plurality of urine biomarkers, provides a more robust assessment of an individual's health status than any of the individual urine biomarkers.

In one or more embodiments, the user selection option between the possible tests on the urine from the urine sample includes at least tests for at least one biomarker each for inflammation, oxidative stress, and antioxidant activity. The tests may be performed in the liquid phase (in test tubes or microplate wells), adapted to a simple dipstick method employing dried reagents, or incorporated into a microfluidic or a lateral flow

immunoassay device.

Oxidative stress occurs when an abnormal level of reactive oxygen species (ROS), such as lipid peroxide, lead to damage of molecules in the body. ROS can e.g. be produced from a fungal or viral infection, ageing, UV radiation, pollution, excessive alcohol consumption, and cigarette smoking. ROS can further cause age-related macular degeneration and cataracts.

The oxidative stress test can include either incorporating a specific malondialdehyde (MDA) or 4-hydroxyonenal (4HNE) method to quantify lipid peroxidation, and/or a thiobarbituric acid reactive substances (TBARS) method to measure a broader range of substances oxidized to aldehydes and ketones due to the actions of free radicals. These tests are known in the art and can be performed by an appropriate analyzing mechanism. Several other biomarkers can be used to test for oxidative stress. High levels of these biomarkers indicate that oxidative stress is occurring in an individual. Low levels of these biomarkers indicate a healthy individual.

The antioxidant power test, sometimes called the antioxidant capacity test, employs the CUPRAC (cupric reducing antioxidant capacity) method for measuring the sum of the antioxidant activity due to multiple species (uric acid, proteins, vitamins, dietary supplements) that are present in a urine sample. Alternatively, or additionally, modified methods can be used to specifically measure or to discriminate among uric acid, ascorbic proteins or other substances that contribute to the overall antioxidant power, thereby monitoring what is referred to as the "antioxidant reserve." These tests are known in the art and can be performed by an appropriate analyzing mechanism. Several other biomarkers can be used to test for antioxidant power. A higher value for antioxidant power, i.e. a greater amount of the biomarkers for antioxidant power, indicates a healthy individual because the individual has compounds that can neutralize free radicals that cause oxidative damage and stress.

Inflammation is comprised of a complex series of physiological and pathological events, including the increased production of several proteins (e.g. cytokines such as IL-6 and IL-8, as well as COX-2 and the inducible form of nitric oxide synthase). The production of nitric oxide, by the inducible isoform of nitric oxide synthase can increase up to 1000 times during inflammation, and has been shown to be a useful biomarker for inflammation. Urinary nitrate excretion is increased in patients with rheumatoid arthritis, and reduced in patients taking prednisolone. Because NO is relatively unstable, the production of NO can be tested by employing methods for the measurement of its degradation products nitrate and nitrite, i.e. measuring nitrite or the sum of nitrite and nitrate in a urine sample, which are often abbreviated as NOx. These tests are known in the art and can be performed by an appropriate analyzing mechanism. Further, although very high levels of protein in urine are associated with kidney disease, it is known that the retention of blood proteins by the kidney is reduced by the effect of certain inflammatory cytokines, so that modest elevations in the levels of urinary proteins that are less than those associated with kidney disease can be used as a biomarker for

inflammation. Several other biomarkers can be used to test for

inflammation. Higher levels of inflammation biomarkers indicate that inflammation is occurring in an individual, possibly indicative of disease. Lower levels of inflammation biomarkers indicate a healthy individual.

Chronic inflammation can lead to hay fever, atherosclerosis, and

rheumatoid arthritis. Anti-inflammatory agents have also been shown to significantly reduce the incidence of heart disease, diabetes, Alzheimer's disease, and cancer.

Since the sequencing of the human genome, it has become increasingly apparent that, while genetics plays a major role in the development of diseases for a small percentage of the population, the overall impact of genetics on major non-infectious diseases in humans is only about 15-20%. Much more important, especially for the development of the diseases that account for most morbidity and mortality in developed countries (chronic diseases such as cancer, cardiovascular diseases, neurodegenerative and autoimmune diseases), are the impact of diet, lifestyle (including exercise, smoking, alcohol use) and the environment. All of these factors influence an individual's health and they result in increases or decreases in inflammation and/or oxidative stress. Moreover, the oxidative stress can trigger some reactions that increase the level of inflammation.

Other tests of the urine sample may be for sexually transmitted diseases, such as Chlamydia Test, Gonorrhea Test, Mycoplasma Test, Ureaplasma Test, Trichomonas Vaginalis Test, Gardnerella Vaginalis Test, Herpes Simplex Type l/l I Test. Almost all of the biomarkers (which are directly determined from the test samples) are preferably measured by the most accurate, recently established biochemical assays using sophisticated, automated

instruments.

The urine sample can optionally be treated with a substance that helps to preserve the components being measured from decomposition during storage or shipment, and/or prevents the generation of additional reactive substances outside of the body, and/or retards the growth of microbes in the specimen that might alter the values during storage or shipment.

Some blood biomarkers indicating an individual's oxidative stress status are briefly described below. The same blood biomarkers may also be used for other indications.

1. Total Alkenals. The test measures products of lipid peroxides

(malonaldehyde ad 4-hydroxynonenal) from free radical attacks on cellular lipid membranes and lipoproteins (i.e. LDL). The measure of the amount of serum lipid peroxides reflects the amount of free radical damage in the body.

2. Aqueous Hydroperoxides. The test measures aqueous hydroperoxides, such as hydrogen peroxide, which can react with prooxidant metals to form the very reactive hydroxy I radical. The measure of the amount of serum hydroperoxides reflects the amount of free radicals being produced in the body at that time.

3. Lipid Hydroperoxides. The test measures lipid hydroperoxides [not hydrogen peroxide or products of lipid peroxide damage, i.e. aldehydes (MDA)j. The measure of the amount of serum lipid hydroperoxides reflects the amount of free radicals being produced in the body at that time. 4. Auto-antibody oxidized-LDL The current and predominant theory of the development of cardiovascular disease is that LDL becomes oxidized, gets engulfed by a monocyte which becomes a 'foam' cell that then gets stuck in the arterial cell wall and causes a fatty acid streak lesion (plaque). Oxidized LDL (Ox- LDL) induces an immune response to remove it from the body. The immune response is directly proportional to the amount of Ox-LDL present throughout the body. Because most of the Ox-LDL is in the arterial cell wall, it is not very effective to measure it in the serum; therefore, the auto-immunity antibody assay toward Ox-LDL is now recognized as a very powerful risk predictor of cardiovascular disease.

5. Total Iron. Unbound iron can act as a prooxidant by catalyzing the production of the very reactive hydroxy I radical from hydrogen peroxide and strong reducing agents such as ascorbate or homocysteine (Fenton reaction). High iron (overload) is associated with high amounts of free radical damage and a high risk for developing most of the age-related diseases such as diabetes, heart disease and cancer.

6. Available Iron Binding Capacity (AIBC) - is the amount of transferrin, ferritin and albumin that is not binding iron and therefore can accept (capture) a free iron molecule. Iron binding proteins are known to be a very effective prevention of iron-catalyzed free radical production. High AIBC offers good protection against the initiation of oxidative damage reactions. AIBC proteins are synthesized in the liver and are kept at a fairly constant steady state level in the serum; generally the higher the iron (iron bound by proteins), the lower the AIBC.

7. Total Iron Binding Capacity (TIBC) - is represented by the value; AIBC + Total Iron. This value is used to reflect the liver's capacity in making iron- binding proteins. 8. Percent Iron Saturation - (total iron TIBC) in percent. This is the relative ratio of iron to iron binding capacity; the higher the iron saturation, the higher the risk for iron to participate in catalyzing free radical species.

9. Ferritin - is an iron binding protein synthesized by the liver in response to the amount of iron in the serum. Ferritin is an indicator of the body's iron storage and possible long-term iron overload. High ferritin levels in serum have been associated with high amounts of free radical damage and a higher risk for developing most of the age-related diseases such as diabetes, heart disease and cancer.

10. Copper. Unbound copper is known to be an even more reactive prooxidant than iron, especially in the presence of strong reducing agents such as ascorbate (vitamin C) or homocysteine. High copper levels in serum can induce and is associated with high levels of oxidative damage. Small amounts are required for CuZn- superoxide dismutase and

ceruioplasmin.

11. Ceruioplasmin binds up to 95% of the copper found in serum. In normal patients, the amount of ceruioplasmin is directly proportional to the amount of copper in the serum. A high copper concentration is usually associated with high amounts of lipid peroxidation and risk for cardiovascular disease. Ceruioplasmin is thought to be an antioxidant in that, it acts as a

ferroxidase (oxidizes free iron) thereby inhibiting it from participating as a prooxidant and is essential in removing excess iron from the body.

Ceruioplasmin also acts as a superoxide dismutase. A decrease of ceruioplasmin is seen in Wilson's disease.

12. Glucose. Glucose levels indicate that the patient is fasting or may indicate uncontrolled diabetes mellitus or hypoglycemia. 13. Glycated Protein (Fructosamine) is used to measure the average blood glucose levels over the last 1-3 weeks prior to sample collection time. This assay measures all of the glycated proteins in serum [total proteins including albumin, but not hemoglobin (RBC) which are only in whole blood]. The amount of glycated proteins increases with oxidative stress and aging.

14. Oxygen Radical Absorption Capacity [ORAC] measures the total antioxidant capacity in a sample. The 95% ORAC value represents the fast acting antioxidants in the serum, which constitutes the first line of defense. These include ascorbate, thiols, uric acid, bioflavonoids, polyphenols etc. The 50% ORAC value represents the fast and medium acting antioxidants used by the serum, which includes the moderately active antioxidants such as albumin and lipids.

15. Aqueous ORAC - measures the antioxidants in a serum sample after the removal of proteins and lipids. Because of their abundance, almost half of the whole serum ORAC value is from proteins and lipids. Most proteins and lipids are not very active antioxidants (sacrificial) and decrease the sensitivity of the ORAC assay in measuring less abundant but more active antioxidants. Removing the lipids and proteins from the serum sample increases the sensitivity of the ORAC assay in measuring the other aqueous soluble antioxidants.

16. Lipid ORAC - measures the antioxidants in a serum sample after the removal of proteins and the aqueous phase of the sample. Because of their abundance, over half of the whole serum ORAC value is from proteins and aqueous antioxidants. Removing the proteins and aqueous antioxidants from the serum sample increases the sensitivity of the assay on measuring the lipid soluble antioxidants. 17. Lipid Peroxidation Inhibition Capacity [LPIC] assay. Plasma antioxidants can be classified into two major types: (a) primary antioxidants such as ceruloplasmin and transferrin, which reduce the initiation rate of lipid peroxidation by binding prooxidant metals, and (b) secondary antioxidants such as tocopherol, which reduces the chain propagation and amplification of lipid peroxidation. Many antioxidants also have multiple antioxidant properties such as uric acid, which can bind many prooxidant metals as well as directly scavenging oxidized species. The LPIC assay measures the activity of both the primary and secondary antioxidant systems as they are working together in a sample. In humans, low serum LPICvalues has been shown to strongly predict the development of adult-onset diabetes.

18. Vitamin C [Ascorbate]. Ascorbic acid can directly scavenge oxidative species as well as generate other oxidized antioxidants such as vitamin E. However, under conditions where there are free prooxidant metals around, such as iron and copper, vitamin C's strong reductive capacity will catalyze the production of oxidtive free radicals.

19. Thiols are very active antioxidants and reducing agents. Most serum thiols are found in albumin followed by free cysteine and glutathione.

Albumin thiols are thought to act as sacrificial antioxidants that have little biological consequences of being damaged. Because of their high antioxidant reactivity and high concentration, albumin thiols act as a major defense against free radical damage to cell membranes.

20. Lutein is a very active lipid-soluble carotenoid antioxidant (2.3 times higher than vitamin E), which is readily absorbed into the serum. Lutein and zeaxanthin are major factors in the prevention of macular degeneration, which is the leading cause of blindness in the elderly and represents 10% of all blindness in humans. 21. Zeaxanthin is a very active lipid-soluble carotenoid antioxidant (2.8 times higher than vitamin E) which is readily absorbed into the serum. Lutein and zeaxanthin are implicated in the prevention of macular degeneration, which is the leading cause of blindness in the elderly and represents 10% of all blindness in humans.

22. β-Cryptoxanthin is probably the most active of the lipid soluble antioxidants (3.1 times higher than vitamin E) which is readily absorbed into the serum.

23. Lycopene is one of the most active lipid-soluble antioxidants (2.8 times higher than vitamin E). Research has indicated that lycopene may be very important in the prevention of prostate cancer.

24. Alpha-Carotene is a known antioxidant and precursor to vitamin A. Experimental evidence shows that alpha-carotene is a stronger antioxidant and cellular differentiating agent than beta-carotene and therefore may be better in preventing cancer.

25. Beta-Carotene is a known antioxidant and precursor to vitamin A, which has been widely used as a diet supplement. It is a strong cellular differentiating agent, and therefore may prevent cancer. 26. Retinol [Vitamin A] is a known antioxidant and cellular differentiating agent and therefore may prevent cancer and many aspects of aging.

27. Retinyl Pa imitate. The retinol ester that is most commonly used in dietary supplements and foods as a source of vitamin A.

28. Carotenoid classes. This grouping of carotenoids contain many uncharacterized carotenoids that most likely are beneficial to health. This value provides a good overall value of the amounts of fruits and vegetables being consumed.

29. Alpha-Tocopherol (Vitamin E) is one of the best characterized and diet supplemented lipid-soluble antioxidants. Apart from its antioxidant capabilities, it has cellular differentiation properties, which are believed to be good in preventing cancer.

30. δ-Tocopherol (Vitamin E). Not much is known about the beneficial effects of δ- tocopherol to humans, though it is normally found at lower amounts in foods and human serum.

31. γ-Tocopherol (Vitamin E). The major type of vitamin E found in the heart and therefore may be selected for the body because of its unique properties either as an antioxidant or as a differentiation agent.

32. Tocopherol/ (Cholesterol + Triglycerides). The ratio of lipid antioxidants per amount of lipids that there is to be protected. This type of parameter has been found to give a much better indication of risk for developing cardiovascular disease than by evaluating these biomarkers alone.

33. Ubiquinol [Coenzyme QIO] is normally synthesized in cells as part of the mitochondrial oxidative phosphorylation system and is present in lipid biomembranes. CoQIO can also be absorbed through the diet and can act as a very active antioxidant and protecting LDL from becoming oxidized.

34. Cholesterol. Cholesterol is a well-known risk predictor for

cardiovascular disease by indicating the amount of lipids that can

potentially be oxidized. The current theory of the development of

cardiovascular disease is that LDL becomes oxidized, gets engulfed by a monocyte which becomes a 'foam' cell that gets stuck in the arterial cell wall and causes a fatty acid streak lesion (plaque).

35. Triglycerides. Triglcerides are esters of fatty acids and glycerol bound to proteins called lipoproteins. Triglycerides and cholesterol both measure the total amount of lipoproteins in the serum, which can be a rough indicator of risk for cardiovascular disease. The associated cardiovascular disease risk prediction offered by triglycerides and cholesterol by themselves is actually low (44%); but, in conjunction with vitamin A and E, the ratio of (cholesterol + triglycerides)/ (vitamin A and E) elevates the risk predictive power to 85% accuracy.

36. Albumin. Each albumin molecule contains many very active thiol groups that act as potent antioxidants. Albumin is known as a sacrificial antioxidant because it has no recycling pathway and the consequences of its damage do not directly affect cellular function. Albumin has a high turnover rate; damaged albumin is degraded and the body reuses the good amino acids. Most other antioxidant mechanisms use some sort of direct regeneration system (i.e. vitamin E, vitamin C and glutathione peroxidase).

37. Total Protein - includes albumin and the immunoglobulins. Thus, the amount of globulins in a serum sample can be calculated from the simple equation,

Amount of globulin = Total Protein - Amount of albumin

38. The Albumin/Globulin ratio is used as a general marker of health and wellbeing. The ideal ratio is 1 .85 or higher. High immunoglobulins can indicate a long history of infections, which may increase the risk of developing autoimmune diseases.

39. Homocysteine. Homocysteine is a strong reducing agent and can promote pro-oxidant metal catalyzed production of free radicals. Elevated levels of homocysteine are highly associated with a high risk of

cardiovascular disease. In most patients, high homocysteine is caused by deficiencies in folic acid and/or vitamin B12.

40. Folic Acid. Folic acid is involved in DNA synthesis, red blood cell regeneration and homocysteine metabolism. Low levels are associated with birth defects, DNA damage and accumulation of homocysteine. Deficiency results in high-elevated DNA mutation rate, oxidized LDL, irreversible nerve degeneration and anemia. Folic acid and vitamin B12 are synergistic in their actions.

41. Vitamin B12 [cyanocobalamin]. Vitamin B12 is involved in DNA synthesis, red Blood cell regeneration and homocysteine metabolism. Low levels are associated with birth defects, DNA damage, and accumulation of homocysteine. Deficiency results in high-elevated DNA mutation rate, oxidized LDL, irreversible nerve degeneration and anemia. Vitamin B12 and folic acid are synergistic in their actions.

42. Low Density Lipoproteins (LDL). Known in popular literature as the 'bad' Cholesterol, LDL is directly associated with risk for heart disease.

Prevention of LDL from becoming oxidized can be achieved by decreasing free prooxidizing metals, increasing water-soluble antioxidants (albumin, uric acid and vitamin C) and lipid-soluble antioxidants (vitamin A, vitamin E, CoQIO and carotenoids).

43. High Density Lipoproteins (HDL). Known in popular literature as the 'good' Cholesterol, HDL is inversely associated with risk for heart disease.

44. Apolipoprotein B is a protein found primarily on LDL and therefore is actually a measure of LDL. 45. Apolipoprotein A is a protein found primarily on HDL and therefore is actually a measure of HDL.

46. 5-Dihydrotestosterone is a toxic form of testosterone known to cause male pattern baldness and to damage prostate cells, which increases the risk of prostate cancer.

47. Cortisol. Cortisol is a steroid hormone that is elevated during many different types of stress including oxidative stress. Long-term exposure to elevated levels of Cortisol has been shown to accelerate the signs of aging.

48. Dehydroepiandrosterone sulfate [DHEA-S]. DHEA-S is known as the master hormone, since it is a precursor for the synthesis of many other hormones. As DHEA-S levels has been demonstrated to decrease with age, it has recently become a very popular dietary supplement used to raise the hormone levels to the range seen in youthful phase of life. DHEA- sulfate is the form that is normally stored in the body and therefore this supplement has less negative side effects compared to supplementing DHEA directly.

49. Estradiol. Estradiol is linked with a high risk of developing breast cancer, especially in post-menopausal women, who take excess of supplements. Other forms of estrogen are reported to be safer. Women with chronically higher amounts of circulating estradiol have been known to reach menopause much earlier than normal.

50. Insulin-like Growth Factor -1 [IGF-1]. IGF-1 mediates the effects of human growth hormone (HGH), such as stimulating cellular renewal, repair and growth. In normal patients, IGF-1 is produced in the liver in amounts directly proportional to growth hormone. Due to its long half-life, IGF-1 can be used to measure the average amount of growth hormone released within the last 48 hours. Because HGH has many cyclic peaks throughout the day and night, a single serum determination of HGH is not very accurate in determining inadequate or excessive release of HGH. HGH and IGF-1 injections have been shown to help the elderly rebuild muscle and strength, thereby improving their quality of life.

51. Progesterone. Progesterone is currently a popular supplement believed to enhance memory and cognitive functions.

52. Testosterone. Testosterone is responsible for the expression and maintenance of most adult male characteristics, such as facial hair and muscle growth. However, testosterone can be converted in some cells, like hair follicles and prostate cells, to a toxic form (dihydrotestosterone, DHT) which is damaging to these cell types.

53. Thyroid Stimulating Hormone (TSH). TSH stimulates the uptake of iodine by thyroid cells.

54. Thyroxine (T4). Thyroxine is a global steroid hormone that regulates metabolic rate and indicates proper thyroid function. The synthesis of thyroxine from iodine produces hydrogen peroxide as a by-product. Those suffering from hyperthyroidism has been shown to have signs of

accelerated aging.

55. Aluminum. Accumulation of aluminum in the brain has been strongly associated with the onset of Alzheimer's disease. This is thought to be an effect of the disease rather than a cause.

56. Antimony. Antimony is a toxin, and has no known human need. 57. Arsenic. Arsenic is a well-known poison that inhibits respiration.

58. Cadmium. Cadmium is a well-known toxin, similar to mercury, and has no known human need.

59. Calcium. Calcium aids in apoptosis, blood clotting and nerve signaling. Low serum amounts are known to cause osteoporosis, poor growth and maintenance of bones and teeth.

60. Chromium. Industrial chromium is a very toxic prooxidant. Small amounts of Cr ⁺³ are required in glucose tolerance proteins and functions to regulate blood glucose levels.

61. Cobalt. Cobalt is a component of vitamin B12. It can be toxic at high levels.

62. Copper. Unbound copper is known to be even more reactive prooxidant than iron, Especially in the presence of strong reducing agents such as ascorbate or homocysteine. High levels of copper can induce oxidative damage. Small amounts are required for CuZn-superoxide dismutase and ceruloplasmin.

63. Iodine. Iodine is required for synthesis of the thyroid hormone thyroxine, which produces hydrogen peroxide as a byproduct. Iodine is a halogen (like fluorine and chlorine) and can readily act as a free radical generator. High amounts of iodine can be very toxic.

64. Iron. Unbound iron can act as a prooxidant by catalyzing the production of the very reactive hydroxy I radical from hydrogen peroxide and strong reducing agents such as ascorbate and homocysteine. High iron (overload) is associated with high amounts of free radical damage and a higher risk for developing most of the age- related diseases such as diabetes, heart disease and cancer.

65. Lead. Lead is a well-known neurotoxin that has no known human need.

66. Magnesium. Magnesium is necessary for RNA/DNA synthesis, protein synthesis, ADP synthesis and muscle contraction. Since it has a fixed outer electron valence of +2, it can inhibit many iron based free radical generating reactions by displacing iron from its binding site. Magnesium has been shown to be helpful in preventing heart disease.

67. Manganese. Unbound manganese is known to be a strong prooxidant, especially in the presence of strong reducing agents such as ascorbate or homocysteine. It is toxic at high levels. Small amounts are required for Mn- superoxide dismutase.

68. Mercury. Mercury is a well-known neurotoxin that has no known human need.

69. Molybdenum. Molybdenum is required by xanthine oxidase in

converting xanthines to uric acid. It is also required in aldehyde oxidase and sulfite oxidase in oxidizing these toxic compounds into less reactive products. Oxidases produce hydrogen peroxide as a byproduct of their reaction.

70. Nickel. Unbound nickel is known to be a strong prooxidant and is toxic at high levels. Small amounts are required for red blood cells and liver function.

71. Selenium. Unbound selenium is known to be a prooxidant with similar valences as oxygen. It is toxic at high levels. Small amounts are required for glutathione peroxidase.

72. Sulfur. Sulfur is essential for protein structures and enzyme activity; it is also required in many detoxification reactions and can lower a person's risk of developing cancer.

73. Strontium. Strontium is known to inhibit vitamin D synthesis; therefore it can be an important risk factor for osteoporosis and bone malformation in developing children.

74. Tin. Tin is required for proper metabolism and growth of bone and teeth.

75. Vanadium. Vanadium is involved in lipid metabolism. Deficiency of vanadium has been shown to increase cholesterol levels (high doses did not lower cholesterol past their normal set point). Current studies are evaluating vanadium ability in killing cancer cells. Vanadium can be toxic at high levels.

76. Zinc. Zinc is necessary for metabolism, RNA polymerases and CuZn- superoxide Dismutase. Because it has a fixed outer electron valence of +2, it can inhibit many iron based free radical reactions by displacing iron from its binding site. Zinc can be toxic at high levels.

Almost all of the biomarkers (which are directly determined from the test samples) are preferably measured by the most accurate, recently

established biochemical assays using sophisticated, automated

instruments.

After selecting a number of body sample tests from the possible ones, the user transmits by the mobile/handheld computing device said selection of one or more body sample tests associated with the unique identification code to a server at a network location and/or to a database at an analyzing unit.

The data sent by the mobile/handheld computing device may include authentication information that identifies a specific user and/or pet/animal and the user's mobile/handheld computing device. The authentication information may include user credentials, such as a username, a password, an email address and answers to security questions, data access

permissions/restrictions, geographical position of the mobile/handheld computing device, as well as information that uniquely identifies a

mobile/handheld computing device such as a telephone number or a hash generated by a user profile.

The user of the mobile/handheld computing device may be required to sign in to a service before providing any information, and may be provided with an explanation of how and why their data is being used. Similarly, users may be provided with the opportunity to cease participation temporarily or permanently at any time. By requiring users to opt-in and sign in for the service, this may also reduce the amount of third parties attempting to spam the system.

Preferably, the mobile/handheld computing device is a smartphone or a tablet computer. In such an embodiment, the machine-readable

representation of the unique identification code takes the form of a Quick Response (QR) code or other matrix (two-dimensional) barcode readable by a scanner, such as by the camera of a mobile phone or other mobile computing device programmed to identify and process matrix barcodes. In alternative embodiments, the machine-readable representation of the encoded information takes the form of a radio-frequency identification (RFID) readable by a radio frequency interface of a mobile phone or other mobile computing device programmed to identify and process the RFID. The body sample may be taken by a device for sampling a body sample, such as urine and blood, and may be positioned within the container for holding the body sample. In one or more embodiments, the container is configured for sampling a body sample.

A second aspect relates to a system for obtaining test results from a body sample, comprising:

- a container adapted for holding a body sample, the container comprising a unique identification code;

- a mobile/handheld computing device comprising a first identification code reader;

- a second identification code reader; and

- analyzing means configured to perform one or more tests of a body sample;

wherein the mobile/handheld computing device is configured to retrieve data from a server at a network location and/or from a database, the data comprising test result(s) of a body sample associated with a unique identification code.

In one or more embodiments, the mobile/handheld computing device is configured to selectively retrieve data associated with a unique

identification code that has previously been identified with the first identification code reader of said mobile/handheld computing device.

In one or more embodiments, the mobile/handheld computing device is configured to propose one or more body sample tests from the number of possible body sample tests, in response to user input, such as gender, age, weight etc.

In one or more embodiments, the mobile/handheld computing device is configured to propose one or more body sample tests from the number of possible body sample tests, in response to user input selected from the group consisting of chronic disease state, hereditary diseases in the family, age, race, ethnicity, gender, height, weight, body mass index (BMI), body volume index (BVI), genotype, phenotype, disease, disease severity, disease progression rate, measures of functional ability, quality of life, interventions, and remedies.

In one or more embodiments, the mobile/handheld computing device is configured to transmit a user-selected selection of one or more body sample tests associated with the unique identification code from the container adapted for holding a body sample to a server at a network location and/or to a database at an analyzing unit.

The analyzing means may be any type of means capable of performing tests on a body sample, either as an aid for laboratory personnel, or as a full automatic system.

In one or more embodiments, the analyzing means is configured to associate a test result from a body sample with the unique identification code on the container in which the body sample was held, and store it on a server at a network location and/or on a database. Alternatively, the laboratory personnel associate a test result on the body sample with the unique identification code on the container in which the body sample was held, and stores it on a server at a network location and/or on a database.

The second identification code reader is used in the process of associating a test result from a body sample with the unique identification code on the container in which the body sample was held. It may in certain

embodiments be an integrated part of the analyzing means. The container adapted for holding a body sample may be of any suitable form or size, and may be made of any suitable material for storing a body sample. Preferably, the container is of a material capable of withstanding transportation by postal services, such as a hard polymeric material.

Preferably, the container is adapted for holding a small volume (1-50 ml) of a body sample for medical tests. Medical tests that require a small volume of e.g. urine and blood are well known.

In one or more embodiments, the container further comprises a device for sampling blood from the skin. In some embodiments, the device for sampling blood from the skin is an integrated part of the container.

In one or more embodiments, the device for sampling blood from the skin comprises:

(a) a fluid-conducting plate unit having one or more openings for facing against the skin of a patient, through which openings one or more lancets can pass to puncture the skin to result in a puncture wound, the plate unit having channels each for conducting fluid from the puncture wound; and

(b) one or more lancets positioned near the plate unit associated therewith for passing through the one or more openings to puncture the skin when pressed into the skin;

wherein the plate unit comprises a first channel for conducting away a first portion of the fluid and a second channel for conducting a second portion of the fluid.

With the incorporation of a fluid-conducting unit and a lancet, blood can be conveniently sampled and transferred to a desired location, simply by placing the unit on the skin and pushing a button. In a preferred

embodiment, through the use of two or more channels, one of which conducts away fluid that contains more of the initial fluid from the lancing wound, a blood sample that is more representative of the blood in the blood vessel can be delivered to a storage site. Further, the lancing device having this capacity of selecting the proper blood portion can be made into a compact, convenient plate-shaped unit, which can easily be inserted into the container. In addition, multiple lancets can be arranged such that the distance between at least two of the lancets is within a limit such that the patient perceives only a single puncture when in fact more than one lancet puncture the skin.

Human blood may require rapid separation of cellular blood constituents to obtain serum or plasma and thereby avoiding sample degradation. A dry blood filter solves this problem.

In one or more embodiments, the container further comprises a dry blood filter.

In one or more embodiments, the dry blood filter comprises at least one substance of the group consisting of antioxidants, coagulants, disinfectants, detergents and inhibitors. These substances advantageously hinder a degradation or alteration of the sample. Furthermore, addition of a disinfectant to the filter paper allows shipment of dried blood spots originating from potentially infectious material spots by ordinary mail service. Such disinfectants may comprise, but are not limited to phenol and its derivatives like thymol, o-polyphenol; Cationic compounds like

benzalconium chloride, chlorhexidine; aldehydes like formaldehyde or others and alcohols such like n-propanol.

In cases in which a separation of the blood cells from the blood is desired to avoid liberation of intracellular compounds from lysing or damaged cells and not a complete haemolysis, a filter according to the invention

comprises pores with unequal pore sizes for separating blood cells from plasma. Due to their larger diameter, blood cells exhibit a different permeability compared to plasma. A simple solution to this problem is the use of different types of filter paper and membranes, which are not permeable to blood cells causing a separation of the cells and plasma by means of chromatography, filtration or capillary forces. For example, the filter spot in the center of the dry blood filter is permeable to blood cells while the surrounding paper is not.

Impregnating the filter paper with a substance leading to rapid

coag u lation/clotting without lysis and destruction of the blood cells and the additional used of a simple color indicator that allows later identification of areas of filter paper outside the blood clot where only cell free blood

(plasma/serum) "diffused". By this method, areas of filter paper

impregnated only by cell free plasma could be easily generated and identified.

In one or more embodiments, the container is configured for sampling blood from the skin.

In one or more embodiments, the container comprises a base and a lid engaging said base, and cooperating with said base to define an enclosure configured for being in a closed or open state;

wherein the lid comprises a first and second generally opposing surface sides, and wherein the second surface side is facing the base in the closed state.

In one or more embodiments, the unique identification code is positioned on the second surface side of the lid and/or on the surface side of the base facing the enclosure. This is to conceal the unique identification code when the container is loaded with a body sample, and hence in a closed state.

In one or more embodiments, the container further comprises a tamper- evident lock. In one or more embodiments, the container further comprises a tamper- evident lock, comprising:

- a lock body housing a keyed lock, the keyed lock comprising a keyhole;

- means on the lock body for permanently retaining a seal effective for preventing access to said keyhole; and

- a seal removable from said retaining means only by being compromised, said compromise of the seal effective to evidence tampering.

In or more embodiments, the container further comprises a seal that must be compromised (for example, removed, bent, or broken) to physically access the body sample within the container.

A third aspect relates to a mobile/handheld computing device comprising a first identification code reader;

wherein the mobile/handheld computing device is configured to retrieve data from a server at a network location and/or from a database, the data comprising test result(s) of a body sample associated with a unique identification code.

In one or more embodiments, the mobile/handheld computing device is configured to selectively retrieve data associated with a unique

identification code that has previously been identified with the first identification code reader of said mobile/handheld computing device.

In one or more embodiments, the mobile/handheld computing device is configured to associate the unique identification code with a number of possible body sample tests.

A fourth aspect relates to a container adapted for holding a body sample, the container comprising a base and a lid engaging said base, and cooperating with said base to define an enclosure configured for being in a closed or open state;

wherein the lid comprises a first and second generally opposing surface sides, and wherein the second surface side is facing the base in the closed state;

wherein the unique identification code is positioned on the second surface side of the lid and/or on the surface side of the base facing the enclosure.

It should be noted that embodiments and features described in the context of one of the aspects of the present invention also apply to the other aspects of the invention.

Brief description of the figures

Figure 1 shows a system in accordance with various embodiments of the invention;

Figures 2A-B show a container in accordance with various embodiments of the invention; and

Figure 3 shows an example embodiment of a user interface of a mobile computing device for use in the system and method of the present invention.

Detailed description of the invention

Referring to Figure 1 , the general scheme of the invention is shown in relation to both system and method. A customer of the system acquires a container 200 adapted for holding a body sample 230, and comprising a unique identification code 220. The user retrieves, by an application executing on his/her smartphone 300, the unique identification code by invoking a scanning function. The application executing on the smartphone 300 associates the unique identification code with a number of possible body sample tests. The user then selects, by the application executing on the smartphone 300, one or more body sample tests from the number of possible body sample tests.

The application executing on the smartphone 300 associates the unique identification code with the selection of one or more body sample tests and transmits the information/request, over a wireless network 120, to a server 610 at a network location and/or to a database 620 at an analyzing unit 500. Preferably, a transaction (payment) for the service must be completed before the information/request is made available to the analyzing unit 500. The user then positions a body sample 230 within the container 200, and send it, e.g. with a commercial delivery service, to the analyzing unit 500. When the container 200 is received at the analyzing unit 500, the unique identification code 220 from the container 200 is retrieved by invoking a scanning function of an identification code reader (not shown) at the analyzing unit 500.

The analyzing unit 500 then retrieves information on which body sample tests to perform on the body sample within the container from the server 610 at a network location and/or from a database 620 at the analyzing unit 500 using the unique identification code.

One or more body sample tests are then performed on the body sample 230 within the container 200. The one or more body sample test results are then associated with the unique identification code, and stored on the server 610 at a network location and/or on the database 620.

The user may then actively be informed by a text or push message on his/her smartphone.

The user then retrieves information from the server 610 at a network location and/or from a database 620 on the one or more body sample test results on the body sample 230 within the container 200 with the application executing on the smartphone using the unique identification code 220.

Figure 2 shows a container in accordance with various embodiments of the invention. The container comprises a base 205 and a lid 210 engaging said base, and cooperating with said base 205 to define an enclosure configured for being in a closed (Figure 2B) or open state (Figure 2A).

The lid 210 comprises a first 211 and second 212 generally opposing surface sides, and the second surface side 212 is facing the base 205 in the closed state.

In Figure 2A, the unique identification code 220 is positioned on the second surface side of the lid 210. This is to conceal the unique identification code when the container is loaded with a body sample, and hence in a closed state.

Figure 3 shows an example embodiment of a user interface 330 of a smartphone for use in the system and method of the present invention. When pushing the circular button 332 on the touch screen 320, a scanning function is invoked for reading the unique identification code 220. Four buttons 334-337 encircle the circular button 332. The button 334 is used to retrieve information from a server at a network location and/or from a database on one or more body sample test results. The remaining three buttons 335-337 are to select different types of tests. Only the circular button 332 is active before the unique identification code 220 has been identified. After that has occurred, the circular button 332 is deactivated, and the buttons 335-337 are activated. When a transaction (payment) for the service has been completed, button 334 is activated when the test results are ready. References

100 System

120 Wireless network

200 Container

205 Base

210 Lid

211 First surface side

212 Second surface side

220 Unique identification code

230 Body sample

300 Mobile/handheld computing device

310 First identification code reader

320 Touch Screen

330 User interface

332 circular button

334 Button

335 Button

336 Button

337 Button

500 Analyzing means/analyzing unit

610 Network location

620 Database