CN108351920B - System and method for obtaining test results from a body sample - Google Patents
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Abstract
本发明涉及用于在有可能在整个过程期间保持匿名的情况下从身体样本获得测试结果的方法和系统。所述系统包括：具有唯一标识代码的容器；移动/手持计算装置，包括第一标识代码读取器、第二标识代码读取器和分析构件，所述分析构件被配置为执行对身体样本的一个或多个测试。所述容器适于保存身体样本。所述移动/手持计算装置被配置为从网络位置处的服务器和/或从数据库取回数据，其中所述数据包括与唯一标识代码相关联的身体样本的（一个或多个）测试结果。
The present invention relates to a method and system for obtaining test results from a body sample with the potential to remain anonymous throughout the procedure. The system includes: a container having a unique identification code; a mobile/handheld computing device including a first identification code reader, a second identification code reader, and an analysis member configured to perform an analysis of a body sample. one or more tests. The container is suitable for holding a body sample. The mobile/handheld computing device is configured to retrieve data from a server at a network location and/or from a database, wherein the data includes the test result(s) of the body sample associated with the unique identification code.
Description
Technical Field
The present invention relates to a system and method for obtaining test results from a body sample.
Background
People generally have health problems and chronic diseases at different stages in their life based on age, gender, genetic background and lifestyle. Knowledge of the physiological and/or medical state of an individual human or animal is critical to the individual itself, the pet owner, and his/her/its health care provider to identify and prevent problems from occurring before they begin.
Regular health checks and tests may help to find problems before they start. However, only a few people and pet owners perform regular checks with his/her medical care provider. This is due to several factors, such as the health care provider's open time, decision ability, embarrassment, and consultation costs.
Especially when sexually transmitted diseases including chlamydia, gonorrhea and herpes are involved, it is undesirable for people to have this information become part of their medical records. Furthermore, some people and pet owners are only interested in monitoring the physiological state of their or pets without involvement of his/her health care provider (e.g., analyzing whether particular exercise and dietary habit changes are effective).
It is therefore desirable to provide a method for obtaining information about the physiological and/or medical state of an individual person or pet without having to perform a periodic examination with his/her health care provider.
At the same time, laboratory optimization of the running time of the equipment at the analysis unit is problematic, since they do not know how many samples arrive each day. Therefore, a system that can solve both of these problems is needed.
Disclosure of Invention
The inventors of the present invention developed a method and system for obtaining test results from a body sample with the potential to remain anonymous during the entire procedure. The testing of a body sample is a testing of biomarkers for the physiological and/or medical state of an individual human or pet.
A first aspect relates to a method for obtaining a test result from a body sample, the method comprising the steps of:
-providing a container adapted to hold 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 plurality of possible body sample tests;
-selecting, by an application executing on the mobile/handheld computing device, one or more body sample tests from the plurality of possible body sample tests;
-transmitting, by the mobile/handheld computing device, the 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 analysis unit;
-positioning a body sample within a container;
-sending/transporting the container to an analysis unit;
-receiving the container at the analysis unit;
-retrieving the unique identification code from the container by invoking a scanning function of an identification code reader at the analysis unit;
-retrieving information about which body sample tests are to be performed on the body sample within the container from a server at a network location and/or from a database at an analysis unit using the unique identification code;
-performing one or more body sample tests on the body sample in the container;
-associating one or more body sample test results on a body sample within a container with the unique identification code and storing them on a server and/or on a database at a network location;
-retrieving, with the application executing on the mobile/handheld computing device, information about the one or more body sample test results on the body sample within the container from a server at a network location and/or from a database using the unique identification code.
The term "body sample" includes, but is not limited to, urine, saliva, breath, hair, nails, buccal cells, oral fluid, stool, skin, sweat, nasal fluid, mucus, semen, vaginal secretions, blood, ocular fluid, ocular swabs, and cerumen.
In one or more embodiments, the body sample is selected from the group consisting of urine, saliva, breath, hair, nails, buccal cells, oral fluid, stool, skin, sweat, nasal fluid, mucus, semen, vaginal secretions, blood, ocular fluid, ocular swabs, and cerumen.
In one or more embodiments, the body sample is selected from the group consisting of blood and urine.
In this context, a unique identification code is a code representing a unique identification of a container adapted to hold a body sample, such as an encrypted serial number (e.g. an electronic product code). The identification code may include a product (container) serial number, model number, lot number, manufacturing date, expiration date, price, country of sale/sale, and other product identity-related information identifying the product or associated with the product.
The code may take the form of: one-dimensional barcode, two-dimensional barcode, QR code or a combination of one-dimensional barcode and/or two-dimensional barcode and/or QR code.
The code may also take 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 the mobile/handheld computing device by invoking a scanning function of the mobile/handheld computing device. Thus, the mobile/handheld computing device (e.g., smartphone) includes an identification code reader/scanner (e.g., camera of the smartphone).
An application executing on the mobile/handheld computing device associates a unique identification code with a plurality of possible body sample tests. Whereby the user can select a number of different tests on his/her body sample. Possible tests for body samples are tests for body biomarkers of physiological and/or medical state of an individual human or pet, such as oxidative stress, antioxidants and inflammatory biomarkers.
Although analysis of oxidative stress, antioxidants and inflammatory biomarkers is typically performed primarily using blood specimens, the present invention employs urine specimens that can be obtained by less skilled individuals in a non-invasive manner and with a lower risk of exposure to blood-borne pathogens. In addition, the levels of some biomarkers of a blood sample may be substantially altered by the release of red blood cell components in a hemolyzed specimen or by the ex vivo oxidation of precursors (e.g., unsaturated lipids) upon exposure of the blood to air.
Tests performed on urine for multiple urine biomarkers provide a more robust assessment of an individual's health status than any individual urine biomarker.
In one or more embodiments, the user-selected options between possible tests for urine from a urine sample include at least: testing of at least one biomarker for inflammation, oxidative stress and antioxidant activity, respectively. The test may be performed in the liquid phase (in a test tube or microplate well), a simple dipstick method suitable for use with dry reagents, or incorporated into a microfluidic or lateral flow immunoassay device.
Oxidative stress occurs when abnormal levels of Reactive Oxygen Species (ROS), such as lipid peroxides, cause molecular damage in the body. ROS can be generated, for example, by fungal or viral infections, aging, UV radiation, pollution, excessive alcohol consumption, and smoking. ROS can further cause age-related macular degeneration and cataracts.
Oxidative stress testing may include the incorporation of specific Malondialdehyde (MDA) or 4-hydroxynonenal (4 HNE) methods to quantify lipid peroxidation, and/or the incorporation of thiobarbituric acid reactive species (TBARS) methods to measure a broader range of species that are oxidized to aldehydes and ketones due to the action of free radicals. These tests are known in the art and may be performed by a suitable analytical mechanism. Several other biomarkers can be used for testing against oxidative stress. High levels of these biomarkers indicate that oxidative stress is occurring in an individual. Low levels of these biomarkers are indicative of healthy individuals.
Antioxidant power test (sometimes referred to as the antioxidant power test) the sum of antioxidant activity caused by multiple species (uric acid, proteins, vitamins, dietary supplements) present in a urine sample is measured using the CUPRAC (cupric reduction antioxidant power) method. Alternatively or additionally, substances known as "antioxidant stores" may be monitored using modified methods to specifically measure or differentiate uric acid, ascorbic protein, or other substances that contribute to overall antioxidant capacity. These tests are known in the art and may be performed by a suitable analysis mechanism. Several other biomarkers can be used to test antioxidant capacity. A higher value of antioxidant capacity (i.e. a greater number of biomarkers for antioxidant capacity) indicates a healthy individual, as that individual has compounds capable of neutralizing free radicals causing oxidative damage and stress.
Inflammation consists of a complex series of physiological and pathological events involving increased production of several proteins (e.g., cytokines such as IL-6 and IL-8, and induced forms of COX-2 and nitric oxide synthase). Nitric oxide production by inducible isoforms of nitric oxide synthase can increase up to 1000-fold during inflammation and has proven to be a useful biomarker for inflammation. Urinary nitrate excretion is increased in patients with rheumatoid arthritis and decreased in patients taking prednisolone. Because NO is relatively unstable, the production of NO can be tested by employing a method of measuring its degradation products nitrate and nitrite, i.e., measuring nitrite or the sum of nitrite and nitrate (often abbreviated as NOx) in a urine sample. These tests are known in the art and may be performed by a suitable analysis mechanism. Furthermore, although very high levels of proteins in urine are associated with kidney disease, it is known that the effects of certain inflammatory cytokines reduce the retention of blood proteins by the kidney, such that a lower modest increase in urine protein levels compared to the increase in urine protein levels associated with kidney disease can be used as a biomarker for inflammation. Several other biomarkers can be used for detection against inflammation. Higher levels of an inflammation biomarker indicate that inflammation is occurring in the individual, possibly indicating disease. Lower levels of inflammatory biomarkers are indicative of healthy individuals. 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.
Due to sequencing of the human genome, it has become increasingly apparent that, although genetics plays a major role in the development of disease for a small segment of the population, the overall impact of genetics on major non-infectious diseases in humans is only about 15-20%. Especially for the development of diseases that account for the highest morbidity and mortality (chronic diseases such as cancer, cardiovascular diseases, neurodegenerative diseases and autoimmune diseases) in developed countries, much of the importance is the impact of diet, lifestyle (including exercise, smoking, alcohol use) and environment. All of these factors affect the health of an individual and they lead to an increase or decrease in inflammation and/or oxidative stress. Moreover, oxidative stress may trigger some reactions that increase the level of inflammation.
Other tests on urine samples may be directed to sexually transmitted diseases, such as chlamydia tests, gonorrhea tests, mycoplasma tests, ureaplasma tests, trichomonas vaginalis tests, gardnerella vaginalis tests, herpes simplex type I/II tests.
Almost all biomarkers (determined directly from test samples) are preferably measured by the most accurate, recently established biochemical assays using advanced automated instruments.
The urine sample may optionally be treated with a substance that helps keep the component being measured from decomposing during storage or transport, and/or prevents the generation of additional reactive substances in vitro, and/or prevents the growth of microorganisms in the specimen that may change values during storage or transport.
Some blood biomarkers indicative of the oxidative stress status of an individual are briefly described below. The same blood biomarkers can also be used for other indications.
1. Total alkenals. This test measures the products of lipid peroxides (malondialdehyde and 4-hydroxynonenal) from free radical attack on cellular lipid membranes and lipoproteins (i.e., LDL). The measurement of the amount of serum lipid peroxides reflects the amount of free radical damage in the body.
2. An aqueous hydroperoxide. This test measures aqueous hydroperoxides, such as hydrogen peroxide, which can react with pro-oxidative metals to form very reactive hydroxyl groups. The measurement of the amount of serum hydroperoxide reflects the amount of free radicals that are produced in the body at the time.
3. A lipid hydroperoxide. This test measures lipid hydroperoxides [ not hydrogen peroxide or the products of lipid peroxide damage, i.e. aldehydes (MDA) ]. The measurement of the amount of serum lipid hydroperoxides reflects the amount of free radicals produced in the body at the time.
4. Auto-antibody oxidation-LDL. The current and leading theories of cardiovascular disease development are: LDL is oxidized, phagocytosed by monocytes, which become 'foam' cells, which then become lodged in the arterial cell wall and cause fatty acid plaque lesions (plaques). Oxidized LDL (Ox-LDL) elicits an immune response that removes it from the body. The immune response is proportional to the amount of Ox-LDL present throughout the body. Since most of Ox-LDL is in the arterial cell wall, measuring Ox-LDL in serum is not very effective; thus, the results of autoimmune antibody assays on Ox-LDL are now considered to be a very powerful risk predictor of cardiovascular disease.
5. The total iron content. Unbound iron can act as a pro-oxidant by catalyzing the production of very reactive hydroxyl groups from hydrogen peroxide and strong reducing agents such as ascorbate or homocysteine (fenton reaction). High-speed rail (overload) is associated with: a high number of free radical damage and a high risk of developing most 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 does not bind iron and therefore can accept (capture) free iron molecules. Iron binding proteins are known to be very effective in preventing iron-catalyzed free radical production. High AIBC provides good protection against initiation of oxidative damage reactions. AIBC proteins are synthesized in the liver and are maintained at fairly constant steady-state levels in serum; generally, the higher the iron (protein-bound iron), 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 ability of the liver to make iron binding proteins.
8. Percent iron saturation-expressed as a percentage (total iron/TIBC). This is the relative ratio of iron to iron binding capacity; the higher the iron saturation, the higher the risk of iron participating 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 body iron storage and possible long-term iron overload. Serum ferritin levels are associated with: a high number of free radical damage and a higher risk of developing most age-related diseases such as diabetes, heart disease and cancer.
10. Copper. Unbound copper is known to be even a more reactive pro-oxidant than iron, especially in the presence of strong reducing agents such as ascorbic acid (vitamin C) or homocysteine. High copper levels in serum can cause and correlate with high levels of oxidative damage. CuZn-superoxide dismutase and ceruloplasmin require small amounts.
11. Ceruloplasmin binds up to 95% of the copper found in serum. In normal patients, the amount of ceruloplasmin is directly proportional to the amount of copper in the serum. High copper concentrations are often associated with a significant amount of lipid peroxidation and risk of cardiovascular disease. Ceruloplasmin is considered an antioxidant, and therefore it acts as an iron oxidase (oxidizes free iron), thereby inhibiting its participation as a pro-oxidant in the removal of excess iron from the body, and is essential in the removal of excess iron from the body. Ceruloplasmin also acts as superoxide dismutase. A decrease in ceruloplasmin is seen in wilson's disease.
12. And (3) glucose. Glucose levels indicate that the patient is fasting or may indicate uncontrolled diabetes or hypoglycemia.
13. Glycated proteins (fructosamine) were used to measure the mean blood glucose level during the last 1-3 weeks before the time of sample collection. This assay measures all glycated proteins in serum [ total proteins, including albumin, but not hemoglobin (RBC) in whole blood ]. The amount of glycated proteins increases with oxidative stress and aging.
14. Oxygen radical absorbance capacity [ ORAC ] measures total antioxidant capacity in a sample. The ORAC value of 95% indicates a fast acting antioxidant in serum, which constitutes the first line of defense. These include ascorbic acid, thiols, uric acid, bioflavonoids, polyphenols, etc. The 50% ORAC values indicate serum use of rapid and intermediate acting antioxidants, including moderately active antioxidants such as albumin and lipids.
15. Aqueous ORAC-measures antioxidants in serum samples after removal of proteins and lipids. Due to their abundance, almost half of the full serum ORAC values are derived from proteins and lipids. Most proteins and lipids are not very active antioxidants (sacrificial) and reduce the sensitivity of the ORAC assay in measuring less abundant but more active antioxidants. Removal of lipids and proteins from serum samples increases the sensitivity of the ORAC assay in measuring other water-soluble antioxidants.
16. Lipid ORAC-measures antioxidants in serum samples after removal of protein and aqueous phases of the samples. Due to their abundance, more than half of the whole serum ORAC values are derived from protein and aqueous antioxidants. Removal of protein and aqueous antioxidants from the serum sample increases the sensitivity of the assay to measuring lipid soluble antioxidants.
17. Lipid peroxidation inhibition [ LPIC ] assay. Plasma antioxidants can be classified into two main types: (a) Primary antioxidants, such as ceruloplasmin and transferrin, which reduce the rate of initiation of lipid peroxidation by binding pro-oxidative metals; and (b) a secondary antioxidant, such as tocopherol, which reduces chain growth and amplification of lipid peroxidation. Many antioxidants (such as uric acid) also have a variety of antioxidant properties, and these antioxidants can bind many pro-oxidative metals as well as directly scavenge oxidative species. The LPIC assay measures the activity of both the primary and secondary antioxidant systems when they work together in a sample. In humans, low serum LPIC values have been shown to be strongly predictive of the development of adult onset diabetes.
18. Vitamin C [ ascorbic acid ]. Ascorbic acid can directly scavenge oxidizing species, and can generate other oxidized antioxidants, such as vitamin E. However, in the presence of free pro-oxidative metals (such as iron, copper, etc.) in the surroundings, the strong reducing power of vitamin C will catalyze the generation of oxidative radicals.
19. Mercaptans are very active antioxidants and reducing agents. Most serum thiols are found in albumin, subsequently free cysteine and glutathione. Albumin thiol is thought to act as a sacrificial antioxidant with little biological consequence of damage. Due to their high antioxidant reactivity and high concentration, albumin thiols act as a primary defense against free radical damage to cell membranes.
20. Lutein is a very active lipid soluble carotenoid antioxidant (2.3 times more vitamin E) that is readily absorbed into serum. Lutein and zeaxanthin are the major factors in the prevention of macular degeneration, which is the leading cause of blindness in the elderly and accounts for 10% of all blindness.
21. Zeaxanthin is a very active fat-soluble carotenoid antioxidant (2.8 times more than vitamin E) that is readily absorbed into serum. Lutein and zeaxanthin are involved in the prevention of macular degeneration, which is the leading cause of blindness in the elderly and accounts for 10% of all blindness.
22. Beta-cryptoxanthin is probably the most active fat-soluble antioxidant (3.1 times as much as vitamin E) and is readily absorbed into serum.
23. Lycopene is one of the most active fat-soluble antioxidants (2.8 times as high as vitamin E). Studies have shown that lycopene may be very important in the prevention of prostate cancer.
24. Alpha-carotene is a known antioxidant and a precursor of vitamin a. Experimental evidence demonstrates that alpha-carotene is a stronger antioxidant and cellular differentiation agent than beta-carotene and can therefore be better at preventing cancer.
25. Beta-carotene, a known antioxidant and precursor to vitamin a, has been widely used as a dietary supplement. It is a strong cell differentiating agent and thus can prevent cancer.
26. Retinol [ vitamin a ] is a known antioxidant and cell differentiation agent and thus can prevent many aspects of cancer and aging.
27. Retinyl palmitate. Retinol esters are most commonly used as a source of vitamin a in dietary supplements and foods.
28. Carotenoids. This group of carotenoids contains many atypical carotenoids which are likely to be beneficial for health. This value provides a good overall value for the consumption of fruits and vegetables.
29. Alpha-tocopherol (vitamin E) is one of the most typical and dietary fat-soluble antioxidants. In addition to its antioxidant capacity, it also has cell differentiation properties that are thought to perform well in the prevention of cancer.
30. Delta-tocopherol (vitamin E). Although not much is known about the beneficial effects of delta-tocopherol on humans, it is generally found in smaller amounts in food and human serum.
31. Gamma-tocopherol (vitamin E). The main type of vitamin E found in the heart and can therefore be selected for use in the body due to its unique properties as an antioxidant or as a differentiating agent.
32. Tocopherol/(cholesterol + triglyceride). The ratio of lipid antioxidant to the amount of lipid to be protected. It has been found that this type of parameter gives a much better indication of the risk for developing cardiovascular disease than 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 biofilms. CoQIO is also absorbed by the diet and can act as a very active antioxidant and protect LDL from oxidation.
34. Cholesterol. Cholesterol is a well-known risk predictor of cardiovascular disease by indicating the amount of lipids that may potentially be oxidized. The current theory for cardiovascular disease development is: LDL is oxidized and phagocytosed by monocytes, which become "foam" cells that become lodged in the arterial cell wall and cause fatty acid plaque lesions (plaques).
35. A triglyceride. Triglycerides are esters composed of glycerol and fatty acids bound to proteins called lipoproteins. Both triglycerides and cholesterol measure the total amount of lipoproteins in serum, which can be used as a rough indicator of cardiovascular disease risk. The associated cardiovascular disease risk prediction provided by triglycerides and cholesterol itself is actually low (44%); however, in combination with vitamins a and E, the ratio of (cholesterol + triglyceride)/(vitamins a and E) improves the risk prediction ability to 85% accuracy.
36. Albumin. Each albumin molecule contains many very reactive thiol groups, which act as effective antioxidants. Albumin is called a sacrificial antioxidant because it has no circulatory pathway and its consequences of injury do not directly affect cellular function. Albumin has a high turnover rate; damaged albumin is degraded and the body reuses good amino acids. Most other antioxidant mechanisms use some direct regeneration system (i.e., vitamin E, vitamin C, and glutathione peroxidase).
Total protein-includes albumin and immunoglobulins. Thus, the amount of globulin in a serum sample can be calculated according to a simple equation,
globulin amount = total protein-albumin amount.
38. The albumin/globulin ratio was used as a general marker for health and well-being. The ideal ratio is 1.85 or higher. A high immunoglobulin may indicate a long-term infection, which may increase the risk of developing autoimmune diseases.
39. Homocysteine. Homocysteine is a strong reducing agent and can promote the production of free radicals catalyzed by pro-oxidative metals. Elevated homocysteine levels are highly correlated with a high risk of cardiovascular disease. In most patients, hyperhomocysteine is caused by folate and/or vitamin B12 deficiency.
40. Folic acid. Folate is involved in DNA synthesis, red blood cell regeneration and homocysteine metabolism. Low levels are associated with birth defects, DNA damage and homocysteine accumulation. The deficiency results in increased DNA mutation rates, LDL oxidation, irreversible neurodegeneration, and anemia. Folic acid and vitamin B12 are synergistic in their effects.
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 homocysteine accumulation. The deficiency results in increased DNA mutation rates, LDL oxidation, irreversible neurodegeneration, and anemia. Vitamin B12 and folic acid are synergistic in their effects.
42. Low Density Lipoprotein (LDL). In the epidemic literature, called 'bad' cholesterol, LDL is positively correlated with heart disease risk. Prevention of LDL oxidation can be achieved by reducing free pro-oxidative metals, increasing water-soluble antioxidants (albumin, uric acid and vitamin C) and fat-soluble antioxidants (vitamin a, vitamin E, coQIO and carotenoids).
43. High Density Lipoprotein (HDL). In the epidemic literature, termed 'good' cholesterol, HDL is negatively associated with heart disease risk.
44. Apolipoprotein B is a protein found primarily on LDL, and thus is in fact a measure of LDL.
45. Apolipoprotein a is a protein found primarily on HDL, and thus is in fact a measure of HDL.
46.5-Dihydrotestosterone is a toxic form of testosterone that is known to cause male pattern alopecia and 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. Chronic exposure to elevated levels of cortisol has been shown to accelerate the signs of aging.
48. Dehydroepiandrosterone sulfate [ DHEA-S ]. DHEA-S is called the major hormone because it is a precursor for the synthesis of many other hormones. Since DHEA-S levels have been shown to decrease with age, it has recently become a very popular dietary supplement for raising hormone levels to the range seen in the young stages of life. DHEA-sulfate is a form that is normally stored in the body and therefore the supplement has fewer negative side effects than direct supplementation of DHEA.
49. Estradiol. Estradiol is associated with a high risk of developing breast cancer, particularly in postmenopausal women taking overdoses of supplements. Other forms of estrogen are reported to be safer. Women with a high long-term circulating amount of estradiol are known to reach the menopause earlier than normal women.
50. Insulin-like growth factor-1 [ IGF-1]. IGF-1 mediates the effects of Human Growth Hormone (HGH), such as stimulating cell renewal, repair, and growth. In normal patients, IGF-1 is produced in the liver in an amount proportional to growth hormone. Due to its long half-life, IGF-1 may be used to measure the average amount of growth hormone released over the past 48 hours. Because HGH has many circulating peaks throughout the day and night, single serum determination of HGH is not very accurate in determining HGH under or over release. HGH and IGF-1 injection have been shown to help the elderly rebuild muscle and strength, thereby improving their quality of life.
51. Progesterone. Progesterone is currently considered a popular supplement for enhancing memory and cognitive function.
52. Testosterone. Testosterone is responsible for the expression and maintenance of most adult male characteristics, such as facial hair and muscle growth. However, testosterone may be converted in some cells (e.g. hair follicles and prostate cells) into a toxic form (dihydrotestosterone, DHT) that is damaging to these cell types.
53. Thyroid Stimulating Hormone (TSH). TSH stimulates uptake of iodine by thyroid cells.
54. Thyroxine (T4). Thyroxine is a common steroid hormone that regulates metabolic rate and indicates proper thyroid function. The synthesis of thyroxine from iodine produces hydrogen peroxide as a byproduct. Those suffering from hyperthyroidism have been shown to have signs of accelerated aging.
55. Aluminum. The accumulation of aluminum in the brain is strongly associated with the onset of alzheimer's disease. This is considered to be the effect of the disease, not the cause.
56. And (5) antimony. Antimony is a toxin and there is no known human need.
57. Arsenic. Arsenic is a well-known respiratory poison.
58. And (4) 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 levels are known to cause osteoporosis, poor growth and maintenance of bones and teeth.
60 chromium. Industrial chromium is a very toxic pro-oxidant. A small amount of Cr +3 Are required in the function for regulating blood glucose levels and glucose tolerance proteins.
61. And (3) cobalt. Cobalt is a component of vitamin B12. It may be toxic at high levels.
62. Copper. Unbound copper is known to be an even more reactive pro-oxidant than iron, especially in the presence of strong reducing agents such as ascorbic acid or homocysteine. High levels of copper can cause oxidative damage. CuZn-superoxide dismutase and ceruloplasmin require small amounts.
63. Iodine. Iodine is required for the synthesis of the thyroid hormone thyroxine, which produces hydrogen peroxide as a byproduct. Iodine is a halogen (such as fluorine and chlorine) and can easily act as a free radical generator. Large amounts of iodine can be very toxic.
64. Iron. Unbound iron can act as a pro-oxidant by catalyzing the production of very reactive hydroxyl groups from hydrogen peroxide and strong reducing agents (such as ascorbic acid and homocysteine). High-speed rail (overload) is associated with: a high number of free radical damage and a higher risk of developing most age-related diseases such as diabetes, heart disease and cancer.
65. Lead. Lead is a well-known neurotoxin, which has no known human need.
66. Magnesium. Magnesium is essential for RNA/DNA synthesis, protein synthesis, ADP synthesis, and muscle contraction. Since it has a fixed external valence of +2, it can inhibit many iron-based radical generating reactions by transferring iron from its binding site. Magnesium has been shown to help prevent heart disease.
67. And (3) manganese. Unbound manganese is known to be a strong oxidizing agent, especially in the presence of strong reducing agents such as ascorbic acid or homocysteine. It is toxic at high levels. Manganese superoxide dismutase needs to be small.
68. And mercury. Mercury is a well-known neurotoxin, which has no known human need.
69. Molybdenum. Molybdenum is required by xanthine oxidase in converting xanthine to uric acid. Molybdenum is also required in aldehyde oxidases and sulfite oxidases in oxidizing these toxic compounds to less reactive products. Oxidases produce hydrogen peroxide as a by-product of their reaction.
70 nickel. Unbound nickel is known to be a strong oxidizing agent and is toxic at high levels. Small amounts of red blood cells and liver function are required.
71. Selenium. Unbound selenium is known to be a pro-oxidant with a similar valence to oxygen. It is toxic at high levels. Glutathione peroxidase is required in small amounts.
72 sulphur. Sulfur is essential for protein structure and enzyme activity; sulfur is also required in many detoxification reactions and can reduce the risk of human cancer development.
73. And (4) strontium. Strontium is known to inhibit vitamin d synthesis; it may therefore be an important risk factor for osteoporosis and bone deformities in developing children.
74. And tin. Tin is required for proper metabolism and growth of bone and teeth.
75. And (3) vanadium. Vanadium is involved in lipid metabolism. The absence of vanadium has been shown to increase cholesterol levels (high doses do not lower cholesterol beyond its normal set point). Current studies evaluate the ability of vanadium to kill cancer cells. Vanadium may be toxic at high levels.
76. And (3) zinc. Zinc is essential for metabolism, RNA polymerase and CuZn superoxide dismutase. Because it has a fixed external valence of +2, it can inhibit many iron-based radical reactions by transferring iron from its binding site. Zinc can be toxic at high levels.
Almost all biomarkers, which are determined directly from a test sample, are preferably measured by the most accurate, recently established biochemical assays using sophisticated, automated instruments.
After selecting a plurality of body sample tests from the possible body sample tests, the user transmits, by the mobile/handheld computing device, the 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 analysis unit.
The data transmitted by the mobile/handheld computing device may include authentication information that identifies the particular user and/or pet/animal and the mobile/handheld computing device of the user. The authentication information may include user credentials, such as a username, password, email address and answers to security questions, data access permissions/restrictions, geographic location of the mobile/handheld computing device, and information uniquely identifying the mobile/handheld computing device, such as a phone number or hash generated by the user profile.
Users of mobile/handheld computing devices may be required to log into the service before providing any information, and may be provided with an explanation of how and why their data is being used. Also, the user may be provided with the following opportunities: participation is temporarily or permanently halted at any time. This may also reduce the number of third parties attempting to spam the system by requiring users to opt-in and log-in to the service.
Preferably, the mobile/handheld computing device is a smartphone or tablet computer. In such embodiments, the machine-readable representation of the unique identification code takes the form of a Quick Response (QR) code or other matrix (two-dimensional) barcode that is readable by a scanner, such as by a camera of a mobile phone or other mobile computing device programmed to recognize and process the matrix barcode. In an alternative embodiment, 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 recognize and process the RFID.
Body samples may be taken by devices for sampling body samples, such as urine and blood, and may be positioned within containers for holding body samples. In one or more embodiments, the container is configured to sample a body sample.
A second aspect relates to a system for obtaining test results from a body sample, comprising:
-a container adapted to hold 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
-an analysis component configured to perform one or more tests on 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 the body sample associated with the unique identification code.
In one or more embodiments, a mobile/handheld computing device is configured to selectively retrieve data associated with a unique identification code that has been previously identified with a first identification code reader of the mobile/handheld computing device.
In one or more embodiments, the mobile/handheld computing device is configured to recommend one or more body sample tests from a plurality 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 respond to user input selected from the group consisting of: chronic disease state, family genetic disease, age, ethnicity, race, gender, height, weight, body Mass Index (BMI), body Volume Index (BVI), genotype, phenotype, disease severity, disease progression rate, measure of functional capacity, quality of life, intervention, and remedial action, and one or more body sample tests are recommended from the plurality of possible body sample tests.
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 a unique identification code from a container adapted to hold a body sample to a server at a network location and/or a database at an analysis unit.
The analysis component may be any type of component capable of performing a test on a body sample, either as an aid to an experimenter or as a fully automated system.
In one or more embodiments, the analysis component is configured to associate the test results from the body sample with the unique identification code on the container in which the body sample is held and store it on a server at a network location and/or on a database. Alternatively, the experimenter associates the test results for the body sample with the unique identification code on the container in which the body sample is stored 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 the test results from the body sample with the unique identification code on the container in which the body sample is stored. In certain embodiments, it may be an integral part of the analysis component.
The container suitable for holding a body sample may have any suitable shape or size and may be made of any material suitable for storing a body sample. Preferably, the container is made of a material capable of withstanding postal service transport, such as a rigid polymeric material. Preferably, the container is adapted to hold a small volume (1-50 ml) of a body sample for medical testing. Medical tests requiring small volumes of, for example, urine and blood are well known.
In one or more embodiments, the container further comprises means for sampling blood from the skin. In some embodiments, the means for sampling blood from the skin is an integral part of the container.
In one or more embodiments, a device for sampling blood from skin includes:
(a) A fluid conducting plate unit having one or more openings against the skin of a patient through which one or more lancets can pass in order to pierce the skin to cause a puncture wound, the plate unit having channels each for conducting fluid from the puncture wound; and
(b) One or more lancets positioned adjacent to its associated plate unit for passing through the one or more openings to pierce the skin when pressed into the skin;
wherein the plate unit comprises a first channel for conducting away a first part of the fluid and a second channel for conducting a second part of the fluid.
In the case of combining the fluid conducting unit and the 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, a blood sample, more representative of intravascular blood, can be delivered to a storage location by using two or more channels, one of which conducts away fluid containing more initial fluid from the puncture wound. Furthermore, a puncturing device with such an ability to select a suitable blood fraction can be manufactured as a compact, convenient plate-like unit, which can be easily inserted into a container. In addition, the plurality of lancets may be arranged such that the distance between at least two lancets is within a limit, such that the patient perceives only a single puncture when more than one lancet actually punctures the skin.
Human blood may require rapid separation of cellular blood components to obtain serum or plasma and thus avoid 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 includes at least one substance from the group consisting of an antioxidant, a coagulant, a disinfectant, a detergent, and an inhibitor. These substances advantageously hinder the degradation or alteration of the sample. Furthermore, the addition of disinfectant to the filter paper allows for the transport of dried blood spots originating from potentially infected material spots through ordinary mail service. Such disinfectants may include, but are not limited to: phenols and derivatives thereof, such as thymol, o-polyhydric phenols; cationic compounds, such as benzalkonium chloride, chlorhexidine; aldehydes, such as formaldehyde or others; and alcohols such as, for example, n-propanol.
In case separation of blood cells from blood is desired to avoid release of intracellular compounds from lysed or damaged and not fully hemolyzed cells, the filter according to the present invention comprises micropores with unequal micropore size 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 to use different types of filter paper and membranes that are impermeable to blood cells so as to cause separation of said cells and plasma by chromatography, filtration or capillary forces. For example, a filter spot in the center of a dry blood filter is permeable to blood cells and the surrounding paper is impermeable to blood cells.
The filter paper is impregnated with a substance that results in rapid clotting/coagulation without lysing and destroying blood cells and additionally a simple color indicator is used that allows later identification of the area of the filter paper outside the blood clot where only cell free blood (plasma/serum) "diffuses". By this method, only the filter paper area impregnated with cell-free plasma can be easily generated and identified.
In one or more embodiments, the container is configured for sampling blood from skin.
In one or more embodiments, the container includes a base and a lid that engages the base and cooperates with the base to define a housing configured to be in a closed or open state;
wherein the cover comprises generally opposing first and second surface sides, and wherein the second surface side faces the base in a closed state.
In one or more embodiments, the unique identification code is positioned on the second surface side of the cover and/or on the surface side of the base facing the housing. This is to hide the unique identification code when the container is loaded with a body sample and is thus in a closed state.
In one or more embodiments, the container further comprises a tamper evident lock (tamper evident lock).
In one or more embodiments, the container further comprises a tamper-evident lock, the tamper-evident lock comprising:
-a lock body housing a key lock, the key lock comprising a key hole;
-a member on the lock body for permanently retaining a seal effective to prevent access to the keyway; and
-a seal which is removable from the retaining member only by being broken, the breaking of the seal being effective to reveal tampering.
In one or more embodiments, the container also includes a seal that must be broken (e.g., 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 the body sample associated with the unique identification code.
In one or more embodiments, a mobile/handheld computing device is configured to selectively retrieve data associated with a unique identification code that has been previously identified with a first identification code reader of the mobile/handheld computing device.
In one or more embodiments, the mobile/handheld computing device is configured to associate the unique identification code with a plurality of possible body sample tests.
A fourth aspect relates to a container adapted to hold a bodily sample, the container comprising a base and a lid engaging the base and cooperating with the base to define a housing configured to be in a closed or open state;
wherein the cover comprises generally opposed first and second surface sides, and wherein the second surface side faces the base in a closed state;
wherein the unique identification code is positioned on the second surface side of the cover and/or on the surface side of the base facing the housing.
It should be noted that embodiments and features described in the context of one aspect of the invention are also applicable to other aspects of the invention.
Drawings
FIG. 1 illustrates a system according to various embodiments of the invention;
2A-B illustrate a container according to various embodiments of the present invention; and
FIG. 3 illustrates an exemplary embodiment of a user interface for a mobile computing device for use in the systems and methods of the present invention.
Detailed Description
Referring to fig. 1, a general scheme of the present invention is shown with respect to both the system and method. A customer of the system obtains a container 200, the container 200 being adapted to hold a body sample 230 and including a unique identification code 220. The user retrieves the unique identification code by invoking the scan function by an application executing on his/her smartphone 300. The application executing on the smartphone 300 associates a unique identification code with a plurality of possible body sample tests. The user then selects one or more body sample tests from the plurality of possible body sample tests by means of the application executing on the smartphone 300.
The application executing on smartphone 300 associates the unique identification code with the selection of one or more body sample tests and transmits the information/request over wireless network 120 to server 610 at the network location and/or database 620 at analysis unit 500. Preferably, the transaction (payment) for the service must be completed before the information/request is made available to the analysis unit 500. The user then positions the body sample 230 within the container 200 and sends it to the analysis unit 500, for example using a commercial delivery service. When the container 200 is received at the analysis 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 analysis unit 500.
The analysis unit 500 then uses the unique identification code to retrieve information about which body sample tests are to be performed on the body sample within the container from a server 610 at the network location and/or from a database 620 at the analysis unit 500.
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 server 610 and/or database 620 at the network location.
The user can then be actively notified by a text or push message on his/her smartphone.
The user then retrieves information regarding one or more body sample test results for the body sample 230 within the container 200 from a server 610 at a network location and/or from a database 620 using the unique identification code 220 with an application executing on the smartphone.
Figure 2 illustrates a container of various embodiments of the present invention. The container includes a base 205 and a lid 210, the lid 210 engaging the base and cooperating with the base 205 to define a housing configured to be in a closed (fig. 2B) or open state (fig. 2A).
The cover 210 comprises a first surface side 211 and a second surface side 212, which are generally opposite, and the second surface side 212 faces the base 205 in the closed state.
In fig. 2A, the unique identification code 220 is positioned on the second surface side of the cover 210. This is to hide the unique identification code when the container is loaded with a body sample and is thus in a closed state.
Fig. 3 illustrates an exemplary embodiment of a user interface 330 for a smartphone for use in the systems and methods of the present invention. When the circular button 332 on the touch screen 320 is pushed, the scan function is invoked to read the unique identification code 220. Four buttons 334-337 surround the circular button 332. Button 334 is used to retrieve information regarding the results of one or more body sample tests from a server at a network location and/or from a database. The remaining three buttons 335-337 are used to select different types of tests. Only the circular button 332 is active until the unique identification code 220 has been identified. After the unique identification code 220 has been identified, the circular button 332 is deactivated and the buttons 335-337 are activated. When the transaction (payment) for the service has been completed, button 334 is activated when the test results are ready.
Reference to
100 system
120 wireless network
200 container
205 base part
210 cover
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 push button
335 push button
336 push button
337 push buttons
500 analysis member/analysis unit
610 network location
620 database.
Claims (10)
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| DKPA201500319 | 2015-06-01 | ||
| PCT/EP2016/061665 WO2016193057A1 (en) | 2015-06-01 | 2016-05-24 | System and method for obtaining test results from a body sample |
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| CN108351920A CN108351920A (en) | 2018-07-31 |
| CN108351920B true CN108351920B (en) | 2022-10-04 |
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| CN201680045239.8A Active CN108351920B (en) | 2015-06-01 | 2016-05-24 | System and method for obtaining test results from a body sample |
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| CN (1) | CN108351920B (en) |
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| CN109900689B (en) * | 2019-03-28 | 2021-12-10 | 复星诊断科技(长沙)有限公司 | Anti-interference membrane and liver function combined test strip |
| CN110215211B (en) * | 2019-06-14 | 2021-10-22 | 成都高鹿科技有限公司 | Individual height measuring and analyzing method and system, readable storage medium and terminal |
| JP2022548289A (en) * | 2019-09-18 | 2022-11-17 | 日東電工株式会社 | Apparatus for dispensing and analyzing biological fluids |
| CN112562865B (en) * | 2021-02-18 | 2022-07-15 | 北京声智科技有限公司 | Information association method, device, terminal and storage medium |
Citations (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CA2560513A1 (en) * | 2004-04-08 | 2005-12-01 | Biomatrica, Inc. | Integration of sample storage and sample management for life science |
| EP2674887A1 (en) * | 2012-06-13 | 2013-12-18 | F. Hoffmann-La Roche AG | Controlling an analysis system of biological samples |
Family Cites Families (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US20020055176A1 (en) * | 2000-11-08 | 2002-05-09 | Ray Robert A. | Diagnostic assay system |
| EP2508896B1 (en) * | 2009-12-03 | 2019-04-17 | Hitachi High-Technologies Corporation | Automatic analyzing device |
| US20130116526A1 (en) * | 2011-11-09 | 2013-05-09 | Telcare, Inc. | Handheld Blood Glucose Monitoring Device with Messaging Capability |
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2016
- 2016-05-24 CN CN201680045239.8A patent/CN108351920B/en active Active
- 2016-05-24 EP EP16724433.4A patent/EP3304386A1/en not_active Withdrawn
- 2016-05-24 WO PCT/EP2016/061665 patent/WO2016193057A1/en not_active Ceased
Patent Citations (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CA2560513A1 (en) * | 2004-04-08 | 2005-12-01 | Biomatrica, Inc. | Integration of sample storage and sample management for life science |
| EP2674887A1 (en) * | 2012-06-13 | 2013-12-18 | F. Hoffmann-La Roche AG | Controlling an analysis system of biological samples |
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| Publication number | Publication date |
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| WO2016193057A1 (en) | 2016-12-08 |
| CN108351920A (en) | 2018-07-31 |
| EP3304386A1 (en) | 2018-04-11 |
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