US20120203465A1

US20120203465A1 - Systems, methods and program products for collecting and organizing health data

Info

Publication number: US20120203465A1
Application number: US13/397,360
Authority: US
Inventors: Denis Callewaert; Frank Lyman; Robert Smith
Original assignee: Individual
Current assignee: Wellness Indicators Inc
Priority date: 2010-07-26
Filing date: 2012-02-15
Publication date: 2012-08-09
Also published as: WO2012018535A2; WO2012018535A3; US20130122518A1; US10161928B2

Abstract

One example embodiment of the invention is a system for collecting, measuring and outputting health data including a plurality of readers that each determine a plurality of different biomarker measurements from a bodily fluid sample, the test readers communicating test data sets over a network. A central computer is linked to each of the plurality of test readers and receives the test data set, the central computer associates at least a first security key with the test data set. The central computer responds to a first request for a test output report that includes the first security key and retrieves the corresponding test data set. The central computer prepares a test output report that includes a plurality of bodily fluid test measurements and transmits it over a network.

Description

FIELD

Fields of the invention include systems, methods and program products for collecting, and organizing health data. Another field is wellness data determination.

BACKGROUND

Health of individuals is important for obvious reasons. Individuals often seek medical advice for diagnosis of disease and as an aid in the evaluation of an individual's overall health and wellness (e.g. as part of a periodic check-up). Unfortunately, consultation with medical professionals often has an economic cost associated with it that limits access for many.
The understanding of the science of health continues to increase. It is now possible to perform certain biochemical measurements on an individual's body fluid(s) and use the results as an indicator of risk for becoming afflicted with a variety of different ailments (e.g. cholesterol and lipoprotein analyses on blood samples). Due to the costs of seeking professional medical advice, the cost of the analyses themselves, in addition to other problems in the art, however, corresponding advances in the science of health and disease risk assessment have not been fully utilized.

SUMMARY

One example embodiment of the invention is a system for collecting, measuring and outputting health data. The system comprises a plurality of test readers that each determine a plurality of different bodily fluid measurements in a bodily fluid sample and that generate a test data set for each bodily fluid sample that comprises the plurality of different biomarker measurements and communicate the test data sets over a network. A central computer is linked to each of the plurality of test readers over the network and receives the test data set and stores the test data sets in a memory, the central computer associating at least a first security key with the test data set. The central computer responds to a first request for a test output report received over a network that includes the first security key by communicating a test output report that includes a plurality of bodily fluid test measurements and transmits it over the network.
Another example embodiment comprises a computer program product comprising executable instructions stored in a non-volatile non-transitory memory (with examples including but not limited to magnetic, chemical and optical memory media), the instructions when executed causing one or more computers to execute steps comprising: receive a plurality of individual test data sets over a network from test readers that are connected to the network, each of the plurality of test data sets generated from a bodily fluid sample taken from an individual and including bodily fluid measurement data for at least three different biomarkers that are useful to estimate oxidative damage, antioxidant capacity, and inflammatory status; store the plurality of data sets in a memory; associate a plurality of the test data sets with a first security key that corresponds to a related group in the memory; receive over a network a first request for a group output report, the request including the first security key; use the first security key to identify from the memory the plurality of test data sets that correspond to the group; calculate averages for each of the bodily fluid measurements from all of the test data sets that correspond to the group; and prepare a group output report that includes the bodily fluid measurement averages for the group and communicate the group output report over the network.

DESCRIPTION OF THE FIGURES

FIG. 1 is a schematic that is useful to illustrate some invention embodiments;

FIG. 2 is a schematic illustration of a bodily fluid test panel device of a system of the invention;

FIG. 3 is a representation of a sample test output report of an invention embodiment;

FIG. 4 is a representation of sample data stored by an invention embodiment;

FIG. 5 is a flowchart illustrating steps performed by an example system or program product of the invention.

DETAILED DESCRIPTION

Before describing example embodiments of the invention, it will be appreciated that the invention may be embodied in one or more of a system, method, software, or program product. Accordingly, it will be appreciated that in describing one example embodiment of the invention, description of other embodiments may likewise be had. As an example, when describing a system of the invention, description of a method, software or program product may also be had. Additionally, a method of the invention may be carried out by a system of the invention, and a program product of the invention may be stored on one or more non-volatile memories linked to a system of the invention that when executed cause the system to carry out a method of the invention.
Example systems, methods and program products of the invention are directed to collecting, storing, processing, and outputting health data. As an example, a system can be provided for collecting, storing, processing and outputting data obtained from measurements performed on bodily fluid samples from individuals, with or without additional information on the individual (such as height, weight, age, gender, lifestyle and health history data that may be input manually or electronically populated and is incorporated into the complete record for a specific test) in a highly efficient manner to provide a useful indication of the individual's overall health, wellness and/or relative risk for contracting one or more illnesses. The bodily fluid sample is contained in a test sample holder, which may contain discrete components for the measurement of multiple substances in bodily fluids for convenience and to reduce time and expense. Resulting test data is measured by a device which may be comprised of a single physical unit or multiple separate components for the measurement of biomarker(s) and for the control of certain aspects of the function of the measurement component and for computation of the results, processing of an on-site report, and transmission of data to a central computer, stored, processed by a central computer. Resultant test reports can be provided to individuals and others in a variety of useful and customizable formats. In some embodiments test results are stored over time so that individuals and others can measure changes in the levels of biomarkers and other metrics of health and wellness over time. In some embodiments, the tests and results are particularly well suited for estimating an individual's overall wellness, which may be thought of as health and/or resistance to one or more chronic diseases.
In further embodiments, pluralities or even multiplicities of individuals that are related to one another to form a group can have their test data organized, analyzed, and otherwise treated as a group. This provides some powerful and useful advantages and benefits over the prior art. One example group is a selected general demographic category(s) (any combination of age, geographic location, gender, lifestyle profiles), another may be employees of a particular employer or students from a particular school, and others are combinations of these (e.g., all women between ages of 35-40 that are employees of a particular company). Such groups can obtain an overall health profile for their members, map it over time, compare individuals or group averages to other selected groups or universes, and in some embodiments make predictive projections of health care costs, incidences of particular diseases and other predictions.
Description of particular example embodiments may now be had, with reference drawn to FIG. 1. A bodily fluid sample is held by a test sample holder, with one example being test panel device 10 test panel device may include urine, feces, blood, saliva or other bodily fluid sample, or some residue thereof, and may include a DNA sample. In many embodiments, the bodily fluid test panel device 10 includes (or is) a dip stick cartridge that supports, contains or otherwise holds one or more urine dip sticks having multiple discretely arranged testing channels or test pads, each of which is embedded with reagents that react with different biochemical components in the bodily fluid sample such as urine. In addition to a dip stick, other test panel device test panel device 10 configurations include (but are not limited to) a microfluidic or a lateral flow immunoassay device and the like. When testing bodily fluids other than urine (with examples including saliva and blood), other configurations may be desirable.
Although other bodily fluids may be utilized in invention embodiments, it has been discovered that many embodiments find significant utility through use of urine. Urine offers advantages in many embodiments since its collection is relatively easy and noninvasive, collection and handling poses minimal infectious disease risk to participants and operators of the testing system and since urine provides sufficient volume for multiple assays. Urine specimens are well suited for large studies because they can be collected and stored by participants, costs of collection are relatively low, and compliance is high.
A test subject such as a person (not illustrated) may provide a urine sample that is communicated to the bodily fluid test device 10 through immersion, dropwise addition, capillary flow, or other manner. In some embodiments the bodily fluid test device 10 includes a plurality of reagents that react with a plurality of different biochemical components of urine. The term biomarker as used herein broadly refers to a substance or group of substances in a biological sample that is (are) associated with a specific disease or condition, with an example being glucose in urine being associated with a hyperglycemic condition of a diabetic individual. The product of the reaction of a given biomarker with reagents, chemicals or antibodies in a specific pad or channel of the test panel device test panel device 10 may result in a color or other detectable change, which detectable change that can be detected and preferably quantified by the reader device 16A. In some embodiments, a bodily fluid test panel device 10 may be comprised of test pads or channels that discretely measure the levels of two biomarkers, in others three biomarkers, others four biomarkers, others five biomarkers, others six biomarkers, others seven biomarkers, and others additional numbers of biomarkers. Including a plurality of different biomarkers on a single bodily fluid test device 10 provides advantages related to efficiency of time, cost, effort and others.
The bodily fluid test panel device 10 may be provided in any number of different mechanical, chemical and/or immunochemical configurations in different invention embodiments. As indicated above, in some embodiments it may include a polymer cartridge containing a urine dipstick. Many aspects of the science of bodily fluid testing, with urine testing being one example, are generally well understood by those knowledgeable in the art and these aspects need not be detailed herein and will not be for sake of brevity. A brief summary of relevant aspects, however, is provided for completeness.
Many (but not all) embodiments of the test panel device 10 use dry chemistry technology. A dry chemical media is provided and attached, held by, supported by or otherwise contained in or on a plastic frame or holder. The dry chemical media may include a dry carrier such as paper, powder (which may be compressed into a solid), pad, gel, glass or plastic fiber or other media that is loaded, embedded, impregnated or otherwise carries one or more reagents which, when exposed to a bodily fluid such as urine, will react to produce a detectable (and in many embodiments a quantitatively measurable) change in physical property. In some embodiments, the reaction product results in a color change. Other examples of physical changes include fluorescence and a change in redox potential.
Again, when practicing an invention embodiment that is directed to testing of urine, urine dipstick technology may be utilized with the dry dipstick media carried in a polymer case for convenience, hygiene, security and other reasons. As further indicated above, in many invention embodiments the bodily fluid test device 10 provides for convenient testing of a plurality of different biomarkers in a single test. Accordingly, some test panel device 10 include different reagents arranged in a particular spatial order with discrete sections to allow for measurement of different biomarkers from a single bodily fluid sample. FIG. 2 is a schematic of one example test panel device 10 in which five individual test pads 12 are arranged in a particular spatial order along the length of the test panel device 10. In other embodiments a single test pad may be embedded with different reagents in a discrete spatial arrangement to provide a similar result. In either case, the entire test panel device 10 may be exposed to a single bodily fluid sample (through dipping, dropwise addition, spraying, other fluidic transfer, or other).
In some invention embodiments that utilize urine, adjustments are made to account for the concentration of the urine specimen. The concentration of biomarkers in urine specimens can depend on an individual's hydration status, time since last urination, and other factors. In some embodiments, test subjects may be directed to follow certain instructions prior to fluid sample collection, such as not urinating for at least 30 minutes prior to the sampling, restricting the intake of fluids on the day (or other period of time) in which the sample is to be obtained, avoiding caffeinated beverages, following other dietary guidelines for a particular time period, and the like. In addition to these steps, some embodiments further include quantitative measurement of a parameter associated with urine concentration. Some invention embodiments may measure the creatinine level in a urine sample and/or the specific gravity of the sample as an indicator of the relative concentration of the sample. Urine specific gravity is the ratio of the density of a urine specimen to the density of water, and increases with solute concentration. It can be measured, for example, by refractometry. Alternatively, dry chemistry technology can be used in which a change in color is directly proportional to the specific gravity of the sample at a given pH value. Creatinine is a byproduct of muscle activity, and is cleared from the bloodstream by the kidneys and excreted in urine. Urinary creatinine concentrations can be determined by colorimetric assay, and analyte concentrations are usually reported as a ratio of the analyte concentration to creatinine concentration. Creatinine is typically present in urine in a generally known range. Likewise, urine typically has relatively known specific gravity ranges, and the average specific gravity of random urine specimens for individuals within a population have been reported (e.g. 1.020 for North American adults).
Embodiments of the invention can measure one or more of these and use the measurement to estimate urine concentration. In some embodiments, the measurement is used as a pass/fail determination—if in an allowed range the sample is deemed acceptable and vice versa, but no changes to the bodily fluid measurements are made. In other embodiments bodily fluid measurements are adjusted or normalized based on the estimated urine concentration.
In one embodiment, the concentration of creatinine in the specimen is measured using a discrete dry chemistry test pad, the general compositions of which are known and need not be discussed in detail herein for sake of brevity. If the creatinine concentration falls within a specified range, then the measured values for all of the biomarkers measured by the test panel device 10 are divided by the concentration value obtained for creatinine and may be expressed in common units such as micrograms/milligram of creatinine. In this embodiment, if the concentration of creatinine is below a specified value (e.g. below 10 mg/dL in some but not all embodiments) then in some invention embodiments the sample may be considered too dilute to permit accurate analysis of the biomarkers therein, and a report may be generated indicating that the sample is too dilute and that the subject should provide another sample at a later time to permit more accurate analysis. In some embodiments employing creatinine for normalization, an upper limit may also be specified to improve accuracy since the relationship of the color produced in typical creatinine dry chemistry technologies is logarithmically related to the concentration of the specimen such that the change in color approaches a plateau value at high levels of creatinine. In this case, (a) a report may be generated indicating that the sample is too concentrated to permit accurate measurement of biomarkers, (b) the operator may dilute and reanalyze the sample, or (c) a fixed high creatinine value may be used for normalization of concentrated specimens.
In another embodiment the specific gravity, measured by refractometry or by a discrete channel or dry chemistry test pad or other method, the general steps of which are well established and need not be discussed herein for sake of brevity, is used for normalization. Further, given the known dependence of the typical colorimetric methods for measurement of specific gravity on the pH of a sample, an additional test pad or channel may be included in the test panel device 10 to measure the pH of the specimen, and this value may be applied to mathematically correct the apparent specific gravity measurement for improved accuracy of the normalization process in some but not all embodiments. As for normalization employing creatinine, if the specific gravity falls within a specified range (e.g. 1.003-1.040 in some embodiments), then the measured values for all of the biomarkers measured by the test panel device 10 are normalized based on the specific gravity measurement in some but not all embodiments. One algorithm that may be employed is to adjust the value obtained for each biomarker to that which would be observed in a sample with the specific gravity of the population norm. Thus, for North American adults, the sample concentration value is multiplied by (1.020−1.0)/(the specific gravity of the sample−1.0), so that for a specimen with a specific gravity of 1.010, the normalized value of a biomarker would be twice that of the measured value.
As for normalization to creatinine, if the specific gravity is below a specified value (e.g. below 1.003) then the sample is considered too dilute to permit accurate analysis of the biomarkers therein, and in some embodiments a report or indicator may be generated indicating that the sample is too dilute and/or that the subject should provide another sample at a later time to permit more accurate analysis. In this embodiment employing specific gravity, which is linearly related to the concentration of the specimen, there is less error introduced for concentrated specimens so that normalization is expected to be accurate over the entire specific gravity range for that population, provided that the raw or unnormalized concentrations of each biomarker lie within the measurable range for each of the discrete test pads or channels of the test panel device 10. Thus normalizing concentration of each biomarker reported for an individual based on the concentration of the sample significantly improves the utility of urine biomarkers for evaluation of health and wellness compared to others within the population and for longitudinal tracking of an individual's health and wellness. It will be noted once again, however, that normalization is not necessary to all invention embodiments and some embodiments may find utility in avoiding any normalization steps. The example bodily fluid test device 10 also includes a unique identifier (“ID”).
Because most applications for invention embodiments will be related to health and medical testing, it can be important to maintain a reliable and secure chain of identity—to ensure that the bodily data obtained using the test panel device 10 is correctly associated with an individual subject that provided the bodily fluid and to ensure that the privacy of test results can be maintained. It is also useful to provide for the recognition by the test reader 16 of specific lot numbers of test panel devices 10, which may be valuable to avoid an operator using an expired lot, to reduce the possibility of inferior counterfeit test panel device 10 devices, to allow for lot-specific adjustments to standard curves or other parameters. It can also be used in combination with the reader device 16 to permit the analysis of multiple test panel device 10 configurations, such that the identifier encodes the nature and order of the dry chemistry or other analytical components and signals that the reader should analyze the reflectance or other physical change at specified wavelengths after specified time intervals.
One example way to benefit these needs is to provide each test panel device 10 with a unique ID which can be recorded at the time of bodily fluid submission (or another time) and related to an individual test subject's name and/or other personal or identifying information. Many varieties of unique ID's can be provided with different invention embodiments. These include, but are not limited to, alphanumeric strings, one two or other dimensional barcodes, other optical means, radio frequency identifiers, and others. The schematic of FIG. 2 illustrates one example unique ID 14 in the form of an optical bar code. Although the example ID 14 is illustrated on the same surface as the pads 12, in some embodiments it may be useful to orient it on the opposite or another different surface for compactness.
The bodily fluid test device 10 is submitted to a test reader 16 for measurement of the concentrations of a set of biomarkers in a bodily fluid. The test reader 16 may be configured in many different manners in different invention embodiments. In some embodiments a test reader may be a dedicated electronic device that is connected to a processor based device such as a computer that controls it, records the resultant data as well as other biometric information that may be manually or electronically added to the file, performs the normalization, generates a report for that sample. The connection may be through a traditional BUS or other analog/digital connection. In other embodiments a different test reader may be integral with a computer, or may otherwise include a processor, memory, display and other computer related components. Many other potential test readers are contemplated in other embodiments. As an example, in still other embodiments a test reader may be a highly compact, portable and wireless handheld device that optically scans a test panel device 10.
In the attached FIGS., the test reader is illustrated as a stand-alone electronic device 16A connected to a separate computer 16B. “A” and “B” designations have been used with the two components in FIG. 1 to indicate that they may be considered in the context of some invention embodiments as two parts of a single component. The computer 16B may be a traditional commercial laptop or other computer that includes one or more processors, a non-volatile (such as a magnetic or optical memory) and volatile memory(s) (such as a RAM memory), data input such as a keyboard, mouse, disk drive, optical reader or other device, display such as a monitor, microphones, cameras, speakers and the like. The computer 16B may be executing a program product of the invention, a client incidence of a client-server program product of the invention, or other program product. The computer 16B may also be a dedicated computer that has been configured only to operate within the scope of the invention. Because the test reader 16A and associated computer 16B operate in conjunction and in some embodiments are integral with one another, reference herein to “test reader” will be understood to include reference to both a test reader 16A and computer 16B and/or a test reader 16A or computer 16B that includes the functionality of the other.
In many embodiments, the test reader 16 finds utility in portability. Portability allows for convenient use in applications such as mobile testing, for example. In an example application, employees at an office, factory or other location may be tested. Portability of test reader 16 allows for convenient use in such applications, with a test operator traveling to the location and administering tests on site. This is particularly useful in applications that include testing of bodily fluid samples that have a relatively short time window of accuracy, with an example being many urine biomarker applications. In some urine testing embodiments, depending on the urine dipstick and other technology used, the sample may be refrigerated or treated with a preservative to impede bacterial growth. However, for greater accuracy in the analysis of a number of urinary biomarkers, preservatives or cold storage may influence the measured biomarker, so that the sample should be analyzed within a few hours—test results in some embodiments lose accuracy after this time period. In some embodiments, testing is performed within 1 hour, within 2 hours, within 3 hours, within 4 hours, or within other time limits. Portability helps address related issues since urine samples can be obtained on-site for groups and the like.
The test reader 16 may operate in any number of different functional manners suitable for performing different bodily fluid measurements. As used herein, the term “bodily fluid measurements” is intended to broadly refer to measuring some aspect of a bodily fluid, including but not limited to measuring a biomarker contained within the bodily fluid, whether measured directly or indirectly. In many (but not all) embodiments a bodily fluid measurement includes a quantitative or semi-quantitative measurement of the presence or concentration of a biomarker. As used herein, a quantitative measurement is intended to broadly refer to one in which a relatively accurate numerical value (e.g., for a concentration) is determined, and a semi-quantitative measurement is one in which an approximate numerical value (e.g., for a concentration) can be estimated. Other embodiments include making qualitative measurements in which no numerical value is determined, but instead a determination is made regarding a quality indicator (e.g., color, pass/fail, presence/absence, other).
It will be appreciated that there are a multitude of potential manners of operation of different test readers of the invention to perform a bodily fluid measurement. Many aspects of the technical operation of a reader suitable for use in invention embodiments are known in the art and need not be detailed herein. The configuration of a particular test reader will depend necessarily on the configuration of the bodily fluid test panel device 10. In most embodiments, a cooperating relationship exists between the test panel device 10 and test reader 16—the test reader 16 necessarily is configured to measure concentration indicators that the test panel device 10 is configured to indicate, and in particular to cooperate with the biomarker to be measured. One example bodily fluid test reader 16 and cooperating test panel device 10 exploits chemical reagents embedded in the test panel device pads 12 (FIG. 2) that react with particular biomarkers within a bodily fluid components to produce a color change, with particular color indicative of the biomarker concentration.
Chemical compositions that produce colored products upon interaction with a number of biomarkers are generally known, but will be briefly described herein below. A wide range of chemical compounds are known to absorb light, with the result that exposing a compound to a known spectrum and measuring light that absorbed and/or reflected at or near certain wavelengths can be used to identify the presence of particular compounds, and/or their concentration. In embodiments of the invention that exploit this technology, the test reader 16A is configured to employ photodiodes or other elements that emit light of particular wavelengths and/or intensity and photodetectors to measuring reflectance/absorbance to determine color and/or degree of color change. By comparison to results obtained for known standard biomarkers, the resulting reflectance/absorbance measurements can be converted to determine a particular biomarkers concentration within a bodily fluid using a known calibration that may be stored on the reader 16A, a computer 16B or elsewhere. In addition to performing bodily fluid measurements, the test reader 16A reads the unique sample and test panel ID 14 (FIG. 2) from the test panel device 10.
The test reader 16A may include various digital and analog components useful to perform the bodily fluid measurements, to read the unique ID 14, and to create a resulting test data set. For example, in an example test reader 16A a plurality of light emitting and reflectance/absorbing measuring components may be spatially arranged to cooperate with the test panel device 10 and its arrangement of pads 12 and unique ID 14 (FIG. 2) so that measurements may be taken from each pad 12 independently and unique ID 14 independently. The light emitting components direct a known spectrum of light toward the test panel device pads 12, and the reflectance/absorbing components measure the resultant reflectance and/or fluorescence. A difference between the emitted and light due to reflection or fluorescence can be measured in toto or over a specific portion of the electromagnetic spectrum and used to determine presence and concentration of particular biomarkers based on their reaction with specific reagents.
Further, test reader 16 and test panel device 10 may be configured in a cooperating manner so that the test panel device 10 is received in a particular and predictable orientation so that pads 12 and unique ID 14 are located in a known location upon insertion of the test panel device 10 in the test reader 16. This can be accomplished in any number of manners, with examples including a mechanical arrangement featuring a cooperating slot or keyed arrangement, a motor driven loading tray that loads the test panel device 10 along a consistent path to a known location. A test reader 16A may also be provided with a digital checking mechanism that includes one or more location markers on the test panel device 10 that are confirmed to be in their required locations before test reading was undertaken. In many embodiments, the test reader 16 makes the plurality of bodily fluid biomarker measurements simultaneously for purposes of efficiency, speed of sample throughput and others. In some other embodiments, the measurements of different pads are not simultaneous, but done in series by a one or more scanners and other components that travel along the length of the test panel device 10.
In some applications there can also be commercial advantages to including security information on the test panel device 10. In some commercial applications, revenue will be received through sales of test panel devices 10. In these applications, there may be risk that a competitor will reverse engineer the test panel device 10 and sell competing products at a lower price that can be used with the test reader 16. To mitigate the risk of this, including the potential for inferior test panel device 10 counterfeits the results from which may not be derived from standard curve data for authentic test panel device 10, some embodiments of test panel device 10 include digital or other security information that acts as a “key” for use of the test reader 16. In these embodiments test reader 16 initially examines the test panel device 10 searching for the presence of the security information before conducting a test. If the information is not present, no test is performed. The security information may be overt or covert, with some examples including a digital bar or other code (similar or identical to ID strip 14), a second digital or other code that in addition to ID strip 14, an RFID chip (which may be on or embedded within the test panel device 10), and others.
The above discussion has focused on a test reader 16 and test panel device 10 that utilize color change and cooperating optical measurement technology to measure biomarker concentration and/or presence. As indicated, many other technologies will be useful in other embodiments. These may include, but are not limited to, illumination at a specified wavelength of light and, e.g. by employing band pass filters, measurement of only the light emitted at a different wavelength by fluorescence, measurement of the refraction of light as it passes through a chamber within the FTD 10 device, (e.g. wherein the refraction of light may be used to determine the specific gravity to evaluate the relative concentration of a urine sample), the measurement of light emitted at a wavelength at which a specific chemical reaction used to quantify a biomarker does not exhibit any significant change in intensity with the biomarker concentration (known as the isobestic point) for purposes of internally calibrating the change in intensity at a second wavelength that is responsive to the concentration of the biomarker, control reaction pads that are sensitive to temperature and which can be used to detect exposure of the test panel device 10 to conditions that would damage its function, control chemical components in the test panel device 10 that may be used to quantify the relative amount of fluid that is taken up by the device and thus the amount of the sample being analyzed, control pads or channels that may be used to correct for endogenous absorption, reflection and/or fluorescence of light by the specimen (e.g. yellow or amber colors of urine or plasma specimens) and/or determination of the redox potential of a biofluid.
The test reader 16 after performing bodily fluid measurements, with or without the separate input (manually or from remote data source) of additional biometric data on the individual being tested, creates a test data set. The test data set may include, for example, quantitative concentrations of biomarkers present in the bodily fluid measured by the test panel device 10, normalized values after adjustment (e.g. based on creatinine or specific gravity values determined by the test panel device 10) in addition to a value corresponding to the unique ID 14. The test data set may be in the form of a digital file that includes numerical values representing biomarker concentrations, identifying and biometric information on the individual tested and an alphanumeric string that corresponds to the unique ID 14, for example, with one value corresponding to the concentration of each biomarker (and corresponding bodily fluid biochemical component) present in the bodily fluid sample 10.
The particular bodily fluid measurements made in invention embodiments will vary with application. Again, in many embodiments, a plurality of measurements are made simultaneously from a single test panel device 10. In some embodiments, bodily fluid measurements that measure concentration of biomarkers that correspond to oxidative stress, anti-oxidative activity, and inflammation are useful. A number of different such bodily fluid measurements will be useful in different invention embodiments, with examples including the following:

Biomarkers/Biochemical Components for Measuring Oxidative Damage:

TBARS (Thiobarbituric Acid Reactive Substances)
Organic Hydroperoxides
Protein Carbonyls
Measure of oxidative damage to specific molecules
Lipids

- Malonaldehyde
- 4-hydroxynonenal
- Lipid hydroperoxides
- Isoprostanes
- Linoleic acid oxidation products

Proteins

- Protein carbonyls
- Nitrotyrosine
- Nitrothiols

Nucleic Acids

- M1dG (malondialdehyde deoxyguanosine)
- 8-hydroxy-deoxyguanosine
- Oxidized derivatives of ribose ring

Small Molecules and Ions

- Selenium
- GSH or GSSG and the GSH/GSSG ratio (Glutathione in reduced (GSH) and oxidized (GSSG) states)

Biomarkers/Biochemical Components for Antioxidant Power

Direct Methods—Measure Reaction with Redox Probe

- CUPRAC (cupric reducing antioxidant capacity) Total Antioxidant Capacity or TAC (using copper-bathocuprione method)

Indirect Methods (Measure Resistance to Oxidation of a Probe by an Added Oxidizer)

- FRAP (ferric reducing ability of plasma)
- TRAP (total reactive antioxidant potential)
- ORAC (oxygen radical absorbance capacity)
- HORAC (hydroxyl radical antioxidant capacity)

Measurement of Molecules that Contribute to the Total Antioxidant Capacity

- GSH or GSSG and the GSH/GSSG ratio
- Glutathione Peroxidase
- Superoxide Dismutase
- Uric acid
- Ascorbic acid

Biomarkers/Biochemical Components for Inflammation

Cytokines (TNF-α, IL-6, IL-8)
Other Proteins

- Osteopontin
- Albumin
- Orosomucoid
- α1-microglobulin

Eicosanoids

- PGE₂and metabolites
- PGF_2α and metabolites

Other Molecules

- Nitric oxide byproducts (NOx=nitrate+nitrite)
- Urinary proteins
- Histamine
  Biomarkers Associated with Hypertension
- 20-HETE

In one example embodiment, an oxidative bodily fluid measurement can incorporate either a relatively specific method to quantify malondialdehyde (MDA) or 4-hydroxyonenal (4HNE) as biomarkers for lipid peroxidation and/or the less specific 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 damage to specific biomolecules or classes of biomolecules with some examples listed above. High levels of these biomarkers indicate the level of oxidative stress that is occurring in an individual, while low levels of these biomarkers indicate a relatively healthy individual.
Oxidative stress occurs when an abnormal level of reactive oxygen species (ROS), such as superoxide and/or hydroxyl ions, and/or hydrogen peroxide, lead to damage of molecules in the body. ROS can be produced from fungal or viral infection, aging, UV radiation, pollution, excessive alcohol/tobacco consumption, drug metabolism, the uncoupling of electron transport systems in mitochondria, among other conditions. ROS can further cause many pathological conditions including age-related macular degeneration and cataracts, and is known to play a role in the development of multiple chronic illnesses including type 2 diabetes, cancers and cardiovascular diseases.
Antioxidants help to control the level of ROS in the body and thus minimize oxidative damage to biomolecules and pathologies that may result. Tests have been developed to quantify many of the antioxidants that are produced by the human body. However, none of these have thus far been reduced to practice for the routine assessment of overall health and wellness. A number of complex tests have been developed to estimate the total level of all antioxidants in a specimen. Many of these tests, e.g. the ORAC test that is widely used to assess that antioxidant activity of foods and beverages, are intended for relatively sophisticated laboratories and involve the addition to a biological specimen of a dye that changes color upon oxidation, along with a source of ROS. In such tests, the higher the antioxidant activity of the specimen, the longer it takes for the dye to change color. Some embodiments of the invention utilize colorimetric tests for monitoring the antioxidant power of a biological sample due to multiple component antioxidants. These antioxidant power tests, sometimes called an antioxidant capacity tests, that employ copper-cuprione complexes (typically neocuprione or bathocuprione) or other complex that has a redox potential of approximately −0.6. In particular the CUPRAC (cupric reducing antioxidant capacity) method, which employs a copper-neocuprione complex, for measuring the sum of the antioxidant activity due to multiple endogenous as well as exogenous (e.g. antioxidants derived from food and vitamin supplements) is particularly useful for providing as integrated value for an individual's ability to maintain a healthy response to ROS.
In some invention embodiments, further information may be included in the test data set. It may be useful in many embodiments that measure individual wellness data to collect various additional physical, personal and demographic data. As used herein the term demographic data is intended to broadly refer to data that may be useful to establish a related group. This might include, for example, demographic categories such as residence information, employer information, gender information, and other. In some embodiments, for example, additional information is provided by a test subject. This data may be manually provided through oral or written communications, or in another manner (with examples including scanning of an identity card such as a license/credit card, finger print scanning, retina scanning, and other). An operator can enter the information at the computer 16B using a keyboard, mouse or other. In some embodiments, a credit card, license or other media with personal information can be scanned by the computer 16B. Personal, physical and demographic data that may be collected in invention embodiments includes but is not limited to demographic categories including:

- Name
- Date of birth
- Social security number/Drivers license number/other government issued identification
- Height/weight/waist size/chest size/wrist and ankle diameter
- Gender/race/nationality
- Medical history (e.g., “history of high blood pressure,” “diabetic,” “allergies,” etc.)
- Family medical history (e.g., “history of high blood pressure in family,” “family history of cardiac issues,” etc.)
- Past or present marital status (e.g., “currently married,” “divorced”)
- Level of education (e.g., “high school graduate”, “2 years college,” etc.)
- Geographic residence (e.g., “current resident of Chicago, II” or “current resident of zip code 60606,” or “current resident of Alabama”)
- Tobacco use profile (example—“smoke 20-40 cigarettes per week,” or “smoke 4 cigars a month” or “do not use tobacco”)
- Alcohol use profile (example—“consume less than 1 drink per day” or “consume 2+ drinks per day” or “consumer 10-15 drinks per week”)
- Drug use profile (examples—“currently using anti-depressant” or “currently using anti-prescription inflammatory” or “currently using prescription blood pressure medication”)
- Exercise profile (examples—“vigorous exercise for at least 2 hours per week” or “exercise 20 minutes per day” or “run 1 mile twice weekly”)
- Vocation (e.g., “carpenter,” “office worker,” “professional,” “attorney,” “police officer,”)/Employer
- Contact information (physical residence address/e-mail address/work address)

This and other data may be included with the test data set. Some of this information does not change, with an example being the name, gender, social security number and date of birth. This information that remains constant over time is referred to herein as “permanent personal information.” As will be detailed further below, in some invention embodiments individuals or groups may submit for multiple different tests over time. In such embodiments, this permanent personal information need not be represented every time a test subject submits a test, but instead can be recalled from prior tests for convenience. In some embodiments the test reader 16 may also record a timestamp that corresponds to the time of measuring the bodily fluid test panel device 10, and includes this timestamp with the test data set. The timestamp may be, for example, a day, month and year. It may be calculated using a clock internal to the test reader 16, may be retrieved from the network 20, may be manually input by an operator, or may otherwise be provided.
Also, for security or sensitivity purposes, some data (including demographic data) may be modified or otherwise adjusted. As an example, in some embodiments a user social security number could include only the final four digits or some other portion, the date of birth may be limited to only a month and year (no day), residence information may be limited to city and state only (no street), user names may be partial or assigned pseudo-names, and the like. In these embodiments, some advantage may be had in terms of security by not collecting and storing highly sensitive information such as a social security number.
Once a test data set is created by the test reader 16, the dataset with or without a copy of a comprehensive text profile generated based on algorithms that are dependent on the biomarkers and other data, is communicated over a data link 18 to a network 20, then to a central computer 30. The data link 18 may be a wired or wireless link, with examples including a cellular phone communications link, a radio frequency connection, a PSTN communications link, a digital communications link, and the like. Similarly, the network 20 may be any of a number of different communications networks, with examples including a wired or wireless phone network, PSTN, a digital network, a local area network, a wide area network, the internet, an internet successor such as the fast internet or next generation internet, a cellular communications network, combinations of one or more of these, and the like.
The central computer 30 may be any number of processor based devices, with examples including a laptop, desktop, or server computer, a mainframe computer, and others. The computer 30 may include one or more memories (volatile and/or non-volatile), one or more displays, one or more data input devices (with examples including keyboards, mouse, microphone, others). The central computer 30 may be executing a program product of the invention, or a server incidence of a program product of the invention, and may have the same stored on a volatile or non-volatile memory. Although the central computer 30 has been illustrated as a single computer in FIG. 1, it will be appreciated that in some embodiments the central computer 30 may include the functionality of a single computer spread across a plurality of computers. Indeed, current technology blurs the definition of computer, with many current devices including processors, memories and other components that are capable of executing stored instructions, storing data, and otherwise functioning as a computer.
In many embodiments, the central computer 30 serves important data processing, organizing, storing, and reporting functions. In many (but not all) embodiments the central computer 30 stores in a memory, for example, average ranges for bodily fluid measurements that can be compared to the bodily fluid measurements from an individual test data set for calculation of a relative bodily fluid measurement. In some other embodiments, the reader 16 (and/or computer 16B) may store these average values in a memory so that these calculations of relative measurements can be made without access to the central computer 30. As used herein, the term “relative” when used in this context refers to a measurement that is compared to a population range of the same measurements. As an example, a relative measurement may include a percentile or scaled or similar ranked measurement, with the result that an individual's bodily fluid measurements may be reported in comparison to a larger universe for context (e.g., “oxidative stress level is in the 35^thpercentile,” or “oxidative stress is a 7.2 on a scale of 1 to 10,” etc.).
The central computer uses this stored data and the test data set communicated from the test reader 16 to create a test output report. The test output report may be configured in any number of different forms as may be desirable. Indeed, as will be detailed below, one of the advantages of systems and methods of the invention is the ability to create highly customized test output reports to serve different needs. In many embodiments, however, the test output report will include a plurality of relative bodily fluid measurements in addition to some personal and demographic information. FIG. 3 illustrates one example test output report.
As illustrated in FIG. 3, the example test output report presents relative biomarker measurement results in a graphical format for convenience of consideration. Biomarker measurements that quantify oxidative damage, for example, are summarized by providing a numerical index for oxidative damage on a color coded line graph, with one end of the line and one color representing the lowest numerical value and corresponding best result, and the distal end of the line having a different (and often “opposite” with red and green being an example) color and representing the highest numerical value and corresponding worst result. This is a useful feature of some invention embodiments, using color to indicate results. Textual indicators may also be provided (e.g., “low, medium, high” or “reduced, elevated, highly elevated”, etc.)
It has been discovered that test output reports that present biomarker measurement results in this relative form are more easily understood and are more likely to have an impact on individuals. For example, it has been discovered that in the context of invention embodiments individuals appreciate health test results favorably through use of color coding which can include, for example, green for healthy readings, yellow for less healthy measurements, and red for most unhealthy measurements, with gradual color shading used to transition from one to the other.
It has also been discovered that obtaining and providing a plurality of different relative bodily fluid measurements in a single test output report has similar benefits and advantages. The impact of multiple test results that may be related to one another appears to be much more impactful than a single test result might be. Also, some invention embodiments are directed to measuring an individual's so-called wellness (generally recognized as including metrics such as physical activity, body mass and lifestyle that are healthy and/or low levels of biomarkers that are indicative of risk for chronic illnesses), as opposed to diagnosis of a particular disease or ailment. These embodiments make measurements of biomarkers in body fluids useful to generally assess an individual's capacity to resist general classes of disease and ailments. For these embodiments, a test output report that includes a plurality of relative biomarker measurements in body fluids including the following has been discovered to be particularly useful: oxidative stress or damage (e.g. bodily fluid measurements of the biomarkers TBARS and MDS), inflammation (e.g. bodily fluid measurements of urinary protein and for NO_x), and total antioxidant capacity (e.g. relative bodily fluid measurements of TAC). In addition to bodily fluid measurements, a test output report may include other results with one example including a body mass index (BMI) that is calculated based on input of an individual's height and weight. Other data such as age, ankle and/or wrist diameter, waist and chest diameter, may also be useful to assess wellness relative to one's peers. Some or all of the personal and demographic data may also be provided. The central computer also stores the bodily fluid test data set and the corresponding test output report in one or more memories.
In some invention embodiments, the demographic data may also be used in formulating a test output report and/or test output data. Demographic data may be used in combination with numerical results to further estimate some aspects of a subject's wellness and disease risk and to provide information on the test output report. For example, demographic data indicating that a subject is a heavy smoker or heavy user of alcohol and that has an elevated level of a biomarker(s) for oxidative stress might be useful to provide a recommendation for lessening the oxidative stress level. At least some literature supports the proposition that smoking cessation reduces oxidative stress using one biomarker. Hence, individuals with high levels of oxidative damage and whose demographic data indicate they are a smoker may obtain a test output report identifying the smoking as a major source of oxidative stress and recommending cessation. Other literature show that exercise increases an individual's antioxidant capacity, so subjects that provide demographic data suggesting they are sedentary and who have with low values for an antioxidant biomarker(s) may receive a test output report that suggests increased exercise to improve antioxidant levels.
Additionally, it is known that strenuous exercise increases oxidative stress biomarkers in the short term, but that the levels return to the basal level within 12-24 hrs. However, systematic exercise programs elevate the endogenous antioxidant levels, which otherwise deteriorate with age or reduced physical activity. So for test subjects that provide demographic data that indicate high levels of physical activity and whose test results indicate high levels of antioxidant biomarker(s) and oxidative damage biomarker(s), the report may indicate that they be retested after abstaining from strenuous exercise for some period of time (e.g., 24 hrs).
Test output reports may be communicated as desired. Individuals that submitted a bodily fluid sample will be one destination for test output reports. These individuals may be mailed (by physical or electronic mail) a test output report. The test output report may be communicated over the communications network 20 to a computer 16B for printing on an attached printer (not illustrated), viewing on a display, or for storing in a memory for future use. Also, an advantage of many invention embodiments is that the test output reports are stored in a memory by the central computer 30 for presentation as desired. An individual may be provided access to the central computer 30 over the data network 20 (or otherwise) so that they can retrieve their test output report as desired whenever and wherever they may be. The individual may submit a request from a home computer, from a work computer, from a portable computer, from a portable communications device or from any number of other devices capable of communicating with the communications network 20. Again, for purposes of ensuring security of what may be sensitive information, test output report communication and storage may be encrypted. Storage and communication may utilize other high security measures to avoid data breach.
By way of example, FIG. 1 shows a mobile communications device 34 that may be a cellular phone, a radio phone, a radio, a smart phone, a gaming or entertainment device or other mobile processor based device that is in communication with the network 20. An individual may use this mobile communications device 34 to communicate a request over the network 20 to the central computer 30 for a test output report. The central computer 30 may respond to this request by communicating the corresponding test output report to the communications device 34, which may display it on a local display, communicate it to another device (monitor or printer or other) for display or output, and/or store it in a memory for future use.
In order to associate an individual with their corresponding bodily fluid test data set and/or a corresponding test output report, the central computer necessarily must be able to identify the stored data with the individual referenced in the request it has received. There are a number of particular steps that can be undertaken to achieve this, but most have in common that some information included in the request can be used to identify the stored data. This may be, for example, personal data such as an individual's name, social security number, address or the like. Also, in many invention embodiments, the test reader 16 and central computer 30 are configured to provide and recognize a unique security key that is associated with an individual. As used herein, the term “security key” is intended to broadly refer to a unique identifier that may be communicated digitally. It can be, for example, an alphanumeric string such as a password.
In some corresponding invention embodiments, the test reader 16 is configured to provide the security key to the individual before the test data set is communicated to the central computer 30, while in other embodiments a request is communicated to the central computer to create a security key which is then communicated to the test reader 16 before the test data set is communicated to the central computer 30. In still other embodiments, the initial test data set may be communicated to the central computer 30 which then creates a corresponding security key and communicates it to the test reader 16. Individuals may also be permitted to create a desired security key for convenience.
In some embodiments more than one security key is provided. As an example, an individual may be asked to create a username and password (each of which may be a security keys in the context of the invention). In these embodiments, the central computer may confirm that the user name and password are available for use through a dialogue, and then assign these to the individual as well as corresponding test data sets and test output reports. Indeed, data used in various invention embodiments may include sensitive personal information, including identification and health related data. Some invention embodiments may include numerous features to ensure a high level of data communication, storage and reporting security. This may include, for example, multiple security keys, data encryption, highly reliable storage procedures, and the like. Data communicated to and from central computer 30, including but not limited to test data sets and test output reports, may be encrypted. In some embodiments encryption may include installation of a client codec on client devices, sharing of a digital encryption key between client and server, and the like.
It may also be useful for one or more others to have access to test data sets and test output reports in addition to the individual that submitted the bodily fluid test sample. Health care professionals that care for the individual, relatives, employers, insurers and others are some examples of others that may find utility in accessing stored test data sets and/or stored test output reports. In these embodiments, the individual can provide his security key to others as he desires so that they can access stored data. Or, in some other embodiments the test reader 16 and/or the central computer 30 are configured to provide one or more additional security keys. In some embodiments different security keys may carry different levels of access, with a first security key allowing access to all stored data, a second security key providing access to only a limited subset of the stored data, a third security key providing access to a still further limited data set, etc.
It may also be useful to organize test data sets, test output reports and other data by groups and to treat that data as a group. Groups may be any number of individuals that are related to one another in some manner. As an example, an employer may contract to administer testing to all of its employees. In addition to providing test output reports to individual employees, in such embodiments the employer may wish to have access to the test output reports for all of its employees. Accordingly, the central computer may provide a security key to the employer that is common to all employees. The different security keys may have different levels of access so that a first security key can access more stored data than a second key. This can be useful, for example, so that an employer can access some but not all stored data for its employees, while employees can access all information.
As discussed above, the central computer 30 of invention embodiments provides unique benefits and advantages through novel data processing, organizing, segmenting, storing, and output features. Some of these features correspond to organizing test data sets into groups. Organizing data into groups may be useful for a variety of different purposes. Groups can be created using data stored by the central computer, or can be defined when submitting data. As an example, in some embodiments a group could be created using demographic data for all women between the ages of 30-35, for all individuals that reside in a particular geographic location (e.g., city, state, county, zip code(s), etc.), all individuals of a certain vocation, and any number of other selections using existing, stored data. In still other embodiments, a group can be created upon submission of initial test data sets. As an example, a test reader 16 operator may input data confirming that a data set to be created by the reader is part of a group. A plurality of corresponding test data sets may include a common group identifier, which may be an assigned alphanumeric string.
These and other aspects of data storage and organization of systems, methods and program products of the invention can be further illustrated through consideration of a portion of an example database of an invention embodiment as shown in FIG. 4. This database may be created by, stored on, and/or retrieved from a non-volatile memory (which may be magnetic, optical or other) that is within or accessible by central computer 30. Although FIG. 4 illustrates a general chart, it will be appreciated that this is an example only and is provided as one example illustration of data that can be stored and organized by systems, methods and program products of the invention. In many embodiments, the data may be manipulated within the configuration of a relational database. In the example of FIG. 4, individual test data sets are organized as rows and categories of data organized by columns. This is a somewhat simple example for purposes of illustration, and it will be appreciated that some actual test data sets will include far more data.
As indicated, each example test data set includes an individual name, a username (representing a first security key), two additional security keys, a birthdate (DOB), a test date (date the test was given), residence, race (coded), group, gender, tobacco use profile (expressed in a code corresponding to severity of use), education (expressed in number of years), vocation (coded), body mass index (BMI—expressed in a code), and normalized (and/or un-normalized or raw) bodily fluid measurement values for five different biomarkers (BM1-BM5). This information can be organized as desired, and may be grouped as has been illustrated in FIG. 4, with “personal data” including DOB, race and gender (columns A-D); security information including three different security keys (columns E-G); other personal data including a group identifier for first and second groups (if any), residence address, tobacco use profile, education level, and vocation (columns H-M); actual test data including a test date and five individual bodily fluid measurements (organized as biomarker measurements or BM) (columns N-T), and a test ID (corresponding to data from ID strip 14 which may be a unique test identifier). It will be appreciated that the data of FIG. 4 is an example only, and that in practice test data sets may include more, less, or different data, and may be organized in different manners.
FIG. 4 shows BMI or body mass index. As is generally known, body mass index can be routinely calculated using weight and height. Body fat percentage estimation, and similar additional metrics, for example, can sometimes also depend on age, waist, chest, wrist, ankle and other measurements. In some invention so embodiments, the underlying data is included in the test data set and stored by the central computer 30 in a memory. In other embodiments, however, the underlying data is provided by a user, but the resulting calculation is performed and only that resulting value stored (as opposed to the underlying data). Also, in some embodiments these calculations are performed by computer 16B with only the resulting calculated value communicated to the central computer 30, while in other embodiments the underlying data is communicated to the central computer and the calculations made by the central computer 30. This illustrates an aspect of the present invention that will be appreciated related to interchangeability of central computer 30 with computer 16B. It will be appreciated that many calculations and other tasks can be made by either of these. Selection of which to use will often be made for purposes of efficiency in many cases it may be more efficient to have one or the other computer perform a particular task. It will be appreciated that selection of one of the other will not escape the scope of the invention.
By way of further illustration of this aspect of the invention, in some invention embodiments the test output report can be generated (including making of all required calculations as described above) can be performed by the local computer 16B. The local computer can store, for example, in a memory all of the data required to generate normalized or relative measurement data. This can be advantageous, for example, in applications in which a network 18 is not available and for other reasons. Again, encryption of the data report may be used in some embodiments for security purposes when it is stored and/or communicated over the network 20.
To further illustrate various features of invention embodiments, assume that a company named “Acme” desires to estimate the overall wellness of its employees. Further assume that Acme has a facility in Chicago and one in Milwaukee. This information may be input by one or more operators using a computer 16B, central computer 30 or other device over network 20. Central computer 30 responds by creating a first group for Acme (indicated by “acme” in FIG. 4, col. H) and a subgroup for each of the Chicago and Milwaukee facilities (indicated by “Chi” and “Mil” in FIG. 4 col. I). An operator, a computer 16B, or the central computer 30 further creates a security key for Acme—“acmeJ23.” This security key may be communicated to an Acme manager or other representative of Acme to facilitate their access to stored test data sets and/or stored test output reports for Acme employees that will be created.
A plurality of employees at each of the Acme Chicago and Milwaukee facilities are then tested. Each employee provides a bodily fluid sample which may be urine. A different test panel device 10 is exposed to each urine sample. Permanent personal data (FIG. 4, col. A-D) and other personal data (Col. H-M) is collected for each individual employee Individual and associated with the corresponding test panel device 10 (FIG. 2). This can be accomplished, for example, by individual employees providing a paper form that is provided with their urine sample, by computer 16B retrieving the data from an Acme database accessible over computer network 20 (not illustrated), by an individual employee or other operator entering the data in response to queries or through a provided form on computer 16B or other computer accessible to network 20, or through other appropriate steps.
Individual test panel device 10 for each Acme employee are then read by a first test reader 16 that is temporarily located at the Acme Chicago facility and by a second test reader 16 that is temporarily at the Acme Milwaukee facility. Individual test data sets are created for each individual employee including the data as indicated in FIG. 4. A username and password (constituting two different security keys) are created for each employee, either by computer 16B or by central computer 30.
This may be accomplished, for example, by computer 16B requesting creation of a new individual account from central computer 30 which responds by providing a unique username and password to computer 16B. An individual account may be thought of as a user identity that will be associated with one or more test data records. Computer 16B may have also included in its request to central computer 30 that the new account would be associated with the Acme group as well as the appropriate subgroup. Or, in an alternate embodiment, when creating the Acme group and Chicago/Milwaukee subgroups, central computer 30 may have been informed of the total number of employees to be tested at each facility (and in some embodiments their names) and created a corresponding number of new accounts.
Each individual test panel device 10 is then read by reader 16A to make individual biomarker measurements BM1-BM5. The body mass index may be calculated by computer 16B (or may be calculated by central computer 30). An individual report may be created by the computer 16B and, along with the test data record communicated from computer 16B over the links 18 and network 20 to central computer 30. Central computer 30 stores the data records in a memory using the general organization as shown in FIG. 4. By way of further illustration of the Acme hypothetical, the test data sets shown in rows 1-5 are stored, with those of rows 1-3 corresponding to Acme employees at the Chicago facility and rows 4-5 Acme employees at the Milwaukee facility. Again, it will be appreciated that FIG. 4 that includes 5 Acme employee individual test data records represents an abbreviated example only, and that in practice tens, hundreds, thousands or more of test data records may be stored.
FIG. 4 illustrates test data sets for two individuals that are associated with the AARP group (rows 6-7), and a test data set for an individual that is not associated with any group (row 8 for Hank Right). The AARP test data sets do not have a second group identifier (no entry in column I). This indicates that for the AARP group no sub-groups have been set up. The Hank Right test data set in row 8 has no group association, which might result if Mr. Right, for example, submitted a bodily fluid sample for testing at his physician's office, at a pharmacy, or other location as an individual.
The final row of FIG. 4 (row 9) is a second test data set for Joe Smith, one of the Acme employees. This test data set, however, is not associated with the Acme group, which could result if Mr. Smith submitted a second bodily fluid sample for testing at another time/location from the Acme business testing. The security data for this test data set overlaps with that of the earlier Smith test data set (shown in row 1), except that there is no security key 3 associated with it (no entry in column G). The username (security key 1) and security key 2, however, are the same as for the first Smith test (row 1). This might result if when submitting his second bodily fluid test sample, Mr. Smith submitted his existing username and security key 2. This may be done, for example, by Mr. Smith filling out a paper form that is read by a test reader 16, by Mr. Smith entering the username and security key directly into test reader 16 using a keyboard, microphone or other data input device, by Mr. Smith providing an identity card or other data carrying device that is read by a test reader 16, or in other steps. When one or both of the computer 16B or central computer 30 receives this information, they may respond by providing Mr. Smith's permanent personal data (columns A-D) from Mr. Smith's prior test that is constant. This data may be directly populated into the second test data set for convenience so that Mr. Smith need not be required to present it a second time.
The request received from Mr. Smith (or someone acting on his behalf) might specify particular desired report characteristics. These might be, for example, a request for a test output report including only relative data for BM1 and BM2.
Additionally, the data of FIG. 4 indicate that three different test data sets exist for Mr. Smith, each taken at a different time. The request for a test output report submitted by Mr. Smith may specify which of the different test data sets to use to create the desired test output report. Also, the request might specify that the test output report should include relative results calculated over time using multiple test data sets. In Mr. Smith's example, it might be useful for him to have a test output report that showed changes in relative biomarker measurements over time. This can be useful, for example, to measure changes in his biomarker levels over time as Mr. Smith attempts to modify his lifestyle (through changes in diet, exercise, or other), or conversely a decline in wellness due to age and no lifestyle changes. Similarly, a group such as Acme could request to view results for its group as they change over time. Aggregate data for Acme employees may also prove useful for Acme to obtain lower rates for coverage.
As indicated above, some of the advantages and benefits of invention embodiments are related to the operation of the central computer in generating highly customizable and useful test output reports. This can be accomplished using the data organized in the table of FIG. 4. FIG. 5 illustrates one example set of steps for generating a test output report which may be embodied in a method or program product embodiment of the invention, or performed by a system of the invention. In discussing the flowchart of FIG. 5, it will be appreciated that various elements of FIG. 1 (and in particular the central computer 30) and data of FIG. 4 will be referenced. Element numbers of these FIGS. will be understood to refer to those FIGS.
The central computer 30 first receives a request for a test output report from the network 20 (block 52). The request may be communicated from an individual such as Mr. Smith, an employer such as Acme, a health care provider representing an individual, or from another source. It can be communicated using any device in communication with the network 20, including computer 16B, smart phone 34, or other device.
The central computer then queries the request to identify what individual(s) a test output report is desired for (block 54). This step also includes the central computer confirming that that request has presented sufficient security key(s) to access the requested data (block 54). If the proper security keys are not provided, an error message results (block 58) and no data is provided. If a request includes proper security keys, the process of collecting and organizing data continues (block 60).
By way of further illustration with regard to resolving security keys, a request may have been received for an output report that specifies the name “Hank Right” or otherwise specifies Mr. Right as shown in row 8 of FIG. 4. In order for the central computer to proceed, the request must necessarily identify Mr. Right and include one or more of the required security keys shown in columns E-G of FIG. 4. As previously discussed, some invention embodiments allow for different levels of data access to be provided with different security keys. As an example, a first request that specifies a test output report based on Mr. Right's data could include the username “Left1” and second security key 899925 shown in columns E and F. The central computer may recognize the inclusion of these two security keys as a signal to allow full access to the Mr. Right's data included in row 8. This username and second security key may have been provided, for instance, to Mr. Right, with the understanding that he would use these to retrieve his test data when desired.
A different request received by the central computer that specifies Mr. Smith may include the third security key shown in col. G of FIG. 4 (Q88P), but not the first or second security keys. The central computer when executing block 56 will recognize this as a signal to provide only limited access to the data. As an example, the access may be limited to only the test data of columns N-S but no other data from row 8. Or, limited access may allow for test data of columns N-S as well as selected (but not all) other personal data and permanent personal data. Many variations may be practiced as desired.
Referring once again to FIG. 5, after the proper security keys have been confirmed, the request is queried for details of the desired output report. As discussed above, some benefits and advantages of embodiments of the invention relate to highly capable, versatile and customizable data processing and reporting capabilities of the central computer 30 and/or computer 16B. Accordingly, in some invention embodiments test output reports are highly customizable and corresponding requests for an output report may specify details of what is desired on the test output report. The input of such detail may be provided through an on-line menu on a processor based device in communication with the network 20 (with examples including computer 16B and portable device 34), through paper forms, or through other means. Also, for convenience, one or more standard output reports may be offered that provide pre-selected relative bodily fluid measurements. Examples of particular output reports will be provided below through further illustration of various invention embodiments, with one such example report illustrated in FIG. 3 and discussed above.
In almost all output reports data from a test data set will be required. In the manner generally discussed above, the central computer 30 retrieves required data from the corresponding test data record(s) (block 62). Again, the required data will vary depending on details of the desired output report. Many requests will require retrieval of only a single test data set, while others may require retrieval of a plurality. As also discussed above, many embodiments feature output reports that provide relative data. This has been discovered to offer unique benefits and advantages as discussed above. To provide relative data, an individual test data set is compared to a larger universe of data to provide further context. A wide variety of universes may be selected and will be determined by the central computer through specifications in the request (block 64).
The central computer 30 may store the universe data in a memory (local or accessible over network 20). Taking the BMI data from FIG. 4 as an example, the central computer 30 may store a universe for BMI data that includes a mean, median, standard deviation(s), maximum, minimum and other statistical averages from across tens of thousands of samples that shows an expected range of from 18 to 30, with a mean of 23.2 and median of 23.7. The universe data may be segmented as desired according to demographic categories, with examples being universe data presented by gender, age, occupation, residence, or any other desired demographic category. Universe data may be obtained from literature or other sources.
Also, in some invention embodiments, advantages and benefits are achieved by configuring the central computer 30 to develop universe data as desired using stored test data sets, as reflected in block 64. Development of universe data is further customizable in invention embodiments as may be desired. It has been discovered, for example, that great utility can be achieved by allowing users to define their own universe. As an example, the Acme employer or an individual Acme employee may wish to view the results of his biomarker measurements relative to the universe of all Acme employees. In this case, test output reports for an individual could be prepared which compared that individual's BM1 measurement to the overall universe of BM1 measurements of all members of the Acme group.
The central computer 30 accomplishes this by retrieving all records specifying the Acme group identifier in column H of the table of FIG. 4. Or, the particular employee may wish to compare their results to only female Acme employees that use tobacco, are married, are accountants, and live in Chicago. Again, the central computer 30 could accomplish this by selecting corresponding records from the table of FIG. 4. Although this universe may appear somewhat arbitrary, it is useful to illustrate the capabilities of invention embodiments in developing a desired universe across a great variety of potential variables that may be useful for one or another reason. A number of universes may be developed using any number of different stored demographic and personal data. The central computer 30 may facilitate selection of the desired universe through presentation of menus or other graphical selection criteria to a user over the network 20.
Referring again to FIG. 5, once the corresponding universe has been retrieved or developed, relative bodily fluid measurements are calculated and the test output report assembled (block 66). The output report may include relative bodily fluid measurements as desired and specified by a user, with an example shown in FIG. 3. In many output reports, advantages and benefits are gained by providing a plurality of biomarker measurements. Relative biomarker measurements may be presented in a graphical form as discussed above and illustrated in FIG. 3, any may include a color grading to aid comprehension. Additional information may be presented in the output report, including but not limited personal information, group information, or other. The assembled output report is then communicated over the network 20 for storage, display, printing or other use at a remote device such as computer 16B, portable device 34, or the like (block 66).
In some embodiments availability of various output reports will also vary with level of security key access. As an example, a representative of the Acme employer may wish to view overall results for the universe of Acme employees, or a selected sub-group such as the Acme Milwaukee facility, male employees between the ages of 30 and 35, or other. The Acme representative may have been provided only the security key “AcmeJ23” shown in column G of FIG. 4. Presentation of this security key in the request communicated to the central computer 30 may allow for access to only limited portions of the test data sets for the Acme employees, with an example being the test data (FIG. 4, columns N-S) but no, or in some embodiments a limited set, of personal and permanent personal data. This may be useful to protect some portions of personal data. In other embodiments, presentation of a particular group level security key such as the AcmeJ23 of column G will provide access only to statistical values representing the overall group data but not any single test data set. So, by way of illustration, in some embodiments presentation of the AcmeJ23 security key serves as a signal for the central computer to include on a test output report only the average, range, mean, median and other statistical values for the Acme group, but not any individual biomarker measurement data.
Test output reports may also present biomarker measurement data taken over time. Again, it has been discovered that this allows for benefits and advantages related to individuals and groups being able to measure changes over time as behavior, diet, and other factors change. A request processed by the central computer may specify, for example, that a particular user desires to have all their bodily fluid measurements charted over time, either in raw (i.e., not relative) form or in relative form. This could be accomplished, for example, by a user specifying some or all of their permanent personal data, security key information, or other data that is associated with each of their test data sets, and the central computer 30 then using this to search a memory or database and identity every test data set that corresponds to that user. Referring to FIG. 4 by way of example, Joe R. Smith has two test data sets (rows 1 and 9) which each have common first and second security key information as well as permanent personal data.
The unique data gathering, storing and reporting capabilities of invention embodiments can be exploited in a number of other ways to offer other valuable benefits and advantages not previously available. As an example, the data stored by invention embodiments can serve as the basis for predictions of future events. As an example, correlations can be utilized to predict future rates of incidents of various diseases, health care costs, and the like for groups or individuals. A correlation could be referenced, for example, that associates the average BM1, BM2, BM3 and BM4 for the Acme employer to predicted health care costs for the coming years. Acme might provide access to its security key 3 to an actuary or other entity that could review data and make such predictions.
Embodiments of the invention also include developing such correlations. Acme and other employers could provide their health care costs by year, for example, which can then be compared to average bodily fluid measurement data to create a health care cost correlation. Such predictive data will find utility in a multitude of applications. One example includes actuarial applications for insurance companies. An insurance company providing insurance cost estimates or determining annual premiums for the Acme company, for instance, could find great use in having all Acme employee test data records and applying a correlation factor to their average measurements to predict future health care costs.
In further invention embodiments, comparisons of different groups' statistical data values can be made for predictive purposes or other purposes. As an example, assume that a central computer 30 of the invention stores test data sets for 17 different Acme facilities, each located remotely from the other. If Acme is considering closing one facility, expanding one facility, it could find utility in comparing statistical data for each different facility to identify those that may have particularly high or particularly low relative bodily fluid measurement data (e.g., particularly healthy or unhealthy facilities). Doing so may be useful to predict expected relative health care costs which can aid decision making. Similarly, Acme may wish to identify which of its 17 facilities has the healthiest workforce so that other facilities can model operations on that facility.
Still other embodiments include further features of analyzing data sets. As the system acquires new data sets, multiple data analysis and cultivation opportunities are presented. Indeed, an important advantage of some invention embodiments lies in their scalability. As the volume of data collected grows, the value of statistical and other information to be gained from the data grows. Analysis of accumulated data is not limited to averages for populations or groups. As an example, as data sets are added, some embodiments further interrogate and identify subgroups at a highly granular level. Such identification can be useful to achieve further predictive usefulness.
In addition to a relatively straightforward subgroup such as Acme employees from one factory, an illustrative example includes identifying a subgroup based on a behavioral change. Data sets for users that stop smoking, begin exercising, or have other behavior change(s) may be useful to offer guidance for others considering the same change as to how data will change in the future and otherwise what to anticipate in the future. Changes other than behavior can be used as well, with examples including loss of a specified amount of weight, geographic moves, employment changes, and others. Further, analysis may be performed from a results perspective going backward to identify subgroups. As an example, some embodiments may employ statistical analysis to identify common traits among users that have reported some measureable change in one or more biomarkers or other data (e.g., a weight loss of 10% or more). Some subgroup may be identified through such analysis that share some common trait(s).
In still another embodiment, a further security key(s) may be provided to access multiple different groups for comparison sake by a third party. Assume that in addition to Acme, the data of FIG. 4 includes group data for a multitude of other companies. An insurance company that is quoting insurance to two of those companies may find utility in accessing the overall statistical values for each company to compare them to one another and determine which should be quoted a higher insurance cost. Similarly, if a third company is considering acquiring Acme or one of its competitors, it may find value in accessing the overall statistical values for each company to compare them to one another and determine which is likely to have higher health care costs in the future. These example embodiments illustrate that some benefits and advantages of some invention embodiments will increase with scale—as more bodily fluid measurement data sets are collected the statistical value of the data to various third parties increases.
Invention embodiments offer still further opportunities to achieve valuable benefits and advantages. As an example, in addition to test data, the central computer may receive, associate with a user and store in a database such as that illustrated in FIG. 4 further data. An individual may upon providing sufficient security information (such as one or more security keys) communicate weight, blood pressure and date data to the central computer 30 so that this data is associated with the user's already stored data. In this manner, the data stored by the central computer may include other data in addition to data sets generated by test readers 16, and may include other data directly input by users at a later time. This may be useful, for example, to create a single health or wellness data collection that a user can track over time to track changes that occur in not only their biomarker measurements but other data that does not require a test reader 16 to determine, with weight, blood pressure and other data being an example. Upon receiving a corresponding request, the central computer 30 may output any selected data in a graphical or other form. A user could, for instance, obtain a chart that plots their weight and other data over time. From a commercial standpoint, these central computer capabilities of allowing users to input and to store and output other data in addition to data sets from test reader 16 may provide significant commercial advantages. It may create additional reasons for users to access the central computer 30 which leads to higher traffic and therefore greater opportunities for advertising or other revenue.
In a still further example embodiment, advertising revenue is collected based on targeted advertising to users as they access data or otherwise interact with central computer 30. Some system, method, and program product embodiments of the invention provide targeted advertising over the network 20. As used herein, the term “targeted advertisement” is intended to broadly refer to selecting particular advertisements for specific users based on some data for that user, as opposed to using the same advertisement for all users. In invention embodiments the advertising is targeted based on some defined criteria using data stored by the central computer 30 related to particular users. In invention embodiments, the targeted ads may be determined based on test data sets, demographic data, or other data.
As an example, in some invention embodiments users that indicate they are high frequency exercisers may be targeted for exercise equipment advertising, users that are identified as having lost a significant amount of weight may be targeted for clothing advertisements (since they may need new clothing), users that indicate they are heavy alcohol users may be targeted for alcohol ads (or substance abuse treatment ads), suggestions for birthday dinners may be provided to a user in advance of a user birthday, and the like. Almost infinite opportunities will exist for targeted advertising as the scale of stored data grows. Advertisements may appear as pop-up or other visual content on a screen connected to the network 20, may be in the form of telephone calls, e-mail instant or other electronic communications, paper mail, or other.
Still other features of some invention embodiments include automated communication of test readers 16 over the network 20. This can be useful to update software running on test readers 16, to diagnose test readers 16 that require maintenance, to automatically track status of test readers 16, and for other purposes. In most embodiments, test readers 16 require execution of some stored program code. Such code will be updated from time to time, with different versions being identified using different version numbers. Likewise, test readers 16 may require periodic maintenance to check and/or repair operation of various components. In some invention embodiments, test readers 16 are configured to communicate over the network 20 with central computer 30 or other computer to address these tasks in an automated manner.
As an example, in some invention embodiments test readers 16 are configured to communicate over the network 20 with the central computer 30 or other computer on some regular interval to perform routine diagnostics. The diagnostics may check operation of various test reader 16 components and operation, and may identify test readers 16 or its components for repair. The interval may be selected as desired, with examples including every time the test reader 16 connects to the network 20, once a week, once a month, once quarterly, and once annually.
Likewise, in some embodiments test readers are configured to communicate over the network 20 with the central computer 30 or other computer on some regular interval to check for operating software updates. The test reader 16 may compare the version number of its operating software with that of the most currently available version available over the network 20, and if a more recent version is available it may automatically download the update. Again, the interval may be selected as desired, with examples including every time the test reader 16 connects to the network 20, once a week, once a month, once quarterly, and once annually.
Further, as described above in some embodiments test readers 16 are configured to store data necessary to provide test output reports without accessing the central computer 30. In these embodiments, test readers will store universe data on a local memory so that relative output data can be calculated. This universe data may be updated from time to time. In some embodiments, such updates are done automatically on a desired interval over the network 20. The test reader may communicate with the central computer 30 or other computer over the network 20 to determine if updated universe data is available. If it is, the test reader 16 may download it.
Various illustrations and discussion of example features of some invention embodiments has been made herein. It will be appreciated that this has been done by way of illustration only, and not limitation. Various features and elements of different embodiments can be altered, substituted for one another, omitted, changed in sequence or inter-relation, and otherwise altered within the scope of the invention as claimed.

Claims

1. A system for collecting, measuring and outputting health data, the system comprising:

a plurality of test readers that each determine a plurality of biomarker measurements in a bodily fluid sample and that generate a test data set for each bodily fluid sample that comprises the plurality of different biomarker measurements, the test readers communicating the test data sets over a network;

a central computer in communication with each of the plurality of test readers over the network, the central computer receiving the test data sets and storing the test data sets in a memory, the central computer associating at least a first security key with each test data set; and,

the central computer responding to a first request for a test output report received over a network that includes the first security key by communicating a test output report that includes the plurality of biomarker measurements over the network.

2. A system as defined by claim 1, wherein the central computer further responds to the first request by retrieving the corresponding test data set and preparing the test output report.

3. A system as defined by claim 1, wherein the test reader prepares a test output report.

4. A system as defined by claim 1 wherein the central computer further compares each of the biomarker measurements from a test data set to a corresponding universe of biomarker measurement data to calculate a relative measurement for each biomarker measurement, and wherein the test output report includes the relative values.

5. A system as defined by claim 1 wherein the biomarker measurements comprise quantitative measurements, wherein the plurality of test readers read a unique sample ID from the bodily fluid sample and include this in the test data set.

6. A system as defined by claim 5 wherein:

the test reader includes a timestamp with each test data set;

the first security key corresponds to a first test subject that submits a plurality of different bodily fluid test samples at different times, the test reader including a different timestamp with each of the plurality of bodily fluid test samples from the first test subject, the central computer assigning the same first security key to each of the corresponding plurality of test data reports from the first test subject; and,

in response to a second request that includes the first security key and that request a historical test output report, the central computer searches the memory to identify all biomarker measurements that correspond to the first security key and creates a historical data output report that includes all biomarker measurements that correspond to the first security key graphed over time.

7. A system as defined by claim 1 wherein:

a plurality of first test data sets are related to one another define a first group of test data sets;

the central computer stores a first group security key with each of the first test data sets in the memory;

in response to a second request that includes the first group security key the central computer creates a first group output report that includes average biomarker measurements calculated using all the biomarker measurements from the first group, and the central computer communicates the first group report over the network.

8. A system as defined by claim 7 wherein:

the test readers includes a timestamp with each test data set;

the first group of test data sets is generated using first bodily fluid samples from a first group of individuals;

the plurality of first test data sets are measured at a first time;

the plurality of test readers generate a second plurality of test data sets at a second time using second bodily fluid samples and biometric data from the first group of individuals;

the central computer stores the first group security key with the second plurality of test data sets in the memory; and,

in response to a third request for a historical test output report that includes the first group security key, the central computer uses the first group security key to retrieve from the memory the first test data sets and the second test data sets, the central computer preparing the historical data output report that includes bodily fluid measurement averages measured over time for the first and second test data sets.

9. A system as defined by claim 7 wherein:

the central computer uses average biomarker measurements for the first group to predict one or more of a number of future incidences of health incidents or future health care costs for the first group.

10. A system as defined by claim 7 wherein:

a plurality of second test data sets are related to one another and define a second group of test data sets;

the central computer stores each of the plurality of second test data sets with a second group security key;

in response to a third request that includes the second group security key the central computer creates a second group output report that includes average bodily fluid measurements for the plurality of second test data sets and communicating the second group report over the network; and,

in response to a fourth request that include at least one of the first group security keys and the second group security keys the central computer creates a group comparison report that compares average biomarker measurements, from the first group to average biomarker measurements from the second group.

11. A system as defined by claim 10 wherein each of the first and second test data sets further includes demographic information, and wherein in response to a fifth request that includes the first security key and the second group identifier and at least one demographic category, the central computer calculates average biomarker measurement data for the second group for the specified demographic category and creates a test output report that compares biomarker measurement data from a individual test data set from the first group to the average biomarker measurement data for the second group.

12. A system as defined by claim 1 wherein:

each test data set further includes demographic information;

in response to a second request that specifies at least one demographic category, the central computer retrieves a universe of data from a plurality of stored test data reports, the universe of data corresponding to the specified demographic category and the central computer creates a customized demographic test output report that includes relative biomarker measurements comparing biomarker data from one individual test data report to the universe of demographic data.

13. A system as defined by claim 12 wherein:

the demographic categories include gender and age, and also include one or more of tobacco use profile, alcohol use profile, occupation, level of education, residence geography information, exercise profile, and employer; and,

wherein the test reader communicates over the data network to download updates.

14. A system for collecting, measuring and outputting health data as defined by claim 1 wherein:

a test subject provides each bodily fluid sample;

the test data set stored by the central computer further includes personal data comprising at least test subject name, residence, date of birth, and sex;

the personal data from a first test data sample submitted by a first test subject is stored by the first computer;

the stored personal data is retrieved by the central computer upon receipt of a second request that includes the first security key and associated with a second test data set that also corresponds with the first security key wherein the personal data is only required to be input one time.

15. A system for collecting, measuring and outputting health data as defined by claim 1 wherein the plurality of test readers interrogate test sample holders that include chemical reagents that react with the bodily fluid, and wherein the test readers make at least two biomarker measurements simultaneously, and wherein the test readers communicate test reader maintenance status over the data network.

16. A system for collecting, measuring and outputting health data as defined by claim 1 wherein the bodily fluid is urine, the plurality of test readers receive a test sample panel device that include a urine test strip that react with urine and include at least 3 different reagents that each measure a different biomarker and wherein the test reader takes at least three different biomarker measurements from the test panel device simultaneously.

17. A system for collecting, measuring and outputting health data as defined by claim 1 wherein:

the test reader takes at least three biomarker measurements simultaneously from the bodily fluid test sample;

the test reader measurements are quantitative and made using reflected light from the test sample;

the test reader makes the bodily fluid measurements within two hours of exposure of the urine test strip to urine;

the output report includes a body mass index value, and

the central computer receives additional data communicated over the network from users upon presentation of the first security key, the additional data unrelated to bodily fluid data, the central computer storing the additional data in a memory and communicating the additional data over the network in response to a second request for the additional data that includes the first security key.

18. A system as defined by claim 1 wherein:

the bodily fluid sample comprises urine contained in a dry chemical media, the dry chemical media supported on a test sample holder that is received by the test readers, the dry chemical media arranged within the test sample holder to allow for at least three different biomarkers to be measured by the test reader, the dry chemical media spatially arranged to define discrete sections for testing of different components;

wherein the presence of chemical components in the urine cause a color change to the dry chemical media; and,

wherein the measurements performed comprise quantitative biomarker measurements that utilize the color changes of the dry chemical media.

19. A system as defined by claim 1 wherein:

the test readers are portable;

the bodily fluid sample is contained in a dry chemical media that is held on a test sample holder that is received by the test readers,

the test sample holder includes security information; and,

the test reader will only perform the bodily fluid measurements if it determines that the test sample holder security information is present.

20. A system as defined by claim 1 wherein:

the plurality of measurements made by the test readers include measurements of a plurality of biomarkers that are useful to indicate at least oxidative stress, oxidative capacity, and inflammation;

the central computer uses the measurements to determine relative indicators for oxidative stress, oxidative capacity, inflammation and body mass index;

the central computer uses at least the height, weight of a test subject to determine the test subject's body mass index;

the test data output report includes relative indicators for oxidative stress, oxidative capacity, inflammation and body mass index;

the central computer stores additional data provided by test subjects over the network that is not test data; and,

the central computer provides targeted advertising over the network to users.

21. A system as defined by claim 1 wherein the central computer is configured to identify sub-groups of users through identification of a change in data provided by users.

22. A computer program product for processing, storing and outputting health data, the program product comprising executable instructions stored in a non-volatile memory, the instructions when executed causing one or more computers to execute steps comprising:

receive a plurality of individual test data sets over a network from test readers that are connected to the network, each of the plurality of test data sets generated from a bodily fluid sample taken from an individual and including measurement data for at least three different biomarkers that are useful to estimate oxidative stress, oxidative capacity, and inflammation;

store the plurality of data sets in a memory;

associate a plurality of the test data sets with a first security key that corresponds to a related group in the memory;

receive over a network a first request for a group output report, the request including the first security key;

use the first security key to identify from the memory the plurality of test data sets that correspond to the group;

calculate averages for each of the biomarker measurements from all of the test data sets that correspond to the group; and,

prepare a group output report that includes the biomarker measurement averages for the group and communicate the group output report over the network.

23. A computer program product as defined by claim 22 wherein the instructions further cause the one or more computers to execute steps including:

read a second security key from each test data set that corresponds to an individual;

read personal data from each test data set;

store the second security key and personal data in the memory with corresponding of the plurality of test data sets;

receive a second request over the network that includes the second security key and at least one demographic category;

identify an individual test data set that corresponds to the second security key and retrieve it from the memory;

use the demographic category to identify a subset of the plurality of test data sets that define the group and calculate average biomarker measurements for the subset of the plurality of test data sets;

create a customized demographic output report that includes relative biomarker measurements that compare the biomarker measurements from the individual test data set that corresponds to the second security key to the average biomarker measurements determined for the subset of the plurality of test data sets that define the group, and to communicate the customized demographic output report over the network.