U.S. patent application number 13/397360 was filed with the patent office on 2012-08-09 for systems, methods and program products for collecting and organizing health data.
Invention is credited to Denis Callewaert, Frank Lyman, Robert Smith.
Application Number | 20120203465 13/397360 |
Document ID | / |
Family ID | 45559970 |
Filed Date | 2012-08-09 |
United States Patent
Application |
20120203465 |
Kind Code |
A1 |
Callewaert; Denis ; et
al. |
August 9, 2012 |
SYSTEMS, METHODS AND PROGRAM PRODUCTS FOR COLLECTING AND ORGANIZING
HEALTH DATA
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.
Inventors: |
Callewaert; Denis;
(Metamora, MI) ; Lyman; Frank; (Lake Zurich,
IL) ; Smith; Robert; (Marengo, IL) |
Family ID: |
45559970 |
Appl. No.: |
13/397360 |
Filed: |
February 15, 2012 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
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PCT/US2011/044786 |
Jul 21, 2011 |
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13397360 |
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61367486 |
Jul 26, 2010 |
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Current U.S.
Class: |
702/19 |
Current CPC
Class: |
G01N 33/53 20130101;
G01N 2800/7009 20130101; Y10T 436/173076 20150115; G01N 33/6893
20130101; G01N 33/50 20130101; G01N 2800/7095 20130101 |
Class at
Publication: |
702/19 |
International
Class: |
G06F 19/00 20110101
G06F019/00 |
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.
Description
FIELD
[0001] Fields of the invention include systems, methods and program
products for collecting, and organizing health data. Another field
is wellness data determination.
BACKGROUND
[0002] 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.
[0003] 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
[0004] 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.
[0005] 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
[0006] FIG. 1 is a schematic that is useful to illustrate some
invention embodiments;
[0007] FIG. 2 is a schematic illustration of a bodily fluid test
panel device of a system of the invention;
[0008] FIG. 3 is a representation of a sample test output report of
an invention embodiment;
[0009] FIG. 4 is a representation of sample data stored by an
invention embodiment;
[0010] FIG. 5 is a flowchart illustrating steps performed by an
example system or program product of the invention.
DETAILED DESCRIPTION
[0011] 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.
[0012] 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.
[0013] 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.
[0014] 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.
[0015] 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.
[0016] 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.
[0017] 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.
[0018] 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.
[0019] 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).
[0020] 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).
[0021] 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.
[0022] 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.
[0023] 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.
[0024] 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").
[0025] 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.
[0026] 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.
[0027] 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.
[0028] 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.
[0029] 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.
[0030] 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).
[0031] 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.
[0032] 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.
[0033] 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.
[0034] 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.
[0035] 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.
[0036] 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.
[0037] 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.
[0038] 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:
[0039] TBARS (Thiobarbituric Acid Reactive Substances)
[0040] Organic Hydroperoxides
[0041] Protein Carbonyls
[0042] Measure of oxidative damage to specific molecules
[0043] Lipids [0044] Malonaldehyde [0045] 4-hydroxynonenal [0046]
Lipid hydroperoxides [0047] Isoprostanes [0048] Linoleic acid
oxidation products
[0049] Proteins [0050] Protein carbonyls [0051] Nitrotyrosine
[0052] Nitrothiols
[0053] Nucleic Acids [0054] M1dG (malondialdehyde deoxyguanosine)
[0055] 8-hydroxy-deoxyguanosine [0056] Oxidized derivatives of
ribose ring
[0057] Small Molecules and Ions [0058] Selenium [0059] GSH or GSSG
and the GSH/GSSG ratio (Glutathione in reduced (GSH) and oxidized
(GSSG) states)
Biomarkers/Biochemical Components for Antioxidant Power
[0060] Direct Methods--Measure Reaction with Redox Probe [0061]
CUPRAC (cupric reducing antioxidant capacity) Total Antioxidant
Capacity or TAC (using copper-bathocuprione method)
[0062] Indirect Methods (Measure Resistance to Oxidation of a Probe
by an Added Oxidizer) [0063] FRAP (ferric reducing ability of
plasma) [0064] TRAP (total reactive antioxidant potential) [0065]
ORAC (oxygen radical absorbance capacity) [0066] HORAC (hydroxyl
radical antioxidant capacity)
[0067] Measurement of Molecules that Contribute to the Total
Antioxidant Capacity [0068] GSH or GSSG and the GSH/GSSG ratio
[0069] Glutathione Peroxidase [0070] Superoxide Dismutase [0071]
Uric acid [0072] Ascorbic acid
Biomarkers/Biochemical Components for Inflammation
[0073] Cytokines (TNF-.alpha., IL-6, IL-8)
[0074] Other Proteins [0075] Osteopontin [0076] Albumin [0077]
Orosomucoid [0078] .alpha.1-microglobulin
[0079] Eicosanoids [0080] PGE.sub.2 and metabolites [0081]
PGF.sub.2.alpha. and metabolites
[0082] Other Molecules [0083] Nitric oxide byproducts
(NOx=nitrate+nitrite) [0084] Urinary proteins [0085] Histamine
Biomarkers Associated with Hypertension [0086] 20-HETE
[0087] 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.
[0088] 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.
[0089] 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.
[0090] 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: [0091] Name [0092] Date of
birth [0093] Social security number/Drivers license number/other
government issued identification [0094] Height/weight/waist
size/chest size/wrist and ankle diameter [0095]
Gender/race/nationality [0096] Medical history (e.g., "history of
high blood pressure," "diabetic," "allergies," etc.) [0097] Family
medical history (e.g., "history of high blood pressure in family,"
"family history of cardiac issues," etc.) [0098] Past or present
marital status (e.g., "currently married," "divorced") [0099] Level
of education (e.g., "high school graduate", "2 years college,"
etc.) [0100] Geographic residence (e.g., "current resident of
Chicago, II" or "current resident of zip code 60606," or "current
resident of Alabama") [0101] Tobacco use profile (example--"smoke
20-40 cigarettes per week," or "smoke 4 cigars a month" or "do not
use tobacco") [0102] Alcohol use profile (example--"consume less
than 1 drink per day" or "consume 2+ drinks per day" or "consumer
10-15 drinks per week") [0103] Drug use profile
(examples--"currently using anti-depressant" or "currently using
anti-prescription inflammatory" or "currently using prescription
blood pressure medication") [0104] Exercise profile
(examples--"vigorous exercise for at least 2 hours per week" or
"exercise 20 minutes per day" or "run 1 mile twice weekly") [0105]
Vocation (e.g., "carpenter," "office worker," "professional,"
"attorney," "police officer,")/Employer [0106] Contact information
(physical residence address/e-mail address/work address)
[0107] 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.
[0108] 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.
[0109] 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.
[0110] 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.
[0111] 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.sup.th percentile," or "oxidative stress is a 7.2 on a scale of
1 to 10," etc.).
[0112] 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.
[0113] 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.)
[0114] 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.
[0115] 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.sub.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.
[0116] 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.
[0117] 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).
[0118] 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.
[0119] 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.
[0120] 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.
[0121] 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.
[0122] 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.
[0123] 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.
[0124] 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.
[0125] 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.
[0126] 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.
[0127] 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.
[0128] 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.
[0129] 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.
[0130] 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.
[0131] 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.
[0132] 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.
[0133] 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.
[0134] 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.
[0135] 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.
[0136] 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.
[0137] 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.
[0138] 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.
[0139] 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.
[0140] 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.
[0141] 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).
[0142] 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.
[0143] 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.
[0144] 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.
[0145] 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).
[0146] 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.
[0147] 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.
[0148] 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.
[0149] 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).
[0150] 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.
[0151] 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.
[0152] 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.
[0153] 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.
[0154] 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.
[0155] 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.
[0156] 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).
[0157] 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.
[0158] 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.
[0159] 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.
[0160] 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.
[0161] 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.
[0162] 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.
[0163] 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.
[0164] 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.
[0165] 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.
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