U.S. patent application number 15/258404 was filed with the patent office on 2016-12-29 for single-use handheld diagnostic test device, and an associated system and method for testing biological and environmental test samples.
This patent application is currently assigned to FIO CORPORATION. The applicant listed for this patent is FIO CORPORATION. Invention is credited to Shlomit DEKEL, Francois DUPOTEAU.
Application Number | 20160377592 15/258404 |
Document ID | / |
Family ID | 41720757 |
Filed Date | 2016-12-29 |
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United States Patent
Application |
20160377592 |
Kind Code |
A1 |
DUPOTEAU; Francois ; et
al. |
December 29, 2016 |
SINGLE-USE HANDHELD DIAGNOSTIC TEST DEVICE, AND AN ASSOCIATED
SYSTEM AND METHOD FOR TESTING BIOLOGICAL AND ENVIRONMENTAL TEST
SAMPLES
Abstract
In a single-use handheld diagnostic test device and an
associated system and method, a biological and/or environmental
test sample is received and reacted with reagents. The test device
tests a single sample and includes a sensor to detect test data.
The test device mates with, and transmits the test data to, an
electronic device. A processor of the electronic device applies
algorithms to the test data to generate highly sensitive and
accurate quantitative test results. A presentation element of the
electronic device presents the test results to a user. The test
device is adapted for disposal, or for sterilization and re-use,
after the electronic device receives the test data. The electronic
device may be, for example, a mobile communications device, a
personal digital assistant, a laptop computer, a navigation device,
a digital audio player, a camera, or a gaming device.
Inventors: |
DUPOTEAU; Francois;
(Toronto, CA) ; DEKEL; Shlomit; (Toronto,
CA) |
|
Applicant: |
Name |
City |
State |
Country |
Type |
FIO CORPORATION |
Toronto |
|
CA |
|
|
Assignee: |
FIO CORPORATION
TORONTO
CA
|
Family ID: |
41720757 |
Appl. No.: |
15/258404 |
Filed: |
September 7, 2016 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
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13061284 |
Feb 28, 2011 |
9459200 |
|
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PCT/CA2009/001206 |
Aug 31, 2009 |
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15258404 |
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61144283 |
Jan 13, 2009 |
|
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61093036 |
Aug 29, 2008 |
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Current U.S.
Class: |
435/5 |
Current CPC
Class: |
A61B 5/1176 20130101;
A61B 5/1172 20130101; G16H 40/63 20180101; G01N 33/48792 20130101;
G01N 21/77 20130101; G01N 21/17 20130101; A61B 5/0077 20130101;
Y10T 436/12 20150115; A61B 5/1171 20160201 |
International
Class: |
G01N 33/487 20060101
G01N033/487; A61B 5/00 20060101 A61B005/00; A61B 5/1171 20060101
A61B005/1171; G06F 19/00 20060101 G06F019/00; A61B 5/1172 20060101
A61B005/1172 |
Claims
1. A method of testing a biological and/or environmental test
sample, for use with one or more reagents, an electronic device,
and a single-use handheld diagnostic test device adapted to receive
and test a single one said sample, the method comprising: (a) a
connection step of connecting a test connection element of the test
device with a mating electronic connection element of the
electronic device; (b) a reaction step of using the test device to
react the sample with the reagents; (c) a sensing step, after the
connection step and the reaction step, of detecting test data from
the sample using at least one sensor of the test device; (c.1) a
test device storage step of electronically storing the test data
and/or one or more algorithms using onboard memory of the test
device; (d) a data transmission step, after the sensing step and
the test device storage step, of electronically transmitting the
test data to the electronic connection element of the electronic
device using the test connection element of the test device; (d.1)
an algorithm transmission step of electronically transmitting the
algorithms to a processor of the electronic device, via the
electronic connection element, using the test connection element of
the test device; (e) a processing step, after the data transmission
step and the algorithm transmission step, of applying the
algorithms to the test data using the processor to generate highly
sensitive and accurate quantitative test results and presentation
data based on the quantitative test results; (f) a presentation
step, after the processing step, of presenting the presentation
data based on the quantitative test results to a user using a
presentation element of the electronic device; and (g) a disposal
step, after the data transmission step, of disposing of the test
device or sterilizing and re-using the sensor and/or the test
connection element.
2. A method according to claim 1, further comprising an
identification step of using an identification element to identify
the user, with the identification element provided in the form of a
standalone identification component and/or integrally with the
electronic device and/or the test device.
3. A method according to claim 2, wherein in the identification
step, the identification element comprises a biometric
identification element and the user is biometrically identified,
with the biometric identification element preferably comprising a
fingerprint scanner, a retinal scanner, a microphone and voice
recognition element, a camera and facial recognition element,
and/or a genetic expression factor identification element.
4. A method according to claim 1, further comprising an ID storage
step, before the identification step, of using the electronic
device to store user identification data associated with the user
and/or an owner of the electronic device, and wherein in the
identification step, the identification element automatically
accesses the user identification data stored in the electronic
device.
5. A method of testing a biological and/or environmental test
sample, for use with one or more reagents, an electronic device,
and a single-use handheld diagnostic test device adapted to receive
and test a single one said sample, the method comprising: (a) a
connection step of connecting a test connection element of the test
device with a mating electronic connection element of the
electronic device; (b) a reaction step of using the test device to
react the sample with the reagents; (c) a sensing step, after the
connection step and the reaction step, of detecting test data from
the sample using at least one sensor of the test device; (d) a data
transmission step, after the sensing step, of electronically
transmitting the test data to the electronic connection element of
the electronic device using the test connection element of the test
device; (e) a processing step, after the data transmission step, of
applying one or more executable algorithms to the test data using a
processor of the electronic device to generate quantitative test
results and presentation data based on the quantitative test
results; (f) a presentation step, after the processing step, of
presenting the presentation data based on the quantitative test
results to a user using a presentation element of the electronic
device; and (g) a disposal step, after the data transmission step,
of disposing of the test device or sterilizing and re-using the
sensor and/or the test connection element; further comprising an
identification step of using an identification element to identify
the user, with the identification element provided in the form of a
standalone identification component and/or integrally with the
electronic device and/or the test device; further comprising an ID
storage step, before the identification step, of using the
electronic device to store user identification data associated with
the user and/or an owner of the electronic device, and wherein in
the identification step, the identification element automatically
accesses the user identification data stored in the electronic
device; and adapted for use with an account associated with the
user identification data, and further comprising a billing step,
after the identification step, of debiting the account in
association with the generation of the quantitative test
results.
6. A method according to claim 5, further comprising a reaction
control step, before completion of the reaction step, of using the
processor to apply the algorithms to control the reaction of the
sample with the reagents.
7. A method according to claim 5, wherein in the presentation step,
the quantitative test results and/or the presentation data are
presented from a display element of the presentation element, and
wherein in the processing step, the algorithms generate the
quantitative test results and/or the presentation data for
presentation from the display element in the form of one or more
visually presentable (a) textual data, (b) graphical data, and/or
(c) colored indicator light data.
8. A method according to claim 5, wherein in the processing step,
the test results are quantified as high, medium, and/or low
results.
9. A method according to claim 5, further comprising a powering
step, before the data transmission step, of using the test
connection element of the test device to receive, via the
electronic connection element, power from a battery of the
electronic device.
10. A method according to claim 5, adapted for use with one or more
of following as the electronic device: (a) a test reader device;
(b) a cellular telephone; (c) a mobile communications device; (d) a
personal digital assistant; (e) a desktop computer; (f) a laptop
computer; (g) a navigation device; (h) a digital audio player; (i)
a camera; (j) a gaming device; (k) a television; and/or (l) a
radio.
11. A method according to claim 5, adapted for use with a
networking electronic device as the electronic device, and further
comprising a network transmission step, after the data transmission
step, of using the networking electronic device to automatically
transmit the test data, the quantitative test results and/or the
presentation data for recordal in one or more remote laboratory
and/or hospital information systems.
12. A method according to claim 5, wherein in the processing step,
the presentation data generated by the algorithms comprises
treatment and follow-up suggestion data based on the test results,
and wherein in the presentation step, the treatment and follow-up
suggestion data is presented by the presentation element.
Description
CROSS REFERENCE TO RELATED APPLICATIONS
[0001] This is a divisional application of U.S. application Ser.
No. 13/061,284 filed Feb. 28, 2011, which is a U.S. National Stage
Application of International Application No. PCT/CA2009/001206
filed Aug. 31, 2009, which claims priority from U.S. Provisional
Application No. 61/144,283 filed Jan. 13, 2009 and U.S. Provisional
Application No. 61/093,036 filed Aug. 29, 2008. The entireties of
all the above-listed applications are incorporated herein by
reference.
FIELD OF THE INVENTION
[0002] The present invention relates generally to diagnostic test
devices, and more particularly, to a single-use handheld diagnostic
test device, and an associated system and method for testing
biological and environmental test samples.
BACKGROUND OF THE INVENTION
[0003] Previously, rudimentary rapid tests may have been available
on the market. Tests of this nature may have afforded a testing of
only relatively basic parameters, such as typically may not have
required any interpretation and/or a data management process in
order to validate the test. More sophisticated and/or accurate
rapid point-of-care tests may not heretofore have been possible,
apart from at the hospital and/or in a core laboratory. This
shortcoming of the prior art may have been due, in part, to the
complexity of these kinds of diagnostic tests. At the same time,
most prior art tests (whether simple or complex) may heretofore
have required medical interpretation by qualified personnel.
[0004] Previously, in addition, the recordal of data in a computer
for analysis and/or compilation in an electronic medical record
(EMR) or healthcare repository may only have occurred in
environments where there was access to a laboratory information
system (LIS) or a hospital information system (HIS). That is,
heretofore, automated recordal of results related to patient
identification may have been, at best, very difficult and, often,
impossible with simple prior art tests (e.g., lateral flow
strips).
[0005] It is an object of an aspect of one preferred embodiment
according to the present invention to provide a single-use handheld
diagnostic test device, and/or an associated system and/or a method
for testing biological and/or environmental test samples.
[0006] It is an object of an aspect of one preferred embodiment
according to the present invention to provide disposable and/or
reusable diagnostic test devices, systems and/or methods.
[0007] It is an object of an aspect of one preferred embodiment
according to the present invention to reduce the number of complex
features or requirements (e.g., IT infrastructure, connectivity,
and/or professional interpretation of result) which may have been
previously associated with substantially complete diagnostic test
devices, systems and/or methods.
[0008] It is an object of an aspect of one preferred embodiment
according to the present invention to provide substantially
complete diagnostic test devices, systems and/or methods which may
preferably be used with few or no complex features or requirements,
such as, for example, IT infrastructure, connectivity, and/or
professional interpretation of result.
[0009] It is an object of an aspect of one preferred embodiment
according to the present invention to provide diagnostic test
devices, systems and/or methods which afford a quality, level of
result, and/or services which, heretofore, may only have been
available in diagnostic tests performed in a core laboratory or
hospital.
[0010] It is an object of an aspect of one preferred embodiment
according to the present invention to provide diagnostic test
devices, systems and/or methods which may preferably combine a
disposable or reusable diagnostic test device with a conventional
computing or networking electronic device.
[0011] It is an object of an aspect of one preferred embodiment
according to the present invention to provide diagnostic test
devices, systems and/or methods which may preferably combine a
disposable or reusable diagnostic test device with a cellular
telephone or laptop.
[0012] It is an object of an aspect of one preferred embodiment
according to the present invention to provide diagnostic test
devices, systems and/or methods which may preferably combine a
disposable or reusable diagnostic test device with an
identification system.
[0013] It is an object of an aspect of one preferred embodiment
according to the present invention to provide diagnostic test
devices, systems and/or methods which may preferably combine a
disposable or reusable diagnostic test device with a biometric
identification system.
[0014] It is an object of an aspect of one preferred embodiment
according to the present invention to provide diagnostic test
devices, systems and/or methods which may preferably be used by a
patient and/or customer with minimal technical or clinical
knowledge concerning the device technology or the interpretation of
the test results.
[0015] It is an object of one preferred embodiment according to the
invention to provide a device, system and/or method for use in
biological and/or medical applications.
[0016] It is an object of the present invention to obviate or
mitigate one or more of the aforementioned mentioned disadvantages
associated with the prior art, and/or to achieve one or more of the
aforementioned objects of the invention.
SUMMARY OF THE INVENTION
[0017] According to the invention, there is disclosed an electronic
device and single-use handheld diagnostic test device system, for
use with a biological and/or environmental test sample. The system
includes an electronic device and a single-use handheld diagnostic
test device. The test device is adapted to receive and operatively
react the sample with one or more reagents. The test device
includes a test connection element and at least one sensor. The
sensor operatively detects test data from the sample after reaction
with the reagents. The electronic device includes a mating
electronic connection element, a processor, and a presentation
element. The electronic connection element is operatively connected
with the test connection element and electronically receives the
test data from the test device. The processor operatively applies
one or more algorithms to the test data to generate highly
sensitive and accurate quantitative test results and presentation
data based on the quantitative test results. The presentation
element operatively presents to a user the presentation data based
on the quantitative test results. The test device is adapted to
test a single one said sample and is adapted for disposal, or for
sterilization and re-use of the sensor and/or the test connection
element, after the electronic device receives the test data.
[0018] According to an aspect of one preferred embodiment of the
invention, the system also includes an identification element
operative to identify the user. The identification element is
provided in the form of a standalone identification component
and/or integrally with the electronic device and/or the test
device.
[0019] According to an aspect of one preferred embodiment of the
invention, the identification element includes a biometric
identification element. The biometric identification element
preferably includes a fingerprint scanner, a retinal scanner, a
microphone and voice recognition element, a camera and facial
recognition element, and/or a genetic expression factor
identification element.
[0020] According to an aspect of one preferred embodiment of the
invention, the electronic device stores user identification data
associated with the user and/or an owner of the electronic device.
Preferably, the identification element automatically accesses the
user identification data stored in the electronic device.
[0021] According to an aspect of one preferred embodiment of the
invention, the system is adapted for use with an account associated
with the user identification data. The system also includes a
billing element operatively debiting the account in association
with the generation of the quantitative test results.
[0022] According to an aspect of one preferred embodiment of the
invention, the test device has onboard memory which electronically
stores the test data and/or the algorithms. Preferably, but not
necessarily, the processor of the electronic device operatively
receives the algorithms from the test device via the test and
electronic connection elements.
[0023] According to an aspect of one preferred embodiment of the
invention, the processor operatively applies the algorithms to
control the reaction of the sample with the reagents.
[0024] According to an aspect of one preferred embodiment of the
invention, the presentation element includes a display element.
Preferably, the algorithms generate the quantitative test results
and/or the presentation data for presentation from the display
element in the form of one or more visually presentable (a) textual
data, (b) graphical data, and/or (c) colored indicator light
data.
[0025] According to an aspect of one preferred embodiment of the
invention, the test results are quantified as high, medium, and/or
low results.
[0026] According to an aspect of one preferred embodiment of the
invention, the electronic device has a battery. Preferably, the
test connection element of the test device receives power, via the
electronic connection element, from the battery.
[0027] According to an aspect of one preferred embodiment of the
invention, the electronic device includes: (a) a test reader
device; (b) a cellular telephone; (c) a mobile communications
device; (d) a personal digital assistant; (e) a desktop computer;
(f) a laptop computer; (g) a navigation device; (h) a digital audio
player; (i) a camera; (j) a gaming device; (k) a television; and/or
(l) a radio.
[0028] According to an aspect of one preferred embodiment of the
invention, the electronic device includes a networking electronic
device. Preferably, the networking electronic device automatically
transmits the test data, the quantitative test results and/or the
presentation data for recordal in one or more remote laboratory
and/or hospital information systems.
[0029] According to an aspect of one preferred embodiment of the
invention, the presentation data presented to the user includes
treatment and follow-up suggestion data based on the test
results.
[0030] According to the invention, there is also disclosed a
single-use handheld diagnostic test device. The test device is
preferably for use with an electronic device which has an
electronic connection element, a presentation element, and a
processor for operative application of one or more algorithms. The
test device is adapted to receive and operatively react a
biological and/or environmental test sample with one or more
reagents. The test device includes at least one sensor and a mating
test connection element. The sensor operatively detects test data
from the sample after reaction with the reagents. The test
connection element is operatively connected with, and
electronically transmits the test data to the electronic device
via, the electronic connection element. As such, the test device
enables the processor to operatively apply the algorithms to the
test data for generation of highly sensitive and accurate
quantitative test results and presentation data based on the
quantitative test results, and the presentation element to
operatively present to a user the presentation data based on the
quantitative test results. The test device is adapted to test a
single one said sample. The test device is adapted for disposal, or
for sterilization and re-use of the sensor and/or the test
connection element, after the electronic transmission of the test
data to the electronic device.
[0031] According to an aspect of one preferred embodiment of the
invention, the test device also includes an identification element
operative to identify the user. The identification element is
provided in the form of a standalone identification component
and/or integrally with the sensor and/or the test connection
element.
[0032] According to an aspect of one preferred embodiment of the
invention, the identification element includes a biometric
identification element. The biometric identification element
preferably includes a fingerprint scanner, a retinal scanner, a
microphone and voice recognition element, a camera and facial
recognition element, and/or a genetic expression factor
identification element.
[0033] According to an aspect of one preferred embodiment of the
invention, the test device is adapted for use with user
identification data which is stored in the electronic device and is
associated with the user and/or an owner of the electronic device.
Preferably, the identification element automatically accesses the
user identification data stored in the electronic device.
[0034] According to an aspect of one preferred embodiment of the
invention, the test device is adapted for use with an account
associated with the user identification data. Preferably, the test
device also includes a billing element operatively debiting the
account in association with the generation of the quantitative test
results.
[0035] According to an aspect of one preferred embodiment of the
invention, the test device also includes onboard memory which
electronically stores the test data and/or the algorithms.
Preferably, the test connection element electronically transmits
the algorithms to the electronic connection element of the
electronic device.
[0036] According to an aspect of one preferred embodiment of the
invention, the electronic transmission of the algorithms by the
test connection element to the electronic connection element of the
electronic device is preferably such as to enable the processor to
operatively apply the algorithms to control the reaction of the
sample with the reagents.
[0037] According to an aspect of one preferred embodiment of the
invention, the test device is adapted for use with a display
element as the presentation element. The algorithms are adapted to
generate the quantitative test results and/or the presentation data
for presentation from the display element in the form of one or
more visually presentable (a) textual data, (b) graphical data,
and/or (c) colored indicator light data.
[0038] According to an aspect of one preferred embodiment of the
invention, the algorithms are adapted to quantify the test results
as high, medium, and/or low results.
[0039] According to an aspect of one preferred embodiment of the
invention, the test device is adapted for use with a battery
onboard the electronic device. The test connection element of the
test device receives power, via the electronic connection element,
from the battery.
[0040] According to an aspect of one preferred embodiment of the
invention, the test device is adapted for use with one or more of
following as the electronic device: (a) a test reader device; (b) a
cellular telephone; (c) a mobile communications device; (d) a
personal digital assistant; (e) a desktop computer; (f) a laptop
computer; (g) a navigation device; (h) a digital audio player; (i)
a camera; (j) a gaming device; (k) a television; and/or (l) a
radio.
[0041] According to an aspect of one preferred embodiment of the
invention, the test device is adapted for use with a networking
electronic device as the electronic device. As such, the test
device enables the networking electronic device to automatically
transmit the test data, the quantitative test results and/or the
presentation data for recordal in one or more remote laboratory
and/or hospital information systems.
[0042] According to an aspect of one preferred embodiment of the
invention, the device is adapted for use with presentation data
presented to the user which includes treatment and follow-up
suggestion data based on the test results.
[0043] According to the invention, there is also disclosed a method
of testing a biological and/or environmental test sample. The
method is for use with one or more reagents, an electronic device,
and a single-use handheld diagnostic test device which is adapted
to receive and test a single one said sample. The method includes
the following steps: (a) a connection step; (b) a reaction step;
(c) a sensing step after the connection step and the reaction step;
(d) a data transmission step after the sensing step; (e) a
processing step after the data transmission step; (f) a
presentation step after the processing step; and/or (g) a disposal
step after the data transmission step. In the connection step, a
test connection element of the test device is connected with a
mating electronic connection element of the electronic device. In
the reaction step, the test device is used to react the sample with
the reagents. In the sensing step, test data is detected from the
sample using at least one sensor of the test device. In the data
transmission step, the test data is electronically transmitted to
the electronic connection element of the electronic device using
the test connection element of the test device. In the processing
step, one or more algorithms are applied to the test data using a
processor of the electronic device to generate highly sensitive and
accurate quantitative test results and presentation data based on
the quantitative test results. In the presentation step, the
presentation data based on the quantitative test results is
presented to a user using a presentation element of the electronic
device. In the disposal step, the test device is disposed of, or
the sensor and/or the test connection element are sterilized and
re-used.
[0044] According to an aspect of one preferred embodiment of the
invention, the method also includes an identification step of using
an identification element to identify the user. The identification
element is provided in the form of a standalone identification
component and/or integrally with the electronic device and/or the
test device.
[0045] According to an aspect of one preferred embodiment of the
invention, in the identification step, the identification element
includes a biometric identification element and the user is
biometrically identified. The biometric identification element
preferably includes a fingerprint scanner, a retinal scanner, a
microphone and voice recognition element, a camera and facial
recognition element, and/or a genetic expression factor
identification element.
[0046] According to an aspect of one preferred embodiment of the
invention, the method also includes an ID storage step before the
identification step. In the ID storage step, the electronic device
is used to store user identification data associated with the user
and/or an owner of the electronic device. In the identification
step, the identification element automatically accesses the user
identification data stored in the electronic device.
[0047] According to an aspect of one preferred embodiment of the
invention, the method is adapted for use with an account associated
with the user identification data. The method also includes a
billing step after the identification step. In the billing step,
the account is debited in association with the generation of the
quantitative test results.
[0048] According to an aspect of one preferred embodiment of the
invention, the method also includes a test device storage step
before the data transmission step. In the test device storage step,
the test data and/or the algorithms are electronically stored using
onboard memory of the test device. The method also includes an
algorithm transmission step before the processing step. In the
algorithm transmission step, the algorithms are electronically
transmitted to the processor, via the electronic connection
element, using the test connection element of the test device.
[0049] According to an aspect of one preferred embodiment of the
invention, the method also includes a reaction control step before
completion of the reaction step. In the reaction control step, the
processor is used to apply the algorithms to control the reaction
of the sample with the reagents.
[0050] According to an aspect of one preferred embodiment of the
invention, in the presentation step, the quantitative test results
and/or the presentation data are presented from a display element
of the presentation element. In the processing step, the algorithms
generate the quantitative test results and/or the presentation data
for presentation from the display element in the form of one or
more visually presentable (a) textual data, (b) graphical data,
and/or (c) colored indicator light data.
[0051] According to an aspect of one preferred embodiment of the
invention, in the processing step, the test results are quantified
as high, medium, and/or low results.
[0052] According to an aspect of one preferred embodiment of the
invention, the method also includes a powering step before the data
transmission step. In the powering step, the test connection
element of the test device is used to receive, via the electronic
connection element, power from a battery of the electronic
device.
[0053] According to an aspect of one preferred embodiment of the
invention, the method is adapted for use with one or more of
following as the electronic device: (a) a test reader device; (b) a
cellular telephone; (c) a mobile communications device; (d) a
personal digital assistant; (e) a desktop computer; (f) a laptop
computer; (g) a navigation device; (h) a digital audio player; (i)
a camera; (j) a gaming device; (k) a television; and/or (l) a
radio.
[0054] According to an aspect of one preferred embodiment of the
invention, the method is adapted for use with a networking
electronic device as the electronic device. The method also
includes a network transmission step after the data transmission
step. In the network transmission step, the networking electronic
device is used to automatically transmit the test data, the
quantitative test results and/or the presentation data for recordal
in one or more remote laboratory and/or hospital information
systems.
[0055] According to an aspect of one preferred embodiment of the
invention, in the processing step, the presentation data generated
by the algorithms includes treatment and follow-up suggestion data
based on the test results. In the presentation step, the treatment
and follow-up suggestion data is presented by the presentation
element.
[0056] Other advantages, features and characteristics of the
present invention, as well as methods of operation and functions of
the related elements of the method, system and device, and the
combination of steps, parts and economies of manufacture, will
become more apparent upon consideration of the following detailed
description and the appended claims with reference to the
accompanying drawings, the latter of which are briefly described
hereinbelow.
BRIEF DESCRIPTION OF THE DRAWINGS
[0057] The novel features which are believed to be characteristic
of the system, device and method according to the present
invention, as to their structure, organization, use, and method of
operation, together with further objectives and advantages thereof,
will be better understood from the following drawings in which
presently preferred embodiments of the invention will now be
illustrated by way of example. It is expressly understood, however,
that the drawings are for the purpose of illustration and
description only, and are not intended as a definition of the
limits of the invention. In the accompanying drawings:
[0058] FIG. 1 is a schematic diagram of a prior art diagnostic
system;
[0059] FIG. 2 is an exploded schematic diagram of a system
according to a first preferred embodiment of the invention;
[0060] FIG. 3 is a schematic diagram of the system of FIG. 2, shown
in use;
[0061] FIG. 4 is an exploded schematic diagram of a system
according to a second preferred embodiment of the invention;
[0062] FIG. 5 is a schematic diagram of the system of FIG. 4, shown
in use;
[0063] FIG. 6 is a schematic diagram of a system according to a
third preferred embodiment of the invention, shown in use;
[0064] FIG. 7 is an exploded schematic diagram of a system
according to a fourth preferred embodiment of the invention;
[0065] FIG. 8 is a schematic diagram of the system of FIG. 7, shown
in use; and
[0066] FIG. 9 is a flowchart of an illustrative method according to
the invention.
DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS
[0067] FIG. 1 shows an example of a prior art system 20 which
includes a prior art diagnostic device 30 and prior art workstation
and IT infrastructure 40. Such a prior art system 20 may have been
for use with a biological test sample 50 and reagents 60 provided
on a sample support 212 (i.e., a slide). As shown in FIG. 1, the
prior art diagnostic device 30 is a desktop-sized device such as
might have been previously used in a laboratory and/or hospital
setting. The desktop-sized diagnostic devices 30 of the prior art
may have included pre-analytical components 208, a measurement
system 214, an electronic memory 206, device management software
202, a plug-in interface 410 (i.e., a USB port), a display
capability 414 (i.e., a screen or printer), a power supply 406, and
data analysis software 204 as shown in FIG. 1.
[0068] The prior art workstation and IT infrastructure 40 shown in
FIG. 1 includes a desktop computer 42, such as may have been
previously considered suitable for generation, recordal and display
of highly sensitive and accurate quantitative test results. Persons
having skill in the art may not generally have considered it
feasible to create comparably sensitive and accurate test results
outside of a laboratory or hospital setting. The desktop computer
42 may have provided CPU capabilities 416 and communication
capabilities 408 (i.e., Internet, GSM). The prior art
infrastructure 40 may also have included a laboratory and/or
hospital information system (LIS/HIS) network 608 such as may have
been, for example, accessible over the Internet. The prior art
workstation and IT infrastructure 40 shown in FIG. 1 may have
provided a database 800 and/or repository for recordal of the test
results.
[0069] In FIGS. 2 to 8, there is shown a system 100 according to
the present invention. The system 100 preferably includes an
electronic device 400, an identification element 300, and a
single-use handheld diagnostic test device 200 for use with a
biological and/or environmental test sample 50.
[0070] The test device 200 may preferably, according to the
invention, be linked with more than one type and, more preferably,
with a large range of electronic devices 400. The electronic device
400 may be a cellular telephone 402 (as shown in FIGS. 2 to 6) or a
laptop computer 404 (as shown in FIG. 8). According to various
other preferred embodiments of the invention, the electronic device
400 may take the form of a test reader device, a mobile
communications device (e.g., a smart phone), a personal digital
assistant, a pocket PC, a desktop computer, a navigation device, a
digital audio player, a camera, a gaming device, a television,
and/or a radio. According to some preferred embodiments of the
invention, it may be suitable to utilize any electronic device 400
which provides a power source and/or the CPU capacity to run,
analyze, record and/or transmit the test results.
[0071] Preferably, the test device 200 is for use with the
electronic device 400, and is adapted to receive and operatively
react the sample 50 with one or more reagents 60. The test device
200 preferably has onboard memory 206, a test connection element
216 and at least one sensor 214. The sensor 214 operatively detects
test data (not shown) from the sample 50 after reaction with the
reagents 60.
[0072] The test device 200 preferably provides components needed
for performing the reaction, such as, all of the pre-analytical
components 208, the reagents 60, and the sample support 212 (e.g.,
housing, slide, substrate) or platform for incubation.
[0073] The pre-analytical components 208 may preferably regroup the
elements to mix the sample 50 with the reagents 60, preferably to
identify the biological components targeted. In the case of lateral
flow technology, one or more (or preferably most) of the
pre-analytical components may be embedded inside the lateral flow
strip.
[0074] The reagents 60 may preferably include reagents for the
sample preparation. The reagents for the sample preparation may
preferably include some (or preferably all) of the chemical
components which may be required to lyse, extract and/or stabilize
some specific biological components, so as to assist, facilitate
and/or enable these biological components to be properly targeted.
The reagents 60 may preferably be provided inside the test device
200. In some preferred embodiments according to the present
invention, the reagents 60 may be stored in a small chamber or
container inside the test device 200 or coated on a lateral flow
strip. In some cases, one or more specific reagents 60 may be added
manually by a user 90 (shown in FIG. 7) and/or by medical
personnel.
[0075] The sample support 212 may preferably be provided as a
housing (e.g., formed of plastic). Preferably, the sample support
212 may house and/or support some (or preferably all) of the
components which are provided inside the test device 200.
[0076] The test device 200 preferably also provides the sensor (or
measurement system) 214 for performing a measurement or detection,
an interface (the test connection element 216) for data
acquisition, and electronic data storage capacity within the
onboard memory 206.
[0077] Depending on the technology used for detection, the sensor
214 may preferably, and by way of a non-limiting example, be
optical in nature (e.g., relying on fluorescence or colorimetry) or
electrical in nature (e.g., relying on impedance effects).
Preferably, many different detection technologies may be capable of
use within the test device 200 (and which may be capable of
modification in function, in the discoveries made, and/or in the
detection field), such as, for example and among other things, one
or more of the following: lateral flow strip detection
technologies; nano and/or micro cytometer detection technologies;
impedance sensor detection technologies; dieletrophoresis detection
technologies; micro PCR detection technologies; and/or electro
peptide sensor technologies. The sensor 214 preferably receives a
signal which is preferably transferred through data acquisition
components so as to be sent, as is described in greater detail
hereinbelow, to the electronic device 400. (In some alternate
embodiments of the invention, optical fiber output or diode sensors
may be used within the electronic device 400 as an excitation
and/or optical sensor in place of, or in addition to, the sensors
214 of the test device 200. Preferably, however, the sensors 214
are provided as part of the test device 200.)
[0078] According to some preferred embodiments of the invention,
the test connection element 216 may be provided as a separate or
embedded component of the test device 200. The test connection
element 216 may preferably link the test device 200 with the
electronic device 400. Preferably, the test connection element 216
may assist, facilitate and enable a transfer of energy, data, and
optical or electrical pulses.
[0079] The onboard memory 206 may preferably be provided within the
test device 200. As is described in greater detail below, the
onboard memory 206 may preferably be used to store data and
software algorithms 202, 204 required to run the test--e.g.,
including the test method, the quality control data, the analysis
process, the GUI interface instructions, and any other software
applications or algorithms associated with the test--for data
transfer or upload from the test device 200 to the electronic
device 400. The onboard memory 206 may preferably store the test
data. Stored test data may preferably be used later--e.g., if a
patient wants to send the test device 200 to a central laboratory
and/or a healthcare provider for further analysis. (In some
embodiments of the invention, the onboard memory 206 may preferably
also be associated with a CPU capability onboard the test device
200 to assist with or manage data transfer between the test device
200 and the electronic device 400.)
[0080] In some embodiments of the invention, the test device 200
may include a battery or power supply (not shown). This power
supply may be provided, for example, in case the electronic device
400 is not capable of supporting the required or preferred power
supply demands of the test device 200. That said, the electronic
device 400 preferably includes a battery (or power supply) 406 of
its own, which is sufficient to provide the test device 200 with an
energy source.
[0081] The electronic device 400 preferably also includes an
electronic connection element 410 and a processor (or CPU
capability) 416. The processor 416 is for application of the
software algorithms 202, 204 to process and/or analyze test
data.
[0082] The electronic connection element 410 may preferably be a
plug-in interface (e.g., a USB port). The electronic connection
element 410 may preferably be provided as any kind of interfacing
element suitable to transfer data and energy to the test device
200. The electronic connection element 410 and the test connection
element 216 are operatively connected with one another in mating
relation (as best seen in FIGS. 3 and 5). The interface between the
test device 200 and the electronic device 400 may preferably
utilize components which meet the connectivity requirements of the
electronic device 400. Alternately or in addition, an interface
component (not shown) may be provided which has a standard
connectivity switch for the test device 200. Preferably, the test
connection element 216 of the test device 200 receives power, via
the electronic connection element 410, from the battery 406. The
electronic connection element 410 is preferably capable of
transferring the energy and/or power from the battery 406 to the
test device 200. Preferably, the battery 406 affords a power supply
capability to transfer energy sufficient to run the test device
200. Preferably, the test connection element 216 electronically
transmits the test data to the electronic device 400 via the
electronic connection element 410. In this manner, the electronic
connection element 410 electronically receives the test data from
the test device 200.
[0083] The processor 416 of the electronic device 400 may
preferably provide enough processing capability to run the test
device 200. Preferably, data included in the onboard memory 206
within the test device 200 may detail the minimum requirements, in
terms of required processing capability, to run the test device
200. The processor 416 operatively applies one or more of the
algorithms 202, 204 in managing the electronic device 400 and its
interface with the test device 200. For example, the algorithms
202, 204 may include device management software 202 and data
analysis software 204.
[0084] The device management software 202 may include graphical
user interface (GUI) software, a framework application, and a data
quality control application. The quality control application is
preferably operative to check on the proper functioning of the test
device 200 or to meet regulation requirements.
[0085] According to the invention, the GUI software may preferably
assist, facilitate or enable display of some (or more preferably
most or all) of the functionalities or results provided by the
system 100. The GUI software may also preferably provide for
connectivity functionalities--e.g., to send or receive data from
one or more databases 800 and/or a communication system 600 via the
electronic device 400. The GUI software may preferably be run, for
example, inside a browser (e.g., an Internet browser) and/or
through another GUI window.
[0086] The framework application may preferably help to regroup
common software components, which may be used for some (or more
preferably most or all) of the software applications or codes, in
the operating system used between the electronic device 400 and the
test device 200.
[0087] The data analysis software 204 may include test data
processing applications and diagnostic applications. The diagnostic
applications may preferably be accessed by the user 90, for
example, to improve diagnostic analysis or to connect with an EMR
repository. According to the invention, the user 90 or a patient
may preferably also be able to download updates or new applications
from a remote database or website.
[0088] The test data processing applications may preferably include
algorithms to analyze the test data, and a data transfer protocol
to enable the electronic device 400 to communicate with or download
data from the test device 200. According to some embodiments of the
invention, the processor 416 may also operatively apply the test
data processing applications to control the reaction of the sample
50 with the reagents 60. Accordingly, by the aforesaid transmission
of the test data processing applications and the test data, the
test device 200 enables the processor 416 to, among other things,
control the reaction of the sample 50 with the reagents 60. The
testing of the sample 50 by the test device 200 may be directly
initiated by the user 90 by controlling a dedicated button or a
context dependent programmable button or key on the electronic
device 400.
[0089] Thereafter, the processor 416 operatively receives the test
data, and applies the test data processing applications to the test
data to generate highly sensitive and accurate quantitative test
results and/or presentation data based on the quantitative test
data. In so doing, according to some preferred embodiments of the
invention, the test results may be quantified as high, medium,
and/or low results (e.g., a low intensity of infection result).
Perhaps notably, the "highly sensitive and accurate quantitative
test results" which are generated according to the present
invention have comparable accuracy and sensitivity with those which
have been previously quantified in a laboratory or hospital
setting. Advantageously, therefore and due in part to the
portability inherent in the handheld test device 200 and the
electronic device 400, the present invention enables the generation
of highly sensitive and accurate quantitative test results outside
of such laboratory and hospital settings.
[0090] It may also be worthwhile to note that the presentation data
presented to the user 90 may preferably include treatment and
follow-up suggestion data based on the test results. The test
device 200 is preferably adapted for use with, and to aid in the
generation of, such presentation data. The treatment and follow-up
suggestion data is preferably determined with reference to one or
more of the algorithms 202, 204 stored onboard the electronic
device 400 or the test device 200, or in one of the remote
databases 800.
[0091] Preferably, the onboard memory 206 of the test device 200
electronically stores the test data and one or more of the
algorithms 202, 204. Preferably, the test connection element 216 of
the test device 200 electronically transmits such algorithms 202,
204 to the electronic connection element 410 of the electronic
device 400. In this manner, the processor 416 operatively receives
such algorithms 202, 204 from the test device 200 via the test and
electronic connection elements, 216 and 410 respectively.
[0092] The electronic device 400 preferably also provides a
presentation element 414, and further connectivity components. As
shown in FIGS. 2 to 8, the presentation element 414 preferably
includes a display element which has a display capability (e.g., a
display screen and/or a printer) and/or which offers a graphical
user interface (or GUI). Preferably, the algorithms 202, 204
generate the quantitative test results and/or the presentation data
for presentation by the electronic device 400 in the form of
visually and/or audibly presentable data. Audibly presentable data
may take the form of a verbal, musical, tonal and/or other alert
sounds. As women, children and men may be thought to have differing
sensitivities from each other to some types of sounds, it may be
preferable (according to some embodiments of the invention) to
adapt the audibly presentable data to be only audible to one or
more intended segments of listeners.
[0093] Visually presentable data may take the form of text,
graphics and/or colored indicator lights. FIGS. 3 and 5-7
illustrate one form of visually presentable data which is
contemplated according to the present invention, namely, visually
presentable graphical data 702. Among other things, graphical data
may include charts and other comparative visual representations of
the quantitative test results. By way of example, and among other
things, visually and/or audibly presentable data may also include
descriptive and/or numerical data. Exemplary types of descriptive
data may include the presentation data (e.g., the treatment and
follow-up suggestion data) and/or intensity information. Intensity
data may be shown in textual and/or graphical format. Exemplary
types of numerical data may include the quantitative test results.
Other visually presentable data may include textual data, and/or
colored indicator light data. Preferably, the display screen
enables display of the quantitative test results and/or
presentation data, and management of the system 100. (In some
embodiments of the invention, the printer or other kinds of output
systems are used for visualization or presentation.) The
presentation element 414 operatively presents the quantitative test
results and/or the presentation data to the user 90. Accordingly,
by the aforesaid transmission of the test data processing
applications and the test data, the test device 200 also enables
generation and presentation of the test results and the
presentation data by the processor 416 and the presentation element
414.
[0094] The identification element 300 is operative to identify the
user 90. The identification element 300 may be provided in the form
of a standalone identification component 302 (as shown in FIGS. 2
and 3) or integrally with the electronic device 400 (as best seen
in FIGS. 4 and 5) or the test device 200 (as shown in FIG.
7)--e.g., with the sample support 212, the sensor 214 and/or the
test connection element 216. That is, the identification element
300 may be provided integrally or in association with the
electronic device 400. Alternately, the identification element 300
may also or instead be provided apart from the electronic device
400 and connected to it via a wireless or USB connection (as best
seen in FIG. 3). In some cases, the identification element 300 may
be embedded inside the test device 200--e.g., to provide a better
and/or higher tracking ID security system. As shown in FIG. 7, the
identification element 300 may preferably be included as part of
the test device 200. For cost reasons, however, it may be more
economical to provide the identification element 300 (and any
related bio-recognition system) as part of the electronic device
300 or in the form of the aforesaid standalone identification
component 302.
[0095] Preferably, the identification element 300 may include a
biometric identification element. For example, the biometric
identification element may be a fingerprint scanner 306 (as shown
in FIGS. 2-5 and 7), a retinal scanner, a microphone and voice
recognition element, a camera and facial recognition element,
and/or a biological sample extractor 308 (or genetic expression
factor identification element 308, as shown in FIG. 7). Of course,
other present and/or future bio-recognition systems which may be
available may also be suitable for use in accordance with the
present invention.
[0096] The electronic device 400 stores user identification data
(not shown) associated with the user 90 and/or an owner of the
electronic device 400. Preferably, the identification element 300
automatically accesses the user identification data stored in the
electronic device 400 in the process of identifying the user
90.
[0097] According to some preferred embodiments of the invention,
the system 100 is adapted for use with an account (not shown)
associated with the user identification data. The system 100 also
includes a billing element (not shown) which operatively debits the
account in association with the generation of the quantitative test
results 702.
[0098] The electronic device 400 is preferably a networking
electronic device and is provided with a communication subsystem
408 to afford connectivity and/or communications (e.g., network
connection, GSM, satellite connection, Internet) capabilities. As
shown in FIGS. 3 and 5-8, the communication subsystem 408 networks
with an external communications system 600 which may include
satellite networks (e.g., GPS networks), terrestrial wireless
networks (e.g., a cellular telephone network 602, a local wireless
network 606), the Internet 604, and laboratory and/or hospital
information systems (LIS/HIS networks) 608. The electronic device
400 may preferably be in wireless (and/or wired) communication with
at least one communication system 600.
[0099] The communication subsystem 408 which is provided may
preferably depend on the type or version of the electronic device
400 used in the system 100. In the case of a cellular telephone
402, for example, the system 100 may preferably use its wireless
capability to transmit data via the cellular telephone network 602
to one of the remote databases 800. In the case of the laptop 404
shown in FIG. 8 (or the pocket PC), the communication subsystem 408
may preferably be an intranet connection, or a wired or wireless
Internet 604 connection.
[0100] The electronic device 400 may preferably also have the
ability to connect quickly and easily to the LIS/HIS networks 608
via, for example, the local wireless network 606 (e.g., a Bluetooth
network) and/or a USB cable. Preferably, the electronic device 400
automatically transmits the test data, the quantitative test
results and/or the presentation data for recordal in one or more
remote LIS/HIS networks 608. Additionally, transmission of the test
data, the quantitative test results or the presentation data by the
electronic device 400, via the communication subsystem 408 over the
communication system 600, may be initiated directly and/or
indirectly by the user 90 by controlling a dedicated button or a
context dependent programmable button or key. Preferably, the
electronic device 400 may be able to record the test results or the
biometrics information related to each test. The remote databases
800 may also be used for various tests or patients and are
preferably linkable with the data stored on the electronic device
400.
[0101] As shown in FIGS. 6 to 8, various databases 800 may
interface with the communications system 600, preferably including,
waste treatment services databases 802, software applications
databases 804 (e.g., clinical software applications, database
software applications, download portals, quality control central
databases), and various test result databases 806 (e.g., healthcare
providers database, governmental agency databases, military
department databases). Notably, the databases 800 may include,
without limitation, epidemiologic databases, UN and
major/international healthcare institution databases, healthcare
and emergency infrastructure databases, education and economic
databases, news databases, demographic databases, communication and
military infrastructure databases, and weather and topographic
databases. The databases 800 may preferably serve as an additional
repository for the test results (test result databases 806), as a
source for test processing algorithms and software applications
(the software applications databases 804), and/or as a resource for
coordination of waste treatment or other services (e.g., the waste
treatment services databases 802).
[0102] Communication functions, including data and voice
communications, may be performed through the communication
subsystem 408. The communication subsystem 408 preferably acts as
both a receiving element and a transmitting element. The
communication subsystem 408 may receive messages from and send
messages via (e.g., USB, wireless) communication signals 500 to the
communication system 600. The electronic device 400 may send and
receive communication signals over the communication system 600.
Some of the subsystems of the electronic device 400 may perform
communication-related functions, and some may provide "resident" or
on-device functions. By way of example, the display element may be
used for both functions.
[0103] The processor 416 may also interact with additional
subsystems of the electronic device 400, such as a random access
memory (RAM), a flash memory, other presentation elements
(including colored indicator lights and a speaker), a short-range
communications system, and a GPS subsystem. Operating system
software for the standard functions of the electronic device 400
used by the processor 416 may typically be stored in a persistent
store such as the flash memory. Those skilled in the art will
appreciate that the operating system, specific device applications,
or parts thereof, may be temporarily loaded into a volatile store,
such as the RAM, for processing by processor 416.
[0104] The test device 200 is adapted to test a single one said
sample 50 and is adapted for disposal or for sterilization and
re-use (e.g., of the sensor 214 and/or the test connection element
216) after the electronic device 400 receives the test data. That
is, the test device 200 may preferably be provided as a fully
disposable or consumable test device, or as a partially reusable
test device.
[0105] In the fully disposable or consumable version of the test
device 200, all of the components needed for the test are included
and many may be consumed during the test or may not endure beyond
the transmission of the test data. At the end of the test, this
test device 200 is adapted to be discarded or sent to healthcare
institutions or corporations for analysis or waste treatment. The
fully disposable or consumable version of the test device 200 may
preferably be adapted for use directly by the patient (e.g., to
test herself).
[0106] In the partially reusable version of the test device 200,
some components may preferably be reusable by the patient or doctor
in subsequent tests. Some of the components which may preferably be
capable of reuse may include, without limitation, the sensors 214
and/or the test connection element 216. Some of the components
which may preferably be provided as consumables may include the
pre-analytical components 208, the reagents 60, and/or the onboard
memory 206. The partially reusable version of the test device 200
may preferably find particularly advantageous utility when a
patient seeks and/or requires recurrent testing (e.g., for
diabetes, cardiac diseases, HIV) or when a patient seeks or needs
to be monitored, on an ongoing basis, in association with a
specific condition or treatment (e.g., thrombosis, chemotherapy).
Another utility for the partially reusable version of the test
device 200 may include contemplated uses in a small medical
dispensary, in clinics, in doctors' offices, or in other locales
where, for example, a small number of tests may be performed per
day. In this version of the test device 200, the ongoing costs
associated with performing any necessary tests may be restricted,
in part, to the price of the consumables--such as, for example, the
reagents, the pre-analytical components, and in some cases, a few
additional components (e.g., the memory).
[0107] Ideally, the above-described combination of the test device
200, the identification element 300, and the electronic device 400
may preferably allow a patient and/or healthcare provider to
readily perform--preferably at their fingertips and/or in the palm
of their hand--one or more diagnostic tests with substantially the
same analytic capability as other substantially more unwieldy prior
art high-tech diagnostic devices.
[0108] Preferably, and as aforesaid, some preferred embodiments of
the invention may involve use of a mobile or cellular telephone 402
as the electronic device 400--i.e., in association with the test
device 200. In other embodiments of the invention, such as that
shown in FIG. 7, the test device 200 integrally includes the
identification element 300. The identification element 300 shown in
FIG. 7 includes a combined fingerprint scanner and biological
sample extractor 304. Preferably, substantially contemporaneous
with the user 90 putting his or her finger on the provided
fingerprint scanner 306, the biological sample extractor 308 may
preferably draw, by capillary action, a drop of blood therefrom,
inter alia, as the sample 50 and for supplemental identification
purposes. Preferably, in still further embodiments (and by way of a
non-limiting example), the identification element 300 may be
integrally included as part of the electronic device 400 by
utilizing a camera (not shown) of the cellular telephone 402 to act
as the biometric element.
[0109] As shown in FIG. 8, according to some embodiments of the
invention, the test device 200 may also be connected with the
laptop 404 via a USB port (as the electronic connection element
410) and/or via any other available port to provide data transfer
and/or energy supply. Similarly, though not shown in the drawings,
the test device 200 may be used with a desktop computer and/or a
pocket PC according to the present invention. As in the case of the
laptop 404 (discussed above), the test device 200 may also be
connected with the desktop computer and/or pocket PC via a USB port
(as the electronic connection element 410) and/or via any other
available port to provide data transfer and/or energy supply.
[0110] With reference to the various embodiments of the system 100
which are shown in the drawings, it will be appreciated by one
skilled in the art that, although some components, relations,
processes and aspects of same are only discussed with reference to
one or more specific drawings, same may be used and/or adapted for
use in association with embodiments shown in other ones of the
drawings.
[0111] FIG. 9 shows, schematically by way of overview, an
associated method 900 of testing the sample 50, for use with the
reagents 60, the electronic device 400, and the test device 200.
The method 900 preferably includes the following steps, among
others: a test device preparation step 902, a sample collection
step 904, a sample loading step 906, a connection step 908, a test
device storage step, an algorithm transmission step 910, a powering
step, a reaction control step, a reaction step (see method step 912
in FIG. 9), a sensing step (see method step 912 in FIG. 9), a test
device storage step, a data transmission step (see method step 912
in FIG. 9), a processing step 914, an ID storage step, an
identification step 916, an ID analysis and recording step 918, a
compilation and report design step 920, a presentation step 922, a
network transmission step 924, a billing step, a use completion
step 926, and/or a disposal step.
[0112] In the test device preparation step 902, the test device 200
is preferably removed from its packaging inside of a hermetically
sealed plastic bag or a small plastic box. Such packaging is used
to keep dry one or more of the reagents 60 and/or the test device
200. Next, a USB cable 250 or other connectivity interface element
is preferably plugged into the test device 200. The USB cable 250
may be considered to be part of the test device 200, the electronic
device 400, or a standalone component of the system 100.
[0113] As shown in FIGS. 2 to 8, the test device 200 (and the USB
cable 250) may preferably be provided with process control
indicator lights 220 to indicate process control data 700
concerning the reaction of the sample 50 with the reagents 60. In
some exemplary embodiments, when three process control indicator
lights 220 are alit, the reaction of the sample 50 with the
reagents 60 has concluded and/or the test data has been transmitted
to the electronic device 400. In any event, in FIGS. 6 to 8, arrow
"B" indicates a diagnostic test processing step which is
performed.
[0114] The sample 50 is collected in the sample collection step
904. In the sample loading step 906, the user 90 (e.g., a patient,
nurse and/or doctor) may preferably load the sample 50 (e.g., a
drop of blood), in a sample loading direction as indicated by arrow
"A" in FIGS. 6 and 8, into a sample chamber 210 of the test device
200.
[0115] In the connection step 908, the test connection element 216
and the electronic connection element 410 are connected in mating
relation, with the test device 200 plugged into the electronic
device 400.
[0116] The test device storage step occurs before the data
transmission step. In the test device storage step, the test data
and/or the algorithms 202, 204 are electronically stored using the
onboard memory 206 of the test device 200.
[0117] The algorithm transmission step 910 occurs before the
processing step 914. In the algorithm transmission step 910, the
test device 200 preferably transfers, to the electronic device 400,
some data concerning use of the test device 200, or one or more
algorithms 202, 204 to process or analyze test data using the
electronic device 400. That is, in the algorithm transmission step
910, the algorithms 202, 204 are electronically transmitted to the
processor 416, via the electronic connection element 410, using the
test connection element 216 of the test device 200.
[0118] The powering step occurs before the data transmission step.
In the powering step, the test connection element 216 of the test
device 200 is used to receive, via the electronic connection
element 410, power from the battery 406 of the electronic device
400.
[0119] The reaction control step occurs before completion of the
reaction step. In the reaction control step, the processor 416 is
used to apply one or more of the algorithms 202, 204 to control the
reaction of the sample 50 with the reagents 60.
[0120] During the reaction step (see method step 912 in FIG. 9),
the test device 200 is used to react the sample 50 with the
reagents 60, and the electronic device 400 may preferably open a
window and/or application with some (or preferably all) of the
information with respect to the relevant diagnostic test being
performed.
[0121] Preferably at substantially the same time, in the sensing
step (see method step 912 in FIG. 9), the test device 200 may
preferably process quality control data and/or measurements. Test
data is detected from the sample 50 using the sensor 214 of the
test device 200.
[0122] In the data transmission step (see method step 912 in FIG.
9), the test data is electronically transmitted to the electronic
connection element 410 of the electronic device 400 using the test
connection element 216 of the test device 200. That is, the test
device 200 transfers the test data to the electronic device
400.
[0123] In the processing step 914, the electronic device 400
preferably receives and analyzes test data for subsequent
presentation of the data inside the aforesaid window and/or
application. That is, in the processing step 914, one or more of
the algorithms 202, 204 are applied to the test data using the
processor 416 of the electronic device 400 to generate the highly
sensitive and accurate quantitative test results and/or
presentation data based on the quantitative test results. The
presentation data so generated preferably includes the treatment
and follow-up suggestion data based on the test results. As
aforesaid, the treatment and follow-up suggestion data is
preferably determined with reference to one or more of the
algorithms 202, 204 stored onboard the electronic device 400 or the
test device 200, or in one of the remote databases 800. Preferably,
one or more of the algorithms 202, 204 generate the quantitative
test results and/or the presentation data for presentation from the
display element in the form of one or more visually presentable
textual data, graphical data 702, or colored indicator light data.
In the processing step 914, the test results may also be quantified
as high, medium, and/or low results.
[0124] The ID storage step occurs before the identification step.
In the ID storage step, the electronic device is used to store user
identification data associated with the user 90 and/or an owner of
the electronic device 400.
[0125] Preferably in the identification step 916, the patient or
user 90 may preferably record his or her ID information through the
biometrics identification element or directly through a keypad 412
of the electronic device 400, or through a camera or a microphone
which may be provided in association with the electronic device
400. To put it another way, in the identification step 916, the
identification element 300 is used to identify the user 90.
Preferably, the user is biometrically identified. In the
identification step 916, the identification element 300 also
preferably automatically accesses the user identification data
stored in the electronic device 400. Thereafter, in the ID analysis
and recording step 918, patient identification analysis and
recording is performed.
[0126] In the compilation and report design step 920, data
compilation and report design is performed, preferably using the
presentation data. Preferably thereafter, in the presentation step
922, the patient or user 90 (or other person) may preferably be
provided with access to the test analysis, preferably via the
screen of the electronic device 400. That is, the quantitative test
results and/or the presentation data (e.g., the treatment and
follow-up suggestion data) are presented to the user 90 using the
presentation element 414 of the electronic device 400. Preferably,
in the presentation step 922, the quantitative test results and/or
the presentation data are presented from the display element of the
presentation element 414.
[0127] Preferably after that, in the network transmission step 924,
the system 100 may preferably provide an option (e.g. via
presentation of a send command prompt 704 on the display element)
to transfer onboard data to a remote database 800, to keep the data
inside the electronic device 400, and/or to keep the data inside
the test device 200. The network transmission step 924 occurs after
the data transmission step. In the network transmission step 924,
the electronic device 400 is used to automatically transmit the
test data, the quantitative test results and/or the presentation
data for recordal in one or more remote laboratory and/or hospital
information systems 608.
[0128] The billing step occurs after the identification step 916.
In the billing step, the account (associated with the user
identification data stored in the electronic device 400) is debited
in association with the generation of the quantitative test
results.
[0129] Thereafter, in the use completion step 926, use of the test
device 200 and the electronic device 400 ceases. In the disposal
step, the test device 200 is disposed in a suitable waste facility
230. Alternately, the reagents 60 and/or biological components may
be neutralized in a suitable recycling facility 240. Preferably in
this step, the system 100 may query the user 90 to release the
waste reagent and/or a waste reagent chamber 218 of the test device
200, or the system 100 may automatically release the waste reagents
inside the test device 200. The sensor 214 and the test connection
element 216 may be sterilized and re-used in the recycling facility
240.
[0130] This concludes the description of presently preferred
embodiments of the invention. The foregoing description has been
presented for the purpose of illustration and is not intended to be
exhaustive or to limit the invention to the precise form disclosed.
Other modifications, variations and alterations are possible in
light of the above teaching and will be apparent to those skilled
in the art, and may be used in the design and manufacture of other
embodiments according to the present invention without departing
from the spirit and scope of the invention. It is intended the
scope of the invention be limited not by this description but only
by the claims forming a part of this application and/or any patent
issuing herefrom.
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