U.S. patent application number 14/499420 was filed with the patent office on 2015-01-15 for method and device for express analysis of acetone traces in gases.
This patent application is currently assigned to PositiveID Corporation. The applicant listed for this patent is PositiveID Corporation. Invention is credited to Benjamin Atkin, Vadim Goldshtein.
Application Number | 20150013429 14/499420 |
Document ID | / |
Family ID | 41341866 |
Filed Date | 2015-01-15 |
United States Patent
Application |
20150013429 |
Kind Code |
A1 |
Atkin; Benjamin ; et
al. |
January 15, 2015 |
Method and Device for Express Analysis of Acetone Traces in
Gases
Abstract
A device apparatus for measuring acetone levels exhaled air in
order to determine the content of glucose in the blood is provided.
The device includes a chemical sensor cell having a vertically
oriented hollow truncated cone with one end having a first diameter
and an opposite end having a second diameter that is larger than
the first diameter and also a solution housed within the chemical
sensor cell.
Inventors: |
Atkin; Benjamin; (North
Miami Beach, FL) ; Goldshtein; Vadim; (Har Hevron,
IL) |
|
Applicant: |
Name |
City |
State |
Country |
Type |
PositiveID Corporation |
Delray Beach |
FL |
US |
|
|
Assignee: |
PositiveID Corporation
Delray Beach
FL
|
Family ID: |
41341866 |
Appl. No.: |
14/499420 |
Filed: |
September 29, 2014 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
|
|
12471935 |
May 26, 2009 |
8848189 |
|
|
14499420 |
|
|
|
|
61055480 |
May 23, 2008 |
|
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|
Current U.S.
Class: |
73/23.3 |
Current CPC
Class: |
G01N 21/78 20130101;
G01N 2021/0193 20130101; G01N 21/59 20130101; G01N 2201/062
20130101; G01N 33/497 20130101; G01N 2021/0162 20130101; G01N 21/01
20130101; G01N 2201/0221 20130101; G01N 33/49 20130101; G01N 33/66
20130101 |
Class at
Publication: |
73/23.3 |
International
Class: |
G01N 33/66 20060101
G01N033/66; G01N 21/59 20060101 G01N021/59; G01N 33/497 20060101
G01N033/497; G01N 21/01 20060101 G01N021/01 |
Claims
1. A device for measuring the concentration of acetone in exhaled
air in order to determine the content of glucose in the blood,
comprising: a chemical sensor cell comprising a vertically oriented
hollow truncated cone with one end having a first diameter and an
opposite end having a second diameter that is larger than the first
diameter; and, a solution housed within the chemical sensor
cell.
2. The device of claim 1, wherein the chemical sensor cell further
comprises an outlet positioned proximal to the one end of the
chemical sensor cell having the first diameter and an inlet
positioned proximal to the opposite end of the chemical sensor cell
having the second diameter.
3. The device of claim 1, wherein the chemical sensor cell is made
of transparent plastic.
4. The device of claim 2, wherein the outlet of the chemical sensor
cell is coupled to a valve.
5. The device of claim 1, wherein the solution contains a solute
selected from the group consisting of Sodium Iodate, Sodium
Nitroprusside, Metadiamine, Phenyl-hydrazone, Furfural,
o-Nitrobenzaldehyde, and combinations thereof.
6. The device of claim 2, further comprising: a dosator coupled to
the inlet of the chemical sensor cell; a light emitter coupled to
the chemical sensor cell; an optical sensor coupled to the chemical
sensor cell; and, a microprocessor coupled to the optical
sensor.
7. The device of claim 6, wherein the dosator is coupled to an
actuator.
8. The device of claim 7, wherein the actuator is coupled to a
valve.
9. The device of claim 6, further comprises a numerical value
output computed by the microprocessor, the number value output
correlates the difference in optical absorbance of an unreacted
solution with a solution reacted with acetone from exhaled air to
produce an output congruous with blood glucose concentration.
10. The device of claim 9, wherein the numerical value output is
displayed on a screen.
Description
CROSS-REFERENCE TO RELATED APPLICATIONS
[0001] The application is a Continuation of U.S. application Ser.
No. 12/471,935, filed May 26, 2009, now allowed, which claims
benefit to U.S. Provisional Application No. 61/055,480, filed May
23, 2008, which are incorporated herein by reference in their
entirety.
BACKGROUND OF THE INVENTION
[0002] 1. Field of the Invention
[0003] The present invention relates to a health monitoring device
and, more particularly, to a glucose monitoring device.
[0004] 2. Description of the Related Art
[0005] For many people, the need to measure and monitor blood
glucose levels is very important. Conventionally, a sample of blood
needs to be drawn and placed in a measuring device in order to
accurately measure in vivo blood glucose concentrations.
[0006] There is a need to develop a non-invasive technique to
accurately measure in vivo blood glucose concentrations.
[0007] The device and method of the present invention addresses
this need.
BRIEF SUMMARY OF THE INVENTION
[0008] The invention relates to the development of technical means
for chemical analysis of acetone in the air, namely portable
devices for quantitative analysis micro amounts of acetone in
exhaled air, primarily the indirect noninvasive blood glucose or
insulin monitoring in human blood.
[0009] There are invasive devices for determining the content of
glucose in the blood of diabetics, athletes, and pregnant women.
These devices have substantial disadvantages that limit their use.
Primarily, these devices require damage to blood vessels, when
drawing blood samples; moreover (except chromatographic analysis)
they do not give necessary precision.
[0010] It is known that a larger quantity of acetone vapors
contained in exhaled air of diabetics, pregnant women, people
engaged in heavy physical labor, and athletes at high physical
loads.
[0011] It is also known that the concentration of acetone in
exhaled air correlates with the content of glucose in the blood. In
other words t the acetone is a reliable biological marker that
allows control of glucose in the blood.
[0012] As established by biochemical studies t glucose in the blood
is one of the main suppliers of energy to the body. If the blood
has not enough insulin t which transports glucose molecules to the
cells of the body (diabetes), or if glucose is expired (because
high physical activity), the body begins the process of oxidation
of fats. It fills a deficit of energy. But the oxidation of fats
results in acetone as a by-product. This is the reason for
increasing of the acetone content in the exhaled air.
[0013] Thus, the increasing of acetone in the exhaled air of
diabetics shows a deficit of insulin in the blood. In the case of
people engaged in heavy physical labor, acetone is demonstration of
glucose deficit in the blood.
[0014] For people with diabetes, increasing of the acetone content
in the exhaled air may be a signal for insulin injections. For
people of heavy physical labor, increased acetone content in the
exhaled air may be a signal to take additional products that
contain sugar or glucose.
[0015] From numerous scientific publications it is well known that
the concentration of acetone in exhaled air is correlated with the
content of glucose in the blood. In other words, the acetone is a
reliable biological marker for monitoring the content of glucose in
the blood.
[0016] There are devices for noninvasive determining of the glucose
content in the blood of people with diabetes. These devices also
have disadvantages, which do not allow them to be used widely. The
main drawback of is the lack of precision and selectivity in
relation to acetone.
[0017] The lack of precision--is the main drawback of the mentioned
devices as well as incorrect and inaccurate information about the
content of glucose in the blood can lead to serious consequences
for the patient.
[0018] For example, one known device is a method that uses cavity
ringtown spectroscopy. Through a small cameral fitted with mirrors,
air filled air with vapor of acetone, the beam of infrared laser is
given. The beam is reflected by mirrors. This mirror method does
not provide an opportunity to build a simple and reliable portable
device.
[0019] A few noninvasive devices for determining glucose in the
blood by determining the concentration of acetone in exhaled air
are described in the literature. They are based on direct
determining of acetone's concentration by optical methods. These
devices are not optimal because they have low accuracy, are
complicated, and cumbersome.
[0020] The present invention has created a handheld portable
device, which will determine the concentration of acetone in
exhaled air with a minimum content of acetone 3-5 mg/liter with an
accuracy that will satisfy doctors and patients.
[0021] In one embodiment, the present invention is a device for
measuring the concentration of acetone in exhaled air in order to
determine the content of glucose in the blood, comprising:
[0022] (a) an inlet for expirated air;
[0023] (b) a dosator for receiving air from said inlet;
[0024] (c) an actuator for receiving air from said dosator with
substantially the same volume for each measurement, said actuator
interrupts air from said inlet when said dosator reaches a
specified volume;
[0025] (d) a chemical cell containing a solution;
[0026] (e) a light emitter constructed and arranged for emitting
light to pass through and spectrally analyze said solution;
[0027] (f) an optical sensor; and
[0028] (g) a microprocessor;
wherein said microprocessor produces an output correlating
measurements of said optical sensor with blood glucose
concentration.
[0029] The device has an actuator that controls a valve that fills
said dosator with a predetermined volume of gas. The actuator
controls either or both of a valve that fills said dosator with a
predetermined volume of gas and a valve that releases gas from a
filled dosator into a chemical cell.
[0030] The device of claim 1 wherein said chemical cell contains a
solution to selectively react with acetone from expired air. The
solution contains a solute selected from Sodium Iodate, Sodium
Nitroprusside, Metadiamine, Phenylhydrazone, Furfural,
o-Nitrobenzaldehyde, or combinations thereof.
[0031] The device further comprises an output of a numerical value,
wherein said numerical value is produced by said microprocessor and
correlates the difference in optical absorbance of an unreacted
chemical cell solution with a chemical cell solution reacted with
acetone from exhaled air to produce an output congruous with blood
glucose concentration. The output is displayed on a screen,
transmitted wirelessly to a receiving device, or combinations
thereof.
[0032] The present invention further includes a method for
determining acetone concentration in exhaled air and correlating
said acetone concentration with blood glucose levels, said method
comprising:
[0033] (a) providing a device according to the invention;
[0034] (b) initiating a blank reading spectral of said chemical
sensor solution;
[0035] (c) instructing a user to inhale and hold their breath for
about 3-5 seconds;
[0036] (d) having said user exhale into an inlet of said
device;
[0037] (e) taking a spectral reading of said chemical cell solution
after reaction with acetone in expired air;
[0038] said device measures the change in absorbance from said
blank reading with said spectral reading after reaction of said
chemical cell solution with acetone from expired air and said
device produces an output whereby said difference in absorbance is
correlated with blood glucose concentration of said user.
[0039] Additional aspects of the invention will be set forth in
part in the description which follows, and in part will be obvious
from the description, or may be learned by practice of the
invention. The aspects of the invention will be realized and
attained by means of the elements and combinations particularly
pointed out in the appended claims. It is to be understood that
both the foregoing general description and the following detailed
description are exemplary and explanatory only and are not
restrictive of the invention, as claimed.
BRIEF DESCRIPTION OF THE SEVERAL VIEWS OF THE DRAWINGS
[0040] The accompanying drawings, which are incorporated in and
constitute part of this specification, illustrate embodiments of
the invention and together with the description, serve to explain
the principles of the invention. The embodiments illustrated herein
are presently preferred; it being understood, however, that the
invention is not limited to the precise arrangements and
instrumentalities shown, wherein:
[0041] FIG. 1 is a top perspective view of the device;
[0042] FIG. 2 is a bottom perspective view of the device;
[0043] FIG. 3 is a block scheme of the measurement system;
[0044] FIG. 4 is a block scheme of the measurement system;
[0045] FIG. 5 is a cross section of the chemical cell;
[0046] FIG. 6 is a graph of precent optical absorbance vs.
Na-nitroprusside concentration in mcg/ml;
[0047] FIG. 7 is an absorbance spectrum;
[0048] FIG. 8 is a scatterplot with linear representation of best
fit line correlating blood glucose concentration with acetone
concentration in exhaled air;
[0049] FIG. 9 is a graph correlating the change in optical
absorbance vs. acetone concentration in mcg/liter in exhaled
air;
[0050] FIG. 10 is a scatterplot with linear representation of best
fit line correlating blood glucose concentration with acetone
concentration in exhaled air; and,
[0051] FIG. 11 is a graph of absorbance spectra of several light
emitting diode (LED) sources.
DETAILED DESCRIPTION OF THE INVENTION
[0052] Device 10 has an inlet 12 that directs exhaled air from a
person into first tube 26 and ultimately into dosator 11. Dosator
11 holds exhaled air until dosator 11 if filled. An actuator 21
closes a valve when dosator 11 is filled such that the volume
delivered to the measurement parts of the system is substantially
constant. The actuator 21 is either mechanical or electrical and is
calibrated to close a valve based on a predetermined volume of
exhaled air in dosator 11. When dosator 11 is filled, and valve is
closed, actuator 21 directs exhaled air from within dosator 11
through second air tube 27 and into chemical cell inlet 28.
Chemical cell 23 is housed in cell cavity 14 formed in device
housing 13. Chemical cell 23 has a sensor solution for selectively
reacting with components of exhaled air. Chemical cell 23 is
positioned such that it is between light emitter 25 and optical
sensor 17. A beam of light 32 from light emitter 25 passes through
chemical cell 23 and is detected by optical sensor 17. Optical
sensor 17 is operatively connected with a microprocessor 22 and an
electrical amplifier 20. Microprocessor 22 received light
absorbance measurements from optical sensor 17 and using programmed
correlation information, assigns a numerical value to acetone
concentration. (A converter 19 converts the optical signal into an
electrical signal.) The acetone concentration is processed using a
mathematical algorithm to produce a correlation with conventional
blood glucose concentration. Screen 15 displays a numerical value
of blood glucose concentration based on the concentration of
acetone in exhaled air.
[0053] Chemical cell 23 is a truncated cone and has solution 35
filled therein to level such that air is present above solution 35
in the interior of chemical cell 23.
[0054] Chemical cell 23 is a truncated cone. This configuration is
advantageous as the shape reduces the scattering and focus beam of
light from the light emitter 25. This reduction in scattering
allows the maximum amount of light from the light emitter 25 to
reach optical sensor 17. Other form shapes lacks this
advantage.
[0055] Chemical cell outlet 30 has valve 31 that regulates the rate
at which air exits chemical cell 23. Air that exits chemical cell
outlet 30 and valve 31 is vented to the atmosphere. In a preferred
embodiment, device 10 has a second air tube 27 that is a capillary
with a diameter of 30-50 microns. In solution 35, which is a
water-alcohol solution of sodium-nitroprusside and sodium
hydroxide, a foam is not formed, and air bubbles with diameter of
50-70 microns pass through the solution 35. The solution 35 itself
remains in the chemical cell 23.
[0056] The device of the presentation invention is constructed and
arranged to carry out an inventive method through a novel system.
The device, system, and method of the invention comprise: [0057]
Chemical cell 23 that can form a complex chemical compound with
acetone (this compound is determined by a spectral method in the
near UV spectral region), [0058] Sampling exhaled air using a
constant-volument container, [0059] Receiving an analytical result,
using a novel cell design.
[0060] Chemical cell 23 is a mini-cell, this is filled with
solution 35 of an organic compound, easily quickly and selectively
reacting with acetone. The product of interaction acetone with
organic compounds is forming a color complex, defined by spectral
method.
[0061] The analytical result is achieved by the registration of a
molecular spectrum, followed by intensification of an electrical
signal.
[0062] The scheme of the device is represented in the FIGS. 3-5.
The device works as follows:
[0063] Exhaled air enters into the inlet 12 of device 10. Dosator
11 is a bellow or balloon type structure that is filled to a fixed
volume. Once dosator 11 is filled, an actuator 21 closes a valve to
restrict any additional air from entering dosator 11 and a valve is
opened by the system automatically sends air through second air
tube 27 to interact with a solution 35 in chemical cell 23.
[0064] The solution 35 is a chemical solution of an organic
compound, easily, quickly and selectively reacting with acetone.
The solution 35 is placed in a chemical cell 23 that is preferably
a mini-cell.
[0065] In chemical cell 23 a foam will not be formed. The air
leaves the chemical cell 23 through cell outlet 30, not taking the
chemical reagents from the solution 35 because of a very low
surface tension of the solution 35. In addition, the design of the
chemical cell 23 and the input and output air's system will protect
against the loss of reagents from the chemical cell 23.
[0066] The system is constructed and arranged such that the
presence of air entering chemical cell 23 through chemical cell
inlet 28 activates the system. Once the air has passed through the
solution 35 of the chemical cell 23, the measurement system turns
on.
[0067] Acetone, which is one component of exhaled air, quickly and
quantitatively reacts with the solution 35, resulting in a new
chemical complex compound, suitable for the precise definition by
spectral methods.
[0068] A beam of light 32 from light emitter 25 passes through a
filter-monochromator 18 (i.e. a monochromatic screen), after that
through the solution of the reacted solution 35, and said beam
falls upon an optical sensor 17 that is a photometer photosensitive
element. Optical sensor 17 produces an electric signal that is
intensified in an electrical amplifier 20, and the signal is
processed by microprocessor 22 to ultimately be displayed on screen
15. A battery 16, which can be covered by a housing cover 6,
provides power.
[0069] The light emitter 25 is selected based on correlation with
the maximum emission needed in the field. In the examples described
herein, light emitter 25 is an LED-7 which has a maximum emission
correlating with sodium nitroprusside absorbance. If other chemical
sensors are used, other sources of emission are selected. Selection
of a light emitter 25 is based on those light sources with a
maximum emission that coincides or is close to the field of
absorption of the particular chemical cell 23.
[0070] In the examples herein, the light source (LED-7) used as
light emitter 25 in the present invention has a constant spectral
characteristic as shown in FIG. 10. While passing the beam of light
through the solution 35 of the chemical cell 23, the partial
absorption of the emission occurs in the field of 380-420 nm. After
the interaction of solution 35 with acetone, beam from the light
emitter 25 passes again through the solution 35. As the acetone
takes out the portion of the chemical cell 23 (proportional to the
concentration of acetone) from this spectral region (380-420 nm),
the second absorption in the 380-420 nm is lower than in the first
case. The difference between the two absorptions gives the change
in the concentration of chemical sensor and proportionally--the
concentration of acetone in 1 liter of breath.
[0071] Monochromatic screen is an optical filter 24 that is a
transparent color film, which transmits a narrow interval of
optical emission within approximately 350-450 nm. A monochromatic
screen (filter) will be used to remove unwanted optical "noise" and
increase the sensitivity of the device.
[0072] In order to obtain reproducible results of air sampling, a
patient needs to inhale air into the lungs, keep the air in the
lungs for 3-5 seconds | and then exhale out the air into inlet 12
where expirated air enters device 10.
[0073] Device 10 measures the concentration of acetone in air
introduced into the device in a range from about 3-5 mg/liter. The
present invention has discovered the range of acetone concentration
of about 3-5 mg/liter is sufficient for accurate correlation with
glucose concentrations in the blood.
[0074] There are several organic compounds that will achieve the
desired result. The present invention contemplates selection of at
least one organic compound to carry out the objective of the
present invention. The reaction product obtained from the
interaction of acetone with at least one organic compound forms a
color complex, defined by spectral method.
[0075] The device, system, and method of the present invention
utilize particular chemical reagents capable of rapid interaction
with traces of acetone in exhaled air. The suitable reagents
include, but are not limited to:
Sodium Iodate,
Sodium Nitroprusside,
Metadiamine,
Phenyl-hydrazone,
Furfural, and
[0076] o-Nitrobenzaldehyde.
[0077] The stoichiometric calculation of concentrations of sodium
nitroprusside and sodium hydroxide was made. As a base, the actual
concentrations of acetone (5 to 80 mcg/liter of breath) were used.
The resulting concentrations of both reagents are necessary and
sufficient to capture any amount of acetone in the specified
limits.
[0078] For other chemical sensors similar stoichiometric
calculations can be made.
[0079] In a preferred embodiment, the device, system, and method of
the present invention utilizes the following reaction scheme:
##STR00001##
[0080] The device 10 has microprocessor 22 incorporated and
operatively associated with all the components of device 10.
[0081] Microprocessor 22 provides the following functions and other
functions as needed:
Pneumatic System Control
[0082] Fixing the amount of breath in dosator 11, [0083] Change the
actuator 21 for the air flow, [0084] Control the speed of air
passing through the solution 35 of the chemical cell 23.
Optical--Chemical System Control
[0084] [0085] Turning on a light emitter 25, [0086] Recording of
the optical sensor 17, such as, for instance, an optical diode.
Reform of Electrical Signal to Device Index
[0086] [0087] Recalculation and correlation of the electrical
signal from an optical sensor 17 to the concentration of acetone,
[0088] Recalculation and correlation of the concentration of
acetone detected to the concentration of glucose in blood, [0089]
Sending the result to the screen 15 of the device 10, [0090]
Sending results by e-mail.
[0091] The microprocessor is contemplated to have appropriate
transmission mechanism to wirelessly transmit by email, text
message or other wireless transmission, the results of a particular
test to an email or server.
[0092] Control of Device Systems [0093] Turning on the device,
[0094] Control sequencing of device work, [0095] Turning off the
device.
Example 1
[0096] Sodium hydroxide and sodium nitroprusside are dissolved in a
mixture of water and ethanol (a ratio of 50:50) to create a
solution 35. The use of water-ethanol mixture as a solvent prevents
a neutralization of sodium hydroxide by carbon dioxide (carbon
dioxide is a part of the exalted air).
[0097] The solution 35 in the amount of 0.5 ml is poured into the
chemical cell 23. The chemical cell 23 is a hollow truncated cone,
made of transparent plastic. The entrance for the air, the chemical
cell inlet 28, is in the wide part of the cone of chemical cell 23,
and in the narrow part there is a chemical cell outlet 30 for air
that is regulated by an valve 31 that ultimately vents air from the
chemical cell 23 to the atmosphere. Chemical cell 23 is oriented
vertically in the optical measurement system of device 10. The wide
part of the chemical cell 23 is facing down, to the source of
light, a light emitter 25. The narrow part of the chemical cell 23
is facing up--to an optical sensor 17.
[0098] A light emitter 25 is a light source in the optical system.
As a light source, the LED-7 element is selected. Its optical
performance is presented in FIG. 11. For other chemical cell
sensors 23 other emitters can be selected, mainly from the group
LED.
[0099] Before testing begins, a measurement is recorded of the
optical absorption of the solution 35 (the first measuring) as a
blank. The absorbance spectrum of the chemical cell 23, including
sodium nitroprusside and sodium hydroxide in the water--ethanol
mixture is presented in FIG. 7:
[0100] The spectrum has a maximum absorption at 393 nm. An absolute
value of the maximum depends on the concentration of sodium
nitroprusside in the solution 35. The dependence of maximum
absorption (an optical density) on the concentration of sodium
nitroprusside is presented is presented below in FIG. 6.
[0101] To determine acetone in the exhaled air the following
concentrations of the solution 35 are selected:
TABLE-US-00001 Sodium-nitroprusside 450-600 micrograms/ml, Sodium
hydroxide 630-850 micrograms/ml.
[0102] The device 10 is now ready to measure acetone in exhaled
air. Dosator 11 is filled with 1 liter of the exhaled air that
enters device 10 through inlet 12 and is delivered to dosator 11
through first air tube 26. Dosator 11 is controlled by actuator 21
that controls one or more air regulator valves. Once dosator 11 is
filled, actuator 21 restricts additional air from exiting dosator
11. Actuator 21 allows air to exit dosator 11 through second air
tube 27 that is directed into chemical cell inlet 28 and ultimately
into solution 35 in chemical cell 23 and exits through chemical
cell outlet 30 and is released to the atmosphere. Exalted acetone
enters into a chemical reaction with the solution 35 and forms a
new chemical substance as demonstrated by reaction scheme 1.
[0103] Device 10 has operative electronics and microprocessor
components such that when dosator 11 is empty, light emitter 25
turns on. The optical absorption of sodium nitroprusside, which
remained after the formation of the new chemical substance (the
second measuring) is measured and recorded.
[0104] After reaction with acetone in exhaled air, the absorption
peak of sodium nitroprusside is reduced. The optical components of
device 10 measure the absorbance of solution 35 after reaction with
acetone in exhaled air.
[0105] The difference between the first measurement i.e. before
reaction with acetone in exhaled air, and second measurement i.e.
after reaction with exhaled air is processed in a microprocessor 22
that has computer readable information for corresponding the
concentration of acetone in the exhaled air based on the change in
absorbance of solution 35. Laboratory results are presented in FIG.
9.
[0106] The present device, system, and method correlate the
concentration of the exalted acetone proportional to the
concentration of glucose in the blood.
[0107] Experimental Correlation
[0108] Measurement of the exalted acetone (two voluntaries) showed
the presence of acetone in amounts of 27 and 42 mg/l. For
determination of glucose, the published data on the correlation
between the content of exalted acetone and the content of glucose
in the blood are used.
[0109] FIGS. 8 and 10 present data on the correlation. In
accordance with these data the content of glucose in the blood of
patients is found equal to 70 and 105 mg/dl. Measurement of glucose
with a standard device has confirmed the reliability of the
results. A comparison was made with a standard device Accu-Check
Go.RTM. (Roche Diagnostics, Indianapolis, Ind.). The difference
between the device of the invention and the Accu Check.RTM. was 19%
for one patient and 4% for the second patient.
[0110] The analytical result is achieved by the registration of
molecular spectrum, followed by intensification of an electrical
signal.
[0111] While the invention has been described in its preferred form
or embodiment with some degree of particularity, it is understood
that this description has been given only by way of example and
that numerous changes in the details of construction, fabrication,
and use, including the combination and arrangement of parts, may be
made without departing from the spirit and scope of the
invention.
[0112] Having thus described the invention of the present
application in detail and by reference to embodiments thereof, it
will be apparent that modifications and variations are possible
without departing from the scope of the invention defined in the
appended claims as follows:
* * * * *