Method of photometric in vitro determination of the content of an analyte in a sample of whole blood

• US 5,366,903 A
• Filed: 02/22/1994
• Issued: 11/22/1994
• Est. Priority Date: 12/22/1988
• Status: Expired due to Term

• Current Assignee: Radiometer A/S (Danaher Corporation)
• Original Assignee: Radiometer A/S (Danaher Corporation)
• Inventors: Lundsgaard, Finn C., Andersen, Willy, Jensen, Niels-Henrik
• Primary Examiner(s): Housel, James C.
• Assistant Examiner(s): Wallenhorst, Maureen M.
• Application Number:
  US08/199,858
• Time in Patent Office: 273 Days
• Field of Search: 422/82.05, 422/82.06, 422/82.11, 436/164, 436/165, 436/68, 436/74, 128/633, 128/634, 356/39, 356/246, 356/434
• US Class Current: 436/165
• CPC Class Codes: G01N 2021/0346 Capillary cells; Microcells
• CPC Class Codes: G01N 2021/036 transformable, modifiable
• CPC Class Codes: G01N 2021/0364 flexible, compressible
• CPC Class Codes: G01N 2021/3148 using three or more wavelengths
• CPC Class Codes: G01N 2021/3166 using separate detectors and filters
• CPC Class Codes: G01N 2021/6417 Spectrofluorimetric devices
• CPC Class Codes: G01N 2021/6432 Quenching
• CPC Class Codes: G01N 2021/6439 with indicators, stains, dyes, tags, labels, marks
• CPC Class Codes: G01N 2021/7786 Fluorescence
• CPC Class Codes: G01N 2021/8405 Application to two-phase or mixed materials, e.g. gas dissolved in liquids
• CPC Class Codes: G01N 2035/00306 Housings, cabinets, control panels (details)
• CPC Class Codes: G01N 2035/00316 Detecting door closure
• CPC Class Codes: G01N 2035/1062 for testing the liquid while it is in the transfer device
• CPC Class Codes: G01N 21/03 Cuvette constructions
• CPC Class Codes: G01N 21/05 Flow-through cuvettes G01N21/09 takes precedence; handling fluid samples G01N1/10
• CPC Class Codes: G01N 21/251 Colorimeters; Construction thereof
• CPC Class Codes: G01N 21/255 Details, e.g. use of specially adapted sources, lighting or optical systems
• CPC Class Codes: G01N 21/276 with alternation of sample and standard in optical path
• CPC Class Codes: G01N 21/6408 with measurement of decay time, time resolved fluorescence
• CPC Class Codes: G01N 21/6428 Measuring fluorescence of fluorescent products of reactions or of fluorochrome labelled reactive substances, e.g. measuring quenching effects, using measuring "optrodes" in vivo A61B5/00; immunoassay G01N33/53
• CPC Class Codes: G01N 21/78 : producing a change of colour
• CPC Class Codes: G01N 21/80 : Indicating pH value
• CPC Class Codes: G01N 2201/0407 : with multiple optical units, e.g. one per sample
• CPC Class Codes: G01N 2201/0476 : Keyboard controlled, e.g. for plural analysis at one sample, channel selection, coding
• CPC Class Codes: G01N 2201/0618 : Halogene sources
• CPC Class Codes: G01N 2201/1288 : Calibration medium periodically inserted in one cell
• CPC Class Codes: G01N 33/4925 : measuring blood gas content, e.g. O2, CO2 , HCO3
• CPC Class Codes: G01N 33/497 : of gaseous biological material, e.g. breath

Abstract

A sampling device for photometric determination of the content of an analyte in a sample of whole blood has at least one measuring chamber having two wall parts, at least one wall part being locally transparent, at least one wall part being sufficiently deformable to facilitate displacement of the whole blood sample from the measuring chamber. The measuring chamber also contains a transparent body having a radiation transmission characteristic dependent upon the concentration of a predetermined analyte in the whole blood sample. The sample device is employed in an analyzer for photometric determination of the content of an analyte in a sample of whole blood and in a method of photometric in vitro determination of the content of an analyte in a sample of whole blood. In the method, a sample of whole blood is transferred directly from an in vivo locality to the sampling device, the measuring chamber therein is deformed in a controlled manner to substantially drain the whole blood from the measuring chamber, radiation is transmitted through the substantially drained measuring chamber, detected, and the analyte content determined.

Claims

1. A sampling device for photometric determination of the content of an analyte in a sample of whole blood, comprising:

at least one measuring chamber which has two wall parts located opposite one another, at least one of the wall parts being locally transparent, at least one of the wall parts being sufficiently deformable to facilitate displacement of the whole blood sample from the at least one measuring chamber, the at least one measuring chamber further including a transparent body disposed between the wall parts, the transparent body being capable of selectively absorbing the analyte or reacting with the analyte such that upon contact of the analyte with the transparent body, a detectable radiation modification is caused in the transparent body which is dependent upon the concentration of the analyte in the whole blood sample, wherein the transparent body maintains the radiation modification after displacement of the whole blood sample from the at least one measuring chamber so that photometric analysis of the analyte in the absence of the whole blood sample can be performed.

2. An analyzer for photometric determination of the content of an analyte in a sample of whole blood comprising:

a) a radiation source;

b) means for detecting radiation transmitted from the radiation source;

c) a sampling device comprising;

at least one measuring chamber which has two wall parts located opposite one another, at least one of the wall parts being locally transparent, at least one of the wall parts being sufficiently deformable to facilitate displacement of the whole blood sample from the at least one measuring chamber for photometric analysis,

the at least one measuring chamber further including a transparent body disposed between the wall parts, the transparent body being capable of selectively absorbing the analyte or reacting with the analyte such that upon contact of the analyte with the transparent body, a detectable radiation modification is caused in the transparent body which is dependent upon the concentration of the analyte in the whole blood sample, wherein the transparent body maintains the radiation modification after displacement of the whole blood sample from the at least one measuring chamber so that photometric analysis of the analyte in the absence of the whole blood sample can be performed;

d) a sampling device station containing the sampling device; and

e) means for deforming the wall parts of the at least one measuring chamber in the sampling device in a controlled manner to reduce the volume of the at least one measuring chamber such that the sample of whole blood is substantially drained from the at least one measuring chamber, wherein the sampling device station of step (d) is arranged relative to the radiation source and the radiation detection means so that the radiation transmitted from the radiation source will pass through the at least one volume-reduced measuring chamber to the radiation detection means.

3. A method of photometric determination of the content of an analyte in a sample of whole blood, comprising the steps of:

a) transferring a sample of whole blood directly from an in vivo locality to a sampling device, wherein the sampling device comprises;

at least one measuring chamber which has two wall parts located opposite one another, at least one of the wall parts being locally transparent, at least one of the wall parts being sufficiently deformable to facilitate displacement of the whole blood sample from the at least one measuring chamber for photometric analysis,

the at least one measuring chamber further including a transparent body disposed between the wall parts, the transparent body being capable of selectively absorbing the analyte or reacting with the analyte such that upon contact of the analyte with the transparent body a detectable radiation modification is caused in the transparent body which is dependent upon the concentration of the analyte in the whole blood sample, wherein the transparent body maintains the radiation modification after displacement of the whole blood sample from the at least one measuring chamber so that photometric analysis of the analyte in the absence of the whole blood sample can be performed;

b) placing the sampling device in a sampling device station wherein the sampling device station is arranged relative to an optical system comprising a radiation source and a means for detecting radiation, such that the sampling device is located between the radiation source and the radiation detection means;

c) deforming the at least one measuring chamber of the sampling device in a controlled manner to reduce the volume of the at least one measuring chamber, thereby substantially draining the sample of whole blood from the measuring chamber;

d) transmitting radiation from the radiation source through the deformed, substantially drained at least one measuring chamber to the radiation detector;

e) detecting the radiation transmitted in step d); and

f) determining the analyte content of the sample of whole blood from the radiation detected in step e).

4. A measuring chamber for photometric determination of the content of an analyte in a sample of whole blood, comprising:

two wall parts located opposite one another, at least one of the wall parts being locally transparent, at least one of the wall parts being sufficiently deformable to facilitate displacement of the whole blood sample from the measuring chamber for photometric analysis,

the measuring chamber further including a transparent body disposed between the wall parts, the transparent body being capable of selectively absorbing the analyte or reacting with the analyte such that upon contact of the analyte with the transparent body, a detectable radiation modification is caused in the transparent body which is dependent upon the concentration of the analyte in the whole blood sample, wherein the transparent body maintains the radiation modification after displacement of the whole blood sample from the at least one measuring chamber so that photometric analysis of the analyte in the absence of the whole blood sample can be performed.

5. An analyzer for photometric determination of the content of an analyte in a sample of whole blood, comprising:

a) a radiation source;

b) means for detecting radiation transmitted from the radiation source;

c) at least one measuring chamber which has two wall parts located opposite one another, at least one of the wall parts being locally transparent, at least one of the two wall parts being sufficiently deformable to facilitate displacement of the whole blood sample from the at least one measuring chamber for photometric analysis,

the at least one measuring chamber further including a transparent body disposed between the wall parts, the transparent body being capable of selectively absorbing the analyte or reacting with the analyte such that upon contact of the analyte with the transparent body, a detectable radiation modification is caused in the transparent body which is dependent upon the concentration of the analyte in the whole blood sample, wherein the transparent body maintains the radiation modification after displacement of the whole blood sample from the at least one measuring chamber so that photometric analysis of the analyte in the absence of the whole blood sample can be performed,

wherein the at least one measuring chamber is arranged relative to the radiation source and the radiation detection means so that the radiation transmitted from the radiation source will pass through the at least one measuring chamber to the radiation detection means; and

d) means for deforming at least one of the wall parts of the at least one measuring chamber in a controlled manner to reduce the volume of the at least one measuring chamber such that the sample of whole blood is substantially drained from the at least one measuring chamber.

6. A method of photometric in vitro determination of the content of an analyte in a sample of whole blood, comprising the steps of:

a) transferring a sample of whole blood to a measuring chamber which has two wall parts located opposite one another, at least one of the wall parts being locally transparent, at least one of the wall parts being sufficiently deformable to facilitate displacement of the whole blood sample from the measuring chamber for photometric analysis,

the measuring chamber further including a transparent body disposed between the wall parts, the transparent body being capable of selectively absorbing the analyte or reacting with the analyte such that upon contact of the analyte with the transparent body a detectable radiation modification is caused in the transparent body which is dependent upon the concentration of the analyte in the whole blood sample, wherein the transparent body maintains the detectable radiation modification after displacement of the whole blood sample from the measuring chamber so that photometric analysis of the analyte in the absence of the whole blood sample can be performed,

the measuring chamber being arranged relative to an optical system comprised of a radiation source and a means for detecting radiation such that the measuring chamber is located between the radiation source and the radiation detection means;

b) deforming the measuring chamber in a controlled manner to reduce the volume of the measuring chamber thereby substantially draining the sample of whole blood from the measuring chamber;

c) transmitting radiation from the radiation source through the deformed, substantially drained measuring chamber to the radiation detector;

d) detecting the radiation transmitted in step c); and

e) determining the analyte content of the sample of whole blood from the radiation detected in step d).

7. A sampling device for photometric determination of the content of an analyte in a sample of whole blood, comprising:

at least one measuring chamber which has two wall parts located opposite one another, at least one of the wall parts being locally transparent, at least one of the wall parts being sufficiently deformable to facilitate displacement of the whole blood sample from the at least one measuring chamber, the at least one measuring chamber further including a transparent body disposed between the wall parts, the transparent body being capable of selectively absorbing the analyte or reacting with the analyte such that upon contact of the analyte with the transparent body, a detectable change in a radiation transmission characteristic of the transparent body occurs which is dependent upon the concentration of the analyte in the whole blood sample, wherein the transparent body maintains the changed radiation transmission characteristic after displacement of the whole blood sample from the at least one measuring chamber so that photometric analysis of the analyte in the absence of the whole blood sample can be performed.

8. An analyzer for photometric determination of the content of an analyte in a sample of whole blood comprising:

a) a radiation source;

b) means for detecting radiation transmitted from the radiation source;

c) a sampling device comprising;

at least one measuring chamber which has two wall parts located opposite one another, at least one of the wall parts being locally transparent, at least one of the wall parts being sufficiently deformable to facilitate displacement of the whole blood sample from the at least one measuring chamber for photometric analysis,

the at least one measuring chamber further including a transparent body disposed between the wall parts, the transparent body being capable of selectively absorbing the analyte or reacting with the analyte such that upon contact of the analyte with the transparent body, a detectable change in a radiation transmission characteristic of the transparent body occurs which is dependent upon the concentration of the analyte in the whole blood sample, wherein the transparent body maintains the changed radiation transmission characteristic after displacement of the whole blood sample from the at least one measuring chamber so that photometric analysis of the analyte in the absence of the whole blood sample can be performed;

d) a sampling device station containing the sampling device; and

e) means for deforming the wall parts of the at least one measuring chamber in the sampling device in a controlled manner to reduce the volume of the at least one measuring chamber such that the sample of whole blood is substantially drained from the at least one measuring chamber, wherein the sampling device station of step (d) is arranged relative to the radiation source and the radiation detection means so that the radiation transmitted from the radiation source will pass through the at least one volume-reduced measuring chamber to the radiation detection means.

9. A method of photometric determination of the content of an analyte in a sample of whole blood, comprising the steps of:

a) transferring a sample of whole blood directly from an in vivo locality to a sampling device, wherein the sampling device comprises;

at least one measuring chamber which has two wall parts located opposite one another, at least one of the wall parts being locally transparent, at least one of the wall parts being sufficiently deformable to facilitate displacement of the whole blood sample from the at least one measuring chamber for photometric analysis,

the at least one measuring chamber further including a transparent body disposed between the wall parts, the transparent body being capable of selectively absorbing the analyte or reacting with the analyte such that upon contact of the analyte with the transparent body, a detectable change in a radiation transmission characteristic of the transparent body occurs which is dependent upon the concentration of the analyte in the whole blood sample, wherein the transparent body maintains the changed radiation transmission characteristic after displacement of the whole blood sample from the at least one measuring chamber so that photometric analysis of the analyte in the absence of the whole blood sample can be performed;

b) placing the sampling device in a sampling device station wherein the sampling device station is arranged relative to an optical system comprising a radiation source and a means for detecting radiation, such that the sampling device is located between the radiation source and the radiation detection means;

c) deforming the at least one measuring chamber of the sampling device in a controlled manner to reduce the volume of the at least one measuring chamber, thereby substantially draining the sample of whole blood from the measuring chamber;

d) transmitting radiation from the radiation source through the deformed, substantially drained at least one measuring chamber to the radiation detector;

e) detecting the radiation transmitted in step d); and

f) determining the analyte content of the sample of whole blood from the radiation detected in step e).

10. A measuring chamber for photometric determination of the content of an analyte in a sample of whole blood, comprising:

two wall parts located opposite one another, at least one of the wall parts being locally transparent, at least one of the wall parts being sufficiently deformable to facilitate displacement of the whole blood sample from the measuring chamber for photometric analysis,

the measuring chamber further including a transparent body disposed between the wall parts, the transparent body being capable of selectively absorbing the analyte or reacting with the analyte such that upon contact of the analyte with the transparent body, a detectable change in a radiation transmission characteristic of the transparent body occurs which is dependent upon the concentration of the analyte in the whole blood sample, wherein the transparent body maintains the changed radiation transmission characteristic after displacement of the whole blood sample from the at least one measuring chamber so that photometric analysis of the analyte in the absence of the whole blood sample can be performed.

11. An analyzer for photometric determination of the content of an analyte in a sample of whole blood, comprising:

a) a radiation source;

b) means for detecting radiation transmitted from the radiation source;

c) at least one measuring chamber which has two wall parts located opposite one another, at least one of the wall parts being locally transparent, at least one of the two wall parts being sufficiently deformable to facilitate displacement of the whole blood sample from the at least one measuring chamber for photometric analysis,

the at least one measuring chamber further including a transparent body disposed between the wall parts, the transparent body being capable of selectively absorbing the analyte or reacting with the analyte such that upon contact of the analyte with the transparent body, a detectable change in a radiation transmission characteristic of the transparent body occurs which is dependent upon the concentration of the analyte in the whole blood sample, wherein the transparent body maintains the changed radiation transmission characteristic after displacement of the whole blood sample from the at least one measuring chamber so that photometric analysis of the analyte in the absence of the whole blood sample can be performed,

wherein the at least one measuring chamber is arranged relative to the radiation source and the radiation detection means so that the radiation transmitted from the radiation source will pass through the at least one measuring chamber to the radiation detection means; and

d) means for deforming at least one of the wall parts of the at least one measuring chamber in a controlled manner to reduce the volume of the at least one measuring chamber such that the sample of whole blood is substantially drained from the at least one measuring chamber.

12. A method of photometric in vitro determination of the content of an analyte in a sample of whole blood, comprising the steps of:

a) transferring a sample of whole blood to a measuring chamber which has two wall parts located opposite one another, at least one of the wall parts being locally transparent, at least one of the wall parts being sufficiently deformable to facilitate displacement of the whole blood sample from the measuring chamber for photometric analysis,

the measuring chamber further including a transparent body disposed between the wall parts, the transparent body being capable of selectively absorbing the analyte or reacting with the analyte such that upon contact of the analyte with the transparent body, a detectable change in a radiation transmission characteristic of the transparent body occurs which is dependent upon the concentration of the analyte in the whole blood sample, wherein the transparent body maintains the changed radiation transmission characteristic after displacement of the whole blood sample from the measuring chamber so that photometric analysis of the analyte in the absence of the whole blood sample can be performed,

the measuring chamber being arranged relative to an optical system comprised of a radiation source and a means for detecting radiation such that the measuring chamber is located between the radiation source and the radiation detection means;

b) deforming the measuring chamber in a controlled manner to reduce the volume of the measuring chamber thereby substantially draining the sample of whole blood from the measuring chamber;

c) transmitting radiation from the radiation source through the deformed, substantially drained measuring chamber to the radiation detector;

d) detecting the radiation transmitted in step c); and

e) determining the analyte content of the sample of whole blood from the radiation detected in step d).