Blood testing unit and blood testing method and apparatus

• US 20060211127A1
• Filed: 05/18/2006
• Published: 09/21/2006
• Est. Priority Date: 03/28/2002
• Status: Abandoned Application

• Current Assignee: Fujifilm Corporation (Fujifilm Holdings Corporation)
• Original Assignee: Fujifilm Corporation (Fujifilm Holdings Corporation)
• Inventors: Tanaka, Hideaki, Nakamura, Kentarou, Iwaki, Yoshihide, Sakaino, Yoshiki, Terashima, Kaoru, Toya, Ichizou
• Application Number:
  US11/435,933
• Publication Number:
  US 20060211127A1
• Time in Patent Office: Days
• US Class Current: 436/169
• CPC Class Codes: B01L 2200/082 Handling hazardous material
• CPC Class Codes: B01L 2300/042 Caps; Plugs
• CPC Class Codes: B01L 2300/044 pierceable, e.g. films, membranes
• CPC Class Codes: B01L 2300/047 Additional chamber, reservoir
• CPC Class Codes: B01L 2300/0681 Filter
• CPC Class Codes: B01L 2300/0816 Cards, e.g. flat sample carriers usually with flow in two horizontal directions
• CPC Class Codes: B01L 2400/0406 capillary forces
• CPC Class Codes: B01L 2400/049 vacuum
• CPC Class Codes: B01L 2400/0633 with moving parts
• CPC Class Codes: B01L 3/502 with fluid transport, e.g. in multi-compartment structures centrifugal-type cuvettes G01N21/07; analysis by separation into components G01N30/00; automatic analysers G01N35/00
• CPC Class Codes: B01L 3/5027 by integrated microfluidic structures, i.e. dimensions of channels and chambers are such that surface tension forces are important, e.g. lab-on-a-chip B01L3/5023 takes precedence; micromixers B01F33/30; microreactors for synthesis B01J19/0093; microcapillary devices in general B81B1/00
• CPC Class Codes: B01L 3/50273 characterised by the means or forces applied to move the fluids micropumps F04B19/006, of the membrane type F04B43/043
• CPC Class Codes: B01L 3/502753 characterised by bulk separation arrangements on lab-on-a-chip devices, e.g. for filtration or centrifugation separation in general B01D; microapparatus for analysis using electrophoresis G01N27/44791; sample preparation G01N1/28
• CPC Class Codes: B01L 3/5082 Test tubes per se
• CPC Class Codes: B01L 3/50825 Closing or opening means, corks, bungs closures for containers B65D; means for removing stoppers B67B7/02
• CPC Class Codes: G01N 33/491 by separating the blood components G01N15/05 takes precedence

Abstract

A blood testing unit comprises a closed vessel having a blood introducing section formed at a certain area of the closed vessel. A blood constituent separating section is located within the closed vessel to separate plasma and/or serum from the blood sample introduced through the blood introducing section into the closed vessel. A reagent layer is located within the closed vessel, such that the reagent layer can be seen from the exterior. The reagent layer comprises a region for spreading the plasma and/or the serum, which has been separated by the blood constituent separating section from the blood sample, and a reagent supported on or in the spreading region, the reagent undergoing a reaction with the plasma and/or the serum and forming a color as a result of the reaction.

Claims

1. A blood testing method, in which a blood test is performed by use of a blood testing unit comprising:

i) a closed vessel provided with a blood introducing section, which is formed at a certain area of the closed vessel and through which a blood sample is capable of being introduced into the closed vessel,

ii) a blood constituent separating section, which is located within the closed vessel and separates blood plasma and/or blood serum from the blood sample having been introduced through the blood introducing section into the closed vessel, and

iii) a reagent layer, which is located within the closed vessel, such that the reagent layer is capable of being seen from the exterior, the reagent layer comprising a region for spreading the blood plasma and/or the blood serum, which has been separated by the blood constituent separating section from the blood sample, and a reagent, which is supported on or in the region for spreading the blood plasma and/or the blood serum, the reagent being capable of undergoing a reaction with the blood plasma and/or the blood serum and forming a color as a result of the reaction, the method comprising the steps of;

i) irradiating measuring light to a reagent area of the reagent layer, which reagent area has formed the color as a result of the reaction with the blood plasma and/or the blood serum,

ii) detecting an intensity of the light having been reflected from the reagent area, and

iii) detecting an optical density of the reagent area in accordance with the thus detected intensity of the light having been reflected from the reagent area.

2. A blood testing method as defined in claim 1, wherein the measuring light is irradiated to the reagent area of the reagent layer of the blood testing unit, which reagent area has formed the color as a result of the reaction with the blood plasma and/or the blood serum, and to a mark area, which is provided with a mark representing information concerning the blood testing unit,

the intensity of the light, which has been reflected from the reagent area, and the intensity of the light, which has been reflected from the mark area, are detected,

the optical density of the reagent area is detected in accordance with the thus detected intensity of the light, which has been reflected from the reagent area, and

the information represented by the mark is read out in accordance with the thus detected intensity of the light, which has been reflected from the mark area.

3. A blood testing method as defined in claim 2, wherein a common photodetector is utilized for both the detection of the optical density of the reagent area and the readout of the information represented by the mark.

4. A blood testing method as defined in claim 2, wherein the region for spreading the blood plasma and/or the blood serum, which region constitutes the reagent layer of the blood testing unit, is provided with the mark representing the information concerning the blood testing unit, and

the detection of the optical density of the reagent area and the readout of the information represented by the mark are performed simultaneously.

5. A blood testing method as defined in claim 2, wherein a dummy testing unit, which is provided with the mark representing the information concerning the blood testing unit, is located at a predetermined position, at which the blood testing unit is to be located, and

the detection of the optical density of the reagent area from the blood testing unit and the readout of the information, which is represented by the mark, from the dummy testing unit are performed one after the other at a certain time interval.

6. A blood testing method as defined in claim 2, wherein the irradiation of the measuring light to the reagent area of the reagent layer and the detection of the intensity of the light having been reflected from the reagent area are performed from the side of one surface of the reagent layer opposite to the other surface of the reagent layer, on which other surface the blood plasma and/or the blood serum has been supplied to the reagent area.

7. A blood testing method as defined in claim 1, wherein a plurality of independent light intensity detecting operations are performed with respect to a plurality of subareas of the reagent area of the reagent layer, each of the independent light intensity detecting operations being performed for one of the plurality of the subareas of the reagent area,

results of the plurality of the independent light intensity detecting operations performed with respect to the plurality of the subareas of the reagent area are subjected to statistical processing, a light intensity value representative of the reagent area being obtained from the statistical processing, and

the thus obtained light intensity value representative of the reagent area is taken as the intensity of the light having been reflected from the reagent area.

8. A blood testing method, in which a blood test is performed by use of a blood testing unit comprising:

i) a closed vessel provided with a blood introducing section, which is formed at a certain area of the closed vessel and through which a blood sample is capable of being introduced into the closed vessel,

ii) a blood constituent separating section, which is located within the closed vessel and separates blood plasma and/or blood serum from the blood sample having been introduced through the blood introducing section into the closed vessel, and

iii) a reagent layer, which is located within the closed vessel, such that the reagent layer is capable of being seen from the exterior, the reagent layer comprising a region for spreading the blood plasma and/or the blood serum, which has been separated by the blood constituent separating section from the blood sample, and a reagent, which is supported on or in the region for spreading the blood plasma and/or the blood serum, the reagent being capable of undergoing a reaction with the blood plasma and/or the blood serum and forming a color as a result of the reaction, wherein a plurality of different kinds of reagents are supported at different positions on the reagent layer, the method comprising the steps of;

i) irradiating measuring light to each of reagent areas of the reagent layer, each of which reagent areas has formed the color as a result of the reaction with the blood plasma and/or the blood serum, the measuring light having a wavelength adapted to the reagent contained in each of the reagent areas,

ii) detecting an intensity of the light having been reflected from each of the reagent areas, the detection of the intensity of the reflected light being performed with respect to each of the reagent areas, and

iii) detecting an optical density of each of the reagent areas in accordance with the thus detected intensity of the light having been reflected from each of the reagent areas.

9. A blood testing method as defined in claim 8, wherein the measuring light irradiated to each of the reagent areas of the reagent layer is a light component, which has been obtained through light separation so as to have the wavelength corresponding to the reagent contained in each of the reagent areas.

10. A blood testing method as defined in claim 8, wherein light, which contains the measuring light having the wavelength corresponding to the reagent contained in each of the reagent areas, is irradiated to each of the reagent areas of the reagent layer, and

the light having been reflected from each of the reagent areas is detected through light separation into light components, the light separation being performed with respect to each of the reagent areas.

11. A blood testing method as defined in claim 8, wherein a plurality of independent measuring light irradiating operations are performed with respect to the blood testing unit, each of the independent measuring light irradiating operations being performed for one of the plurality of the reagent areas of the blood testing unit.

12. A blood testing method as defined in claim 8, wherein the intensity of the light having been reflected from each of the reagent areas is detected with a photodetector, which has been divided into pixels, and with respect to each of the reagent areas.

13. A blood testing method as defined in claim 12, wherein the light having been reflected from each of the reagent areas is collected by at least one lens, which is located so as to have a correspondence relationship with each of the reagent areas, and

the thus collected light is guided to the photodetector, which has been divided into the pixels.

14. A blood testing method as defined in claim 8, wherein the irradiation of the measuring light to each of the reagent areas of the reagent layer and the detection of the intensity of the light having been reflected from each of the reagent areas are performed from the side of one surface of the reagent layer opposite to the other surface of the reagent layer, on which other surface the blood plasma and/or the blood serum has been supplied to the reagent areas.

15. A blood testing method as defined in claim 8, wherein a plurality of independent light intensity detecting operations are performed with respect to a plurality of subareas of each of the reagent areas of the reagent layer, each of the independent light intensity detecting operations being performed for one of the plurality of the subareas of each of the reagent areas,

results of the plurality of the independent light intensity detecting operations performed with respect to the plurality of the subareas of each of the reagent areas are subjected to statistical processing, a light intensity value representative of each of the reagent areas being obtained from the statistical processing, and

the thus obtained light intensity value representative of each of the reagent areas is taken as the intensity of the light having been reflected from each of the reagent areas.

16. A blood testing apparatus, in which a blood test is performed by use of a blood testing unit comprising:

i) a closed vessel provided with a blood introducing section, which is formed at a certain area of the closed vessel and through which a blood sample is capable of being introduced into the closed vessel,

ii) a blood constituent separating section, which is located within the closed vessel and separates blood plasma and/or blood serum from the blood sample having been introduced through the blood introducing section into the closed vessel, and

iii) a reagent layer, which is located within the closed vessel, such that the reagent layer is capable of being seen from the exterior, the reagent layer comprising a region for spreading the blood plasma and/or the blood serum, which has been separated by the blood constituent separating section from the blood sample, and a reagent, which is supported on or in the region for spreading the blood plasma and/or the blood serum, the reagent being capable of undergoing a reaction with the blood plasma and/or the blood serum and forming a color as a result of the reaction, the apparatus comprising;

i) means for irradiating measuring light to a reagent area of the reagent layer, which reagent area has formed the color as a result of the reaction with the blood plasma and/or the blood serum,

ii) means for detecting an intensity of the light having been reflected from the reagent area, and

iii) means for detecting an optical density of the reagent area in accordance with the thus detected intensity of the light having been reflected from the reagent area.

17. A blood testing apparatus as defined in claim 16, wherein the measuring light is irradiated to the reagent area of the reagent layer of the blood testing unit, which reagent area has formed the color as a result of the reaction with the blood plasma and/or the blood serum, and to a mark area, which is provided with a mark representing information concerning the blood testing unit,

the intensity of the light, which has been reflected from the reagent area, and the intensity of the light, which has been reflected from the mark area, are detected,

the optical density of the reagent area is detected in accordance with the thus detected intensity of the light, which has been reflected from the reagent area, and

the information represented by the mark is read out in accordance with the thus detected intensity of the light, which has been reflected from the mark area.

18. A blood testing apparatus as defined in claim 17, wherein a common photodetector is utilized for both the detection of the optical density of the reagent area and the readout of the information represented by the mark.

19. A blood testing apparatus as defined in claim 17, wherein the region for spreading the blood plasma and/or the blood serum, which region constitutes the reagent layer of the blood testing unit, is provided with the mark representing the information concerning the blood testing unit, and

the detection of the optical density of the reagent area and the readout of the information represented by the mark are performed simultaneously.

20. A blood testing apparatus as defined in claim 17, wherein a dummy testing unit, which is provided with the mark representing the information concerning the blood testing unit, is located at a predetermined position, at which the blood testing unit is to be located, and

the detection of the optical density of the reagent area from the blood testing unit and the readout of the information, which is represented by the mark, from the dummy testing unit are performed one after the other at a certain time interval.

21. A blood testing apparatus as defined in claim 16, wherein the irradiation of the measuring light to the reagent area of the reagent layer and the detection of the intensity of the light having been reflected from the reagent area are performed from the side of one surface of the reagent layer opposite to the other surface of the reagent layer, on which other surface the blood plasma and/or the blood serum has been supplied to the reagent area.

22. A blood testing apparatus as defined in claim 16, wherein a plurality of independent light intensity detecting operations are performed with respect to a plurality of subareas of the reagent area of the reagent layer, each of the independent light intensity detecting operations being performed for one of the plurality of the subareas of the reagent area,

results of the plurality of the independent light intensity detecting operations performed with respect to the plurality of the subareas of the reagent area are subjected to statistical processing, a light intensity value representative of the reagent area being obtained from the statistical processing, and

the thus obtained light intensity value representative of the reagent area is taken as the intensity of the light having been reflected from the reagent area.

23. A blood testing apparatus, in which a blood test is performed by use of a blood testing unit comprising:

i) a closed vessel provided with a blood introducing section, which is formed at a certain area of the closed vessel and through which a blood sample is capable of being introduced into the closed vessel,

ii) a blood constituent separating section, which is located within the closed vessel and separates blood plasma and/or blood serum from the blood sample having been introduced through the blood introducing section into the closed vessel, and

iii) a reagent layer, which is located within the closed vessel, such that the reagent layer is capable of being seen from the exterior, the reagent layer comprising a region for spreading the blood plasma and/or the blood serum, which has been separated by the blood constituent separating section from the blood sample, and a reagent, which is supported on or in the region for spreading the blood plasma and/or the blood serum, the reagent being capable of undergoing a reaction with the blood plasma and/or the blood serum and forming a color as a result of the reaction, wherein a plurality of different kinds of reagents are supported at different positions on the reagent layer, the apparatus comprising;

i) means for irradiating measuring light to each of reagent areas of the reagent layer, each of which reagent areas has formed the color as a result of the reaction with the blood plasma and/or the blood serum, the measuring light having a wavelength adapted to the reagent contained in each of the reagent areas,

ii) means for detecting an intensity of the light having been reflected from each of the reagent areas, the detection of the intensity of the reflected light being performed with respect to each of the reagent areas, and

iii) means for detecting an optical density of each of the reagent areas in accordance with the thus detected intensity of the light having been reflected from each of the reagent areas.

24. A blood testing apparatus as defined in claim 23, wherein the measuring light irradiated to each of the reagent areas of the reagent layer is a light component, which has been obtained through light separation so as to have the wavelength corresponding to the reagent contained in each of the reagent areas.

25. A blood testing apparatus as defined in claim 23, wherein light, which contains the measuring light having the wavelength corresponding to the reagent contained in each of the reagent areas, is irradiated to each of the reagent areas of the reagent layer, and

the light having been reflected from each of the reagent areas is detected through light separation into light components, the light separation being performed with respect to each of the reagent areas.

26. A blood testing apparatus as defined in claim 23, wherein a plurality of independent measuring light irradiating operations are performed with respect to the blood testing unit, each of the independent measuring light irradiating operations being performed for one of the plurality of the reagent areas of the blood testing unit.

27. A blood testing apparatus as defined in claim 23, wherein the intensity of the light having been reflected from each of the reagent areas is detected with a photodetector, which has been divided into pixels, and with respect to each of the reagent areas.

28. A blood testing apparatus as defined in claim 27, wherein the light having been reflected from each of the reagent areas is collected by at least one lens, which is located so as to have a correspondence relationship with each of the reagent areas, and

the thus collected light is guided to the photodetector, which has been divided into the pixels.

29. A blood testing apparatus as defined in claim 23, wherein the irradiation of the measuring light to each of the reagent areas of the reagent layer and the detection of the intensity of the light having been reflected from each of the reagent areas are performed from the side of one surface of the reagent layer opposite to the other surface of the reagent layer, on which other surface the blood plasma and/or the blood serum has been supplied to the reagent areas.

30. A blood testing apparatus as defined in claim 23, wherein a plurality of independent light intensity detecting operations are performed with respect to a plurality of subareas of each of the reagent areas of the reagent layer, each of the independent light intensity detecting operations being performed for one of the plurality of the subareas of each of the reagent areas,

results of the plurality of the independent light intensity detecting operations performed with respect to the plurality of the subareas of each of the reagent areas are subjected to statistical processing, a light intensity value representative of each of the reagent areas being obtained from the statistical processing, and

the thus obtained light intensity value representative of each of the reagent areas is taken as the intensity of the light having been reflected from each of the reagent areas.