U.S. patent application number 10/397262 was filed with the patent office on 2003-10-02 for biochemical analysis method and apparatus.
This patent application is currently assigned to FUJI PHOTO FILM CO., LTD.. Invention is credited to Endo, Yoichi, Seto, Yoshihiro, Tokiwa, Nobuaki.
Application Number | 20030186447 10/397262 |
Document ID | / |
Family ID | 28456293 |
Filed Date | 2003-10-02 |
United States Patent
Application |
20030186447 |
Kind Code |
A1 |
Seto, Yoshihiro ; et
al. |
October 2, 2003 |
Biochemical analysis method and apparatus
Abstract
Samples and dry chemical analysis elements, which are necessary
for analyses of the samples, are loaded on a sample tray. Each
sample is sucked with a spotting nozzle of a spotting unit and
spotted onto one dry chemical analysis element. Analysis
information, which contains information representing a type of
analysis, is appended to each dry chemical analysis element. The
analysis information is read with a reading device located such
that, when a certain sample is located at a position for sample
suction by an operation of the sample tray, the reading device
reads the analysis information, which has been appended to a next
dry chemical analysis element to be used for the analysis of the
certain sample, at a position at which the next dry chemical
analysis element is located.
Inventors: |
Seto, Yoshihiro;
(Minamiashigara-shi, JP) ; Tokiwa, Nobuaki;
(Minamiashigara-shi, JP) ; Endo, Yoichi;
(Minamiashigara-shi, JP) |
Correspondence
Address: |
SUGHRUE MION, PLLC
2100 PENNSYLVANIA AVENUE, N.W.
WASHINGTON
DC
20037
US
|
Assignee: |
FUJI PHOTO FILM CO., LTD.
|
Family ID: |
28456293 |
Appl. No.: |
10/397262 |
Filed: |
March 27, 2003 |
Current U.S.
Class: |
436/48 ;
422/64 |
Current CPC
Class: |
G01N 2035/00118
20130101; G01N 2035/0446 20130101; Y10T 436/114165 20150115; G01N
35/1011 20130101; Y10T 436/112499 20150115 |
Class at
Publication: |
436/48 ;
422/64 |
International
Class: |
G01N 035/02 |
Foreign Application Data
Date |
Code |
Application Number |
Mar 27, 2002 |
JP |
089030/2002 |
Mar 28, 2002 |
JP |
092286/2002 |
Claims
What is claimed is:
1. A biochemical analysis method, comprising the steps of: i)
loading a plurality of samples and a plurality of dry chemical
analysis elements, which are necessary for analyses of the samples,
on a sample tray, ii) sucking each of the samples, which have been
loaded on the sample tray, with a spotting nozzle of a spotting
unit, and iii) spotting the sucked sample onto one of the dry
chemical analysis elements with the spotting nozzle of the spotting
unit, wherein analysis information, which contains information
representing a type of analysis, is appended to each of the dry
chemical analysis elements, and the analysis information having
been appended to each of the dry chemical analysis elements is read
with reading means located such that, at the time at which a
certain sample is located at a position for sample suction by an
operation of the sample tray, the reading means is capable of
reading the analysis information, which has been appended to a next
dry chemical analysis element to be used for the analysis of the
certain sample, from the next dry chemical analysis element and at
a position at which the next dry chemical analysis element is
located.
2. A biochemical analysis apparatus, comprising: i) a sample tray,
which is capable of being loaded with a plurality of samples and a
plurality of dry chemical analysis elements necessary for analyses
of the samples, and ii) a spotting unit for sucking each of the
samples, which have been loaded on the sample tray, with a spotting
nozzle and spotting the sucked sample onto one of the dry chemical
analysis elements with the spotting nozzle, wherein analysis
information, which contains information representing a type of
analysis, is appended to each of the dry chemical analysis
elements, and reading means for reading the analysis information
having been appended to each of the dry chemical analysis elements
is located such that, at the time at which a certain sample is
located at a position for sample suction by an operation of the
sample tray, the reading means is capable of reading the analysis
information, which has been appended to a next dry chemical
analysis element to be used for the analysis of the certain sample,
from the next dry chemical analysis element and at a position at
which the next dry chemical analysis element is located.
3. An apparatus as defined in claim 2 wherein a number of dry
chemical analysis elements, which number corresponds to the types
of the analyses to be made with respect to one sample, are loaded
in a laid-up state on the sample tray, the laid-up dry chemical
analysis elements are conveyed to a position for sample spotting
one after another in an ascending order, beginning with the lowest
dry chemical analysis element, and successively spotted with the
sample at the position for sample spotting, and the reading means
reads the analysis information, which has been appended to a bottom
surface of a dry chemical analysis element to be conveyed next.
4. An apparatus as defined in claim 2 wherein the dry chemical
analysis elements are accommodated in an element cartridge, and the
element cartridge, in which the dry chemical analysis elements have
been accommodated, is loaded on the sample tray.
5. An apparatus as defined in claim 3 wherein the dry chemical
analysis elements are accommodated in an element cartridge, the
element cartridge, in which the dry chemical analysis elements have
been accommodated, is loaded on the sample tray, and a window for
information reading is formed at a bottom of the element
cartridge.
6. An apparatus as defined in claim 2 wherein each of the samples
and the dry chemical analysis elements necessary for analyses of
the sample are located on the sample tray such that the sample and
the dry chemical analysis elements form a pair with each other.
7. An apparatus as defined in claim 3 wherein each of the samples
and the dry chemical analysis elements necessary for analyses of
the sample are located on the sample tray such that the sample and
the dry chemical analysis elements form a pair with each other.
8. An apparatus as defined in claim 4 wherein each of the samples
and the dry chemical analysis elements necessary for analyses of
the sample are located on the sample tray such that the sample and
the dry chemical analysis elements form a pair with each other.
9. An apparatus as defined in claim 3 wherein the reading means is
located at a position under the sample tray.
10. An apparatus as defined in claim 2 wherein, at the time at
which the sample tray has been moved from a position for element
takeout to the position for sample suction, the reading means reads
the analysis information of the next dry chemical analysis element
and at the position, to which the next dry chemical analysis
element has been moved.
11. An apparatus as defined in claim 2 wherein the sample tray has
a circular shape and is moved to a position for element takeout and
the position for sample suction through a rotating operation.
12. An apparatus as defined in claim 10 wherein the sample tray has
a circular shape and is moved to a position for element takeout and
the position for sample suction through a rotating operation.
13. An apparatus as defined in claim 11 wherein a plurality of
sample loading sections, which support the samples and a plurality
of element loading sections, which support the unused dry chemical
analysis elements necessary for types of analyses of the samples,
are located on the sample tray and around a center region of the
sample tray, such that each of the sample loading sections is
adjacent to one of the element loading sections.
14. An apparatus as defined in claim 2 wherein an operation of the
reading means for reading the analysis information from a certain
dry chemical analysis element is performed before an operation for
sucking the corresponding sample and an operation for conveying the
certain dry chemical analysis element are started.
15. An apparatus as defined in claim 11 wherein an operation of the
reading means for reading the analysis information from a certain
dry chemical analysis element is performed before an operation for
sucking the corresponding sample and an operation for conveying the
certain dry chemical analysis element are started.
16. An apparatus as defined in claim 10 wherein, in cases where
analyses of a new sample are to be made, an operation for reading
the analysis information from a first dry chemical analysis element
is performed by locating the first dry chemical analysis element at
a position for information reading, the first dry chemical analysis
element is thereafter moved to the position for element takeout and
is taken out and conveyed to a position for sample spotting, the
new sample is then moved to the position for sample suction, and an
operation for reading the analysis information from a next dry
chemical analysis element is performed at the same time as the
suction and the spotting of the new sample.
17. An apparatus as defined in claim 11 wherein, in cases where
analyses of a new sample are to be made, an operation for reading
the analysis information from a first dry chemical analysis element
is performed by locating the first dry chemical analysis element at
a position for information reading, the first dry chemical analysis
element is thereafter moved to the position for element takeout and
is taken out and conveyed to a position for sample spotting, the
new sample is then moved to the position for sample suction, and an
operation for reading the analysis information from a next dry
chemical analysis element is performed at the same time as the
suction and the spotting of the new sample.
18. An apparatus as defined in claim 2 wherein the sample tray is
constituted such that a position for element takeout and the
position for sample suction are located at an identical position of
movement of the sample tray, and the reading means reads the
analysis information from the dry chemical analysis element, which
is being located at the position for element takeout.
19. An apparatus as defined in claim 3 wherein the sample tray is
constituted such that a position for element takeout and the
position for sample suction are located at an identical position of
movement of the sample tray, and the reading means reads the
analysis information from the dry chemical analysis element, which
is being located at the position for element takeout.
20. An apparatus as defined in claim 18 wherein the sample tray has
a circular shape, and the position for element takeout and the
position for sample suction are located on an identical center line
of the sample tray.
21. A dry chemical analysis element for biochemical analysis,
comprising: i) a mount section, and ii) an analyzing region, which
is to be spotted with a sample, the analyzing region being
supported on the mount section, wherein analysis type information,
production lot information, and advance direction information have
been recorded on a surface of the mount section and with a dot
recording technique for recording information by a dot array
pattern.
22. A dry chemical analysis element for biochemical analysis as
defined in claim 21 wherein the advance direction information is
recorded by the absence of notation at a dot located at a specific
site in the dot array pattern.
23. A dry chemical analysis element for biochemical analysis as
defined in claim 21 wherein the dot array pattern is recorded at a
position other than positions which overlap upon a bar code
recording region having already been formed on the mount section,
and both the dot array pattern and a bar code are capable of being
recorded on the dry chemical analysis element.
24. A dry chemical analysis element for biochemical analysis as
defined in claim 21 wherein the dot array pattern is recorded by
use of a plurality of colors.
Description
BACKGROUND OF THE INVENTION
[0001] 1. Field of the Invention
[0002] This invention relates to a biochemical analysis method and
apparatus, wherein a sample, such as blood or urine, is spotted
onto a dry chemical analysis element, such as a colorimetric-type
dry chemical analysis element or an electrolyte-type dry chemical
analysis element, by use of a spotting unit, and a substance
concentration of a specific biochemical substance contained in the
sample, an ionic activity of a specific ion contained in the
sample, or the like, is determined. This invention also relates to
a dry chemical analysis element for biochemical analysis and
particularly to a technique for imparting analysis information, and
the like, to the dry chemical analysis element.
[0003] 2. Description of the Related Art
[0004] Colorimetric-type dry chemical analysis elements and
electrolyte-type dry chemical analysis elements have heretofore
been used in practice. When a droplet of a sample is merely spotted
onto the colorimetric-type dry chemical analysis element, a
specific chemical constituent or a specific physical constituent
contained the sample is capable of being analyzed quantitatively.
Also, when a droplet of a sample is merely spotted on to the
electrolyte-type dry chemical analysis element, an ionic activity
of a specific ion contained the sample is capable of being analyzed
quantitatively. Biochemical analysis apparatuses utilizing the dry
chemical analysis elements are capable of performing sample
analyses easily and quickly and have therefore been utilized widely
in medical facilities, medical laboratories, and the like.
[0005] Colorimetry utilizing colorimetric-type dry chemical
analysis elements is performed in the manner described below.
Specifically, after a sample has been spotted onto a dry chemical
analysis element, the dry chemical analysis element having been
spotted with the sample is kept at a constant temperature for a
predetermined time within an incubator and is there by caused to
undergo a color reaction (i.e., a dye forming reaction).
Thereafter, measuring light, which has wavelengths selected
previously in accordance with a combination of a predetermined
biochemical substance contained in the sample and a reagent
contained in the dry chemical analysis element, is irradiated to
the dry chemical analysis element, and an optical density of the
dry chemical analysis element is thereby measured. The
concentration of the predetermined biochemical substance contained
in the sample is determined from the measured optical density and
by use of a calibration curve having been formed previously, which
represents a correspondence relationship between the optical
density and the substance concentration of the predetermined
biochemical substance.
[0006] Potentiometry utilizing electrolyte-type dry chemical
analysis elements is performed in the manner described below.
Specifically, in lieu of the optical density described above being
measured, the ionic activity of a specific ion contained in a
sample, which has been spotted onto an electrode pair comprising a
pair of two dry type ion selective electrodes of an identical type,
is determined through quantitative analysis with potentiometry by
use of a reference liquid.
[0007] In each of the colorimetry and the potentiometry described
above, the liquid-state sample is accommodated in a sample vessel
(such as a blood-collecting tube), and the sample vessel
accommodating the sample is set on a biochemical analysis
apparatus. Also, the dry chemical analysis element necessary for
the measurement is loaded into the biochemical analysis apparatus.
Further, the dry chemical analysis element is conveyed from a
position for element loading into a spotting section and into an
incubator. Furthermore, the sample is fed by a spotting nozzle from
a position for sample loading to the spotting section and spotted
onto the dry chemical analysis element.
[0008] The kind of the dry chemical analysis element and the
technique for the sample spotting onto the dry chemical analysis
element vary in accordance with the type of the analysis.
Therefore, each of the dry chemical analysis elements utilized for
the analyses is appended with analysis information, which contains
information representing the type of the analysis, by use of a bar
code recording technique, or the like. Also, in cases where the dry
chemical analysis element is loaded onto a sample tray of a
biochemical analysis apparatus directly or by use of a cartridge,
the biochemical analysis apparatus is controlled such that the dry
chemical analysis element is taken out from the sample tray, the
analysis information is read from the dry chemical analysis
element, and an operation for sucking a sample, which corresponds
to the type of the analysis to be made with the dry chemical
analysis element, is performed in accordance with the analysis
information having been read from the dry chemical analysis
element.
[0009] Also, ordinarily, a plurality of types of analyses are
performed with respect to one sample. Therefore, there have
heretofore been proposed biochemical analysis apparatuses, in which
a plurality of kinds of dry chemical analysis elements are loaded
in a laid-up state on a sample tray in accordance with each sample,
and analyses are performed successively by use of the dry chemical
analysis elements. In such cases, in order for the one sample to be
successively spotted onto the plurality of the kinds of the dry
chemical analysis elements, it is necessary that the operation for
reading the analysis information and the operation for sucking the
sample are iterated with respect to each of the dry chemical
analysis elements.
[0010] Ordinarily, the operation for reading the analysis
information, which has been appended to the dry chemical analysis
element, from the dry chemical analysis element is performed in the
manner described below. Specifically, information reading means is
located at an intermediate point of an element conveyance path,
along which the dry chemical analysis element having been taken out
from the sample tray, is conveyed to the position for sample
spotting. Also, the operation for reading the analysis information
is performed in accordance with the operation for conveying the dry
chemical analysis element.
[0011] However, with the aforesaid technique for reading the
analysis information from the dry chemical analysis element, if the
dry chemical analysis element having been taken out from the sample
tray onto the element conveyance path is conveyed in a state in
which the front surface and the back surface of the dry chemical
analysis element are reversed or in a state in which the
orientation of the dry chemical analysis element is incorrect, the
problems will occur in that the analysis cannot be made accurately,
and the analysis information cannot be read from the dry chemical
analysis element. In such cases, warning, or the like, is given by
the reading means. However, in such cases, the dry chemical
analysis element, which has already been sent onto the element
conveyance path must be taken out from the element conveyance path,
the conveyance of the dry chemical analysis element must then
performed again, and the operation for reading the analysis
information from the dry chemical analysis element must again be
performed. Therefore, a considerable time and labor are required,
and the processing efficiency cannot be kept high. Also, in cases
where, for example, the biochemical analysis apparatus comes short
of expendables, or the sample and the dry chemical analysis element
do not conform to each other, after the analysis operation has been
started, a necessary correcting operation must be performed, and
the analysis operation must then be performed again. In such cases,
a considerable time and labor are required.
[0012] In order for the problems described above to be solved, it
may be considered that the operation for reading the analysis
information from the dry chemical analysis element is performed in
the state, in which the dry chemical analysis element is loaded on
the sample tray, and before the conveyance of the dry chemical
analysis element is started. However, in such cases, it becomes
necessary, depending upon the position at which the reading means
is located, that the sample tray is moved to the position for
information reading, then moved to the position for element
takeout, and thereafter moved to the position for sample suction.
Therefore, the problems occur in that control of the operation of
the sample tray and sequence control cannot be kept simple, a
considerable time is required to perform the processing, and the
analyses cannot be performed quickly.
SUMMARY OF THE INVENTION
[0013] The primary object of the present invention is to provide a
biochemical analysis method, wherein an operation for reading
analysis information, which has been appended to a dry chemical
analysis element, from the dry chemical analysis element and an
operation for sucking a sample are capable of being performed
efficiently.
[0014] Another object of the present invention is to provide a
biochemical analysis apparatus for carrying out the biochemical
analysis method.
[0015] A further object of the present invention is to provide a
dry chemical analysis element for biochemical analysis, on which
information is capable of being recorded such that information
representing a production lot of the dry chemical analysis element
and analysis management information are capable of being matched
with each other.
[0016] The present invention provides a biochemical analysis
method, comprising the steps of:
[0017] i) loading a plurality of samples and a plurality of dry
chemical analysis elements, which are necessary for analyses of the
samples, on a sample tray,
[0018] ii) sucking each of the samples, which have been loaded on
the sample tray, with a spotting nozzle of a spotting unit, and
[0019] iii) spotting the sucked sample onto one of the dry chemical
analysis elements with the spotting nozzle of the spotting
unit,
[0020] wherein analysis information, which contains information
representing a type of analysis, is appended to each of the dry
chemical analysis elements, and
[0021] the analysis information having been appended to each of the
dry chemical analysis elements is read with reading means located
such that, at the time at which a certain sample is located at a
position for sample suction by an operation of the sample tray, the
reading means is capable of reading the analysis information, which
has been appended to a next dry chemical analysis element to be
used for the analysis of the certain sample, from the next dry
chemical analysis element and at a position at which the next dry
chemical analysis element is located.
[0022] The present invention also provides a biochemical analysis
apparatus, comprising:
[0023] i) a sample tray, which is capable of being loaded with a
plurality of samples and a plurality of dry chemical analysis
elements necessary for analyses of the samples, and
[0024] ii) a spotting unit for sucking each of the samples, which
have been loaded on the sample tray, with a spotting nozzle and
spotting the sucked sample onto one of the dry chemical analysis
elements with the spotting nozzle,
[0025] wherein analysis information, which contains information
representing a type of analysis, is appended to each of the dry
chemical analysis elements, and
[0026] reading means for reading the analysis information having
been appended to each of the dry chemical analysis elements is
located such that, at the time at which a certain sample is located
at a position for sample suction by an operation of the sample
tray, the reading means is capable of reading the analysis
information, which has been appended to a next dry chemical
analysis element to be used for the analysis of the certain sample,
from the next dry chemical analysis element and at a position at
which the next dry chemical analysis element is located.
[0027] The biochemical analysis apparatus in accordance with the
present invention should preferably be modified such that a number
of dry chemical analysis elements, which number corresponds to the
types of the analyses to be made with respect to one sample, are
loaded in a laid-up state on the sample tray,
[0028] the laid-up dry chemical analysis elements are conveyed to a
position for sample spotting one after another in an ascending
order, beginning with the lowest dry chemical analysis element, and
successively spotted with the sample at the position for sample
spotting, and
[0029] the reading means reads the analysis information, which has
been appended to a bottom surface of a dry chemical analysis
element to be conveyed next.
[0030] Also, the biochemical analysis apparatus in accordance with
the present invention should preferably be modified such that the
dry chemical analysis elements are accommodated in an element
cartridge, and
[0031] the element cartridge, in which the dry chemical analysis
elements have been accommodated, is loaded on the sample tray.
[0032] Further, the biochemical analysis apparatus in accordance
with the present invention should preferably be modified such that
the dry chemical analysis elements are accommodated in an element
cartridge,
[0033] the element cartridge, in which the dry chemical analysis
elements have been accommodated, is loaded on the sample tray,
and
[0034] a window for information reading is formed at a bottom of
the element cartridge.
[0035] Furthermore, the biochemical analysis apparatus in
accordance with the present invention should preferably be modified
such that each of the samples and the dry chemical analysis
elements necessary for analyses of the sample are located on the
sample tray such that the sample and the dry chemical analysis
elements form a pair with each other.
[0036] Also, the biochemical analysis apparatus in accordance with
the present invention should preferably be modified such that the
reading means is located at a position under the sample tray.
[0037] Further, the biochemical analysis apparatus in accordance
with the present invention should preferably be modified such that
the sample tray has a circular shape and is moved to a position for
element takeout and the position for sample suction through a
rotating operation.
[0038] Alternatively, the movement of the sample tray may be
performed through a linear movement operation.
[0039] The present invention further provides a dry chemical
analysis element for biochemical analysis, comprising:
[0040] i) a mount section, and
[0041] ii) an analyzing region, which is to be spotted with a
sample, the analyzing region being supported on the mount
section,
[0042] wherein analysis type information (such as information
representing an analysis type number and information representing a
sample kind number), production lot information (such as
information representing a production lot and information
representing an inherent number concerning the production), and
advance direction information have been recorded on a surface of
the mount section and with a dot recording technique for recording
information by a dot array pattern.
[0043] The dry chemical analysis element for biochemical analysis
in accordance with the present invention should preferably be
modified such that the advance direction information is recorded by
the absence of notation at a dot located at a specific site in the
dot array pattern.
[0044] Also, the dry chemical analysis element for biochemical
analysis in accordance with the present invention should preferably
be modified such that the dot array pattern is recorded at a
position other than positions which overlap upon a bar code
recording region having already been formed on the mount section,
and
[0045] both the dot array pattern and a bar code are capable of
being recorded on the dry chemical analysis element.
[0046] Further, the dry chemical analysis element for biochemical
analysis in accordance with the present invention should preferably
be modified such that the dot array pattern is recorded by use of a
plurality of colors. In such cases, the amount of information
recorded is capable of being kept large. Furthermore, information
representing a serviceable life should preferably be recorded.
[0047] The biochemical analysis apparatus for performing an
analysis by use of the dry chemical analysis element for
biochemical analysis in accordance with the present invention is
provided with means for reading the dot array pattern from the dry
chemical analysis element and a control unit for matching the
analysis type information and the production lot information, which
have been read from the dry chemical analysis element, and analysis
management information, which corresponds to the dry chemical
analysis element and has been read with a different reading
operation, with each other. The control unit should preferably be
constituted so as to store a plurality of pieces of analysis
management information.
[0048] With the biochemical analysis method and apparatus in
accordance with the present invention, the analysis information,
which contains the information representing the type of the
analysis, is appended to each of the dry chemical analysis
elements. Also, the analysis information having been appended to
each of the dry chemical analysis elements is read with the reading
means located such that, at the time at which a certain sample is
located at the position for sample suction by the operation of the
sample tray, the reading means is capable of reading the analysis
information, which has been appended to the next dry chemical
analysis element to be used for the analysis of the certain sample,
from the next dry chemical analysis element and at the position at
which the next dry chemical analysis element is located. Therefore,
at the time at which the operation for sucking the sample to be
spotted to a dry chemical analysis element located at the position
for sample spotting is performed, the operation for reading the
analysis information from the next dry chemical analysis element is
capable of being performed simultaneously by the reading means.
Accordingly, movement of the sample tray for the information
reading becomes unnecessary, and sequence control is capable of
being simplified. As a result, a plurality of types of analyses are
capable of being made efficiently.
[0049] With the biochemical analysis apparatus, wherein the reading
means is located under the sample tray, the analysis information is
capable of being read before the conveyance of the dry chemical
analysis element toward the position for sample spotting is
performed. Therefore, in cases where a failure is found from the
information having been read, a warning is capable of being given.
Also, since the analysis operation has not yet been started
substantially at this time, correcting operations with respect to
shortage of expendables, inconformity of the sample and the type of
the analysis with each other, and the like, are capable of being
performed easily.
[0050] Also, with the biochemical analysis apparatus in accordance
with the present invention, in cases where a plurality of sets of
the samples and the dry chemical analysis elements are loaded on
the sample tray, the operation for reading the information from the
dry chemical analysis element, the operation for takeout and
conveyance of the dry chemical analysis element, and the operation
for sucking and spotting the sample are capable of being performed
successively and efficiently. Therefore, as a whole, the unit
analyzing time is capable of being kept short.
[0051] With the dry chemical analysis element for biochemical
analysis in accordance with the present invention, the analysis
type information, the production lot information, and the advance
direction information have been recorded on the surface of the
mount section and with the dot recording technique for recording
information by the dot array pattern. Therefore, the analysis type
information and the production lot information, which have been
recorded on the dry chemical analysis element, and the analysis
management information are capable of being matched with each
other. Accordingly, the biochemical analysis is capable of being
performed accurately in accordance with the accurate analysis
management information, and the reliability of the biochemical
analysis is capable of being enhanced.
[0052] Also, with the dry chemical analysis element for biochemical
analysis in accordance with the present invention, erroneous
setting of an electrolyte-type dry chemical analysis element with
respect to the advance direction of the dry chemical analysis
element is capable of being detected, and a warning is capable of
being given.
[0053] With the dry chemical analysis element for biochemical
analysis in accordance with the present invention, the dot array
pattern may be recorded at the position other than the positions
which overlap upon the bar code recording region having already
been formed on the mount section, such that both the dot array
pattern and the bar code are capable of being recorded on the dry
chemical analysis element. In such cases, the dry chemical analysis
element for biochemical analysis in accordance with the present
invention is capable of being utilized in a conventional
biochemical analysis apparatus.
[0054] In cases where a plurality of pieces of the analysis
management information are stored in the control unit of the
biochemical analysis apparatus, the dry chemical analysis elements
corresponding to different pieces of analysis management
information are capable of being loaded in a mixed state to the
biochemical analysis apparatus. Therefore, in cases where a sample
is to be analyzed urgently, the analysis processing need not be
ceased and is capable of being performed efficiently.
BRIEF DESCRIPTION OF THE DRAWINGS
[0055] FIG. 1 is a partially sectional front view showing an
embodiment of the biochemical analysis apparatus in accordance with
the present invention,
[0056] FIG. 2 is a plan view showing a major part of the embodiment
of FIG. 1 with a spotting unit being omitted for clearness,
[0057] FIG. 3 is a sectional front view showing sections along an
element conveyance path for dry chemical analysis elements,
[0058] FIG. 4 is a schematic plan view showing a state in which a
sample tray has been moved to a position for information
reading,
[0059] FIG. 5 is a schematic plan view showing a major part of a
different embodiment of the biochemical analysis apparatus in
accordance with the present invention,
[0060] FIG. 6A is a plan view showing an embodiment of the dry
chemical analysis element for biochemical analysis in accordance
with the present invention, which is constituted as a
colorimetric-type dry chemical analysis element,
[0061] FIG. 6B is a bottom view showing the embodiment of the dry
chemical analysis element shown in FIG. 6A,
[0062] FIG. 7A is a plan view showing a different embodiment of the
dry chemical analysis element for biochemical analysis in
accordance with the present invention, which is constituted as an
electrolyte-type dry chemical analysis element,
[0063] FIG. 7B is a bottom view showing the embodiment of the dry
chemical analysis element shown in FIG. 7A,
[0064] FIG. 8 is an explanatory view showing an example of notation
allocation in a dot array pattern.
DESCRIPTION OF THE PREFERRED EMBODIMENTS
[0065] The present invention will hereinbelow be described in
further detail with reference to the accompanying drawings.
[0066] FIG. 1 is a partially sectional front view showing an
embodiment of the biochemical analysis apparatus in accordance with
the present invention. FIG. 2 is a plan view showing a major part
of the embodiment of FIG. 1 with a spotting unit being omitted for
clearness. FIG. 3 is a sectional front view showing sections along
an element conveyance path for dry chemical analysis elements. FIG.
4 is a schematic plan view showing a state in which a sample tray
has been moved to a position for information reading.
[0067] A biochemical analysis apparatus 1 comprises a sample tray
2, a spotting section 3, a first incubator 4, a second incubator 5,
a spotting unit 6, an element conveying mechanism 7, a transfer
mechanism 8, a tip scrapping section 9, and an element scrapping
mechanism 10.
[0068] The sample tray 2 has a circular shape and is loaded with a
plurality of sample vessels 11, 11, . . . , each of which
accommodates one of samples, a plurality of element cartridges 13,
13, . . . , each of which accommodates a plurality of dry chemical
analysis elements 12, 12, . . . (colorimetric-type dry chemical
analysis elements and/or electrolyte-type dry chemical analysis
elements) having not been used, and expendables (nozzle tips 14,
14, . . . , diluent liquid vessels 15, 15, 15, mixing cups 16, 16,
. . . , and a reference liquid vessel 17). Each of the sample
vessels 11, 11, . . . is loaded via a sample adapter 18 on the
sample tray 2. The nozzle tips 14, 14, . . . are accommodated in
each of tip racks 19, 19 and are loaded in this form on the sample
tray 2.
[0069] The spotting section 3 is located on an extension of a
center line of the sample tray 2. In the spotting section 3, a
sample, such as blood plasma, whole blood, blood serum, or urine,
is spotted to the dry chemical analysis element 12 having been
conveyed into the spotting section 3. Specifically, with the
spotting unit 6, the sample is spotted onto the colorimetric-type
dry chemical analysis element 12. Also, the sample and a reference
liquid are spotted onto the electrolyte-type dry chemical analysis
element 12. The tip scrapping section 9 for scrapping each of the
nozzle tips 14, 14, . . . is located on the side downstream from
the spotting section 3.
[0070] The first incubator 4 has a circular shape and is located at
a position on an extension of the tip scrapping section 9. The
first incubator 4 accommodates the dry chemical analysis elements
12, 12, . . . , which are of the colorimetric types, and keeps the
temperature of the colorimetric-type dry chemical analysis elements
12, 12, . . . at a constant temperature for a predetermined length
of time in order to perform colorimetry. As illustrated in FIG. 2,
the second incubator 5 is located at a position in the vicinity of
a side of the spotting section 3. The second incubator 5
accommodates the dry chemical analysis element 12, which is of the
electrolyte type. Also, the second incubator 5 keeps the
temperature of the electrolyte-type dry chemical analysis element
12 at a constant temperature for a predetermined length of time in
order to perform potentiometry.
[0071] As illustrated in FIG. 3, the element conveying mechanism 7
is provided with an element conveying member (a conveying bar) 71.
Though not shown in detail, the element conveying member 71 is
located within the sample tray 2. The element conveying mechanism 7
conveys the dry chemical analysis elements 12, 12, . . . one after
another from the sample tray 2 into the spotting section 3 and then
into the first incubator 4 along a straight element conveyance path
R (illustrated in FIG. 2). As illustrated in FIG. 2, the element
conveyance path R connects a center point of the sample tray 2 and
a center point of the first incubator 4 with each other and passes
through the spotting section 3 and the tip scrapping section 9. The
element conveying member 71 is supported for sliding movement by a
guide rod 38 and is operated for reciprocal movement by a driving
mechanism (not shown). The leading end of the element conveying
member 71 is inserted through a guide hole 34a of a vertical plate
34. The element conveying member 71 slides in the guide hole
34a.
[0072] The transfer mechanism 8 is formed so as to act also as the
spotting section 3. The transfer mechanism 8 transfers the
electrolyte-type dry chemical analysis element 12 from the spotting
section 3 into the second incubator 5 along a direction normal to
the element conveyance path R.
[0073] The spotting unit 6 is located at an upper part of the
biochemical analysis apparatus 1. The spotting unit 6 is provided
with spotting nozzles 45, 45 which are capable of being moved
vertically. The spotting nozzles 45, 45 move on the straight line
identical with the element conveyance path R described above in
order to perform the spotting of the samples and the reference
liquid, and dilution of the samples with a diluent liquid. The
nozzle tip 14 is fitted to a bottom end of each of the spotting
nozzles 45, 45. Each of the spotting nozzles 45, 45 sucks the
sample, the reference liquid, or the like, into the nozzle tip 14
and discharges the sucked liquid from the nozzle tip 14. The
spotting unit 6 is provided with syringe means (not shown) for
performing the suction and the discharging of the liquid. In the
tip scrapping section 9, the nozzle tip 14, which has been used, is
removed from each of the spotting nozzles 45, 45, allowed to fall,
and thus scrapped.
[0074] The element scrapping mechanism 10 is associated with the
first incubator 4. The element scrapping mechanism l0 pushes the
colorimetric-type dry chemical analysis element 12, which has been
used for the analysis, toward a center region of the first
incubator 4. At the center region of the first incubator 4, the
colorimetric-type dry chemical analysis element 12 is allowed to
fall and is thus scrapped. The colorimetric-type dry chemical
analysis element 12 is also capable of being scrapped by the
element conveying mechanism 7 described above. The electrolyte-type
dry chemical analysis element 12, which has been used for the
analysis at the second incubator 5, is scrapped by the transfer
mechanism 8 described above into a scrapping hole 69.
[0075] Though not shown, a blood filtering unit for separating
blood plasma from blood is located in the vicinity of the sample
tray 2.
[0076] The biochemical analysis apparatus 1 will hereinbelow be
described in more detail. The sample tray 2 comprises a circular
rotating disk 21, which is capable of being rotated forwardly and
reversely, and a circular disk-shaped non-rotating section 22,
which is formed at the center region of the sample tray 2.
[0077] As illustrated in FIG. 2, the rotating disk 21 is provided
with five sample loading sections 23, 23, . . . (indicated by A, B,
C, D, and E). Each of the sample loading sections 23, 23, . . .
supports the sample vessel 11, such as a blood-collecting tube
accommodating the sample, via the sample adapter 18. The rotating
disk 21 is also provided with five element loading sections 24, 24,
. . . , each of which is located in the vicinity of one of the
sample loading sections 23, 23, . . . Each of the element loading
sections 24, 24, . . . supports the element cartridge 13, in which
the plurality of the dry chemical analysis elements 12, 12, . . .
having not been used are accommodated in the laid-up state.
Ordinarily, multiple kinds of dry chemical analysis elements 12,
12, . . . are prepared in accordance with the types of analyses of
the samples. The rotating disk 21 is further provided with two tip
loading sections 25, 25. Each of the tip loading sections 25, 25
supports a tip rack 19 having a plurality of support holes arrayed
for accommodating the plurality of the nozzle tips 14, 14, . . .
The rotating disk 21 is still further provided with a diluent
liquid loading section 26 for supporting the three diluent liquid
vessels 15, 15, 15, which accommodate the diluent liquid. The
rotating disk 21 is also provided with a cup loading section 27 for
supporting a plurality of the mixing cups 16, 16, . . . , in each
of which the diluent liquid and the sample are to be mixed with
each other. (The mixing cups 16, 16, . . . are formed as cup-shaped
recesses located on a molded product.) The sample loading sections
23, 23, . . . , the element loading sections 24, 24, . . . , the
tip loading sections 25, 25, the diluent liquid loading section 26,
and the cup loading section 27 are located around the center region
of the rotating disk 21.
[0078] The non-rotating section 22 is provided with a cylindrical
reference liquid loading section 28 for supporting the reference
liquid vessel 17, which accommodates the reference liquid. The
reference liquid loading section 28 is located on the extension of
the element conveyance path R and within the movement range of the
spotting nozzles 45, 45. As illustrated in FIG. 1, an evaporation
preventing cover 35, which opens and closes the opening of the
reference liquid vessel 17, is located at the reference liquid
loading section 28.
[0079] The evaporation preventing cover 35 is supported by a
swinging member 37, whose bottom end is pivotably supported on the
non-rotating section 22. The evaporation preventing cover 35 is
urged toward the direction which closes the opening of the
reference liquid vessel 17. The swinging member 37 has an
engagement region 37a, which is projected at the top end region of
the swinging member 37. The engagement region 37a of the swinging
member 37 is capable of being brought into abutment with a bottom
end corner region 42a of a moving frame 42 of the spotting unit 6.
Also, when the moving frame 42 of the spotting unit 6 is moved to
the position above the reference liquid loading section 28 in order
to perform the suction of the reference liquid with one of the
spotting nozzles 45, 45, the bottom end corner region 42a of the
moving frame 42 comes into abutment with the engagement region 37a
of the evaporation preventing cover 35. As a result, the swinging
member 37 is swung to the opening position. Also, the evaporation
preventing cover 35 opens the reference liquid vessel 17.
Therefore, it becomes possible for the spotting nozzle 45 to suck
the reference liquid accommodated in the reference liquid vessel
17. When the moving frame 42 is moved toward the spotting section
3, the evaporation preventing cover 35 closes the opening of the
reference liquid vessel 17. In this state, the reference liquid is
prevented from evaporating. Therefore, the problems are capable of
being prevented from occurring in that the accuracy of analysis
becomes low due to a change in concentration of the reference
liquid.
[0080] The rotating disk 21 described above is supported by support
rollers 31, 31, . . . , which are located at an outer peripheral
region of the rotating disk 21. The center region of the rotating
disk 21 is supported for rotation around a support shaft (not
shown). Also, a timing belt (not shown) is threaded over the outer
periphery of the rotating disk 21. The timing belt is rotated
forwardly or reversely by a driving motor. The circular
non-rotating section 22 is secured to the support shaft and cannot
be rotated.
[0081] As illustrated in FIG. 3, the dry chemical analysis elements
12, 12, . . . having not been used are introduced into the element
cartridge 13 from above. Ordinarily, the plurality of the dry
chemical analysis elements 12, 12, . . . , which may be of
different types, are superposed one upon another in the element
cartridge 13. When the element cartridge 13 is fitted into one of
the element loading sections 24, 24, . . . of the sample tray 2,
the bottom of the element cartridge 13 is supported by a bottom
wall 24a of the element loading section 24. The lowest dry chemical
analysis element 12, which is among the plurality of the dry
chemical analysis elements 12, 12, . . . superposed one upon
another in the element cartridge 13, is located at a height
identical with the height of the plane of conveyance of the dry
chemical analysis element 12. A left side wall of the element
cartridge 13 in FIG. 3 is provided with an opening 13a at a
position corresponding to the lowest dry chemical analysis element
12, which is among the plurality of the dry chemical analysis
elements 12, 12, . . . superposed one upon another in the element
cartridge 13. The size of the opening 13a of the element cartridge
13 is set such that only one dry chemical analysis element 12 is
capable of passing through the opening 13a. A right side wall of
the element cartridge 13 in FIG. 3 is provided with an opening 13b,
through which the element conveying member 71 is capable of
passing.
[0082] Also, the bottom surface of the dry chemical analysis
element 12 is appended with analysis information (such as
information representing the type of the analysis and information
representing the production lot number), which has been recorded
with the dot recording technique, the bar code recording technique,
or the like. Such that the analysis information is capable of being
read from below the element cartridge 13, the bottom surface of the
element cartridge 13 is provided with a window 13c, and the bottom
wall 24a of the element loading section 24 is provided with a
window 24b.
[0083] Further, reading means 33 for reading the analysis
information from the dry chemical analysis element 12 is located
under the sample tray 2. The reading means 33 is located such that,
when the rotating disk 21 has been rotated by the operation of the
sample tray 2 from the position for element takeout illustrated in
FIG. 2, and the sample vessel 11 (the sample loading section 23)
has thus been moved to the position for sample suction illustrated
in FIG. 4, which position for sample suction is located on the
movement path of the spotting nozzles 45, 45 (i.e., the element
conveyance path R), the reading means 33 is located under the
position, to which the element cartridge 13 (the element loading
section 24) accommodating the dry chemical analysis element 12 to
be used for the analysis of the sample contained in the sample
vessel 11 has been moved. Specifically, as illustrated in FIG. 4,
the reading means 33 is located at the position, to which the
element loading section 24 has been moved in the manner described
above, at the phase angle shifted from the element conveyance path
R by the phase pitch between the sample loading section 23 and the
element loading section 24. In FIG. 2, for clearness, part of the
rotating disk 21 is cut away, and the reading means 33 is
illustrated at the cut-away area of the rotating disk 21. Also, in
FIG. 3, for clearness, the reading means 33 is illustrated under
the element loading section 24, which is located on the element
conveyance path R.
[0084] In cases where the analysis information is recorded with the
dot recording technique, the reading means 33 is constituted of a
CCD camera. In cases where the analysis information is recorded
with the bar code recording technique, the reading means 33 is
constituted of a bar code reader. The operation for reading the
analysis information from the dry chemical analysis element 12 by
use of the reading means 33 is performed before the operation for
sucking the sample from the corresponding sample vessel 11 and the
operation for conveying the dry chemical analysis element 12 are
performed. The analysis information, the production lot
information, and the like, are capable of being acquired from a
number of six figures or a number of four figures having been
obtained from the reading of the information appended to the dry
chemical analysis element 12. Also, the front and back surfaces of
the dry chemical analysis element 12 and the anterior and posterior
directions of the dry chemical analysis element 12 are capable of
being recognized in accordance with the recording pattern, or the
like. Therefore, an element setting failure is capable of being
detected, and a warning is capable of being given. Further, in
cases where the type of the analysis is the one requiring the
reference liquid and the diluent liquid, and the sample tray 2
comes short of the expendables (nozzle tips 14, 14, . . . , diluent
liquid vessels 15, 15, 15, mixing cups 16, 16, . . . , and a
reference liquid vessel 17) for the analysis, a warning is capable
of being given. Furthermore, in cases where the kind of the sample
and the type of the analysis with the dry chemical analysis element
12 do not conform to each other, a warning is capable of being
given.
[0085] The sample adapter 18 has a cylindrical shape. The sample
vessel 11 is inserted into the sample adapter 18 from above. The
sample adapter 18 is provided with an identification region (not
shown), at which the kind of the sample (processing information),
the kind (the size) of the sample vessel 11, and the like, are set.
At an initial stage of the analysis, the identification information
is read with an identification sensor 30 (shown in FIG. 2), which
is located at the outer periphery of the sample tray 2. In this
manner, a judgment is made as to whether the sample is to be or is
not to be diluted, whether blood filtration is to be or is not to
be performed, and the like. Also, an amount of change in liquid
level due to the size of the sample vessel 11 is calculated, and
processing control is made in accordance with the calculated amount
of change in liquid level. In cases where the blood filtration is
to be performed, after the sample vessel 11 has been inserted into
the sample adapter 18, a holder (not shown) provided with a filter
is fitted into the sample vessel 11 via a spacer (not shown).
[0086] The spotting section 3 and the transfer mechanism 8 comprise
a common support base 61, which is long in the direction normal to
the element conveyance path R. The support base 61 is located
between the sample tray 2 and the first incubator 4. Also, a
sliding frame 62 is located on the plunger 61, such that the
sliding frame 62 is capable of moving. A main element retainer 63
and a subsidiary element retainer 64 are fitted to the sliding
frame 62. The main element retainer 63 and the subsidiary element
retainer 64 are located at positions adjacent to each other and are
capable of moving together. As illustrated in FIG. 3, the main
element retainer 63 is provided with a spotting opening 63a. Also,
as illustrated in FIG. 3, the bottom surface of the main element
retainer 63, which bottom surface stands facing the support base
61, is provided with a recess 63b, through which the dry chemical
analysis element 12 is capable of being conveyed along the element
conveyance path R. The subsidiary element retainer 64 is
constituted in the same manner as that in the main element retainer
63. One end region of the sliding frame 62 is guided by a guide bar
65. The other end region of the sliding frame 62 is provided with a
long groove 62a. The long groove 62a of the sliding frame 62 is
engaged with a pin 66. The sliding frame 62 is also provided with a
rack gear 62b. The rack gear 62b of the sliding frame 62 is engaged
with a driving gear 67 of a driving motor 68 in order to move the
sliding frame 62. The support base 61 is provided with the second
incubator 5 described above and the scrapping hole 69 described
above.
[0087] As illustrated in FIG. 2, when the main element retainer 63
is located at the position corresponding to the position of the
spotting section 3, the colorimetric-type dry chemical analysis
element 12 having been spotted with the sample is pushed by the
element conveying mechanism 7 out of the spotting section 3 and
transferred into the first incubator 4. In cases where the spotting
onto the electrolyte-type dry chemical analysis element 12 has been
performed, the sliding frame 62 is moved, and the electrolyte-type
dry chemical analysis element 12, which has been spotted, is slid
on the support base 61 in the state, in which the electrolyte-type
dry chemical analysis element 12 is being supported by the main
element retainer 63. In this manner, the electrolyte-type dry
chemical analysis element 12 is transferred into the second
incubator 5. At the second incubator 5, the potential difference
measurement is performed. At this time, the subsidiary element
retainer 64 of the sliding frame 62 moves to the spotting section 3
(i.e., the spotting position). Therefore, with respect to the
colorimetric-type dry chemical analysis element 12, which may be
conveyed thereafter from the sample tray 2 into the spotting
section 3, the sample spotting and the conveyance into the first
incubator 4 are capable of being performed. When the analysis at
the second incubator 5 is finished, the sliding frame 62 is moved
even further in order to transfer the electrolyte-type dry chemical
analysis element 12, which has been analyzed, into the scrapping
hole 69. The electrolyte-type dry chemical analysis element 12,
which has been analyzed, is thus allowed to fall and scrapped.
[0088] As illustrated in FIG. 1, the spotting unit 6 comprises the
moving frame 42. The moving frame 42 is supported on a horizontal
guide rail 41 of a secured frame 40, such that the moving frame 42
is capable of being moved horizontally. The two spotting nozzles
45, 45 are located for vertical movement in the moving frame 42. A
vertical guide rail 43 is secured at the center region of the
moving frame 42. Also, two nozzle securing bases 44, 44 are
supported for sliding movement on opposite sides of the vertical
guide rail 43. A top end of the spotting nozzle 45 is secured to
the lower area of each of the two nozzle securing bases 44, 44.
Also, a shaft-shaped member extending upwardly from the top area of
each of the nozzle securing bases 44, 44 is inserted into one of
driving force transmitting members 47, 47. Further, a compression
spring is located between the nozzle securing base 44 and the
driving force transmitting member 47. The compression spring yields
the force for fitting the nozzle tip 14. Each of the nozzle
securing bases 44, 44 is capable of moving vertically together with
the corresponding driving force transmitting member 47. Also, in
cases where the nozzle tip 14 is to be fitted onto the bottom end
region of the spotting nozzle 45, the driving force transmitting
member 47 is capable of compressing the compression spring and
moving downwardly with respect to the nozzle securing base 44.
[0089] Each of belts 50, 50 is threaded over upper and lower
pulleys 49, 49. Each of the driving force transmitting members 47,
47 described above is secured to one of the belts 50, 50. Each of
the belts 50, 50 is moved by a motor (not shown), and each of the
driving force transmitting members 47, 47 is thereby moved
vertically. A balancing weight 51 is secured to an outer region of
each of the belts 50, 50 in order to prevent the spotting nozzle 45
from moving down when each of the belts 50, 50 is not driven.
[0090] The moving frame 42 is moved horizontally by a belt driving
mechanism (not shown). The horizontal movements and the vertical
movements of the two nozzle securing bases 44, 44 are controlled
such that each of the two nozzle securing bases 44, 44
independently undergoes the vertical movement. The two spotting
nozzles 45, 45 move together in the horizontal direction. Also,
each of the two spotting nozzles 45, 45 independently undergoes the
vertical movement. By way of example, one of the two spotting
nozzles 45, 45 is used for the sample, and the other spotting
nozzle 45 is used for the diluent liquid and the reference
liquid.
[0091] Each of the spotting nozzles 45, 45 has a rod-like shape. An
axially extending air path is formed within each of the spotting
nozzles 45, 45. The pipette-shaped nozzle tip 14 is fitted in a
sealed state onto the bottom end region of each of the spotting
nozzles 45, 45. An air tube, which is connected to a syringe pump
(not shown), or the like, is connected to each of the spotting
nozzles 45, 45 in order to supply the suction pressure and the
discharging pressure to each of the spotting nozzles 45, 45. The
liquid level of the sample, or the like, is capable of being
detected in accordance with a change in suction pressure.
[0092] The tip scrapping section 9 is located such that the tip
scrapping section 9 vertically intersects with the plane of
conveyance of the dry chemical analysis element 12. The tip
scrapping section 9 comprises an upper member 81 and a lower member
82. The region of the support base 61 described above, which region
is located at the position corresponding to the position of the tip
scrapping section 9, is provided with an elliptic fall opening 83.
The upper member 81 of the tip scrapping section 9 is secured to
the top surface of the support base 61. Also, the upper member 81
of the tip scrapping section 9 is provided with an engagement
cut-away region 84 at a position exactly above the fall opening 83
of the support base 61. The lower member 82 of the tip scrapping
section 9 is formed in a cylindrical shape and is located under the
bottom surface of the support base 61 so as to surround the region
beneath the fall opening 83 of the support base 61. The lower
member 82 of the tip scrapping section 9 guides the nozzle tip 14,
which falls from the region within the upper member 81 of the tip
scrapping section 9 through the fall opening 83 of the support base
61.
[0093] In cases where the nozzle tip 14 having been fitted onto the
spotting nozzle 45 is to be removed from the spotting nozzle 75 and
scrapped, the spotting nozzle 45, onto which the nozzle tip 14 has
been fitted, is moved downwardly into the region within the upper
member 81 of the tip scrapping section 9 and is then moved toward
the left side in FIG. 3 until the top end region of the nozzle tip
14 engages with the engagement cut-away region 84 of the upper
member 81 of the tip scrapping section 9. There after, the spotting
nozzle 45 is moved upwardly, and the nozzle tip 14 is thereby
removed from the spotting nozzle 45. The nozzle tip 14 having thus
been removed from the spotting nozzle 45 is allowed to fall from
the region within the upper member 81 of the tip scrapping section
9 through the fall opening 83 of the support base 61 into the lower
member 82 of the tip scrapping section 9. The nozzle tip 14 is thus
scrapped.
[0094] The first incubator 4 for performing the colorimetry
comprises an annular rotating member 87, which is located at an
outer peripheral region of the first incubator 4. A tapered
rotating cylinder 88 is secured to a bottom surface of an inner
peripheral region of the rotating member 87. The tapered rotating
cylinder 88 is supported for rotation by a bearing 89, which is
located at a bottom area of the tapered rotating cylinder 88. A top
member 90 is located on the rotating member 87, such that the top
member 90 is capable of rotating together with the rotating member
87. The top member 90 has a flat bottom surface. A plurality of
recesses (in the case of FIG. 1, 13 recesses) are formed at
predetermined intervals in the top circumferential surface of the
rotating member 87. In this manner, element compartments 91, 91, .
. . are formed as slit-shaped spaces between the rotating member 87
and the top member 90. The height of the bottom surface of each of
the element compartments 91, 91, . . . coincides with the height of
the plane of conveyance of the dry chemical analysis element 12.
The inner hole of the tapered rotating cylinder 88 acts as a
scrapping hole 92 for the dry chemical analysis element 12 having
been used for the analysis. The dry chemical analysis element 12,
which has been accommodated in each of the element compartments 91,
91, . . . and has been used for the analysis, is moved from the
element compartment 91 toward the center region of the first
incubator 4. The dry chemical analysis element 12 is thus allowed
to fall through the scrapping hole 92 and scrapped.
[0095] The top member 90 is provided with heating means (not
shown). The temperature of the dry chemical analysis element 12,
which has been accommodated in each of the element compartments 91,
91, . . . , is kept at a predetermined temperature by the
temperature adjustment with the heating means. Also, as illustrated
in FIG. 3, the top member 90 is provided with retaining members 93,
93, . . . at the positions corresponding to the element
compartments 91, 91, . . . Each of the retaining members 93, 93, .
. . retains the mount of the dry chemical analysis element 12 from
above in order to prevent the sample from evaporating. A heat
insulating cover 94 is located so as to cover the top surface of
the top member 90. Also, the entire area of the first incubator 4
is covered with a light blocking cover 95. Further, an opening 91a
for photometry is formed at a center area of the bottom surface of
each of the element compartments 91, 91, . . . of the rotating
member 87, which element compartments 91, 91, . . . accommodate the
dry chemical analysis elements 12, 12, . . . Through the opening
91a of each of the element compartments 91, 91, . . . , the
measurement of a reflection optical density of each dry chemical
analysis element 12 is performed with a photometric head 96, which
is located at the position shown in FIG. 2. The first incubator 4
is rotated reciprocally by a belt mechanism (not shown).
[0096] The element scrapping mechanism 10 comprises a scrapping bar
101. The scrapping bar 101 is capable of being moved from the outer
peripheral side of the first incubator 4 toward the center region
of the first incubator 4 and thus entered into each of the element
compartments 91, 91, . . . Also, the scrapping bar 101 is capable
of being moved reversely and retracted from the element compartment
91. A tail end region of the scrapping bar 101 is secured to a belt
102, which is moved horizontally by a driving motor 103. The
scrapping bar 101 moves in accordance with the movement of the belt
102 in order to push the dry chemical analysis element 12, which
has been used for the analysis, out of the element compartment 91
into the scrapping hole 92. A collecting box (not shown) for
collecting the dry chemical analysis elements 12, 12, . . . , which
have been used for the analyses, is located under the scrapping
hole 92.
[0097] In the second incubator 5 for the measurement of the ionic
activity of the specific ion, the main element retainer 63 of the
sliding frame 62 described above acts as a top member, and a single
element compartment is formed by the recess at the bottom of the
main element retainer 63 and on a top surface of a measuring main
body 97. The second incubator 5 is provided with heating means (not
shown). The temperature of an ionic activity measurement region of
the dry chemical analysis element 12, which has been accommodated
in the element compartment, is kept at a predetermined temperature
by the temperature adjustment with the heating means. Also, three
pairs of potential difference measuring probes 98, 98, . . . for
the measurement of the ionic activity are located along the sides
of the measuring main body 97. The three pairs of the potential
difference measuring probes 98, 98, . . . are capable of being
moved and brought into contact with the ion selective electrodes of
the dry chemical analysis element 12.
[0098] As described above, the blood filtering unit (not shown) for
separating blood plasma from blood is located in the vicinity of
the sample tray 2. The blood filtering unit operates in the manner
described below. Specifically, blood plasma is separated with
suction from blood via the holder (not shown), which has been
inserted into the sample vessel (blood-collecting tube) 11
supported by the sample tray 2 and is provided with the glass fiber
filter fitted to the top end opening of the sample vessel 11. Also,
the blood plasma, which has been separated from the blood by the
filtration, is retained in a cup region located at the top end of
the holder.
[0099] How the biochemical analysis apparatus 1 operates will be
described hereinbelow. Firstly, before the analyses are performed,
preparation for the analyses is made. Specifically, each of the
sample vessels 11, 11, . . . accommodating the samples is fitted in
to one of the sample loading sections 23, 23, . . . of the sample
tray 2. Also, each of the element cartridges 13, 13, . . .
accommodating the dry chemical analysis elements 12, 12, . . . is
fitted into one of the element loading sections 24, 24, . . .
Further, the tip racks 19, 19 accommodating the nozzle tips 14, 14,
. . . , are fitted into the tip loading sections 25, 25.
Furthermore, the mixing cups 16, 16, . . . are fitted into the cup
loading section 27, the diluent liquid vessels 15, 15, 15 are
fitted into the diluent liquid loading section 26, and the
reference liquid vessel 17 is fitted into the reference liquid
loading section 28.
[0100] Thereafter, analysis processing is begun. Firstly, in cases
where it has been judged that the blood filtration is to be
performed with respect to the sample, the whole blood accommodated
in the sample vessel 11 is subjected to the filtration with the
blood filtering unit, and the blood plasma constituent is
obtained.
[0101] Thereafter, the rotating disk 21 is rotated, and the element
cartridge 13 corresponding to the sample to be analyzed is located
at the position for information reading (the position illustrated
in FIG. 4), which position corresponds to the position of the
reading means 33. In this state, the analysis information, which
has been appended to the lowest dry chemical analysis element 12
among the dry chemical analysis elements 12, 12, . . . accommodated
in the element cartridge 13, is read from the lowest dry chemical
analysis element 12. Thereafter, the rotating disk 21 is rotated,
and the element cartridge 13 is located at the position for element
takeout (the position illustrated in FIG. 2), which position
corresponds to the position of the spotting section 3. The dry
chemical analysis element 12, from which the analysis information
has thus been read, is then taken out by the element conveying
member 71 from the element cartridge 13 and conveyed into the
spotting section 3.
[0102] In cases where it has been detected from the thus read
analysis information that the type of the analysis with the dry
chemical analysis element 12 is the colorimetry, the sample tray 2
is rotated, and a nozzle tip 14 accommodated in one of the tip
racks 19, 19 is located at the position under one of the spotting
nozzles 45, 45. Also, in the manner described above, the spotting
nozzle 45 is moved downwardly, and the nozzle tip 14 is fitted onto
the end of the spotting nozzle 45. Thereafter, the spotting nozzle
45 is moved upwardly.
[0103] Thereafter, the sample tray 2 is rotated in order to locate
the sample vessel 11 at the position for sample suction (the
position illustrated in FIG. 4). The spotting nozzle 45 is then
moved downwardly, and the sample is sucked from the sample vessel
11 into the nozzle tip 14. Thereafter, the spotting nozzle 45 is
moved to the position above the spotting section 3, and the sample
is spotted from the nozzle tip 14 onto the dry chemical analysis
element 12, which has been conveyed to the spotting section 3. At
the time of the sample suction, the element cartridge 13
corresponding to the sample vessel 11 is located at the position
for information reading, and the analysis information is read
simultaneously from a dry chemical analysis element 12, which is
now located at the lowest position in the element cartridge 13 and
is to be used for the next analysis.
[0104] Thereafter, the colorimetric-type dry chemical analysis
element 12, which has been spotted with the sample, is inserted
from the spotting section 3 into an element compartment 91 of the
first incubator 4. After the dry chemical analysis element 12 has
been kept at a predetermined temperature for a predetermined time
in the element compartment 91, the rotating member 87 of the first
incubator 4 is rotated, and the dry chemical analysis element 12
having been inserted into the element compartment 91 of the first
incubator 4 is located at the position which stands facing the
photometric head 96. In this state, the reflection optical density
of the dry chemical analysis element 12 is measured with the
photometric head 96. After the measurement of the reflection
optical density of the dry chemical analysis element 12 is
finished, the dry chemical analysis element 12 having been measured
is pushed out from the element compartment 91 toward the center
region of the first incubator 4 and into the scrapping hole 92 and
is thus scrapped. Also, the results of the measurement are
outputted. Further, the nozzle tip 14 having been used is removed
from the spotting nozzle 45 in the tip scrapping section 9. In the
tip scrapping section 9, the nozzle tip 14 having been removed from
the spotting nozzle 45 is allowed to fall and scrapped. At this
stage, the processing of the colorimetry is finished.
[0105] Also, on the side of the sample tray 2, after the suction
and the spotting of the sample described above have been finished,
the rotating disk 21 is rotated again, and the element cartridge 13
is located at the position for element takeout, which position
corresponds to the position of the spotting section 3. In this
state, the dry chemical analysis element 12, from which the
analysis information has been read, is taken out from the element
cartridge 13 by the element conveying member 71 and conveyed to the
spotting section 3 by the element conveying member 71. Thereafter,
the sample tray 2 is rotated, and the sample vessel 11 is moved to
the position for sample suction. Also, the spotting nozzle 45 is
moved downwardly, and the sample is sucked from the sample vessel
11 into the nozzle tip 14. The spotting nozzle 45 is then moved to
the spotting section 3, and the sample is spotted onto the dry
chemical analysis element 12. At the time of the sample suction,
the element cartridge 13 corresponding to the sample vessel 11 is
located at the position for information reading, and the analysis
information is read simultaneously from a next dry chemical
analysis element 12, which is now located at the lowest position in
the element cartridge 13 and is to be used for the next analysis.
The operations described above are iterated with respect to all of
the dry chemical analysis elements 12, 12, . . . accommodated in
the element cartridge 13.
[0106] In cases where analyses of a sample accommodated in a new
sample vessel 11 are to be made, the reading of the analysis
information of a first dry chemical analysis element 12 is
performed by locating the corresponding element cartridge 13 at the
position for information reading (the position illustrated in FIG.
4). Thereafter, the element cartridge 13 is moved to the position
for element takeout (the position illustrated in FIG. 2), and the
first dry chemical analysis element 12 is taken out from the
element cartridge 13 and conveyed to the spotting section 3.
Thereafter, in the same manner as that described above, the sample
vessel 11 is moved to the position for sample suction (the position
illustrated in FIG. 4), and the sample is sucked from the sample
vessel 11. Also, at the same time as the suction and the spotting
of the sample, the operation for reading the analysis information
from a next dry chemical analysis element 12 is performed.
[0107] In cases where it has been detected from the read analysis
information that the type of the analysis with the dry chemical
analysis element 12 is the dilution request type, e.g. in cases
where the concentration of the blood is high and it is regarded
that an accurate analysis cannot be made, the dry chemical analysis
element 12 is conveyed to the position for sample spotting, and a
nozzle tip 14 is fitted onto the spotting nozzle 45. The spotting
nozzle 45 is then moved downwardly, and the sample is sucked from
the sample vessel 11 into the nozzle tip 14. At this time, the
operation for reading the analysis information from a next dry
chemical analysis element 12 is performed simultaneously. Also, the
sucked sample is introduced from the nozzle tip 14 into the mixing
cup 16. The nozzle tip 14 having thus been used is then removed
from the spotting nozzle 45. Thereafter, a new nozzle tip 14 is
fitted onto the spotting nozzle 45, and the diluent liquid is
sucked from a diluent liquid vessel 15 into the new nozzle tip 14.
The sucked diluent liquid is then discharged from the nozzle tip 14
into the mixing cup 16, into which the sample has been introduced.
Also, the nozzle tip 14 is inserted into the mixing cup 16, and the
mixture of the sample and the diluent liquid is stirred through
repeated suction of the mixture into the nozzle tip 14 and
discharging of the mixture from the nozzle tip 14. The sample
having thus been diluted with the diluent liquid is then sucked
into the nozzle tip 14. The spotting nozzle 45 fitted with the
nozzle tip 14 is then moved to the position above the spotting
section 3, and the diluted sample is spotted onto the dry chemical
analysis element 12. Thereafter, the photometry, the element
scrapping, the outputting of results of the measurement, and the
tip scrapping are performed in the same manner as that described
above, and the processing is finished.
[0108] In cases where it has been detected from the read analysis
information that the type of the analysis with the dry chemical
analysis element 12 is the measurement of the ionic activity, the
processing is performed in the manner described below. In the cases
of the measurement of the ionic activity, the electrolyte-type dry
chemical analysis element 12 is conveyed from the element cartridge
13 into the spotting section 3. Thereafter, firstly, a nozzle tip
14 is fitted onto one of the spotting nozzles 45, 45, and a sample
is sucked from the sample vessel 11 into the nozzle tip 14. At this
time, the operation for reading the analysis information from a
next dry chemical analysis element 12 is performed simultaneously.
Thereafter, a nozzle tip 14 is fitted onto the other spotting
nozzle 45, and the reference liquid is sucked from the reference
liquid vessel 17 into the nozzle tip 14, which has been fitted onto
the other spotting nozzle 45. Thereafter, the sample is spotted
from the nozzle tip 14, which has been fitted onto the one spotting
nozzle 45, into one of the two liquid feeding holes of the dry
chemical analysis element 12. Also, the reference liquid is spotted
from the nozzle tip 14, which has been fitted onto the other
spotting nozzle 45, into the other liquid feeding hole of the dry
chemical analysis element 12.
[0109] The dry chemical analysis element 12, which has been spotted
with the sample and the reference liquid in the manner described
above, is transferred from the spotting section 3 into the second
incubator 5 in accordance with the movement of the sliding frame
62. When the dry chemical analysis element 12 has thus been
inserted into the second incubator 5, the measurement of the ionic
activity of the specific ion contained in the sample is performed
with the potential difference measuring probes 98, 98, . . . After
the measurement of the ionic activity of the specific ion is
finished, the dry chemical analysis element 12 having been measured
is transferred into the scrapping hole 69 and scrapped in
accordance with the movement of the sliding frame 62. Also, the
results of the measurement are outputted. Further, the two nozzle
tips 14, 14 having been used are removed from the spotting nozzles
45, 45 and scrapped. At this stage, the processing of the
measurement of the ionic activity is finished.
[0110] In the embodiment described above, before the dry chemical
analysis element 12 is conveyed from the element cartridge 13 to
the position for sample spotting in accordance with the rotating
operation of the sample tray 2, the analysis information of the dry
chemical analysis element 12 is read by the reading means 33, which
is located under the sample tray 2. Also, the spotting of the
sample corresponding to the type of the analysis is performed in
accordance with the thus read analysis information. Further,
simultaneously with the suction of the sample from the sample
vessel 11 and the spotting of the sample, the operation for reading
the analysis information from a dry chemical analysis element 12,
which is to be subjected to the spotting next, is performed.
Therefore, it is sufficient for the movement for the information
reading to be performed only at the first time, and thereafter the
movement for the information reading need not be performed.
Accordingly, the sequence control is capable of being kept simple,
and the time required to make the analyses is capable of being kept
short.
[0111] Also, the analysis information of the dry chemical analysis
element 12 is read before the dry chemical analysis element 12 is
taken out from the element cartridge 13. Therefore, a setting
failure with respect to the front and back surfaces of the dry
chemical analysis element 12 and the anterior and posterior
directions of the dry chemical analysis element 12 is capable of
being detected in accordance with the information having been read.
In such cases, a correcting operation is capable of being performed
easily by removing the element cartridge 13 from the sample tray 2
and again accommodating the dry chemical analysis element 12 in a
correct state in the element cartridge 13. Also, shortage of
expendables to be used for the corresponding analysis, inconformity
of the type of the analysis corresponding to the dry chemical
analysis element 12 and the kind of the sample with each other, and
the like, are capable of being detected in accordance with the
information having been read. Therefore, a warning is capable of
being given to the operator, and correcting operations are capable
of being performed.
[0112] FIG. 5 is a schematic plan view showing a major part of a
different embodiment of the biochemical analysis apparatus in
accordance with the present invention. This embodiment is provided
with a sample tray 20 constituted such that the sample loading
section 23 for loading the sample vessel 11 and the element loading
section 24 for loading the element cartridge 13, in which the dry
chemical analysis elements 12, 12, . . . necessary for the analyses
of the sample contained in the sample vessel 11 have been
accommodated, are located respectively at an inner circumferential
section and an outer circumferential section on an identical center
line. Also, the reading means 33 for reading the analysis
information is located under the sample tray 20 and at the position
on the element conveyance path R, to which position the element
loading section 24 is rotated. The other features are the same as
those of the embodiment described above. In FIG. 5, similar
elements are numbered with the same reference numerals with respect
to FIG. 4.
[0113] In the embodiment of FIG. 5, the position for element
takeout and the position for sample suction are set so as to
coincide with each other with respect to the rotating movement of
the rotating disk 21 of the sample tray 20. Therefore, in cases
where a plurality of analyses with the same sample are to be
performed successively, particularly in the cases of the
colorimetry, the operation for conveying the dry chemical analysis
element 12, the operation for sucking the sample, and the operation
for spotting the sample are capable of being performed without the
rotating movement of the rotating disk 21 being performed.
Accordingly, little time loss occurs, and the analyzing efficiency
is capable of being enhanced.
[0114] In the embodiments described above, the sample tray 2 or the
sample tray 20 has the circular shape and undergoes the rotating
movement. Alternatively, the sample tray may be constituted as a
rack-shaped sample tray undergoing linear movement. In such cases,
the reading means 33 is located such that the reading means 33 is
capable of reading the analysis information from the dry chemical
analysis element 12, which is to be next conveyed to the position
for sample spotting, when the sample is located at the position for
sample suction.
[0115] Further, in the embodiments described above, the reading
means 33 is located under the element cartridge 13 (the element
loading section 24). Alternatively, the reading means 33 may be
located at a position spaced away from the element cartridge 13
(the element loading section 24), from which position the reading
means 33 is capable of reading the analysis information of the dry
chemical analysis element 12 accommodated in the element cartridge
13.
[0116] Embodiments of the dry chemical analysis element for
biochemical analysis in accordance with the present invention will
be described hereinbelow. FIG. 6A is a plan view showing an
embodiment of the dry chemical analysis element for biochemical
analysis in accordance with the present invention, which is
constituted as a colorimetric-type dry chemical analysis element.
FIG. 6B is a bottom view showing the embodiment of the dry chemical
analysis element shown in FIG. 6A. FIG. 7A is a plan view showing a
different embodiment of the dry chemical analysis element for
biochemical analysis in accordance with the present invention,
which is constituted as an electrolyte-type dry chemical analysis
element. FIG. 7B is a bottom view showing the embodiment of the dry
chemical analysis element shown in FIG. 7A. FIG. 8 is an
explanatory view showing an example of notation allocation in a dot
array pattern.
[0117] A colorimetric-type dry chemical analysis element 102
illustrated in FIG. 6A is used for measuring the degree of
coloration of the spotted sample. The dry chemical analysis element
102 comprises a rectangular mount section 121, which is made from a
plastic material, and an analyzing region 122, which has a reagent
layer and is supported within the mount section 121. As illustrated
in FIG. 6A, a spotting hole 121a is open at the center area of the
front surface of the mount section 121. A front surface of the
analyzing region 122 is exposed to the exterior at the spotting
hole 121a. The sample is spotted onto the exposed analyzing region
122. Also, as illustrated in FIG. 6B, a photometric hole 121b is
open at the center area of the back surface of the mount section
121. A back surface of the analyzing region 122 is exposed to the
exterior at the photometric hole 121b. The degree of coloration of
the spotted sample is measured with a photometric head of a
biochemical analysis apparatus.
[0118] Also, as illustrated in FIG. 6B, dot array patterns 105, 105
have been formed respectively at the anterior and posterior areas
of the back surface of the mount section 121 of the dry chemical
analysis element 102. Each of the dot array patterns 105, 105 is
formed at the middle part of the back surface of the mount section
121 with respect to the width direction of the mount section 121 by
use of a dot printing technique. Further, a lateral stripe-shaped
bar code pattern 106 has been formed with a printing technique and
at the area in the vicinity of the photometric hole 121b, which is
located at the center area of the back surface of the mount section
121. Furthermore, an analysis type name 107 has been printed on the
front surface of the mount section 121 of the dry chemical analysis
element 102.
[0119] A plurality of kinds of the colorimetric-type dry chemical
analysis elements 102, 102, . . . , which correspond to different
types of the analyses and have an identical shape, are formed. Each
of the colorimetric-type dry chemical analysis elements 102, 102, .
. . is provided with the analyzing region 122 containing one of
different reagents (coated reagents). The dot array patterns 105,
105 having been encoded as illustrated in FIG. 8 are recorded on
the dry chemical analysis element 102 in accordance with the type
of the analysis, the production lot information, and the like.
[0120] An electrolyte-type dry chemical analysis element 103
illustrated in FIG. 7A is used for measuring the ionic activity of
a specific ion contained in the spotted sample. The
electrolyte-type dry chemical analysis element 103 comprises amount
section 131 and an analyzing region 132, which is supported within
the mount section 131. The mount section 131 has an outside shape
approximately identical with the shape of the mount section 121 of
the colorimetric-type dry chemical analysis element 102 described
above.
[0121] As illustrated in FIG. 7A, two liquid receiving holes 131a
and 131b have been formed approximately at the center area of the
front surface of the mount section 131. The sample is spotted into
the liquid receiving hole 131a. The reference liquid, whose ionic
activity has been known, is spotted into the liquid receiving hole
131b. Also, as illustrated in FIG. 7B, a pair of ion selective
electrodes 132a, 132a have been formed on opposite side areas of
the back surface of the mount section 131. Further, a pair of ion
selective electrodes 132b, 132b have been formed on opposite side
areas of the back surface of the mount section 131. Furthermore, a
pair of ion selective electrodes 132c, 132c have been formed on
opposite side areas of the back surface of the mount section 131.
Potential difference measuring probes (electrode pins) of a
biochemical analysis apparatus are electrically connected to the
pair of the ion selective electrodes 132a, 132a, the pair of the
ion selective electrodes 132b, 132b, and the pair of the ion
selective electrodes 132c, 132c of the analyzing region 132. The
pair of the ion selective electrodes 132a, 132a are provided with
Cl.sup.- ion selective layers. The pair of the ion selective
electrodes 132b, 132b are provided with K.sup.+ ion selective
layers. The pair of the ion selective electrodes 132c, 132c are
provided with Na.sup.+ ion selective layers.
[0122] Also, as illustrated in FIG. 7B, the dot array patterns 105,
105 have been formed respectively at the anterior and posterior
areas of the back surface of the mount section 131 of the dry
chemical analysis element 103. Each of the dot array patterns 105,
105 is formed at the middle part of the back surface of the mount
section 131 with respect to the width direction of the mount
section 131 by use of a dot printing technique. Further, though not
shown in FIG. 7B, a lateral stripe-shaped bar code pattern has been
formed with a printing technique and at the center area of the back
surface of the mount section 131.
[0123] As illustrated in FIG. 7A, the advance direction of the dry
chemical analysis element 103 is indicated on the front surface of
the mount section 131 of the dry chemical analysis element 103,
such that the user is capable of recognizing the advance direction
of the dry chemical analysis element 103. Specifically, as for the
electrolyte-type dry chemical analysis element 103, it is necessary
that the positions of the potential difference measuring probes and
the position of the dry chemical analysis element 103 are matched
with each other, and therefore the advance direction of the dry
chemical analysis element 103 is defined.
[0124] The analyzing region 132 of the electrolyte-type dry
chemical analysis element 103 is provided with a porous bridge. The
porous bridge is located so as to communicate the pair of the ion
selective electrodes 132a, 132a, at which potentials corresponding
to the ionic activities of the specific ion occur, with each other,
so as to communicate the pair of the ion selective electrodes 132b,
132b, at which potentials corresponding to the ionic activities of
the specific ion occur, with each other, and so as to communicate
the pair of the ion selective electrodes 132c, 132c, at which
potentials corresponding to the ionic activities of the specific
ion occur, with each other. When the sample and the reference
liquid are spotted respectively to the liquid receiving holes 131a
and 131b, the interfaces of the sample and the reference liquid
come into contact with each other by the effect of the porous
bridge, and electrical conduction occurs between the sample and the
reference liquid. As a result, a potential difference occurs
between each pair of the ion selective electrodes in accordance
with the difference between the ionic activities of the ion in the
sample and the reference liquid. The potential difference is
measured, and the ionic activity of the specific ion contained in
the sample is calculated in accordance with the measured potential
difference and by use of a calibration curve having been determined
previously (in accordance with the principle of the Nernst
equation).
[0125] The bar code pattern 106 has heretofore been printed at the
position described above. The dot array patterns 105, 105 are
formed at the positions other than the position of the bar code
pattern 106 and the position for the reading with the bar code
reader (the side edge area). Specifically, the dot array patterns
105, 105 are formed on the side more anterior than the bar code
pattern 106 and on the side more posterior than the bar code
pattern 106 and at the center area with respect to the width
direction of the dry chemical analysis element. With the
conventional biochemical analysis apparatus, the side edge area of
the dry chemical analysis element 102 or the dry chemical analysis
element 103 being conveyed is scanned with the bar code reader of
the biochemical analysis apparatus, the bar code pattern 106 is
thus read, the type of the analysis is discriminated in accordance
with the thus read bar code pattern 106, and the spotting, the
conveyance, the keeping at the predetermined temperature, and the
measurement are controlled in accordance with the discriminated
type of the analysis. The dot array patterns 105, 105 are located
so as not to obstruct the operations of the biochemical analysis
apparatus.
[0126] The dot array pattern 105 may be formed at only either one
of the anterior and posterior areas of the back surface of the
mount section 121 of the dry chemical analysis element 102 or the
mount section 131 of the dry chemical analysis element 103.
[0127] FIG. 8 is an explanatory view showing an example of notation
allocation in the dot array pattern 105. The dot array pattern 105
is a matrix comprising six rows and nine columns. The first
left-hand column represents a start code 105a. Dot setting
positions of the matrix are represented by reference dots 105b,
105b located along the first row and the sixth row. The dots
appended with a sign N represents a slide type number, a slide
sample kind number, a production lot number, and other inherent
numbers concerning the production. P1 to P4 are parity dots. The
two dots indicated by the broken lines are spaces with no
notation.
[0128] In cases where each piece of information is expressed with
the binary notation, each of the dots described above is set in the
manner described below. Specifically, in cases where the subject
bit is at a "1" level, dot notation is effected. Also, in cases
where the subject bit is at a "0" level, dot notation is not
effected. Also, the parity dots P1 to P4 are utilized for the
parity check in the manner described below. Specifically, in cases
where the dot notation of each row is of an odd number, dot
notation is effected. Also, in cases where the dot notation of each
row is of an even number, dot notation is not effected. Further,
the spaces with no notation are utilized for the discrimination of
the advance direction of the dry chemical analysis element 102 or
the dry chemical analysis element 103.
[0129] The slide type number and the slide sample kind number
described above represent the analysis type information. The
production lot number and other inherent numbers concerning the
production represent the production lot information. Each of these
pieces of information is encoded and expressed with the dot array
pattern. The dot array pattern 105 may be recorded by use of a
plurality of colors, and the amount of information may thereby be
kept large. Also, serviceable life information may also be
recorded.
[0130] The direction of the start code of the dot array pattern 105
of the colorimetric-type dry chemical analysis element 102 and the
direction of the start code of the dot array pattern 105 of the
electrolyte-type dry chemical analysis element 103 are set to be
identical with each other.
[0131] The biochemical analysis apparatus for making the analysis
of the constituent of the sample by use of the dry chemical
analysis element 102 and the dry chemical analysis element 103
comprises a sample tray for loading the sample, the dry chemical
analysis element 102, the dry chemical analysis element 103, the
reference liquid, and the like. The biochemical analysis apparatus
also comprises information reading means constituted of a CCD
camera for reading the dot array patterns 105, 105 of the dry
chemical analysis element 102 and the dot array patterns 105, 105
of the dry chemical analysis element 103. The biochemical analysis
apparatus further comprises a spotting unit for sucking the sample
into a spotting nozzle and spotting the sample onto the dry
chemical analysis element 102, and for sucking the sample and the
reference liquid into spotting nozzles and spotting the sample and
the reference liquid onto the dry chemical analysis element 103.
The biochemical analysis apparatus still further comprises
incubators for keeping the spotted dry chemical analysis element
102 and the spotted dry chemical analysis element 103 at
predetermined temperatures. The biochemical analysis apparatus also
comprises concentration measuring means provided with a photometric
head for colorimetry and potential difference measuring means
provided with potential difference measuring probes for ionic
activity measurement. The biochemical analysis apparatus further
comprises a control unit for controlling the operations of the
respective sections of the biochemical analysis apparatus and
calculating the substance concentration and the ionic activity from
the measured values The control unit stores a plurality of pieces
of analysis management information having been read from a magnetic
card. Also, the control unit has the functions for making a
judgment as to the matching of the information, which has been read
from the dot array patterns 105, 105 of the dry chemical analysis
element 102 and the dry chemical analysis element 103, and the
analysis management information with each other. The plurality of
pieces of analysis management information are thus capable of being
stored, and the dry chemical analysis elements 102, 102, . . . and
the dry chemical analysis elements 103, 103, . . . , which are of
different production lots, are capable of being loaded in a mixed
form and utilized for the analyses.
[0132] In cases where a sample analysis is to be made with the
biochemical analysis apparatus described above, the operator sets
the dry chemical analysis element 102 or the dry chemical analysis
element 103, which is of the kind corresponding to the analysis of
the sample, on the sample tray of the biochemical analysis
apparatus directly or in the form accommodated in an element
cartridge. A bottom surface of the element loading section is
provided with a window, which allows the reading of the dot array
patterns 105, 105 from below. Also, the information reading means
constituted of the CCD camera is located under the window. The
colorimetric-type dry chemical analysis elements 102, 102, . . .
and the electrolyte-type dry chemical analysis elements 103, 103, .
. . described above are set in the mixed form on the sample tray of
the biochemical analysis apparatus.
[0133] The operation for reading the dot array patterns 105, 105
from the dry chemical analysis element 102 or the dry chemical
analysis element 103 is performed before the conveyance of the dry
chemical analysis element 102 or the dry chemical analysis element
103 is started. The spotting operation, the operation for keeping
the dry chemical analysis element at the predetermined temperature,
and the like, are controlled in accordance with the type of the
analysis and the sample kind information, which have been obtained
from the information reading. Also, the production lot and the
analysis management information are matched with each other in
accordance with the production lot information, and the measurement
data processing is performed accurately in accordance with the
analysis management information corresponding to the production
lot. Further, the front and back surfaces of the dry chemical
analysis element and the anterior and posterior direction of the
dry chemical analysis element are capable of being detected.
Therefore, a setting failure of the dry chemical analysis element
102 or the dry chemical analysis element 103 is capable of being
detected, and a warning is capable of being given. Furthermore, in
cases where the type of the analysis is the one requiring the
reference liquid and the diluent liquid, and the sample tray comes
short of the expendables for the analysis, a warning is capable of
being given. Also, in cases where the kind of the sample and the
type of the analysis with the dry chemical analysis element 102 or
the dry chemical analysis element 103 do not conform to each other,
a warning is capable of being given.
[0134] With the aforesaid embodiment of the dry chemical analysis
element for biochemical analysis in accordance with the present
invention, the production lot of the dry chemical analysis element
102 or the dry chemical analysis element 103 used for the analysis
and the analysis management information are capable of being
matched with each other. Therefore, the biochemical analysis is
capable of being performed accurately, and the time required to
make the analysis is capable of being kept short.
[0135] Also, the information of the dry chemical analysis element
102 or the dry chemical analysis element 103 is capable of being
read before the conveyance of the dry chemical analysis element 102
or the dry chemical analysis element 103 is started. Therefore, a
setting failure with respect to the front and back surfaces of the
dry chemical analysis element and the anterior and posterior
direction of the dry chemical analysis element is capable of being
detected in accordance with the information having been read. In
cases where the setting failure is detected, the setting of the dry
chemical analysis element 102 or the dry chemical analysis element
103 is capable of being performed again, and the correcting
operation is thus capable of being performed easily.
* * * * *