Title of Invention

BLOOD TRANSFUSION TEST ANALYZING SYSTEM AND METHOD FOR ANALYZING BLOOD TRANSFUSION TEST

Abstract A blood transfusion test analyzing system comprises a center station and a local station installed at a blood transfusion test facility which is connected to the center station via a data transmission line. The center station includes antigen profile information inputting means for inputting antigen profile information of reagent red blood cells to be distributed to the facility and an antigen profile data transferring means for transferring the input antigen profile information to the local station via the data transmission line. The local station includes an antigen profile information receiving means for receiving the antigen profile information transferred from the center station, a storing means for storing the antigen profile information received by the antigen profile information receiving means, a blood transfusion test result inputting means for inputting a result of a blood transfusion test performed by using the reagent red blood cells and a blood transfusion test analyzing means for analyzing the blood transfusion test based on the result of the blood transfusion test and the antigen profile information stored in the storing means.
Full Text [Detailed Explanation of the Invention]
[Technological Field of the Invention]
This invention relates to a blood transfusion test
analyzing system and a method for examining adaptability of
blood transfusion before blood is transfused to a patient in a
facility such as a hospital.
[0002]
[Prior Art]
It is necessary to perform various tests including an ABO
blood typing test in order to avoid agglutination of blood or
laky blood occurred by an antigen-antibody reaction between
patient's blood and provided blood when blood is transfused to
a patient in a hospital.
[0003]
Especially, when irregular antibodies should be
identified, it is checked up whether agglutination occurs or
not between blood to be examined and plural kinds of reagent
red blood cells after selecting the plural kinds of reagent
red blood cells based on the reference to an antigen profile
"table 'Based on the result of the checkup, other kinds of
reagent red blood cells are selected and used for identifying
irregular antibodies. Conventionally, such an antigen profile
table is printed on a paper attached to a group of plurality
of kinds of reagent red blood cells when it is sold. A person
such as a clinical test technician selects an appropriate
combination of kinds of reagent red blood cells referring to
the antigen profile based on his or her experience.
[0004]
However, selection of an appropriate combination of kinds
of reagent blood cells is a troublesome work. Sometimes, the
selection must be performed in a short period at the facility.
P'urther, a decision of the test performed by a person depends
on the individual differences. Therefore, it is difficult to
accurately perform an objective identification of antibodies.
[0005]
[Problem to be solved]
As explained above, a blood test for blood transfusion is
very troublesome and it is difficult to make an objective
judgement of blood test accurately.
[0006]
The present invention is made in view of the above
explained points. Accordingly, the object of the present
invention is to provide a blood test analyzing system which
aids a test technician so that the technician can easily
perform decisions concerning a blood transfusion test such as
antibody identification.
[0007]
[Means for Solving Problem]
In order to accomplish the above object, the blood
transfusion test analyzing system according to the present
invention comprises: a center station having an antigen
profile information of reagent red blood cells and a local
station installed at a facility where a blood transfusion test
is performed by using the reagent red blood cells, the local
station being connected to the center station via a data
transmission line; wherein the center station includes antigen
profile information inputting means for inputting antigen
profile information of reagent red blood cells to be
distributed to the facility and an antigen profile data
transferring means for transferring the input antigen profile
information to the local station via the data transmission
line; and Wherein the local station includes an antigen
profile information receiving means for receiving the antigen
profile information transferred from the center station, a
storing means for storing the antigen profile information
received by the antigen profile information receiving means, a
blood transfusion test result inputting means for inputting a
result of a blood transfusion test performed by using the
reagent red blood cells and a blood transfusion test analyzing
means for analyzing the blood transfusion test based on the
result of the blood transfusion test and the antigen profile
information stored in the storing means.
[0C08]
Further, a method for analyzing a blood transfusion test
using reagent red blood cells according to the present
invention comprises the steps of: transmitting antigen profile
information concerning the reagent red blood cells from a
center station having the antigen profile information to a
local station installed at a blood transfusion test facility
via a data transmission line; receiving the antigen profile
information at the local station via the data transmission
line; carrying out a blood transfusion test at the blood
transfusion test facility using the reagent red blood cells;
and analyzing the blood transfusion test at the local station
based on the antigen 'profile information received by the local
station and a result of the blood transfusion test.
[0009]
[embodiments of the present invention]
Next, embodiments of the present invention are explained
in detail with reference to the drawings.
Fig, 1 is a figure showing a structure of the blood
transfusion test system according to an embodiment of the
present invention. In this Fig., reference numeral 100 denotes
a center station which inputs antigen profile information and
which transmits the antigen profile information via a public
telephone line 300, 200a and 200b respectively denote a
facility station which receives the antigen profile
information transmitted by the center station 100. The center
station 100 includes a host computer 110, terminal computer
120a and a terminal computer 120b. Printers 130a, 130b are
connected to the terminal computers 120a, 120b respectively. A
modem 150 is connected to the host computer 110 so that the
host computer can communicate with an external apparatus. A
bar code reader 140 is connected to the terminal computer
120b. The host computer 110 includes a main frame portion 111
in which a CPU is mounted, and a hard disk 112.
[0010]
On the other hand, facility stations 200a and 200b,
installed at facilities such as a hospital are connected to
the public telephone line 300. In Fig. 1, only two facility
stations are illustrated. However, it is possible that more
than two facility stations are connected to the public
telephone line 300. Here, only the functions of the facility
stations 200a is explained as an example because the facility
stations 200a and 200b are substantially the same. The
facility station 200a includes a terminal computer 201a, a
printer 202a connected to the terminal computer 201a, a bar
code reader 203a and a modem 204a which is connected to the
public telephone line 300. The reference numeral 205a denotes
an image processing apparatus which inputs an image of a test
reaction of the a reagent cassette.
[0011]
Fig. 2 is an illustrative figure showing operations of
the distribution of the reagent red blood cells or reagent
cassettes to each of the facilities and the transferring of
antigen profile information of the reagent red blood cells and
reagent cassettes performed by the center station 100. As
shown in Fig. 2, reagent red blood cells and reagent cassettes
are delivered to the facilities such as a hospital and the
information concerning reagent blood cells and reagent
cassettes are stored in reagent red blood cell data base which
is structured in the hard disk 112 of the host computer 110 of
the center station 100. The kinds of the antigen composition,
lot numbers, doner numbers of the reagent blood cells, which
are used for antibody screening and for antibody
identification, are registered in this reagent blood cell data
base. The antigen profile information is manually input by a
person with reference to an antigen profile table printed on a
paper. The same antigen profile is input based on the same
antigen profile table plurality of times and a supervisor
confirms the input antigen profile information, thereby
accurate information can be obtained. The information
concerning the reagent red blood cells including the antigen
profile information is automatically transmitted to the
facilities to which the reagent red blood cells or reagent
cassettes are delivered via the modem 150 and the public
telephone line 300 at a predetermined time during night for
example. The information concerning the reagent red blood
cells should be reached to the facility prior to the arrival
ot the reagent red blood cells to the facility. When a
malfunction occurs in transmitting the information concerning
the reagent red blood cells, a list of the pieces of
information which have not properly been transmitted to the
facilities is displayed on a display screen of the host
computer 110. In addition, a procedure of re-transmitting the
information is performed. The information concerning reagent
red blood cells including the antigen profile is stored in a
floppy disk and the floppy disk is sent to the facilities
which do not have a communication device such as a modem. The
floppy disk may be sent even to the facilities having a
Communication device as a security measure in case a
Communication cannot be made due to the malfunction of the
communication network or a trouble of the modem. The
operations of the facility station 200a can be performed on-
line from the center station 100. Namely, remote maintenance
of data base and so forth can be executed.
[0012]
Next, the operations of the facility station 200a
installed in a hospital and so forth will be explained.
Fig. 3 is a figure illustrating the operations of the
facility station 200a. As shown in Fig. 3, analysis of the
test result for a patient and administration of the history of
the test result are performed based on the information
concerning the reagent red blood cells v/hich are transmitted
by the center station 100. Blood tests include an ABD blood
typing 'test, DAT (Direct Anti-globulin Test), an Rh-hr factor
test, an irregular antibody test, a cross-matching test and an
antibody identification test. There tests will be explained in
detail later.
[0013]
The facility station 200a receives the information
concerning the reagent red blood cells including the antigen
profile information transmitted by the center station 100 or
the facility station 200a receives a floppy disk containing
the information concerning the reagent red blood cells
including the antigen profile information. The necessary
information is extracted from the reagent red blood cell
information and is stored in the reagent red blood cell data
base. As a test specimen reception and registration procedure,
patient (recipient of blood) information and test specimen
information are registered. In addition, requested test items
are set. Further-, the reagent cassettes are reserved to use.
The information concerning the reagent cassettes is input by
reading a bar code with the bar code reader 203a.
[0014]
Fig. 4 is a figure showing an outlook of an example of a
reagent cassette 400. As shown in this Fig., columns 401 to
406 are provided on the reagent cassette 400. Anti-A serum,
anti-B serum and anti-D serum are sealed into the columns 401
to 403 respectively. Different phosphoric acid buffers are
sealed into columns 404 to 406 respectively. An ID number for
specifying the reagent cassette 400, an ID number for
specifying anti serums sealed into the columns 401 to 406 and
other ID numbers are recorded as bar code information. In
using this reagent cassette 400 the state of the
agglutination after centrifugals force is' applied to the
reagent cassette 400 after red blood: cells as test specimens
are put into the columns 401 to 406 indicates a result of the
test. Glass beads which are minute particles are sealed into
the columns 401 to 406 in order to make the state of the
agglutination clearer. Namely, agglutinated red blood cells
are captured by glass beads which show a filtering effect. On
the other hand, non-agglutinated red blood cells subsides at
the bottoms of the columns 401 to 406 by passing through the
glass beads.
[0015]
A reagent cassette 500 shown in Fig. 5 is similar to the
reagent cassette 400. However, polyspecific coombs serum
(mixture of anti-IgG serum, anti-C3b serum and anti-C3d serum)
is sealed into the columns 501 to 506. A result of the test
can be found by observing the state of agglutination after
reagent red blood ceils and blood of a patient are poured in
the columns. A bar code 510 is printed on the surface of the
reagent cassette 500, which is similar to the bar code 410
illustrated in Fig. 4.
[0016]
Namely, the information about the reagent cassettes is
input by reading the bar codes 410 and 510 with the bar code
reader 203a at. the facility station 200a. As a test result of
a specimen test at the facility station 200a, the result of
the test using the reagent cassette 400 or 500, i.e.,,. each
state of agglutination of the columns 40l to 406 of the
reagent cassette 400 and of the columns 501 to 506 of the
reagent cassette 500 is input by eye sight of a test
performing person. Alternatively, each state of agglutination
may be input automatically by an image processing apparatus
205a having a CCD camera for example. In this case, the image
processing apparatus 205a takes an image of the columns and
inputs the state of agglutination of the columns by image
processing. The image processing apparatus 205a makes a
decision of a test result using an image processing algorithm
working based on change of colors in the columns 401 to 406
and 501 to 506. The decision of the test result is transferred
to the terminal computer 201a. By inputting test results as
explained above, a judgement of a result of an ABD typing
test, DAT (Direct Anti-globulin test), an Rh-hr factor test
and a cross-matching test are performed. The results of the
specimen tests are stored in patient information data base and
specimen information data base. Retrieval of the information
stored in each data base is possible. In the patient
information data base, patient information is stored with
patient IDs for specifying patients. In the specimen
information data base, specimen information is stored with
specimen IDs for specifying specimens. An elimination method
is applied to the antigen profile information included in
reagent red blood cell information based on the input states
of agglutination of the columns 401 to 406 and 501 to 506 of
the reagent cassettes 400 and 500, thereby antibody whose
existence seems to be likely and antibody whose existence
cannot be denied are displayed. In addition, probabilities of
the identified antibodies are calculated and displayed.
Further, when supplemental reagent blood cells are necessary
to identify antibodies, A list of proposed kinds of reagent
blood cells is displayed based on the antigen profile
information.
[0017]
Next, the operations of the facility station 200a will be
explained more in detail. Fig. 6 is a flowchart showing the
operations at the time of the initiation. The program runs on
the Windows NT which is an operating system of Microsoft
cooperation. As shown in this figure, a password for opening
Windows NT is input (step ST601), and a password for Data
Management Program (DMP) is input (step ST602) . When these
passwords are in conformity with the stored passwords
respectively, a main menu is displayed (step ST603) . When the
reagent red blood cell reception procedure is selected in the
main menu, the sequence shifts to this procedure (step ST604).
VJhen the specimen reception procedure is selected in the main
menu, the sequence shifts to this procedure (step ST605) . When
the result input procedure is selected in the main menu, the
sequence shifts--to.-this procedure (step ST606). When the
identification procedure is selected in the main menu, the
sequence shifts to this procedure (step ST607). The detailed
explanations of steps ST604 to ST607 will be explained later.
When the utility is selected in the main menu (step ST608),
either a data base maintenance procedure or a document
printing procedure can be selected. When the data base
maintenance procedure is selected, the sequence shifts to this
procedure (step ST609). When the document printing procedure
is selected (step ST610), one among blood transfusion history-
retrieval (step ST611), test result retrieval (step ST612) and
patient information retrieval (step ST613) can be selected. In
these retrievals, after inputting retrieval conditions (step
ST614), the retrieval is performed and the result of the
retrieval is displayed (steps ST615, ST616). When the result
should be printed on a paper (step ST617), the retrieved data
are printed on a paper (step ST618). On the other hand, it is
not necessary to print the retrieved data on a paper, the
sequence shifts back to step ST614. In step ST619, when the
document printing procedure is terminated, the sequence shifts
back to step ST603 where the main menu of the data management
program is displayed. When "quit" is selected at the step
ST603 (step ST620), the sequence shifts back to the main menu
of the Windows NT.
Fig. 7 is a flowchart showing the operations of the step
ST604 of Fig. 6 in greater detail. At first, when the reagent
red blood cells are received, either the reagent red blood
cell information stored in a distributed floppy disk (steps
ST701 ST702) or the reagent red blood cell information
received via the modem 204a (step ST703) is selected to read.
Next, when transmission date of reagent red blood cell
information for the received reagent red blood cells and lot
numbers are selected (steps ST704, ST705), selection for the
registration is performed (step ST706). When the registration
is executed, the whole procedure is terminated and the
sequence shifts back to the main menu of the data management
program.
[0019]
Fig. 8 is a flowchart showing the operations of the step
ST605 of Fig. 6 in greater detail. At first, when a new
specimen is to be registered (step ST801), a patient ID is
input and information including the name of the patient and
birth date of the patient is registered (steps ST802, ST803),
a specimen ID is input and specimen information as to whether
anti-coagulant is included or not for example is input (step
ST805) and requested items for the test is input (step ST806).
On the other hand, in a case where information of the specimen
which has been registered should be added, a patient ID is
input (step ST808) . When the patient information should be
added or changed, registering procedure for the patient
information is performed (steps ST809, ST810). Next,
registration of a specimen ID is performed (step ST811) and
the sequence shifts to the input procedure for requested test
items (step ST806). Subsequently, registration procedure for
reagent cassette to be used is performed (steps ST812 to
ST815). If it is not necessary to add or change other
information (steps ST816 to ST817), when the whole procedures
should be terminated, the sequence shifts back to the main
menu. On the other hand, when the whole procedures should not
be terminated, the sequence shifts back to the step ST605
(step ST818). When patient information is not to be added or
changed, a specimen ID is input (step ST819) and specimen
information is input (step ST820). Further, the registration
procedure of requested items for the test and the registration
procedure of the reagent cassette are performed (steps ST821
to ST825).
[0020]
Fig. 9 is a flowchart showing the operations of the step
ST606 of Fig. 6 in greater detail. At first, IDs of the
reagent cassettes are input manually or with the bar code
reader (steps ST901 and ST902). The information concerning the
reagent cassettes is stored in the reagent cassette data base
with reagent cassette IDs so that the information can be
retrieved. If the reagent cassette has already been
registered, a specimen information input window is displayed
(step ST903) and results of the tests are input (step ST904).
When the results are not registered, judgements of blood tests
including ABD, Rh-hr, DAT blood tests are made (steps ST906).
The judging operations of these tests are explained later in
greater detail. As a result of these blood tests, when an
abnormal reaction occurs (step ST907), possible causes are
displayed. Abnormal patterns in each of the tests and causes
of the abnormal patterns are related to each other and stored
in the abnormal cause data base structured in the hard disk of
the computer 201a at the facility station 200a and the
possible causes are displayed after retrieving the possible
causes from the abnormal cause data base (ST908). When the
input results of the tests are registered at step ST905 or
when it is decided that no abnormalities occur at step ST907,
the information is input as to whether there are the reagent
cassettes which have not been input or not (step ST909). If
there is such a reagent cassette, the sequence shifts back to
the step ST901. On the other hand, if the reagent cassette
which has not been input does not remain, a special dialog
window is displayed (step ST910). In this window, one among
dialog windows for cross-matching and irregular antibody, and
antibody identification initial window can be selected (step
ST912). The step of inputting test results can be reached from
the specimen reception and registration window (step ST913)
through the display of specimen information window (step
ST913). Namely, an input of cassette ID is performed by
selecting a cassette ID from cassette IDs in the pull-down
list on the specimen reception and registration window (step
ST915). Thereafter, the sequence shifts to-the step ST904
where the test results can be input.
[0021]
-Fig. 10 is a figure showing a window for inputting
results of specimen tests. As shown in the center portion of
this figure, results of each columns are input and registered.
The results of the tests are indicated as one of "0", "W+",
"1+", "2+", "3+", "4+" respectively depending on the degree of
the states of agglutination.
[0022]
Figs. 11 and 12 are flowcharts showing the detailed
operations of antibody identification procedure in the step
ST607 of Fig. 6. After a specimen ID is input from the main
menu (step STll0l) or the sequence shifts from a test result
input window (step ST1102), identification mode is input (step
ST1103). Thereafter, selection of reagent red blood cells to
be used and identification are performed using an elimination
method (steps ST1104 to ST1106). This identification procedure
is performed mainly for the purpose of screening irregular
antibodies. Therefore, a few kinds of reagent red blood cells
are used for identification. In this case, coincidence of
likely antibody pattern is obtained at the step ST1107, an
antibody existence probability value (p-value) is calculated
and meaning of the probability and mathematical expression for
this calculation are displayed (steps ST1108 and ST1109). When
the coincidence of likely antibody pattern is not obtained,
causes of the fact that there are no coincidence of likely
antibody pattern are displayed (step STlllO).
[0023]
Next, when "continue" is selected (step STllll), the
selection of the reagent red blood cells to be used is
performed (step ST1112). In this selection, plural kinds of
reagent red blood cells stored in the facility are displayed
so that a test performing person can select some kinds of
reagent red blood cells. Therefore, this eases the selection
of reagent red blood cells. A test is performed by using the
selected reagent red blood cells and judgement of
identification of antibody is performed with an elimination
method (steps ST1113 and ST1114). Further, when coincidence of
likely antibody pattern is obtained at the step ST1115,
antibody existence probability value (p-value) is calculated
and meaning of the probability and mathematical expression for
this calculation are displayed (steps ST1116 and ST1117). When
the coincidence of likely antibody pattern is not obtained,
causes of the fact that there are no coincidence of likely
antibody pattern are displayed (step ST1118)
[0024]
Next, when "continue" is selected (step ST1119), whether
or not antigen typing 'is to be performed or not is selected
(step ST1120). When the antigen typing is selected to perform,
antigen typing to the antigen corresponding to the antibody
whose existence is not denied and the result of the antigen
typing is input (step ST1121). Taking this result of the
antigen typing into account, identification of antibodies is
performed (step ST1122). In this case, if a certain antigen
.which corresponds to antibody whose existence cannot be denied
is identified, the existence of the antibody is practically
denied. Further, when coincidence of likely antibody pattern
is obtained at the step ST1123, antibody existence probability
value (p-value) is calculated and meaning of the probability
and mathematical expression for this calculation are displayed
(steps ST1124 and ST1125). When the coincidence of likely
antibody pattern is not obtained, causes of the fact that
there are no coincidence of likely antibody pattern are
displayed (step ST1126).
[0025]
Next, when "continue" is selected (step ST1127), a
selection of reagent red blood cells to be used is performed
(step ST1128). In selection procedure of reagent red blood
cells to be used, a proposed combination of plural kinds of
reagent red blood cells is displayed, which include kinds of
the reagent red blood cells which show positive to only one of
antibodies which cannot be eliminated and kinds of the reagent
red blood cells which show negative to the antibodies which
cannot be eliminated. A test performing person selects reagent
red blood cells among the proposed combination and a test is
carried out using the selected reagent blood cells. Therefore,
this eases the selection of reagent blood cells to be used
next. The result of the test using the selected reagent red
blood cells is input (step ST1129). A judgement of the test is
performed using an elimination method (steps ST1130 and
ST1131). In this case, coincidence of likely antibody pattern
is obtained (step ST1132), antibody existence probability
value (p-value) is calculated and meaning of the probability
and mathematical expression for this calculation are displayed
(steps ST1133 and ST1134). When the coincidence of likely
antibody pattern is not obtained, causes of the fact that
there are no coincidence of likely antibody pattern and
reasons why the judgement cannot be possible are displayed
(steps ST1135 and ST1136). The sequences from the step ST1134
and from the step ST1136 shift to the step ST1137 where the
result of antibody identification is stored and the whole
procedure is terminated.
[0026]
Fig. 13 is a figure showing a window where antibody
identification is performed referring to antigen profile
(antigram (trademark)) with an elimination method. As shown in
the lower portion of the figure, antibodies whose existence is
considered to be likely and antibodies whose existence cannot
be denied are displayed with probability values.
[0027]
Fig. 14 is a figure showing a window where antibody
identification is performed using supplemental reagent red
blood,cells after the antibody identification indicated in
Fig. 13 is completed. As shown in Fig. 14, antibodies whose
existences are considered to be likely and antibodies whose
existences cannot be denied are different from those indicated
in Fig. 13. Further, in the current window indicated in Fig.
14, how the probability of existence of E antibody is
calculated is displayed. Namely, probability of identification
of antibody is calculated based on the mathematical expression
indicated at the bottom line of the current window of Fig. 14.
[0028]
Fig. 15 is a flowchart showing the operations of the ABO
typing which is a test among the blood tests of the step ST906
of Fig. 9. As shown in Fig. 15, it is judged whether the
reaction is normal or abnormal for each of the forward test
and backward test of the ABO typing test (steps ST1501, ST1502
and ST1503). Further, it is judged whether the result of the
forward test and the result of the backward test are
coincident or not for all combinations of the tests (steps
ST1504 to ST1507). The forward test is defined to be a test of
patient's blood cells. Namely, in the forward test, anti-A
serum (B type serum) and anti-B serum (A type serum) are used
for determining the existence of A antigen and B antigen on
the surfaces of the blood cells of the patient. The backward
test is defined to be a test of patient's serum. Namely, in
the backward test, standard A type red blood cells and
standard B type red blood cells are used for determining the
existenue of anti-A and anti-B antibodies included in the
patient's serum (step ST1508). Only when both the forward test
and the backward test show a normal reaction and the result of
the forward test is identical to that of the backward test,
the judgement of ABO typing becomes definite (step ST1508). On
the other hand, when the result of the forward test is not
identical to that of the backward test, the judgement is
suspended (steps ST1509 and ST1511) and major causes of
inconsistency of the forward test and backward test are
displayed (step ST1513). At least one of the forward test and
backward test does not show a normal reaction although the
results of the forward test and backward test are consistent,
the result is decided to be provisional (steps ST1510 and
ST1512) and major causes of the fact that an abnormal reaction
occurs are displayed (step ST1514).
[0029]
Fig. 16 is a flowchart showing operations of the
judgement of the Rho (D) test which is a test among the blood
tests of the step ST906 of Fig. 9. In this test, blood having
D antigen is classified as Rh(+) and blood not having D
antigen is classified as Rh(-). As shown in Fig. 16, when the
reaction of the anti-D column of the reagent cassette shows
positive (step ST1601), the reaction is strongly positive
(step ST1602) and the reaction of the control column is
negative (step ST1603), the test of Rho (D) is decided to be
positive (step ST1604) However, when strongly positive
reaction is not: obtained at the step ST1602 and the reaction
of the control column shows negative (step ST1605), the
judgement of the test is decided to be provisionally positive
(step ST1605) and major causes of the fact that a weak
reaction occurs (step ST1607). When the reaction of the anti-D
column shows negative (step ST1601) and the reaction of the
control column shows negative (step ST1608), the judgement of
this test is decided to be provisionally negative (step
ST1609), necessity of performing Du test is displayed (step
ST1610) and the sequence shifts to step ST1607 where major
causes of the fact that a weak reaction occurs are displayed.
When the reaction of control column shows positive at the
steps ST1603, ST1605 and ST1608, the judgement of the Rho (D)
test is decided to be impossible (step ST1611) and major
causes of the fact that a reaction of the control column
(autologous control) shows positive are displayed (step
ST1612).
[0030]
Fig. 17 is a flowchart showing the operations of the
judgement of the Rh-hr test which is a test among the blood
tests of the step ST906 of Fig. 9. When the reaction of the
Rh-hr test column shows normal (step ST1701 ) and the reaction
of the control column shows negative (step ST1702), the
judgement of the Rh-hr test is decided to be definite (step
ST1703) and Rh phenotype and blood type ratio appeared among
Japanese are displayed (step ST1704). When the reaction of the
Rh-hr /test column does not show normal and the reaction of the
control column shows negative (step ST1705), the result of the
Rh-hr test is decided to be provisional (step ST1706) and
provisional Rh phenotype is displayed (step ST1707) with major
causes of the fact that a weak reaction occurs (step ST1708).
When the reaction of the control column shows positive at the
steps ST1702 or ST1705, judgement of result of the Rh-hr test
is decided to be impossible (steps ST1709 and ST1710) and
major causes of the fact that reaction of the control column
(autologous control) shows positive are displayed (step
ST1711).
[0031]
Fig. 18 is a flowchart showing the operations of the
judgement of the Direct Anti-globulin Test (DAT) which is a
test among the blood tests of the step ST905 of Fig. 9. The
direct anti-globulin test is a test for determining whether
antigen-antibody reaction has occurred inside a patient's body
or not. When the reaction of the column of the reagent
cassette showt.i positive (step ST1801), the reaction of the
control column is taken into consideration. When the reaction
of the control column shows negative (step ST1802), the direct
anti-globulin test is decided to be positive (step ST1803).
Thereafter, a warning to carry out an elution test is
displayed (step ST1804). When the test is to be terminated
(step ST1805), the sequence shifts back to the main menu. When
the test should continue, the sequence shifts to the step
ST1801. When the reaction of the control column shows positive
at the step ST1802, the judgement of the result of the test is
suspended (step ST1806). Thereafter, at least one of a test
using polyspecific coombs serum and a test using IgG coombs
serum shows positive (step ST1807), the sequence shifts to
step ST1804 and a warning to carry out an elution test is
displayed. When both of the test using polyspecific coombs
serum and the test using IgG coombs serum show negative, the
sequence shifts to the step ST1805 where it is decided whether
DAT should be terminated or not. On the other hand, when the
reaction of the column of the reagent cassette shows negative
at step ST1801, the reaction of the control column is taken
inot consideration. When the reaction of the control column
shows nagative (step ST1808), the direct anti-globulin test is
decided to be negative (step ST1809) and the sequence shifts
to the step ST1805. On the other hand, when the reaction of
the control column shows positive at the step ST1808, the
judgement of the result of the direct anti-globulin test is
suspended (step ST1810), major causes of the fact that
reaction of the control column shows positive are displayed
(step ST1811) and the sequence shifts to the step ST1805.
[0032]
In order to determine whether the antigen-antibody
reaction has occurred in the past or it is occurring now, a
monospecific cassette and polyspecific cassette are used.
Fig. 19 is a flowchart showing the operations of the
judgement of the cross-matching test which is selected at the
cross-matching and irregular antibody dialog window displayed
at step ST911 of Fig. 9. The cross-matching test is a test for
determining whether agglutination occurs or not by causing an
antigen-antibody reaction in a cassette, which could occur
inside a patient's body when blood for transfusion and
patient's blood are mixed.
[0034]
At first, it is determined whether there is a control
(autologous control) or not in this cross-matching test (step
ST1901). This is previously set by the configuration of the
program run at the facility station 200a. When there is an
autologous control and a main test shows positive (step
ST1902), the result of the autologous control is taken into
consideration. When the result of the autologous control shows
positive (step ST1903), causes of the fact that the result of
the autologous control shows positive are displayed (step
ST1904) and the sequence shifts back to the main menu. When
the result of the autologous control shows negative at the
step ST1903, the whole procedure is terminated directly and
the sequence shifts back to the main menu. Further, the result
of the main test shows negative and the result of the
autologous control shows positive (step ST1905), the sequence
shifts to the step ST1904 and causes of the fact that the
result of the control shows positive are displayed. When the
result of the control shows negative at the step ST1905, the
sentence meaning that the accuracy of the cross-matching test
is limited is displayed (step ST1906), a certificate of cross-
matching test is printed out by the printer 202a of the
facility station 200a (step ST1907), the whole procedure is
terminated and the sequence shifts back to the main menu. On
the other hand, when there is not an autologous control at
step ST1901, if the result of the main test shows positive
(step ST1908), the whole procedure is terminated, and if the
result shows negative, the sequence shifts to step ST1906, the
sentence meaning that the accuracy of the cross-matching test
is limited is displayed and a certificate of the cross-
matching test is printed out (step ST1907).
[0035]
Fig. 20 is a flowchart showing the operations of the
judgement of the irregular antibody test which is selected at
the cross-matching and irregular antibody dialog window
displayed at step ST911 of Fig. 9. The irregular antibody test
(screening) is a test for detecting antibodies included in the
serum of the blood of a donor, a patient and a pregnant woman,
in advance at a high sensitivity, which may cause transfusion
side effects and neonate laky blood illness by using O type
red blood cells whose antigen profile has already been known.
Whether agglutination occurs or not is investigated using the
reagent red blood cells and patient's serum. When
agglutination occurs, identification of the antibody is
At first, it is determined whether there is an autologous
control or not in this irregular antibody test (step ST2001).
This is previously set by the configuration - of the program run
at the facility station 200a. When there is an autologous
control and a main test shows positive (step ST2002), the
result of the autologous control is taken into consideration.
When the result of the autologous control shows positive (step
ST2003), causes of the fact that the result of the autologous
control shows positive are displayed (step ST2004).
Thereafter, the instruction to carry out an elution
identification test is displayed (step ST2005), the whole
procedure is terminated and the sequence shifts back to the
main menu. When the result of the autologous control shows
negative at step ST2003, the instruction to carry out an
antibody identification procedure is displayed (step ST2006)
and the sequence shifts back to the main menu. Further, the
result of the main test shows negative at step ST2002 and the
result of the autologous control shows positive (step ST2007),
the sequence shifts to the step ST2004 where causes of the
fact that the result of the autologous control shows positive
are displayed. When the result of the autologous control shows
negative at step ST2007, a sentence meaning that there is a
possibility of pseudo-positive is displayed (step ST2008), the
V7hole procedure is terminated and the sequence shifts back to
the mein menu. On the other hand, when there is not an
autologous control at step ST2001 and the result of the main
test shows positive (step ST2009), an instruction to carry out
an antibody identification procedure is displayed (step
ST2010), ..the whole procedure is terminated and the sequence
shifts back to the main menu. When the result shows negative
at step ST2009, the sequence shifts to step ST2008 where the
possibility of pseudo-negative is displayed.
[0037]
[Effect of the Invention]
As explained above, in this invention, the antigen
profile information of the reagent red blood cells is
transferred to a local station installed at a facility such as
a hospital via a data transmission line. Analysis to the
result of the blood transfusion test is performed based on the
received antigen profile. Therefore, objective judgement of
the adaptability of the blood transfusion can be performed
accurately.
[Brief Description of the Drawings]
[Fig. 1]
A figure showing the structure of the blood transfusion
test system according to the embodiment of the present
invention.
[Fig. 2]
An illustrative figure showing the operations of the
distribution of the reagent red blood cells or reagent
cassettes to each of the facilities and the transferring of
antigen profile information of the reagent red blood cells and
reagent cassettes.
[Fig. 3]
A figure illustrating the operations of the facility
station.
[Fig. 4]
A figure showing an outlook of an example of a reagent
cassette.
[Fig. 5]
A figure showing an outlook of an example of a reagent
cassette.
[Fig. 6]
A flowchart showing the operations at the time of the
initiation.
[Fig. 7]
A flowchart showing the detailed operations of reception
of blood cells.
[Fig. 8]
A flowchart showing the detailed operations of reception
of specimens.
[Fig. 9]
A flowchart showing the detailed operations of input of
results of specimens.
[Fig. 10]
A figure showing a window for inputting results of
speciment tests.
[Fig. 11]
A flowchart showing the operations of antibody
identification procedure.
[Fig. 12]
A flowchart which follows the Fig. 11, showing the
operations of antibody identification procedure.
[Fig. 13]
A figure showing a window where antibody identification is
performed referring to antigen profile with an elimination
method.
[Fig. 14]
A figure showing a window where antibody identification is
performed using supplemental reagent red blood cells after the
antibody identification indicated in Fig. 13 is completed.
[Fig. 15]
A flowchart showing the operations of the ABO typing.
[Fig. 16]
A flowchart showing the operations of the judgement of the
Rho (D) test.
[Fig. 17]
A flowchart showing the operations of the judgement of the
Rh-hr test.
[Fig. 18]
A flowchart showing the operations of the judgement of the
direct anti-globulin test.
['Fig. 19]
A flowchart: showing the operations of the judgement of the
cross-matching test.
[Fig. 20]
A flowchart showing the operations of the judgement of the
irregular antibody test.
[Explanation of reference symbols]
100 center station
110 host computer
150, 204a modem
200a facility station
201a terminal station
203a bar code reader
205a image processing apparatus
300 public telephone line
400, 500 reagent cassette
401, 402, 403, 404, 405, 406, 501, 502, 503,
504, 505, 506 column
410, 510 bar code (data area)
[Document Name] Specification
[Tile of the Invention] Blood Transfusion Test Analyzing
System and Method For Analyzing Blood Transfusion Test
[Scope of the-.Invention]
[Claim 1] A blood transfusion test analyzing system
comprising a center station having an antigen profile
information of reagent red blood cells and a local station
installed at a facility where a blood transfusion test is
performed by using said reagent red blood cells, said local
station being connected to said center station via a data
transmission line;
wherein said center station includes antigen profile
information inputting means for inputting antigen profile
information of reagent red blood cells to be distributed to
said facility and an antigen profile information transferring
means for transferring the input antigen profile information
to said local station via said data transmission line; and
wherein said local station includes an antigen profile
information receiving means for receiving the antigen profile
information transferred from said center station, a storing
means for storing the antigen profile information received by
said antigen profile information receiving means, a blood
transfusion test result inputting means for inputting a result
of a blood transfusion test performed by using said reagent
red blood cells and a blood transfusion test analyzing means
for analyzing said blood transfusion test based on said jcesult
of Said blood transfusion test and the antigen profile
information stored in said storing means.
[Claim 2] A blood transfusion test analyzing system
according to claim 1, wherein said blood transfusion test is
performed by using at least one reagent cassette having a
plurality of columns, at least one of which includes reagent.
[Claim 3] A blood transfusion test analyzing system
according to claim 2, wherein said blood transfusion test
result inputting means inputs a state of agglutination in said
plurality of columns in a case where said reagent red blood
cells and serum to be examined are put in said plurality of
columns, and wherein said blood transfusion test analyzing
means includes antibody identification means which identifies
an antibody included in said serum to be examined based on
said antigen profile information and said state of said
agglutination and displays an identified antibody.
[Claim 4] A blood transfusion test analyzing system
according to claim 3, wherein said antibody identification
means includes probability calculating means which calculates
an existence probability of said identified antibody and an
existence probability of an antibody whose existence cannot be
denied based on said antigen profile information and said
state of said agglutination, and displays said existence
probabilities.
[Claim 5] A blood transfusion test analyzing system
according to claim 3 or 4, wherein said antibody
identification means includes appropriate reagent red blood
cell specifying means which specifies appropriate reagent red
blood cells to be used in a supplemental blood transfusion
test based on said antigen profile information in a case where
there remains an antibody whose existence cannot be denied as
a result of an execution of antibody identification.
[Claim 6] A blood transfusion test analyzing system
according to any one of claims 1 to 5, wherein said local
station includes abnormality cause data base in which abnormal
patters of a result of an analysis performed by said blood
transfusion test analyzing means and possible causes of said
abnormal patterns are stored with relationship between said
abnor-mal patterns and said possible causes, and wherein said
blood transfusion test analyzing means includes abnormality
cause displaying means which displays a possible cause or
possible causes for an abnormality by referring to said
abnormality cause data base when a result of said blood
transfusion test shows said abnormality.
[Claim 7; A blood transfusion test analyzing system
ciccording to any one of claims 2 to 5, wherein said blood
transfusion test result inputting means inputs a state of
agglutination in at least one of said plurality of columns of
said reagent cassette in a case where serum of a recipient who
receives blood in blood transfusion and donated blood cells
are put in said at least one of said plurality of columns,
v7herGin said blood transfusion test analyzing means makes a
judgement of a result of a cross-matching test based on said
state of said agglutination input by said blood transfusion
test result inputting means, and wherein said local station
includes printing means for printing a certificate of said
cross-matching test when said judgement shows adaptability of
said cross-matching test.
[Claim 8] A blood transfusion test analyzing system
according to any one of claims 2 to 5 and 7, wherein said
reagent cassette includes a data area in which an reagent
cassette ID for specifying said reagent cassette, and wherein
said local station includes: a reagent cassette information
data base in which information concerning reagent cassettes is
stored with reagent cassette IDs of reagent cassettes which
are used in a blood transfusion test; a blood recipient
information data base in which information concerning blood
recipients is stored with recipient IDs for specifying
recipients who receive blood in blood transfusion; a specimen
data base in which information concerning specimens used for
said blood transfusion test; and data base retrieving means
for retrieving said data bases.
[Claim 9] A blood transfusion test analyzing system
according to any one of claims 1 to 8, wherein said blood
transfusion test result inputting means inputs a state of
agglutination between anti-serum and blood cells to be
examined, and wherein said blood transfusion test analyzing
means judges a blood type of said blood cells to be examined
based on said state of said agglutination.
[Claim 10] A blood transfusion test analyzing system
according to any one of claims 2 to 5 and 7 to 9, wherein said
blood transfusion test inputting means includes: image
inputting means for inputting an image of said plurality of
columns of said reagent cassette; and test result decision
means for deciding a result of a test based on an image input
by said image inputting means.
[Claim 11] A method for analyzing a blood transfusion
test using reagent red blood cells, comprising the steps of:
transmitting antigen profile information concerning said
reagent red blood cells from a center station having said
antigen profile information to a local station installed at a
blood transfusion test facility via a data transmission line;
receiving said antigen profile information at said local
station via said data transmission line;
carrying out a blood transfusion test at said blood
transfusion test facility using said reagent red blood cells;
and
analyzing said blood transfusion test at said local
station based on said antigen profile information received by
said local station and a result of said blood transfusion
test.
[Claim 12] A method for analyzing a blood transfusion
test according to claim 11, further comprising the steps of:
storing said antigen profile information in a computer
readable recording medium at a center station;
sending said computer readable recording medium to said
local station;
analyzing said blood transfusion test at said local
station based on said antigen profile information stored
in said computer readable recording medium when said data
transmission line cannot be used.

A blood transfusion test analyzing system
comprises a center station and a local station installed at a
blood transfusion test facility which is connected to the
center station via a data transmission line. The center
station includes antigen profile information inputting means
for inputting antigen profile information of reagent red blood
cells to be distributed to the facility and an antigen profile
data transferring means for transferring the input antigen
profile information to the local station via the data
transmission line. The local station includes an antigen
profile information receiving means for receiving the antigen
profile information transferred from the center station, a
storing means for storing the antigen profile information
received by the antigen profile information receiving means, a
blood transfusion test result inputting means for inputting a
result of a blood transfusion test performed by using the
reagent red blood cells and a blood transfusion test analyzing
means for analyzing the blood transfusion test based on the
result of the blood transfusion test and the antigen profile
information stored in the storing means.

Documents:

512-cal-1997-abstract.pdf

512-cal-1997-claims.pdf

512-cal-1997-correspondence.pdf

512-cal-1997-description (complete).pdf

512-cal-1997-drawings.pdf

512-cal-1997-form 1.pdf

512-cal-1997-form 2.pdf

512-cal-1997-form 3.pdf

512-cal-1997-form 5.pdf

512-cal-1997-specification.pdf

512-cal-1997_abandoned_letter.pdf


Patent Number 184250
Indian Patent Application Number 512/CAL/1997
PG Journal Number 30/2009
Publication Date 24-Jul-2009
Grant Date 02-Feb-2001
Date of Filing 21-Mar-1997
Name of Patentee ORTHO-CLINICAL DIAGNOSTICS K.K.
Applicant Address 6-3-2, TOYO-CHO, KOTO-KU, TOKYO
Inventors:
# Inventor's Name Inventor's Address
1 MITSUAKI KOSUGI 1666, OAZA MINAMI YOSHIMI, YOSHIMI-CHO, HIKI-GUN, SAITAMA
2 TAKASHI FURUBOU 5-24-18, MATSUGAOKA, TSURUGASHIMA-SHI, SAITAMA
3 HITOSHI SUGIOKA 4-5-15-505, CHUOU, EDOGAWA-KU, TOKYO
4 CHARLES DAVID JONES CORPORATE CENTRE, CITY OF INDIAN POLIS, STATE OF INDIANA, UNITED STATES OF AMERICA.
5 ALAN DAVID PALKOWITZ CORPORATE CENTRE, CITY OF INDIAN POLIS, STATE OF INDIANA, UNITED STATES OF AMERICA.
PCT International Classification Number N/A
PCT International Application Number N/A
PCT International Filing date
PCT Conventions:
# PCT Application Number Date of Convention Priority Country
1 104110/96 1996-03-29 Japan