WO1997037231A1

WO1997037231A1 - Blood transfusion test analyzing system and method for analyzing blood transfusion test

Info

Publication number: WO1997037231A1
Application number: PCT/JP1997/001130
Authority: WO
Inventors: Mitsuaki Kosugi; Takashi Furubou; Hitoshi Sugioka
Original assignee: Ortho-Clinical Diagnostics Kabushiki Kaisha
Priority date: 1996-03-29
Filing date: 1997-03-31
Publication date: 1997-10-09
Also published as: JP3466815B2; JPH09269324A; AU2177397A

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 unit for inputting antigen profile information of reagent red blood cells to be distributed to the facility and an antigen profile data transferring unit 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 unit for receiving the antigen profile information transferred from the center station, a storing unit for storing the antigen profile information received by the antigen profile information receiving unit, a blood transfusion test result inputting unit for inputting a result of a blood transfusion test performed by using the reagent red blood cells and a blood transfusion test analyzing unit for analyzing the blood transfusion test based on the result of the blood transfusion test and the antigen profile information stored in the storing unit.

Description

DESCRIPTION

Blood Transfusion Test Analyzing System and Method For Analyzing Blood Transfusion Test

Technical Field

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.

Background 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.

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. 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. Further, 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.

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.

Disclosure of Invention

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.

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.

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.

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 Drawings

Fig. 1 is a figure showing the structure of the blood transfusion test system according to the embodiment of the present invention.

Fig. 2 is 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 is a figure illustrating the operations of the facility station. Fig. 4 is a figure showing an outlook of an example of a reagent cassette.

Fig. 5 is a figure showing an outlook of an example of a reagent cassette. Fig. 6 is a flowchart showing the operations at the time of the initiation.

Fig. 7 is a flowchart showing the detailed operations of reception of blood cells.

Fig. 8 is a flowchart showing the detailed operations of reception of specimens.

Fig. 9 is a flowchart showing the detailed operations of input of results of specimens.

Fig. 10 is a figure showing a window for inputting results of specimen tests. Fig. 11 is a flowchart showing the operations of antibody identification procedure.

Fig. 12 is a flowchart which follows the Fig. 11, showing the operations of antibody identification procedure. Fig. 13 is a figure showing a window where antibody identification is performed referring to antigen profile with an elimination method.

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.

Fig. 15 is a flowchart showing the operations of the ABO typing .

Fig. 16 is a flowchart showing the operations of the judgement of the Rho (D) test.

Fig. 17 is a flowchart showing the operations of the judgement of the Rh-hr test.

Fig. 18 is a flowchart showing the operations of the judgement of the direct anti-globulin test.

Fig. 19 is a flowchart showing the operations of the judgement of the cross-matching test. Fig. 20 is a flowchart showing the operations of the judgement of the irregular antibody test.

Best Mode for Carrying Out the 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.

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.

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 of 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.

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 which 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. 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.

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 centrifugal 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.

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-C_3b serum and anti- C_3d 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 cells 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. 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 401 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. 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) . When 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.

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 ) .

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. 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.

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 ST1101) 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 ST1110).

Next, when "continue" is selected (step ST1111), 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) 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).

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.

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.

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.

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 existence 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).

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 ST1606) 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). 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).

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 ST906 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 shows 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. 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.

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).

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 0 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 performed.

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 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 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.

Industrial Applicability

This invention may be applied 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.

Claims

CLAIMS 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 result of said blood transfusion test and the antigen profile information stored in said storing means.

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.

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.

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.

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.

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 abnormal 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.

7. A blood transfusion test analyzing system according 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, wherein 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.

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.

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.

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.

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.

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.