JPH0323868B2 - - Google Patents

Description

[Detailed description of the invention]

The present invention performs RH blood type determination (RH) on test blood used for blood transfusions based on immunological agglutination reaction.
Tests such as ABO blood type determination (ABO), antibody screening determination (IRA), HB antigen determination (HB), syphilis antibody determination (SYP), etc. are performed, and if an abnormality is detected in any of the above determination items. A blood analysis system that automatically determines a sample as an abnormal sample, automatically attaches an abnormal sample mark to the judgment result for each sample, and outputs it to an output device such as a printer, along with the overall judgment result for each of the above judgment items. This invention relates to an automatic determination and display method for abnormal samples. Conventional blood transfusion testing equipment outputs test results to an output device such as a printer, but it is not possible to determine at a glance which specimens are unsuitable for transfusion (hereinafter referred to as abnormal specimens), and all specimens are sent for retesting. Humans had to visually follow and judge the test results while they were being charted. FIG. 1 shows a part of a chart in which test results of such a conventional specimen are output and displayed. As shown in the chart of FIG. 1, in the conventional chart display method, the more the number of test items and the number of specimens to be tested, the more labor-intensive and tiring the work was. A chart with normal judgment results printed as shown in Figure 1 is
Sample No. (S.NO), identification code number (ID), inspection results for each channel CH (1 to 12), judgment items for each channel CH (1 to 12) (RH, ABO,
For example, based on the judgment results of IRA, HB, SYP)
CH ₁ and CH ₂ are RH blood type, CH ₃ ~ _{CH 6} are ABO
Blood type, CH ₇ , CH ₈ is antibody screening test (IRA), CH ₉ , CH ₁₀ is syphilis antibody test (SYP),
CH ₁₁ and CH ₁₂ are assigned as HB antigen test (HB), and the overall judgment is RH, ABO, IRA, SYP, HB will decide. In this way, it is impossible to tell at a glance which samples are normal and which are abnormal just by displaying (+), (-), and (?), which requires a lot of effort, time, and fatigue for the operator. It will force you to In addition, humans are prone to make many mistakes when making judgments like this, and an abnormal situation may occur in which an abnormal sample is transfused as a normal sample. The present invention eliminates such human judgment as much as possible, and allows an automatic discriminator such as a computer with few errors to automatically judge whether a sample is normal or abnormal, and performs sample processing to distinguish abnormal samples. The aim is to provide an automatic judgment display method for abnormal samples by attaching and displaying an abnormal sample mark on a comprehensive judgment chart, and to perform the judgment of abnormal samples in an extremely short time and to reduce the large amount of labor required for the judgment. be. The object of the present invention is to dispense specimens collected from the same subject into a plurality of predetermined channels formed in a microplate, and to collect the aggregates formed on the bottom surface of the reaction vessel of the microplate by an immunological agglutination reaction. A sample testing method for an automatic analyzer that analyzes blood based on a pattern includes a step of detecting photometric data according to the agglutination state of the sample in the reaction container, and detecting agglutination (+) for each channel based on the photometric data. , non-aggregation (-) and indistinguishability (?), a step of storing and storing the determination results in the channel area of the memory means, and a predetermined inspection of the determination results for each channel stored in the memory means. A step of comprehensively judging the items and storing the results in respective test item areas having memory means, and a step of comprehensively judging the respective test items and among the test items
If an abnormality is detected in either the ABO blood type determination result and the ABO blood type reading result displayed on the identification label attached to the sample container, an abnormal sample mark will be added to the sample determination chart. The present invention provides a method for automatically determining and displaying an abnormal sample, which includes a step of automatically outputting and displaying the sample in a predetermined area. An embodiment of the present invention will be described in detail below with reference to the drawings. First, to explain how transfused blood sample testing is performed, the sample to be determined is collected from the general public, a portion of it is separated for testing, an anticoagulant is added to it, and it is centrifuged vigorously. The specimen in tube 1 can be roughly divided into plasma 2 as shown in Figure 2.
It separates into two layers: and blood cells 3. The centrifuged plasma 2 and blood cells 3 are each tested using the apparatus shown in FIG. FIG. 3 shows an example of an automatic judgment display device for abnormal specimens applied to the present invention. In FIG. 3, numeral 4 is a microplate in which a large number of containers consisting of a large number of depressions are arranged in parallel for each channel, 5 is a light source lamp, 6 is a photoelectric converter, 7 is an amplifier, 8 is an A/D converter, and 9 is a computer, 1
0 indicates a memory circuit, and 11 indicates an output circuit such as a printer. Microplate 4 in Fig. 3 has 12 channels of reaction vessels CH ₁ , CH ₂ , CH ₃ to CH ₆ , CH ₇ , CH ₈ ,
CH ₉ , CH ₁₀ , CH ₁₁ , CH ₁₂ are provided, and the reaction vessel CH ₁
and RH blood type determination (RH) sample for CH ₂ ,
In addition, samples for ABO blood grouping (ABO) were placed in reaction vessels CH ₃ to _{CH 6} , and samples for antibody screening assessment (IRA) were placed in CH ₇ and CH ₈ .
Samples for HB antigen determination (HB) are placed in CH ₉ and CH ₁₀ , and syphilis antibody determination (SYP) is placed in reaction vessels CH ₁₁ and CH ₁₂ .
A sample for use shall be included. Table 1 shows the relationship between the judgment items of the specimen, the reaction container, the sample, the first reagent, and the second reagent.

【table】

[Table] FIG. 3 is a circuit system diagram showing an outline of photometry of a specimen and transmission of signals to a computer. In the sample test, the plasma 2 and blood cells 3 are transferred to a microplate 4, which has a container consisting of many depressions arranged in parallel for each channel, and a specific reagent is mixed therein, and after a certain period of time, the reaction is determined whether it is agglutination (+) or not. It is determined whether it is non-agglomerated (-) or indistinguishable (?) and sent to the computer 9 and stored. The above-mentioned test solution and reagent are placed in the reaction containers in each depression of the microplate 4, and a pattern of aggregation or non-aggregation is formed after a predetermined time. The pattern for each reaction container is read by a mechanism (not shown) in which the lamp 5 and the photoelectric converter 6 are integrally held and transported laterally.
The output of the photoelectric conversion 6 is input to an A/D converter 8 via an amplifier 7, which converts the analog value into a digital value and inputs it to a computer 9. -) for each channel. The judgment results for each channel are stored together with sample numbers, identification code numbers, etc. in a memory circuit 10 connected to a computer for judgment results for each channel. FIG. 4 shows the details of the circuit system diagram in FIG. 3, and the microplate 4 has sample detection circuits for channels CH ₁ to CH ₁₂ shown in Table 1 above.
As mentioned above, the photoelectric converter, which is a combination of a light emitting lamp and a light receiver, is held together and can be scanned by a lateral feed mechanism for each channel.
The light transmitted through the specimen contained in each reaction container is photoelectrically converted and sent as an electric signal to the amplifier 7 via the next delay circuit 12, where it is amplified. Since the scanning time interval of each channel is about 4 to 5 seconds, the delay time is set to an interval of about 4 to 5 seconds. Since the electrical signal amplified by the amplifier 7 is an analog signal, it cannot be input to a computer or an automatic determination circuit as it is. For this purpose, the output signal from the amplifier 7 is converted into an analog-to-digital signal through the A/D converter 8, and is input to the photometric data latch circuit 13 of the computer 9, where it is stored in memory so as to be held. This computer 9 has reference upper limit data output means 14 and reference lower limit data output means 15, and their latches 14' and
A reference upper limit data signal and a reference lower limit data signal are each held at 15'. 16 and 17 are comparison circuits, and the comparison circuit 16 compares the photometric data signal of each channel with the reference upper limit data signal, and displays when the level is higher than the reference upper limit data signal, and displays when the level is lower than the reference upper limit data signal. Displays when the level is reached. The other comparison circuit 17 compares the photometric data signal and the reference lower limit data signal, and displays when the level is lower than the reference lower limit data signal and when it is at a higher level. The symbol indicates when the blood coagulates, and the symbol indicates when the blood does not coagulate. Therefore, when the answers of both the comparison circuits 16 and 17 are , the answer of the judgment circuit 18 means that the plasma is aggregated. When the answer of the judgment circuit 18 is lower than the level of the reference upper limit data signal and higher than the level of the reference lower limit data signal, the answer of the judgment becomes ◯? is displayed. The judgment results of these judgment circuits are respectively or ○? Memory circuit 19 for the next judgment result
are stored in each channel (CH ₁ to _{CH 12} ). Figure 4A schematically shows the judgment results in Figure 4. When the level of the photometric data signal is higher than the upper limit level (HL) of the upper limit data signal of the reference upper limit data signal, it is expressed as , and this is lower than the upper limit level. Time is expressed in . Also, when this is lower than the lower limit level (LL) of the reference lower limit data signal, it is displayed as agglomeration, and when it is higher, it is displayed as
Is it non-agglomerated or undeterminable○? It turns out that. Figure 5A shows the specified area of memory (RH, ABO,
This figure shows an example of a circuit that stores data in memory (IRA, SYP, HB), and for the sake of simplicity, the blood type (ABO) determination circuit will be explained. 19 is a memory circuit for the judgment results, ○? for each channel CH ₃ to _{CH 6} . The judgment results are stored in memory. The respective outputs of the memory circuit 19 as a result of this judgment are combined with the AND circuits 26 to 29, and the judgment is not possible ○? For mark judgment
When the blood is input to the OR circuit 21, the combination of symbols as a result of the determination as shown in FIG.
Type, B type, AB type, O type, or undetermined ○? I can tell. In Figure 5B, for example (01000) is type A,
(00100) is type B, (00010) is type AB, (00001) is type O, and (1××××) cannot be determined? It is read as a case of . In the conventional specimen test chart shown in Figure 1, the operator traces combinations of symbols such as (01000) or (00100) with his or her eyes and reads out which specimen is an abnormal specimen from the specimen test chart. This can easily cause fatigue, and it takes a relatively long time, so it may not be possible to make it in time if an emergency blood transfusion is requested. In order to improve the above-mentioned points, the present invention provides blood transfusion by directly displaying an abnormal specimen mark by printing or stamping on the specimen test chart to indicate that the specimen is an abnormal specimen when an abnormal specimen is detected. It is possible to instantly and automatically determine whether or not the blood is suitable for use. In Figure 6, 30 is blood type A, type B,
ABO with AB type and O type memories
Blood type memory circuit, 31 is a memory circuit for RH blood type determination results, 32 is a memory circuit for antibody screening (IRA) determination results, 33 is a memory circuit for antigen determination (HB) results, 34 is syphilis antibody determination (SYP) Memory circuit for the results, 35 is a blood type memory circuit for the barcode on the label attached to the material container, 36 is undeterminable ○? The memory circuit of the judgment result is shown. 37 is a phase inversion circuit provided on the output side of the memory circuit 31 for the comprehensive judgment result of RH blood type; 38-A, 38-B, 38-AB, 38-O;
is an exclusive OR circuit connected in parallel to each output side of the memory circuit for the ABO blood type determination result and the memory circuit for the barcode blood type determination result, respectively.
Reference numeral 9 indicates an OR circuit for detecting an abnormal sample, and 40 indicates a memory circuit for an abnormal sample mark connected to the output side of the OR circuit 39. Reference numeral 41 indicates an abnormal sample detection circuit that integrates these components, 42 an information format conversion circuit, 43 a printer, and 44 an abnormal sample display output circuit that integrates these components. FIG. 8 is a system diagram showing an overview of the processing of the sample testing apparatus applied to the present invention, and is used to explain the operation of the determination circuits shown in FIGS. 4, 5, and 6. FIG. 7 shows an example of a chart for abnormal sample determination applied to the present invention, and the chart for each sample includes a sample number storage column 46, an identification code (ID) storage column 47,
Judgment result storage column for each channel CH ₁ to _{CH 12} ,
Comprehensive judgment result storage column (RH, ABO, IRA, SYP,
HD) is provided. +, -, ? for storage in memory? etc., but the code is not particularly specified and may be an ASCII code or bits such as 1, 0/ corresponding to +, -, etc. The sample number in FIG. 7 is a number that is automatically assigned each time the device receives a sample, and is stored in a designated memory area when a sample is received. In addition, the identification code storage column ID is obtained by reading the barcode affixed to the sample test tube using a barcode reader installed separately in the device, and when the barcode is read, it is stored in the specified memory area. Stored. In the sample testing system diagram shown in Figure 8, the sample number or identification code number of the sample that has arrived at the photometry position.
The ID is uniquely determined from the device sequence.
Therefore, the data sampled by the photoelectric converter is A/D converted as shown in FIG. 4, and according to the predetermined determination processing method shown in FIGS.
○? The designated memory area (CH ₁ in Figure 7) where the sample number or identification number matches has been determined.
- memory area corresponding to CH ₁₂ ). Then CH ₁ ~ CH ₁₂ ,,○? The overall judgment results of RH blood type, ABO blood type, antibody screening test (IRA), syphilis antibody test (SYP), and HB antigen test are determined by the combination of are stored in each storage area. This information is collectively converted to a format conversion means (Fig. 6, 4) for each sample.
2) and is outputted by the printer 43 as shown in FIG. Next, based on the determination results obtained above, abnormal sample processing as shown in FIG. 6 is performed. The abnormal specimen processing here refers to a specimen unsuitable for blood transfusion, and the following processing is performed. Check the information in the memory area for each sample (1) Samples for which there is an undeterminable (?) item or channel (CH) in the judgment result (2) Samples for which the RH blood type is determined to be (-) ( 3) Samples for which the antibody screening test was determined to be (-) (4) Samples for which the HB antigen test was determined to be (+) (5) Samples for which the syphilis antibody test was determined to be (+) (6) Samples for which it was determined that there was no sample necessary for testing (7) Samples for which the identification code ID could not be read by the barcode reader (8) Samples for which the ABO blood type determination result and the determination result obtained from the ID do not match An abnormal sample mark is written in the memory area corresponding to the abnormal sample mark area 48 in Figure 7. This allows the sample information to be outputted by subsequent printer output, etc., and displayed on the record chart. is shown in Fig. 7, and the abnormal specimen mark 48
By adding (*), abnormal samples can be identified at a glance, which saves time, effort, fatigue, etc. for humans searching for abnormal samples later, and also reduces errors. The reason why items (1) to (8) above are treated as abnormal specimens will be explained below. (1) There are two main reasons for the presence of undeterminable (?) in the determination results. The first is that the sample may not be dispensed due to an abnormality in the mechanism of the analyzer, and there may be positional deviations in optical reading.
Although it is extremely rare because it is human blood, there may be people with blood type B who are close to type A, and the titer weakens as the sample gets older, so even if it is an agglutination, it may be a semi-aggregation. By creating patterns. (2) There are rare people whose RH blood type is (-). Although this is not abnormal, it is rare and makes the patient ineligible for common RH (+) blood transfusions. (3) tests all blood types other than ABO and RH, which is not desirable because if the person receiving the blood transfusion does not match, symptoms such as a slight fever may occur. Generally, (-) is normal. (4) and (5) are undesirable as transfusion of (+) blood may cause disease transmission. (6) Blood transfusion tests are performed using the blood cells and serum of the sample mentioned above, so a liquid level detection or interface detection mechanism is installed to determine the blood cells and serum and aspirate and test. This mechanism provides information when blood cells or serum levels are absent or low. If the serum or blood cell count is low, there is a possibility that the test was not normal and a retest is necessary. (7) As mentioned above, a barcode label is attached to the sample test tube and is read by a barcode reader, but there are reading errors. If a reading error occurs, it may cause inconvenience when dealing with the name of the person collecting blood later, or it may become impossible to correspond between the judgment result and the blood bag, so it is important to inform the operator. (8) Generally, when blood is collected, a simple procedure is carried out before blood collection.
An ABO type check and an interview will be conducted to find out what blood type the blood sampler has. As a result, A, B, AB,
You will be given a standard barcode label divided into O's and your blood will be drawn. Its general format for barcodes is as follows. (7 digits shown). Here, the type of ABO type in the third digit from the top is determined by the number: 0, 1, 2, 3...A type 4,5,6...O type 7,8...B type 9...AB type There is. Therefore, if a person is found to have type AB blood through a simple check or interview before blood collection, they will be given a barcode label with a 9 in the third digit from the top, and the barcode will be affixed to their blood bag. become. The device then performs a complete blood transfusion test, but if the ABO blood type result does not match the ABO blood type indicated by the third digit from the top of the barcode affixed to the sample test tube ( (a) The blood bag was changed during blood sampling, etc. (b) The blood type was difficult to distinguish in a simple check (c) It is possible that the person collecting the blood did not remember his or her own blood type. In the case of (a), it is necessary to check all the collected blood bags again to make sure there are no mistakes, and in the case of (c), the person must be informed of the exact blood type. Therefore, it is absolutely necessary to clearly mark abnormal specimens in this way. Here, we explained about print output, but
In addition, it may be output to a CRT output, ON-LINE output to a host computer, data communication to a dedicated data processor that edits or corrects data, etc. Further, the present invention may be incorporated into the analyzer main body, or a data processor may be provided separately from the analyzer.
The analyzer and the data processor may be connected and incorporated into the data processor. Further, in this example, an asterisk (*) is used as the abnormal sample mark, but other characters or symbols may be used.
In addition, other marks may be used for liquid level detection abnormality, boundary surface detection abnormality, over or under photometry range, etc. The effects of the present invention are as follows. (1) Abnormal samples can be detected at a glance, eliminating the operator's effort, time, and fatigue of detecting abnormal samples from a row of small letters. (2) Operator errors are reduced, eliminating mistakes such as taking the wrong blood or transfusing incompatible blood.

[Brief explanation of the drawing]

Fig. 1 is a partial diagram showing an example of a conventional sample measurement chart, Fig. 2 is an explanatory diagram showing the state of agglutination of a sample in a centrifuged test tube, and Fig. 3 is an automatic judgment display circuit applied to the present invention. FIG. 4 is a partial detailed circuit diagram of FIG. 3, and shows the data detection of each channel applied to the present invention and the data detection of each channel. FIG. 4A is a diagram schematically showing the determination results, and FIG. 5 is an example circuit layout diagram for storing the determination results in the specified area of the memory circuit. Before storing in the area (RH, ABO, IRA, SYP, HB), the circuit configuration for comprehensive judgment of RH, IRA, SYP, HB is omitted, and the blood type judgment circuit (ABO) is used.
FIG. 6 is a partial circuit layout diagram illustrating only an example of the abnormal sample detection and display circuit diagram applied to the present invention, and FIG.
The figure shows an example of a judgment chart that displays the judgment results according to the method of the present invention, and FIG. 8 is a judgment system diagram of the apparatus to which the present invention is applied. 1...test tube, 2...plasma, 3...blood cells, 4...
...Microplate, 5...Flood lamp, 6...
Photoelectric converter, 7...Amplifier, 8...A/D converter, 9...Computer, 10...Memory circuit, 11...Output circuit for printers, etc., 12...Delay circuit, 13...Photometry data latch circuit , 14...
... Reference upper limit data element, 14'... Reference upper limit latch, 15... Reference lower limit data element, 15'... Reference lower limit latch, 16, 17... Comparison circuit, 18...
...judgment circuit, 19...memory circuit for judgment results,
20...Comprehensive judgment storage circuit, 21...OR circuit for detecting undeterminable state, 22, 23, 24, 25...Phase inversion circuit, 26, 27, 28, 29...ABO
AND circuit for blood type determination, 30...Memory circuit for ABO comprehensive determination result, 31...Memory circuit for RH comprehensive determination result, 32...Memory circuit for antibody screening (IRA) determination result, 33...Antigen determination (HB) ) Result memory circuit, 34...Memory circuit for syphilis antibody determination result, 35...Blood type memory circuit from barcode, 36...Memory circuit for undetermined (?), 37...Phase inversion circuit,
38...Exclusive OR (EXOR) circuit, 39...
...OR circuit for abnormal sample processing, 40...Abnormal sample mark memory circuit, 41...Abnormal sample detection circuit,
42... Information format conversion circuit, 43... Printer, 44... Abnormal sample display output circuit, 45
...Chart for abnormal sample determination, 46...Sample number, 47...Identification code, 48-58...Record column for judgment results for each channel, RH...Record column for RH blood type determination results, ABO... ABO blood type determination result record column, IRA...Antibody screening determination result record column, SYP...Syphilis antibody determination result record column, HB...HB antigen determination result record column, 59...
...Memory circuit for abnormal sample mark.

Claims (1)

[Claims] 1. An automatic system that dispenses specimens collected from the same subject into a plurality of predetermined channels formed in a microplate, and analyzes the blood based on the agglutination pattern formed on the bottom of the reaction container of the microplate through an immunological agglutination reaction. A method for testing a specimen in an analyzer includes a step of detecting photometric data according to the agglutination state of the specimen in the reaction container, and determining agglutination (+), non-aggregation (-), and discrimination for each channel based on the photometry data. A step of determining impossibility (?), a step of storing the determination result in the channel area of the memory means, and a step of comprehensively determining the determination result for each channel stored in the memory means for a predetermined inspection item. The process of storing and memorizing the results in a test item area having a memory means, the comprehensive judgment result of each test item, the ABO blood type determination result among the test items, and the display on the identification label affixed to the sample container. Ta
The feature includes a step of automatically outputting and displaying an abnormal sample mark in a scheduled area of the sample determination chart when an abnormality is detected in any one of the matching ABO blood type reading results. A method for automatically determining and displaying abnormal samples.