CN116507919A - Method for determining blood sample, and determination device and computer program therefor - Google Patents
Method for determining blood sample, and determination device and computer program therefor Download PDFInfo
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- 210000004369 blood Anatomy 0.000 title claims abstract description 303
- 239000008280 blood Substances 0.000 title claims abstract description 303
- 238000000034 method Methods 0.000 title claims description 78
- 238000004590 computer program Methods 0.000 title claims description 21
- 208000007502 anemia Diseases 0.000 claims abstract description 123
- 208000002903 Thalassemia Diseases 0.000 claims abstract description 94
- 230000002757 inflammatory effect Effects 0.000 claims abstract description 61
- 102000008857 Ferritin Human genes 0.000 claims abstract description 46
- 108050000784 Ferritin Proteins 0.000 claims abstract description 46
- 238000008416 Ferritin Methods 0.000 claims abstract description 46
- 210000002966 serum Anatomy 0.000 claims abstract description 42
- 208000015710 Iron-Deficiency Anemia Diseases 0.000 claims abstract description 20
- 238000012360 testing method Methods 0.000 claims description 59
- 108010054147 Hemoglobins Proteins 0.000 claims description 47
- 102000001554 Hemoglobins Human genes 0.000 claims description 47
- 108010074051 C-Reactive Protein Proteins 0.000 claims description 41
- 102100032752 C-reactive protein Human genes 0.000 claims description 41
- 238000007689 inspection Methods 0.000 claims description 25
- 238000009534 blood test Methods 0.000 claims description 17
- 238000005194 fractionation Methods 0.000 claims description 17
- 210000003743 erythrocyte Anatomy 0.000 claims description 15
- 208000003367 Hypopigmentation Diseases 0.000 claims description 3
- 206010027540 Microcytosis Diseases 0.000 claims description 3
- 230000003425 hypopigmentation Effects 0.000 claims description 3
- 238000003752 polymerase chain reaction Methods 0.000 description 30
- 238000005259 measurement Methods 0.000 description 16
- 238000004159 blood analysis Methods 0.000 description 9
- 210000000601 blood cell Anatomy 0.000 description 8
- 238000004820 blood count Methods 0.000 description 8
- 108091005902 Hemoglobin subunit alpha Proteins 0.000 description 6
- 201000010099 disease Diseases 0.000 description 5
- 208000037265 diseases, disorders, signs and symptoms Diseases 0.000 description 5
- 238000003018 immunoassay Methods 0.000 description 5
- 238000003556 assay Methods 0.000 description 3
- 239000003153 chemical reaction reagent Substances 0.000 description 3
- 102000018146 globin Human genes 0.000 description 3
- 108060003196 globin Proteins 0.000 description 3
- 102100027685 Hemoglobin subunit alpha Human genes 0.000 description 2
- XEEYBQQBJWHFJM-UHFFFAOYSA-N Iron Chemical compound [Fe] XEEYBQQBJWHFJM-UHFFFAOYSA-N 0.000 description 2
- 150000001413 amino acids Chemical class 0.000 description 2
- 238000004458 analytical method Methods 0.000 description 2
- 230000015572 biosynthetic process Effects 0.000 description 2
- 230000007812 deficiency Effects 0.000 description 2
- 238000004128 high performance liquid chromatography Methods 0.000 description 2
- 238000011005 laboratory method Methods 0.000 description 2
- 239000004816 latex Substances 0.000 description 2
- 229920000126 latex Polymers 0.000 description 2
- 230000035772 mutation Effects 0.000 description 2
- 208000024891 symptom Diseases 0.000 description 2
- 238000003786 synthesis reaction Methods 0.000 description 2
- 238000004879 turbidimetry Methods 0.000 description 2
- 238000012795 verification Methods 0.000 description 2
- 230000005856 abnormality Effects 0.000 description 1
- 230000004520 agglutination Effects 0.000 description 1
- 238000005251 capillar electrophoresis Methods 0.000 description 1
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- 238000003745 diagnosis Methods 0.000 description 1
- 238000010586 diagram Methods 0.000 description 1
- 230000000694 effects Effects 0.000 description 1
- 230000002068 genetic effect Effects 0.000 description 1
- 238000005534 hematocrit Methods 0.000 description 1
- 229910052742 iron Inorganic materials 0.000 description 1
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- 108090000623 proteins and genes Proteins 0.000 description 1
- 238000012163 sequencing technique Methods 0.000 description 1
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- G—PHYSICS
- G01—MEASURING; TESTING
- G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
- G01N33/00—Investigating or analysing materials by specific methods not covered by groups G01N1/00 - G01N31/00
- G01N33/48—Biological material, e.g. blood, urine; Haemocytometers
- G01N33/50—Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing
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Abstract
The Hb value, the MCV value, and the CRP value of the blood sample exclude blood samples of a subject originating from inflammatory anemia, and the blood sample (A1) is determined to be a blood sample of a subject originating from iron deficiency anemia or a blood sample (A2) of a subject originating from thalassemia based on serum ferritin values of other blood samples (A1).
Description
Technical Field
The present invention relates to a determination method for determining whether or not a blood sample is a blood sample of a subject derived from thalassemia, a determination device for performing the determination method, and a computer program for causing a computer to perform the determination method.
Background
Thalassemia is a disease in which anemia is manifested by genetic abnormalities in the globin constituting hemoglobin (tetramers of 2 molecules each of which is composed of an alpha globin having 141 amino acids and a non-alpha globin having 146 amino acids (β, γ, δ)). Thalassemia includes, for example, a disease caused by a deficiency in synthesis of the alpha chain of globin, that is, a disease caused by a deficiency in synthesis of the beta chain of globin.
Conventionally, when a disease of a patient showing an anemic symptom is identified as thalassemia instead of iron deficiency anemia, the following steps (i) to (iii) are performed.
(i) A blood sample collected from a patient is subjected to CBC (complete blood count, whole blood count) examination, and whether or not the blood sample is anemic is determined from a hemoglobin value and an average red blood cell volume value (MCV value) among the examination values.
(ii) When the blood sample of the patient is determined to be an anemia in the above (i), a ferritin test is performed to determine whether the anemia is caused by iron deficiency anemia or thalassemia. The judgment result in this stage is a result showing a high possibility, but is not as reliable as the judgment step in (iii) below.
(iii) When the blood sample of the patient is determined to be thalassemia in the above (ii), further hemoglobin classification and PCR (polymerase chain reaction) test are performed on the blood sample of the patient, and the determination of thalassemia is determined as a result of the determination.
Patent document 1 describes an invention that attempts to determine whether iron deficiency anemia or thalassemia is caused by fluorescence.
Prior art literature
Patent literature
Patent document 1: japanese patent laid-open publication No. 2016-50931
Disclosure of Invention
Technical problem to be solved by the invention
However, the present inventors studied the judgment steps of (i) to (iii) in detail, and found that the following problems to be improved are included.
First, the ferritin assay in the step of determining (ii) above is an assay requiring an expensive reagent. Furthermore, even if ferritin examination is performed, thalassemia cannot be distinguished from inflammatory anaemia (especially chronic inflammatory anaemia). Therefore, when the patient is suffering from inflammatory anemia, the patient becomes a subject who is required to provide a blood sample for the ferritin examination, and the burden on the patient is increased. In addition, the patient suffering from inflammatory anemia is transferred to the next examination step to receive the next judgment step (iii).
The PCR test in the step of determining (iii) is a test requiring an expensive reagent. In addition, when the patient is an inflammatory anemia, an expensive hemoglobin fractionation and PCR test that should not be performed are performed in the same way as in (ii), and the patient who is in need of an inflammatory anemia is provided with a blood sample for these tests, which increases the burden on the patient.
The present invention has been made to solve the above-mentioned problems, and an object of the present invention is to prevent unnecessary examination from occurring in a step of determining whether or not a blood sample is derived from a patient suffering from thalassemia.
Technical scheme for solving technical problems
[1] A method for judging whether or not a blood sample (A) to be analyzed is a blood sample derived from a subject suffering from thalassemia, the method comprising: a first step of determining whether the blood sample (a) is a blood sample derived from a subject suffering from inflammatory anemia or a blood sample (A1) derived from a subject suffering from anemia other than inflammatory anemia, based on the hemoglobin value, the average red blood cell volume value, and the C-reactive protein value of the blood sample (a); and a second step of determining, based on the serum ferritin value of the blood sample (A1), whether the blood sample (A1) is a blood sample derived from a subject suffering from iron deficiency anemia or a blood sample (A2) derived from a subject suffering from thalassemia.
[2] The method according to [1], wherein in the first step, when the hemoglobin value and the average red blood cell volume value of the blood sample (A) represent a blood sample of a subject derived from anemia, the blood sample (A) is judged to be a blood sample of a subject derived from inflammatory anemia when the C-reactive protein value of the blood sample (A) is higher than a predetermined value, and the blood sample (A) is judged to be a blood sample (A1) of a subject derived from anemia other than inflammatory anemia when the C-reactive protein value of the blood sample (A) is lower than the predetermined value.
[3] The method according to [1], wherein in the first step, the anemia is microcytopenic anemia.
[4] The method according to any one of [1] to [3], further comprising a third step of judging whether or not the blood sample (A2) is a blood sample derived from a subject suffering from thalassemia, based on the hemoglobin classification of the blood sample (A2) and the result of the PCR test.
[5] A method for judging whether or not a blood sample to be analyzed is a blood sample of a subject originating in thalassemia, wherein the method judges whether or not the blood sample is a blood sample of a subject originating in thalassemia based on a hemoglobin value, an average red blood cell volume value, a C-reactive protein value, and a serum ferritin value of the blood sample.
[6] A judging device for judging whether or not a blood sample (A) to be analyzed is a blood sample derived from a subject suffering from thalassemia, the judging device comprising: a first test value receiving unit that receives a blood test value including at least a hemoglobin value, an average red blood cell volume value, and a C-reactive protein value of the blood sample (a); a first determination unit that determines, based on the blood test value, whether the blood sample (a) is a blood sample derived from a subject with inflammatory anemia or a blood sample (A1) derived from a subject with anemia other than inflammatory anemia, and outputs the result as a first determination result; a second test value receiving unit that receives a serum ferritin value of the blood sample (A1) when the first judging unit judges that the blood sample (a) is the blood sample (A1); and a second determination unit that determines, based on the serum ferritin value of the blood sample (A1), whether the blood sample (A1) is a blood sample derived from a subject suffering from iron deficiency anemia or a blood sample (A2) derived from a subject suffering from thalassemia, and outputs the result as a second determination result.
[7] The judgment device according to [6], further comprising: a third test value receiving unit that receives the results of the hemoglobin fractionation and the PCR test of the blood sample (A2) when the second judging unit judges that the blood sample (A1) is the blood sample (A2); and a third judgment unit that judges whether or not the blood sample (A2) is a blood sample derived from a subject suffering from thalassemia, based on the results of the hemoglobin fractionation and the PCR test of the blood sample (A2), and outputs the result as a third judgment result.
[8] A computer program for causing a computer to execute a determination as to whether or not a blood sample (a) to be analyzed is a blood sample of a subject originating from thalassemia, the computer program causing the computer to function as a first test value receiving unit that receives a blood test value including at least a hemoglobin value, an average red blood cell volume value, and a C-reactive protein value of the blood sample (a), a first determination unit that determines whether the blood sample (a) is a blood sample of a subject originating from inflammatory anemia or a blood sample (A1) originating from an anemia other than inflammatory anemia, as a first determination result output, and a second determination unit that receives a serum ferritin value of the blood sample (A1) when the blood sample (a) is determined to be the blood sample (A1) by the first determination unit, and determines whether the blood sample (a) is a blood sample of a subject originating from anemia or an iron sample of a blood sample originating from serum (A2) of the subject originating from anemia.
[9] The computer program according to item [8], wherein the computer program further comprises a computer program for causing a computer to function as a third examination value receiving unit that receives a result of a hemoglobin classification and a PCR examination of the blood sample (A2) when the second judging unit judges that the blood sample (A1) is the blood sample (A2), and a third judging unit that judges whether the blood sample (A2) is a blood sample of an examinee who is derived from thalassemia, based on the result of the hemoglobin classification and the PCR examination of the blood sample (A2), and outputs the result as a third judging result.
Effects of the invention
In the present invention, when judging whether or not a blood sample to be analyzed is a blood sample derived from a subject suffering from thalassemia, a C-reactive protein (CRP) value is measured at an initial stage of a judgment step, a blood sample derived from a patient suffering from inflammatory anemia is judged based on the CRP value, and measurement of a serum ferritin value of the blood sample derived from the patient suffering from inflammatory anemia is not performed. In the present invention, when judging whether or not a blood sample to be analyzed is a blood sample derived from a subject suffering from thalassemia, unnecessary hemoglobin fractionation and PCR test are avoided.
In contrast, there has been no idea of excluding inflammatory anemia in the initial stage of blood test, and there has been no idea of using CRP values that can be obtained at low cost in the initial stage of blood test for detecting inflammatory anemia.
According to the present invention, a patient suffering from inflammatory anemia may not receive a measurement of serum ferritin value, a measurement for obtaining hemoglobin grade, and a test for determining thalassemia such as a PCR test. Therefore, the burden on the patient suffering from inflammatory anemia can be reduced, and the unnecessary use of expensive reagents and the labor for examination required for the determination of thalassemia can be suppressed.
Drawings
Fig. 1 is a flowchart illustrating a first embodiment of the determination method of the present invention. In the flow chart of the same figure, a third step for more accurately judging whether thalassemia is included as a preferable mode. The flowchart is also a flowchart for explaining the judgment operation of the judgment device of the present invention, and is also a flowchart for explaining the configuration of the computer program of the present invention.
Fig. 2 is a flowchart illustrating a second embodiment of the determination method of the present invention.
Fig. 3 is a block diagram showing an example of the structure of the blood analysis device of the present invention.
Detailed Description
(judgment method of the invention)
The determination method determines whether or not the blood sample (a) to be analyzed is a blood sample derived from a subject suffering from thalassemia. As shown in the flowchart of fig. 1, the determining method (first mode) at least includes: a first step S1 for excluding a blood sample representing inflammatory anemia from a blood sample representing total anemia; and a second step S2 of judging whether or not the blood sample of the patient from which the inflammatory anemia has been excluded in the first step is thalassemia. Thus, the blood sample of the inflammatory anemia is excluded in the initial judgment stage, and the implementation of the examination concerning thalassemia described below can be prevented for the patient suffering from inflammatory anemia.
As shown in the flowchart of fig. 2, the determination method (second embodiment) determines whether or not the blood sample (a) to be analyzed is thalassemia based on the hemoglobin value, the average red blood cell volume value, the C-reactive protein value, and the serum ferritin value. Thus, unnecessary hemoglobin fractionation and PCR test performed when the thalassemia is determined can be prevented.
(examined person)
The subject may be a patient who complains about the symptoms of anemia, or may be a healthy subject who has received a health diagnosis or the like. That is, the blood sample (a) to be judged by the judgment method may be a blood sample collected from a subject who has been previously known to some extent to be anemic, or may be a blood sample collected from a subject who is not known to be healthy. The blood sample (a) used in the determination method may be all or part of the blood collected from the subject. In addition, as long as the value of the measurement object such as CRP in the determination method is not affected, a plurality of blood samples in different sample tubes (blood collection tubes) may be collected separately for use in the determination method. The additional collection of the blood sample may be, for example, continuous collection while the blood collection tube is continuously replaced during the puncturing of the same blood collection needle, or collection into another blood collection tube by puncturing with another blood collection needle after a predetermined time within an allowable range has elapsed.
The judgment method of the present invention will be described in detail below. The following description will be made based on fig. 1 showing the first embodiment of the determination method of the present invention, but all the following descriptions may be cited as necessary parts concerning the second embodiment of the determination method of the present invention shown in fig. 2.
(step S1a of determining anemia in the first step S1)
In the first step S1, as shown in step S1a in the flowchart of fig. 1, it is determined whether or not the blood sample (a) is a blood sample derived from an examinee, more specifically, from microcytosis, based on a hemoglobin value (Hb value) and an average red blood cell volume value (MCV value) of the blood sample (for distinction, referred to as "blood sample (a)") collected from the examinee. The microcytic hypopigmentation anemia includes iron deficiency anemia, inflammatory anemia, thalassemia, and the like as the disease state.
(relation between Hb value, MCV value and anemia)
The Hb value (hemoglobin concentration) of a blood sample of a patient suffering from anemia varies depending on the sex, age, etc. of the patient, but may be generally set appropriately based on, for example, a common reference range of the japanese clinical examination standards association (JCCLS), a numerical value described in the abstract of the clinical examination method (revised 35 th edition), and the like. Specifically, the ratio is, for example, 11.0g/dl or less, less than 11.6g/dl, less than 12.0g/dl, 13.0g/dl or less, less than 13.7g/dl, or less than 14.0g/dl. The MCV value of a blood sample derived from a patient suffering from anemia, particularly microcytopenic anemia, can be generally set appropriately, for example, according to the common standard range of the japanese clinical laboratory standards institute (JCCLS), the numerical values described in the abstract of the clinical laboratory method (revised 35 th edition), or the like. Specifically, the ratio is, for example, 80.0fl or less and less than 83.6fl.
(method for obtaining Hb value and MCV value)
The method for obtaining the Hb value and the MCV value is not particularly limited, and a conventionally known blood test method (blood test apparatus) can be used. For example, in the case of a blood analysis device such as the whole blood cell immunoassay device described in japanese unexamined patent publication No. 11-108923, not only the result of counting blood cells (the number of blood cells, the volume frequency distribution of blood cells) but also Hb values and MCV values can be obtained, and these Hb values and MCV values can be obtained as data signals through an interface.
(additional check value usable in the first step S1)
In the first step S1, in order to determine anemia, more specifically microcytopenic hypopigmentation anemia, for example, average erythrocyte hemoglobin concentration (MCHC) can be used in addition to Hb value and MCV value. MCHC can be calculated according to the following formula (1):
[ mathematics 1]
MCHC (g/d 1) =hb (g/dl)/Ht (hematocrit) (%) x 100
The value of MCHC can be obtained based on the value obtained from a blood cell volume meter even if the value is a blood analysis device such as a whole blood cell immunoassay device described in japanese unexamined patent publication No. 11-108923. In addition, the value of MCHC may also be obtained as a data signal through the interface. The MCHC value of a blood sample derived from a patient suffering from anemia, particularly microcytopenic anemia, can be generally set appropriately, for example, according to the common standard range of the japanese clinical examination standards association (JCCLS), the numerical values described in the abstract of the clinical examination method (revised 35 th edition), or the like. Specifically, for example, less than 30g/dl, less than 31g/dl, and less than 31.7g/dl.
(step S1b of judging inflammatory anemia in the first step S1)
In the first step S1, as shown in step S1b in the flowchart of fig. 1, it is determined whether or not the blood sample (a) is a blood sample derived from a subject suffering from inflammatory anemia, based on the CRP value of the blood sample (a).
(relation of CRP value to inflammatory anemia)
The CRP value of a patient suffering from inflammatory anemia can be generally set appropriately according to, for example, a common standard range of the japanese clinical laboratory standards institute (JCCLS), a numerical value described in the abstract of clinical laboratory methods (revised 35 th edition), or the like. Specifically, the concentration is, for example, 0.14mg/dl or more and 0.2mg/dl or more.
(method for obtaining CRP value)
The method for obtaining the CRP value is not particularly limited, and a conventionally known blood test method (blood test apparatus) can be used. In the same manner as in the acquisition of the Hb value and the MCV value, if the blood analysis device having the CRP value measurement function is a whole blood cell immunoassay device described in japanese unexamined patent publication No. 11-108923, the CRP value of the blood sample can be obtained, and the CRP value can be obtained as a data signal through an interface.
The order of the determination in the step S1a and the step S1b is not particularly limited, and any preceding step may be used.
(step S1c of judging anemia other than inflammatory anemia in the first step S1)
As shown in step S1c in the flowchart of fig. 1, the determination result of step S1c, which is a determination result of step S1a that is a blood sample of the subject determined to be (derived from anemia (more specifically, microcytochrome anemia) and is determined to be (not derived from inflammatory anemia) in step S1b, is given to (derived from anemia other than inflammatory anemia (more specifically, microcytochrome anemia) (for distinction, referred to as "blood sample (A1)")) as the determination result of the first step. In the present invention, the blood sample (A1) from which the determination result is obtained is sent to the second step.
On the other hand, in step S1a, the determination result of step S1c is given as the determination result of the first step to the blood sample determined in step S1b as (the blood sample of the subject derived from the inflammatory anemia), which is the blood sample of the subject derived from the anemia (more specifically, microcytochrome anemia). In the present invention, the blood sample from which the determination result is obtained is not sent to the second step, and as the determination result of the determination method, a determination result (that is, a blood sample from a subject suffering from inflammatory anemia, not a blood sample from a subject suffering from thalassemia) can be given, and the determination concerning thalassemia can be ended.
If the determination result (not derived from the blood sample of the subject with anemia) is obtained in step S1a, step S1c does not perform the determination, and as the determination result of this determination method, a determination result (derived from the blood sample of the subject with anemia) such as this may be given, and the determination concerning thalassemia may be ended.
In a preferred embodiment of the present invention, when the determination result (which is a blood sample derived from an examinee with anemia (in more detail, microcytopenic anemia)) is obtained in step S1a, step S1b may transmit the CRP value of the blood sample (a) to step S1c, and step S1c may give the following determination result.
(a) When the CRP value of the blood sample (A) is higher than a predetermined value, it is determined that the blood sample (A) is a blood sample derived from a subject suffering from inflammatory anemia. The CRP value is specified to be 0.2mg/dl, preferably 0.14mg/dl.
(b) When the CRP value of the blood sample (A) is lower than the predetermined value, it is determined that the blood sample (A) is a blood sample (A1) of a subject who has been suffering from anemia other than inflammatory anemia.
When the determination of (a) is performed, a determination result such as a blood sample (a blood sample derived from an examinee with inflammatory anemia, not a blood sample derived from an examinee with thalassemia) to obtain the determination result may be given, and the determination concerning thalassemia may be ended.
When the determination of (b) is performed, a determination result such as a blood sample (A1) derived from an examinee who is an anemia other than inflammatory anemia (more specifically, microcytopenic anemia) may be given to the blood sample (A1) from which the determination result is obtained, and the blood sample (A1) from which the determination result is obtained may be sent to the second step.
(second step S2)
As shown in the flowchart of fig. 1, in the second step S2, it is determined whether the blood sample (A1) is a blood sample derived from a subject suffering from iron deficiency anemia or a blood sample derived from a subject suffering from thalassemia (referred to as "blood sample (A2)" for distinction) based on the serum ferritin value of the blood sample (A1) determined in the first step S1.
The blood sample (A1) to be judged in the second step may be the same blood sample as the blood sample judged to be the blood sample (A1) in the first step (for example, a blood sample stored in the same sample tube), or may be a blood sample (a blood sample derived from the same subject) collected separately from the same subject as the blood sample judged to be the blood sample (A1) in the first step (as described above, a different sample tube is collected continuously or a predetermined time within an allowable range has elapsed, and then a different sample tube is collected).
(relation of serum ferritin value to iron deficiency anemia, thalassemia)
Serum ferritin values of adult healthy subjects are also determined by the assay, but as an example, they are about 32 to 126ng/ml in Japanese men (adult) and about 9 to 94ng/ml in Japanese women (adult). In the case of suspected anemia, the standard value (normal region) of serum ferritin is usually 25 to 250ng/ml.
In contrast, serum ferritin values decreased for iron deficiency anemia and increased for anemia due to thalassemia. Therefore, it is possible to determine whether the blood sample (A1) is a blood sample derived from a subject suffering from iron deficiency anemia or a blood sample (A2) derived from a subject suffering from thalassemia based on the serum ferritin value of the blood sample (A1).
In the second step, the reference value and the threshold value of the serum ferritin value of the blood sample of the subject to be judged to be derived from the iron deficiency anemia, and the reference value and the threshold value of the serum ferritin value of the blood sample of the subject to be judged to be derived from the thalassemia may be appropriately determined according to the race and the sex of the subject. For example, the standard value of serum ferritin value of the blood sample of the subject judged to be derived from iron deficiency anemia is 12ng/ml or less, particularly 10ng/ml or less. Further, for example, the standard value of serum ferritin value of the blood sample of the subject judged to be derived from thalassemia is more than 12ng/ml.
(method for obtaining serum ferritin values)
The method for obtaining the serum ferritin value is not particularly limited, and a conventionally known examination method can be used. Specifically, examples thereof include latex turbidimetry, chemiluminescent immunoassay (chemiluminescent method), latex agglutination turbidimetry, and the like.
When the determination result (the blood sample derived from the subject with iron deficiency anemia) is obtained in the second step S2, the determination regarding thalassemia can be terminated by using the determination result as the determination result of the determination method. In the case where the determination result (the blood sample (A2) of the subject derived from thalassemia) is obtained in the second step S2, the determination regarding thalassemia may be ended as the determination result of the determination method, or whether the blood sample (A2) of the subject derived from thalassemia may be determined more accurately in the third step S3 described later.
(third step S3)
As shown in the flowchart of fig. 1, in a preferred embodiment of this determination method, a third step S3 is performed. In the third step S3, it is determined whether or not the blood sample (A2) is a blood sample derived from the subject suffering from thalassemia (referred to as "blood sample (A3)" for distinction) based on the hemoglobin classification of the blood sample (A2) determined in the second step S2 and the result of the PCR test. The third step S3 can further improve the accuracy and reliability of the determination result that the blood sample is a blood sample derived from the subject suffering from thalassemia. In addition, since the blood sample for inflammatory anemia is removed, hemoglobin fractionation and PCR examination are not wasted.
(method for obtaining hemoglobin fractionation)
The hemoglobin fractionation used in the third step S3 can be obtained by a conventionally known analytical method. For example, high performance liquid chromatography (HPLC method), capillary electrophoresis (CE method), and the like are preferable. Further, based on the obtained classification result, hbA can be reduced 2 And HbF increase as an index, and thalassemia is determined.
(PCR check)
The PCR test used in the third step S3 is a test configured to be able to determine thalassemia by the polymerase chain reaction. More specifically, for example, the mutation of the α -globin gene or the non- α -globin gene of hemoglobin can be measured or detected by a method known per se such as a quantitative (real-time) PCR method or a second-generation gene sequencing method, and thalassemia can be determined based on the measurement result or the like. In this case, it is possible to determine what thalassemia is (for example, [ alpha ] thalassemia (- -SEA, - -THAI, - -FIL, etc.)) using the results. In the present specification, the "result of the PCR test" refers to a result of determining whether or not the blood sample obtained by the PCR test is a blood sample derived from a subject suffering from thalassemia, using the mutation of the α -globin gene or the non- α -globin gene as an index.
(second mode of the judgment method of the invention)
Fig. 2 is a flowchart showing a second embodiment of the determination method of the present invention. As shown in the flowchart, in the second embodiment, the Hb value, the MCV value, the CRP value, and the serum ferritin value of the blood sample are obtained, and based on these values, it is determined whether or not the blood sample is a blood sample derived from a subject suffering from thalassemia.
The method for measuring the Hb value, the MCV value, the CRP value, and the serum ferritin value, the meaning of these values, and how to determine whether or not the blood sample is a blood sample derived from a subject suffering from thalassemia by taking these values into consideration can be described with reference to the first embodiment.
(judgment device of the invention)
The judgment device is configured to carry out the above-described judgment method of the present invention, and is configured to judge whether or not the blood sample (a) to be analyzed is a blood sample derived from a subject suffering from thalassemia. As schematically illustrated in fig. 3, the determination device 1 includes at least: an inspection value receiving unit 10 configured to receive inspection values (including inspection results) obtained by various inspection devices according to the determination method (first or second aspect) of the present invention; and a judging unit 20 configured to perform judgment according to the judging method (first mode or second mode) of the present invention based on the inspection value. Fig. 3 shows a configuration preferable for the implementation of the first embodiment in particular, but the configuration may be appropriately changed to be preferable for the implementation of the second embodiment. The inspection value receiving unit 10 includes at least a first inspection value receiving unit 11 and a second inspection value receiving unit 12, and the judging unit 20 includes at least a first judging unit 21 and a second judging unit 22, and the first inspection value receiving unit 11 and the first judging unit 21 and the second inspection value receiving unit 12 and the second judging unit 22 operate in pairs, respectively, to implement the judging method of the present invention. In the example of fig. 3, a third examination value receiving unit 13 and a third judging unit 23 for confirming the judgment of thalassemia are preferably added.
(first check value receiving section and first judging section)
The first test value receiving unit 11 is configured to receive a blood test value including at least the Hb value, the MCV value, and the CRP value of the blood sample (a) collected from the subject. The first determination unit 21 processes the blood test value received by the first test value receiving unit 11, and determines whether the blood sample (a) is a blood sample derived from a subject with inflammatory anemia or a blood sample (A1) derived from a subject with anemia other than inflammatory anemia, based on the blood test value.
The blood test value (at least Hb value, MCV value, and CRP value) received by the first test value receiving unit 11 and the determination by the first determining unit 21 according to this are as described in the description of the first step of the determination method of the present invention.
In the example of fig. 3, the blood cell counting device 110 for measuring the whole blood cell count value (CBC value) such as Hb value or MCV value and the blood analysis device 120 for measuring the CRP value are connected to the first test value receiving unit 11 as separate devices, but these blood cell counting device 110 and blood analysis device 120 may be the same one analysis device (such as the device described in japanese patent laid-open publication No. 11-108923), or may be three separate devices for measuring the Hb value, MCV value, and CRP value, respectively.
The test value input to the first test value receiving unit 11 may be data transmitted by data communication from the blood cell counting device 110, the blood analysis device 120, or the like, or the test value obtained by the blood cell counting device 110, the blood analysis device 120 may be input to the first test value receiving unit 11 by manual input, bar code input, or the like. The same applies to the inspection values input to the second inspection value receiving unit 12 and the third inspection value receiving unit 13 described later.
The determination device may be included in a control unit of a measurement device having a measurement means, such as the blood cell counting device, the blood analysis device, or the whole blood cell immunoassay device, or may be configured to receive, from another external measurement device, an examination value which cannot be obtained in the measurement device, such as a serum ferritin value, a hemoglobin fraction, or a result of a PCR examination.
(output of first judgment result)
The first determination unit 21 outputs the determination result to the external device 400 as a first determination result. In the example of fig. 3, the external device 400 is a display device such as a liquid crystal display, but a device capable of transmitting a determination result to a user such as a lamp display device or a printer may be used.
(display content of first judgment result)
The display content of the first determination result may be, for example, a display or a symbol that can be understood by a user of the determination device (e.g., an operator or a doctor who views the determination result) such as "the blood sample is a blood sample of the subject derived from the inflammatory anemia", "the possibility of the inflammatory anemia is high", "the blood sample is a blood sample of the subject derived from the anemia other than the inflammatory anemia", "the possibility of the anemia other than the inflammatory anemia" or the like.
When the determination result of the content of the blood sample of the subject (which is derived from an anemia other than inflammatory anemia) is displayed, the input of the serum ferritin value of the blood sample to the user may be requested in order to proceed to the second step of the determination method of the present invention.
(second check value receiving section and second judging section)
When the first determination unit 21 determines that the blood sample (a) is a blood sample (A1) of a subject that is derived from an anemia other than inflammatory anemia, the second test value receiving unit 12 receives a serum ferritin value of the blood sample (A1) to perform the second step (determination of thalassemia) of the determination method of the present invention. The second determination unit 22 determines whether the blood sample (A1) is a blood sample derived from a subject suffering from iron deficiency anemia or a blood sample (A2) derived from a subject suffering from thalassemia, based on the serum ferritin value of the blood sample (A1).
The serum ferritin value received by the second examination value receiving unit 12 and the determination by the second determination unit 22 based on the serum ferritin value are as described in the description of the second step of the determination method of the present invention.
In the example of fig. 3, the measurement device 210 for measuring a serum ferritin value is connected to the second test value receiving unit 12, but the determination device may be included in a control unit of a measurement device including a mechanism for measuring a serum ferritin value, or may be configured to receive test values such as Hb value, MCV value, CRP value, and the like from an external measurement device.
(output of the second judgment result)
The second determination unit 22 outputs the determination result to the external device 400 as a second determination result. The external device 400 is a display device such as a display, as in the description of the output of the first determination result, but a device capable of transmitting the determination result to the user such as a lamp display device or a printer may be used.
(display content of the second judgment result)
The display content of the second determination result may be, for example, a display or a sign that can be understood by a user of the determination device, such as "the blood sample is a blood sample derived from an examinee who has iron deficiency anemia", "the possibility of iron deficiency anemia" is high "," the blood sample is a blood sample derived from an examinee who has thalassemia "," anemia due to thalassemia "," high possibility of thalassemia ".
In order to advance to the third step of the determination method of the present invention, when the determination result of the content of the blood sample of the subject derived from thalassemia is displayed, the user may be presented with an input of the result of the request for hemoglobin classification and PCR test, or it may be recommended not to display the input of the result of the request for hemoglobin classification and PCR test but to examine whether thalassemia is more accurately based on these tests.
(third check value receiving section and third judging section)
In a preferred embodiment of the determination device, the third examination value receiving unit 13 and the third determination unit 23 for performing the third step of the determination method of the present invention (confirmation of thalassemia) may be provided, so that the second determination unit may determine that the blood sample (A1) is the blood sample (A2) of the subject who originates from thalassemia). The inspection value referred to in the present specification also includes the result of inspection other than a numerical value. When the second determination unit determines that the blood sample (A1) is the blood sample (A2), the third test value receiving unit 13 receives the results of the hemoglobin fractionation and the PCR test of the blood sample (A2). The third determination unit 23 determines whether or not the blood sample (A2) is a blood sample derived from a subject suffering from thalassemia, based on the hemoglobin classification of the blood sample (A2) and the results of the PCR test.
The results of the hemoglobin classification and the PCR test received by the third test value receiving unit 13 and the determination by the third determining unit 23 are as described in the description of the third step of the determination method of the present invention.
In the example of fig. 3, the measurement device 310 for measuring hemoglobin fractionation and the device 320 for performing PCR test are connected to the third test value receiving unit 13, but the determination device may be included in the measurement device 310 for measuring hemoglobin fractionation and the control unit of the device for performing PCR test, or may be configured to receive test values such as Hb value, MCV value, CRP value, serum ferritin value, and the like from an external measurement device.
(output of third judgment result)
The third determination unit 23 outputs the determination result to the external device 400 as a third determination result. The external device 400 is a display device such as a display, as in the description of the output of the first and second determination results, but a device capable of transmitting the determination results to a light display device, a printer, or the like may be used.
(display content of third judgment result)
The display content of the third determination result may be, for example, a display that the user of the determination device can understand, such as "the blood sample is a blood sample derived from a subject suffering from thalassemia", "anemia due to thalassemia", "a very high possibility of thalassemia", "the blood sample is not a blood sample derived from a subject suffering from thalassemia", "is not anemia due to thalassemia", "a very low possibility of thalassemia".
The determination device may be a device constructed by a logic circuit or the like, but is suitably constructed by a computer. The computer executes a computer program according to the present invention (described below) configured to control the operation of the inspection value receiving unit and perform the operation of the judgment unit.
In the case where the determination device is a computer, the inspection value receiving unit 10 may be configured by having an interface as hardware and software (computer program) for receiving a received inspection value signal as a data set (data set) of the inspection value and transferring the received inspection value signal to the determination unit 20. The inspection value receiving unit 10 stores each of the received inspection values in a storage device (not shown).
(computer program of the invention)
The computer program according to the present invention (hereinafter also referred to as the program) causes a computer to function as the above-described determination device according to the present invention (the first check value receiving unit 11, the first determination unit 21, the second check value receiving unit 12, and the second determination unit 22). The program is also used to cause a computer to perform the above-described determination method of the present invention (first step S1 and second step S2). That is, the program is for causing a computer to determine whether or not the blood sample (a) to be analyzed is a blood sample derived from a subject suffering from thalassemia. The program may be configured to cause a computer to implement the first or second embodiment of the determination method of the present invention.
The program further includes a computer program for causing a computer to function as the third inspection value receiving unit 13 and the third judging unit 23 (i.e., a computer program for causing a computer to perform the third step S3 of the judging method of the present invention).
The program may be provided in a state of being installed on a computer, may be provided as a program stored in a computer-readable medium, or may be provided from another computer or an external storage device via a network.
Examples
Example 1
Blood samples were collected from subjects suspected of anemia and from healthy subjects, with informed consent based on writing. The hemoglobin (Hb) value, the average red blood cell volume (MCV) value, and the C-reactive protein (CRP) value in each collected blood sample are measured, and each measured value is compared with a common reference range (reference value) of JCCLS to determine whether or not the sample is a blood sample derived from an object of anemia other than inflammatory anemia (first step S1 in fig. 1). Serum ferritin values in the blood samples of subjects derived from anemia other than inflammatory anemia determined in the above were measured, the measured values were compared with a standard value (12 ng/ml), and a sample exceeding the standard value was determined as a blood sample of subjects derived from thalassemia.
Example 2
For each blood sample obtained in example 1 from a subject suspected of being anemic and a healthy subject, a PCR (Gap PCR) method and a hemoglobin fractionation method were used to determine whether the blood sample was a blood sample from a subject suffering from thalassemia.
Example 3
Based on the results of the judgment concerning the blood sample of the subject derived from thalassemia in example 1 and the same results of the judgment in example 2, the validity of the judgment method of the present invention was verified. From the results of the verification, it was confirmed that the judging method of the present invention is particularly suitable for judging whether or not the prepared blood sample is a blood sample derived from a subject of thalassemia.
Example 4
The Hb value, MCV value, CRP value, and serum ferritin value in each blood sample obtained in example 1 were measured, and each measured value was compared with a common reference range of JCCLS (reference value) and a reference value of serum ferritin (12 ng/ml), and a sample exceeding the reference value was determined as a blood sample derived from a subject of thalassemia.
Example 5
Based on the results of the judgment concerning the blood sample of the subject derived from thalassemia in example 4 and the same results of the judgment in example 2, the validity of the judgment method of the present invention was verified. The determination method of the present invention is particularly suitable for determining whether or not the prepared blood sample is a blood sample derived from a subject suffering from thalassemia, as confirmed by the results of the verification.
Industrial applicability
According to the present invention, it is possible to exclude a blood sample of a patient suffering from inflammatory anemia from a blood sample of a patient suffering from the inflammatory anemia in an initial stage, and it is possible to prevent unnecessary tests such as ferritin tests, hemoglobin fractionation, and PCR tests on the blood sample of the patient suffering from inflammatory anemia.
The present application is based on Japanese patent application 2020-189678 (application date: 11/13/2020), the contents of which are incorporated herein in their entirety.
Description of the reference numerals
S1 first step
S2 second step
S3 third step
Claims (9)
1. A method for judging whether or not a blood sample (A) to be analyzed is a blood sample derived from a subject suffering from thalassemia, characterized by comprising,
the judging method comprises the following steps:
a first step of determining whether the blood sample (a) is a blood sample derived from a subject suffering from inflammatory anemia or a blood sample (A1) derived from a subject suffering from anemia other than inflammatory anemia, based on the hemoglobin value, the average red blood cell volume value, and the C-reactive protein value of the blood sample (a); and
and a second step of determining, based on the serum ferritin value of the blood sample (A1), whether the blood sample (A1) is a blood sample derived from a subject suffering from iron deficiency anemia or a blood sample (A2) derived from a subject suffering from thalassemia.
2. The method according to claim 1, wherein,
in the case where the hemoglobin value and the average red blood cell volume value of the blood sample (a) in the first step represent a blood sample derived from an anemic subject,
when the C-reactive protein value of the blood sample (A) is higher than a predetermined value, it is determined that the blood sample (A) is a blood sample derived from an examinee with inflammatory anemia,
when the C-reactive protein value of the blood sample (A) is lower than the predetermined value, it is determined that the blood sample (A) is a blood sample (A1) of a subject derived from anemia other than inflammatory anemia.
3. The method according to claim 1, wherein,
in a first step, the anemia is microcytic hypopigmentation anemia.
4. A judging method according to any one of claims 1 to 3, wherein,
the method further comprises a third step of judging whether or not the blood sample (A2) is a blood sample derived from a subject suffering from thalassemia, based on the hemoglobin classification of the blood sample (A2) and the result of the PCR test.
5. A method for judging whether or not a blood sample to be analyzed is a blood sample derived from a subject suffering from thalassemia, characterized by,
And judging whether the blood sample is a blood sample of a subject from thalassemia or not based on the hemoglobin value, the average red blood cell volume value, the C-reactive protein value and the serum ferritin value of the blood sample.
6. A judging device for judging whether or not a blood sample (A) to be analyzed is a blood sample derived from a subject suffering from thalassemia, characterized in that,
the judging device includes:
a first test value receiving unit that receives a blood test value including at least a hemoglobin value, an average red blood cell volume value, and a C-reactive protein value of the blood sample (a);
a first determination unit that determines, based on the blood test value, whether the blood sample (a) is a blood sample derived from a subject with inflammatory anemia or a blood sample (A1) derived from a subject with anemia other than inflammatory anemia, and outputs the result as a first determination result;
a second test value receiving unit that receives a serum ferritin value of the blood sample (A1) when the first judging unit judges that the blood sample (a) is the blood sample (A1); and
and a second determination unit that determines, based on the serum ferritin value of the blood sample (A1), whether the blood sample (A1) is a blood sample derived from a subject suffering from iron deficiency anemia or a blood sample (A2) derived from a subject suffering from thalassemia, and outputs the result as a second determination result.
7. The judging apparatus of claim 6, wherein,
the judgment device further comprises:
a third test value receiving unit that receives the results of the hemoglobin fractionation and the PCR test of the blood sample (A2) when the second judging unit judges that the blood sample (A1) is the blood sample (A2); and
and a third determination unit that determines, based on the results of the hemoglobin fractionation and the PCR test of the blood sample (A2), whether or not the blood sample (A2) is a blood sample derived from a subject suffering from thalassemia, and outputs the result as a third determination result.
8. A computer program for causing a computer to determine whether or not a blood sample (A) to be analyzed is a blood sample derived from a subject suffering from thalassemia, characterized in that,
the computer program causes a computer to function as a first inspection value receiving unit, a first judging unit, a second inspection value receiving unit, and a second judging unit,
the first test value receiving unit receives a blood test value including at least a hemoglobin value, an average red blood cell volume value, and a C-reactive protein value of the blood sample (A),
the first judgment unit judges whether the blood sample (A) is a blood sample derived from an examinee with inflammatory anemia or a blood sample (A1) derived from an examinee with anemia other than inflammatory anemia based on the blood test value, outputs the blood sample as a first judgment result,
The second test value receiving unit receives a serum ferritin value of the blood sample (A1) when the first judging unit judges that the blood sample (A) is the blood sample (A1),
the second determination unit determines whether the blood sample (A1) is a blood sample derived from a subject suffering from iron deficiency anemia or a blood sample (A2) derived from a subject suffering from thalassemia, based on the serum ferritin value of the blood sample (A1), and outputs the result as a second determination result.
9. The computer program according to claim 8, wherein the computer program comprises,
the computer program further includes a computer program for causing a computer to function as a third check value receiving unit and a third judging unit,
the third test value receiving unit receives the results of the hemoglobin fractionation and the PCR test of the blood sample (A2) when the second judging unit judges that the blood sample (A1) is the blood sample (A2),
the third determination unit determines whether or not the blood sample (A2) is a blood sample derived from a subject suffering from thalassemia, based on the results of the hemoglobin fractionation and the PCR test of the blood sample (A2), and outputs the result as a third determination result.
Applications Claiming Priority (3)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| JP2020189678 | 2020-11-13 | ||
| JP2020-189678 | 2020-11-13 | ||
| PCT/JP2021/041655 WO2022102734A1 (en) | 2020-11-13 | 2021-11-12 | Method for determination of blood samples, and determination system and computer program therefor |
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|---|---|
| CN116507919A true CN116507919A (en) | 2023-07-28 |
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| Application Number | Title | Priority Date | Filing Date |
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| CN202180073668.7A Pending CN116507919A (en) | 2020-11-13 | 2021-11-12 | Method for determining blood sample, and determination device and computer program therefor |
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| Country | Link |
|---|---|
| JP (1) | JPWO2022102734A1 (en) |
| CN (1) | CN116507919A (en) |
| WO (1) | WO2022102734A1 (en) |
Family Cites Families (5)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| JPH11326315A (en) * | 1998-05-21 | 1999-11-26 | Sysmex Corp | Method for screening beta-thalassemia |
| CA2459972A1 (en) * | 2001-09-14 | 2003-03-27 | F. Hoffmann-La Roche Ag | Differential diagnosis of disorders of iron metabolism by means of three independent parameters and recommendations for the treatment of these disorders of iron metabolism |
| JP4822562B2 (en) * | 2006-01-20 | 2011-11-24 | ベックマン コールター， インコーポレイテッド | Low hemoglobin concentration cell percentage and method of use in detecting iron deficiency |
| JP5868982B2 (en) * | 2010-09-16 | 2016-02-24 | ザ ジェネラル ホスピタル コーポレイション | Red blood cell dynamics for diagnosis |
| JP6612050B2 (en) * | 2014-08-28 | 2019-11-27 | シスメックス株式会社 | Hematology analyzer, diagnosis support method, and computer program |
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- 2021-11-12 JP JP2022562193A patent/JPWO2022102734A1/ja active Pending
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| WO2022102734A1 (en) | 2022-05-19 |
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