JP5588336B2 - Blood analyzer and blood analysis method - Google Patents
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Description
本発明は、全血を用いて、全血中のヘモグロビン濃度と、血漿中のC−反応性蛋白質(C−reactive protein、以下CRPともいう)濃度とを測定する血液分析装置及び血液分析方法に関する。 The present invention relates to a blood analyzer and a blood analysis method for measuring hemoglobin concentration in whole blood and C-reactive protein (hereinafter also referred to as CRP) concentration in plasma using whole blood. .
この種の血液分析装置には、特許文献1に示すように、ヘモグロビン濃度を測定するためのHgbセル(WBCセルに相当する)、及びCRP濃度を測定するためのCRPセルそれぞれに、全血と溶血試薬を含む各測定に必要な試薬とを供給して、各測定用の試料を生成し、前記各試料に光を照射して、各セルを透過した光の光強度から各濃度を算出するものがある。なお、本出願において、溶血とは赤血球の細胞膜が破壊される現象を指す。 In this type of blood analyzer, as shown in Patent Document 1, whole blood and HRP cells (corresponding to WBC cells) for measuring hemoglobin concentration, and CRP cells for measuring CRP concentration, respectively, Reagents necessary for each measurement, including hemolytic reagent, are supplied to generate samples for each measurement, each sample is irradiated with light, and each concentration is calculated from the light intensity of the light transmitted through each cell There is something. In the present application, hemolysis refers to a phenomenon in which the cell membrane of erythrocytes is destroyed.
しかしながら、各測定用の試料をそれぞれ別途生成するようにしているので、試料等の供給回数が多くなり、しかも供給のたびに供給に用いるノズルを洗浄するようにしているので、測定時間の短縮が難しく、手間もかかってしまう。 However, since each measurement sample is generated separately, the number of times of supply of the sample and the like is increased, and the nozzle used for the supply is washed each time supply is performed, so that the measurement time can be shortened. It is difficult and time consuming.
さらに、測定精度を担保するためには、各測定用の試料をそれぞれ一定量以上用意する必要がある。そのため、試薬の使用量を減らしてランニングコストを低減したり、血液の採取量を減らして血液を採取される被験者の負担を軽減したりすることが難しいという問題がある。 Furthermore, in order to ensure measurement accuracy, it is necessary to prepare a certain amount or more of each sample for measurement. Therefore, there is a problem that it is difficult to reduce the usage cost of the reagent by reducing the amount of the reagent used, or to reduce the burden on the subject who collects the blood by reducing the amount of blood collected.
そこで、本発明は、上記の問題を解決すべく図ったものであり、測定精度を担保しながらも、ランニングコストや被験者の負担を軽減でき、全血中のヘモグロビン濃度及び血漿中のCRP濃度を迅速かつ簡便に測定できる血液分析装置を提供することをその主たる所期課題とするものである。 Therefore, the present invention has been made to solve the above-mentioned problems, and while guaranteeing measurement accuracy, the running cost and the burden on the subject can be reduced, and the hemoglobin concentration in whole blood and the CRP concentration in plasma can be reduced. The main objective is to provide a blood analyzer that can measure quickly and easily.
すなわち、本発明に係る血液分析装置は、全血に溶血試薬及び免疫試薬を供給して第1試料を生成する試薬供給手段と、前記第1試料に光を照射する第1光源と、前記第1光源から射出されて前記第1試料を透過した光を受光し、その強度を示す第1光強度信号を出力する第1光検出手段と、前記第1試料に希釈液を供給して、前記第1試料を所定倍率に希釈し、第2試料を生成する希釈手段と、前記第2試料に光を照射する第2光源と、前記第2光源から射出されて前記第2試料を透過した光を受光し、その強度を示す第2光強度信号を出力する第2光検出手段と、前記第2光強度信号の値に基づいて、ヘモグロビン濃度を算出するHgb算出部と、前記第1光強度信号の値及び前記ヘモグロビン濃度に基づいて血漿中のC−反応性蛋白質濃度を算出するCRP算出部とを具備することを特徴とするものである。 That is, the blood analyzer according to the present invention includes a reagent supply unit that supplies a hemolyzing reagent and an immune reagent to whole blood to generate a first sample, a first light source that irradiates light to the first sample, and the first light source. Receiving a light emitted from one light source and transmitted through the first sample, and outputting a first light intensity signal indicating the intensity; and supplying a diluent to the first sample; Diluting means for diluting the first sample at a predetermined magnification to generate the second sample, a second light source for irradiating the second sample with light, and light emitted from the second light source and transmitted through the second sample , A second light detecting means for outputting a second light intensity signal indicating the intensity, an Hgb calculating section for calculating a hemoglobin concentration based on a value of the second light intensity signal, and the first light intensity. C-reactive protein in plasma based on signal value and said hemoglobin concentration It is characterized in that it comprises a CRP calculation unit for calculating a degree.
このようなものであれば、CRP濃度の測定に用いた後の第1試料を希釈して第2試料を生成し、その第2試料を用いてヘモグロビン濃度を測定するようにしているので、試薬等の供給回数及び供給に用いるノズルの洗浄回数を減らすことができ、測定時間を短縮できるとともに、手間を軽減することができる。また、ヘモグロビン測定用の試料と、CRP測定用の試料とを別々に一定量以上確保しなくとも良いので、測定精度を担保しながらも、試薬の使用量を減らしてランニングコストを低減できる。また、血液の採取量を減らして血液を採取される被験者の負担を軽減することも可能である。 In such a case, the second sample is generated by diluting the first sample after being used for the measurement of the CRP concentration, and the hemoglobin concentration is measured using the second sample. The number of times of supply and the number of times of cleaning the nozzle used for supply can be reduced, the measurement time can be shortened, and the labor can be reduced. In addition, since it is not necessary to secure a certain amount or more separately for the hemoglobin measurement sample and the CRP measurement sample, it is possible to reduce the amount of reagent used and reduce the running cost while ensuring the measurement accuracy. It is also possible to reduce the burden on the subject who collects blood by reducing the amount of blood collected.
また、全血に免疫試薬を供給すると、例えば全血中のCRPと免疫試薬中の免疫成分とが免疫反応するので、この反応物を利用してCRP濃度が測定される。一方、前記反応物は、ヘモグロビン濃度の測定においては測定の妨げとなってしまうという問題がある。これに対し、第1試料を所定倍率に希釈して第2試料を生成してあるので、例えば前記反応物のような免疫試薬の影響を可及的に低減して、ヘモグロビン濃度を精度良く測定することができる。 Further, when an immunoreagent is supplied to whole blood, for example, CRP in whole blood and an immune component in the immunoreagent undergo an immunoreaction, and the CRP concentration is measured using this reaction product. On the other hand, there is a problem that the reaction product hinders measurement in measuring hemoglobin concentration. On the other hand, since the second sample is produced by diluting the first sample at a predetermined magnification, for example, the influence of an immune reagent such as the reaction product is reduced as much as possible to accurately measure the hemoglobin concentration. can do.
また、従来の装置では、採血した全血を収容する採血容器を、前記装置にセットしてから、前記全血を複数のセルそれぞれに供給するまで、前記採血容器を取り外すことができず、その間オペレータが待機しなければならないという問題がある。これに対し、このようなものであれば、前記採血容器から全血を1回採取するだけで前記採血容器を除去することができ、待機時間を格段に減らすことができる。 In addition, in the conventional apparatus, the blood collection container cannot be removed until the whole blood is supplied to each of the plurality of cells after the blood collection container for storing the collected whole blood is set in the apparatus. There is a problem that the operator has to wait. On the other hand, if it is such, the said blood collection container can be removed only by collect | recovering whole blood from the said blood collection container once, and waiting time can be reduced significantly.
上述した免疫試薬の影響としては、第2試料が免疫試薬を含むこと自体による影響と、免疫試薬と第2試料中のCRPとの免疫反応の影響とが挙げられる。前者の免疫試薬そのものの影響をさらに低減して、より正確にヘモグロビン濃度を算出するためには、前記希釈液によって所定倍率に希釈した前記免疫試薬に対し、前記第2光源又は前記第2光源からの光の波長域を含む光を射出する光源から光を照射したときの透過光強度に関連する値である第1関連値を記憶する第1関連値記憶部をさらに具備し、前記Hgb算出部が、前記第1関連値及び前記第2光強度信号の値に基づいて、ヘモグロビン濃度を算出するものが望ましい。 As the influence of the above-described immunoreagent, there are an influence due to the fact that the second sample contains the immunoreagent itself and an influence of an immune reaction between the immunoreagent and the CRP in the second sample. In order to further reduce the influence of the former immunoreagent itself and more accurately calculate the hemoglobin concentration, the immunoreagent diluted to a predetermined magnification with the diluent is used from the second light source or the second light source. A first related value storage unit that stores a first related value that is a value related to the intensity of transmitted light when light is emitted from a light source that emits light including a wavelength range of the light, and the Hgb calculating unit However, it is desirable to calculate the hemoglobin concentration based on the first related value and the value of the second light intensity signal.
一方、後者の免疫反応の影響の大きさは、本出願の発明者の鋭意検討により、全血中のCRP濃度に依存することが見いだされた。従って、免疫反応の影響をさらに低減して、より正確にヘモグロビン濃度を算出するためには、全血中のC−反応性蛋白質濃度が既知である全血に、溶血試薬及び免疫試薬を供給して生成した基準試料に対し、前記第2光源又は前記第2光源からの光の波長域を含む光を射出する光源から光を照射したときの透過光強度に関連する値である第2関連値を記憶する第2関連値記憶部をさらに具備し、前記Hgb算出部が、第2関連値と、前記第1光強度信号の値と、前記第2光強度信号の値とに基づいて、ヘモグロビン濃度を算出するものが望ましい。このヘモグロビン濃度の算出方法の具体的な一例としては、前記Hgb算出部が、前記第2関連値と、前記第1光強度信号の値から算出した全血中のC−反応性蛋白質濃度とから補正値を算出し、該補正値及び前記第2光強度信号の値に基づいてヘモグロビン濃度を算出するものを挙げることができる。 On the other hand, the magnitude of the influence of the latter immune reaction has been found to depend on the CRP concentration in whole blood by the inventor's earnest study. Therefore, in order to further reduce the influence of the immune reaction and more accurately calculate the hemoglobin concentration, a hemolysis reagent and an immune reagent are supplied to whole blood whose C-reactive protein concentration in the whole blood is known. The second related value, which is a value related to the transmitted light intensity when light is emitted from the second light source or the light source that emits light including the wavelength range of light from the second light source to the reference sample generated A second related value storage unit for storing the second related value, the Hgb calculating unit based on the second related value, the value of the first light intensity signal, and the value of the second light intensity signal. It is desirable to calculate the concentration. As a specific example of the method for calculating the hemoglobin concentration, the Hgb calculating unit calculates the C-reactive protein concentration in the whole blood calculated from the second related value and the value of the first light intensity signal. Examples include calculating a correction value and calculating a hemoglobin concentration based on the correction value and the value of the second light intensity signal.
なお、各関連値には、透過光強度、光透過率又は吸光度を示す値だけでなく、透過光強度等に基づいて算出した検量線を示す値等が含まれる。 Each related value includes not only a value indicating transmitted light intensity, light transmittance, or absorbance, but also a value indicating a calibration curve calculated based on transmitted light intensity or the like.
この血液分析装置に用いられる血液分析方法もまた、本発明の1つである。すなわち、本発明に係る血液分析方法は、全血に溶血試薬及び免疫試薬を供給して第1試料を生成する試薬供給ステップと、前記第1試料に光を照射し、前記第1試料を透過した光を受光し、その強度を示す第1光強度を測定する第1光強度測定ステップと、前記第1試料に希釈液を供給して、前記第1試料を所定倍率に希釈し、第2試料を生成する希釈ステップと、第2試料に光を照射し、前記第2試料を透過した光を受光し、その強度を示す第2光強度を測定する第2光強度測定ステップと、前記第2光強度に基づいて、全血中のヘモグロビン濃度を算出するHgb算出ステップと、前記第1光強度及び前記ヘモグロビン濃度に基づいて血漿中のC−反応性蛋白質濃度を算出するCRP算出ステップとを具備することを特徴とする方法である。 The blood analysis method used in this blood analyzer is also one aspect of the present invention. That is, the blood analysis method according to the present invention includes a reagent supply step of supplying a hemolyzing reagent and an immune reagent to whole blood to generate a first sample, irradiating the first sample with light, and transmitting the first sample. A first light intensity measuring step for receiving the light and measuring a first light intensity indicating the intensity; supplying a diluent to the first sample; diluting the first sample at a predetermined magnification; A dilution step for generating a sample, a second light intensity measurement step for irradiating the second sample with light, receiving the light transmitted through the second sample, and measuring a second light intensity indicating the intensity; A Hgb calculating step for calculating a hemoglobin concentration in whole blood based on two light intensities, and a CRP calculating step for calculating a C-reactive protein concentration in plasma based on the first light intensity and the hemoglobin concentration. In a method characterized by comprising That.
上述した構成の本発明によれば、測定精度を担保しながらも、ランニングコストや被験者の負担を軽減でき、全血中のヘモグロビン濃度及び血漿中のCRP濃度を簡便かつ迅速に測定できる。 According to the present invention configured as described above, the running cost and the burden on the subject can be reduced while ensuring the measurement accuracy, and the hemoglobin concentration in whole blood and the CRP concentration in plasma can be measured easily and rapidly.
以下に、本発明の実施形態に係る血液分析装置100について、図面を参照して説明する。本実施形態に係る血液分析装置100は、例えば人血や動物血等の全血を用いて、全血中のヘモグロビン濃度及び血漿中のCRP濃度とを測定するものである。具体的にこの血液分析装置100は、図1に示すように、大きくは、測定機構110及びその測定機構110に係る演算処理を行う演算機構120からなる。なお、全血とはヒトや動物から採取した血液であって、血球成分と血漿成分とを含んでいるものであり、抗凝固剤や希釈液などをさらに含むものであってもよい。 Hereinafter, a blood analyzer 100 according to an embodiment of the present invention will be described with reference to the drawings. The blood analyzer 100 according to the present embodiment measures the hemoglobin concentration in whole blood and the CRP concentration in plasma using whole blood such as human blood or animal blood. Specifically, as shown in FIG. 1, the blood analyzer 100 mainly includes a measurement mechanism 110 and a calculation mechanism 120 that performs calculation processing related to the measurement mechanism 110. Note that whole blood is blood collected from humans or animals, and includes blood cell components and plasma components, and may further include an anticoagulant or a diluent.
前記測定機構110は、試料を収容するセル10と、前記セル10に試薬を供給する試薬供給手段20と、前記セル10に収容された試料に光を照射する第1光源30と、前記第1光源30から射出されて試料を透過した光を受光し、その強度を示す第1光強度信号を出力する第1光検出手段40とを具備している。 The measurement mechanism 110 includes a cell 10 that contains a sample, a reagent supply means 20 that supplies a reagent to the cell 10, a first light source 30 that irradiates light to the sample contained in the cell 10, and the first First light detection means 40 is provided for receiving light emitted from the light source 30 and transmitted through the sample and outputting a first light intensity signal indicating the intensity of the light.
各部を詳述する。前記セル10は、試料を収容する内部空間を有する容器である。前記内部空間における、光が入射する入射窓及び光が射出する射出窓は、互いに平行に向かい合っており、前記内部空間の底面中央部には、試料を排出する排出口(図示しない)が設けられている。このセル10には、前記全血を収容する採血容器(図示しない)から、全血供給ノズル(図示しない)によって、所定量の全血が供給される。 Each part will be described in detail. The cell 10 is a container having an internal space for storing a sample. In the internal space, an incident window through which light enters and an exit window through which light exits face each other in parallel, and a discharge port (not shown) for discharging a sample is provided at the center of the bottom surface of the internal space. ing. A predetermined amount of whole blood is supplied to the cell 10 from a blood collection container (not shown) containing the whole blood by a whole blood supply nozzle (not shown).
試薬供給手段20は、溶血試薬と、緩衝試薬と、免疫試薬とを収容する試薬容器21と、前記各試薬を前記セル10に供給する試薬供給ノズル22と、該試薬供給ノズル22を所定量の前記各試薬が通過するように、弁体の開度を調整する電磁弁(図示しない)とを具備する。前記試薬供給手段20は、前記セル10に収容された全血に、溶血試薬(例えば溶血性サポニン類溶液)、緩衝試薬、及び免疫試薬(例えばCRP−X2(デンカ生研))を順次供給して第1試料を生成する。この免疫試薬には、前記第1試料中のCRPと免疫反応を起こして凝集する免疫成分(ここでは抗CRP抗体感応性のラテックス)を含む。 The reagent supply means 20 includes a reagent container 21 that contains a hemolytic reagent, a buffer reagent, and an immune reagent, a reagent supply nozzle 22 that supplies each reagent to the cell 10, and a predetermined amount of the reagent supply nozzle 22. And an electromagnetic valve (not shown) for adjusting the opening of the valve body so that each of the reagents passes. The reagent supply means 20 sequentially supplies a hemolysis reagent (for example, a hemolytic saponin solution), a buffer reagent, and an immunological reagent (for example, CRP-X2 (Denka Biotechnology)) to the whole blood accommodated in the cell 10. A first sample is generated. The immunoreagent contains an immune component (here, anti-CRP antibody sensitive latex) that aggregates by causing an immune reaction with CRP in the first sample.
第1光源30は、前記セル10に臨んで配置されており、ピーク波長が600nm以上である光を射出するLEDであり、ここではピーク波長は660nmである。 The 1st light source 30 is arrange | positioned facing the said cell 10, and is LED which inject | emits the light whose peak wavelength is 600 nm or more, and a peak wavelength is 660 nm here.
第1光検出手段40は、前記セル10を挟んで、前記第1光源30に対向して配置されたものであり、ここではフォトダイオードである。 The first light detection means 40 is disposed to face the first light source 30 with the cell 10 interposed therebetween, and here is a photodiode.
演算機構120は、汎用又は専用のコンピュータであり、メモリに所定のプログラムを格納し、当該プログラムに従ってCPUやその周辺機器を協働動作させることによって、CRP算出部50及び制御部(図示しない)としての機能を発揮する。CRP算出部50は、前記第1光強度信号の値及び後述するヘモグロビン濃度に基づいて、血漿中のCRP濃度を算出するものであり、ここではラテックス免疫比濁法を用いて算出している。具体的には、第1試料に免疫試薬を供給すると、第1試料中のCRPと前記免疫試薬中の免疫成分とが免疫反応して徐々に凝集していくので、その凝集過程での前記第1光強度信号の値の時間変化量を測定する。この時間変化量と全血中のCRP濃度との間には相関性があり、この相関性を示す検量線を、全血中のCRP濃度が既知である全血を用いて予め算出して、CRP算出部50に記憶させておく。CRP算出部50は、測定された第1光強度信号の値の時間変化量を、前記検量線に代入して、全血中のCRP濃度を算出する。さらに全血中のCRP濃度を、後述するヘモグロビン濃度を用いて補正して、血漿中のCRP濃度を算出する。制御部は、この血液分析装置100の各部が、測定開始から所定時間経過後に動作するように、指令を出力するものである。 The calculation mechanism 120 is a general-purpose or dedicated computer, stores a predetermined program in a memory, and operates the CPU and its peripheral devices in cooperation with each other as the CRP calculation unit 50 and a control unit (not shown). Demonstrate the function. The CRP calculating unit 50 calculates the CRP concentration in plasma based on the value of the first light intensity signal and the hemoglobin concentration described later, and here, it is calculated using a latex immunoturbidimetric method. Specifically, when an immunoreagent is supplied to the first sample, the CRP in the first sample and the immune component in the immunoreagent undergo an immunoreaction and gradually aggregate, so the first in the aggregation process. Measure the amount of time change in the value of one light intensity signal There is a correlation between the amount of change with time and the CRP concentration in whole blood, and a calibration curve showing this correlation is calculated in advance using whole blood whose CRP concentration in whole blood is known, The data is stored in the CRP calculation unit 50. The CRP calculating unit 50 calculates the CRP concentration in whole blood by substituting the time variation of the measured value of the first light intensity signal into the calibration curve. Further, the CRP concentration in the whole blood is corrected using the hemoglobin concentration described later, and the CRP concentration in the plasma is calculated. The control unit outputs a command so that each unit of the blood analyzer 100 operates after a predetermined time has elapsed from the start of measurement.
さらに、本実施形態に係る血液分析装置100は、CRP濃度の測定に用いた後の第1試料を利用して、ヘモグロビン濃度を測定するための構成を具備する。具体的には前記測定機構110が、前記セル10に希釈液を供給する希釈手段60と、前記セル10に光を照射する第2光源70と、前記第2光源70から射出されて試料を透過した光を受光し、その強度を示す第2光強度信号を出力する第2光検出手段80とを具備している。 Furthermore, the blood analyzer 100 according to the present embodiment includes a configuration for measuring the hemoglobin concentration using the first sample after being used for measuring the CRP concentration. Specifically, the measuring mechanism 110 includes a diluting means 60 for supplying a diluent to the cell 10, a second light source 70 for irradiating the cell 10 with light, and a sample emitted from the second light source 70 and transmitted through the sample. And second light detection means 80 for receiving the light and outputting a second light intensity signal indicating the intensity of the light.
前記希釈手段60は、セル10に収容された第1試料に希釈液を供給して第1試料を所定倍率(150〜400倍であり、ここでは306倍である。以下、希釈倍率ともいう)に希釈し、第2試料を生成するものである。希釈手段60は、前記試薬供給手段20と同様に、希釈液を収容する希釈液容器61と、前記希釈液を前記セル10に供給する希釈液供給ノズル62と、該希釈液供給ノズル62を所定量の希釈液が通過するように弁体の開度を調整する電磁弁(図示しない)とを具備する。 The diluting means 60 supplies a diluting solution to the first sample accommodated in the cell 10 to give the first sample a predetermined magnification (150 to 400 times, here, 306 times, hereinafter also referred to as dilution magnification). To produce a second sample. As with the reagent supply means 20, the dilution means 60 is provided with a dilution liquid container 61 that contains a dilution liquid, a dilution liquid supply nozzle 62 that supplies the dilution liquid to the cell 10, and the dilution liquid supply nozzle 62. And a solenoid valve (not shown) that adjusts the opening of the valve body so that a fixed amount of diluent passes therethrough.
第2光源70は、セル10に臨んで配置されており、ピーク波長が500〜550nmである光を射出するLEDであり、ここではピーク波長は510nmである。 The 2nd light source 70 is arrange | positioned facing the cell 10, and is LED which inject | emits the light whose peak wavelength is 500-550 nm, and a peak wavelength is 510 nm here.
第2光検出手段80は、前記セル10を挟んで前記第2光源70に対向して配置されたものであり、ここではフォトダイオードである。 The second light detection means 80 is disposed opposite to the second light source 70 with the cell 10 interposed therebetween, and is a photodiode here.
また、前記演算機構120は、Hgb算出部51及びHct換算部57としての機能を有する。Hgb算出部51は、第2光強度信号の値に基づいてヘモグロビン濃度を算出するものであり、前記第2光強度信号の値を補正するための補正値を算出する補正値算出部52と、該補正部が算出した補正値及び第2光強度信号の値に基づいて、ヘモグロビン濃度を算出するHgb算出部本体53とを有する。 The arithmetic mechanism 120 functions as an Hgb calculation unit 51 and an Hct conversion unit 57. The Hgb calculation unit 51 calculates a hemoglobin concentration based on the value of the second light intensity signal, and a correction value calculation unit 52 that calculates a correction value for correcting the value of the second light intensity signal; And an Hgb calculating unit main body 53 that calculates a hemoglobin concentration based on the correction value calculated by the correcting unit and the value of the second light intensity signal.
補正値算出部52は、予め定められた第1関連値を記憶する第1関連値記憶部54と、予め定められた第2関連値を記憶する第2関連値記憶部55と、前記第1関連値、前記第2関連値、及び測定された第1光強度信号の値に基づいて補正値を算出する補正値算出部本体56とを具備する。 The correction value calculation unit 52 includes a first related value storage unit 54 that stores a predetermined first related value, a second related value storage unit 55 that stores a predetermined second related value, and the first A correction value calculating unit main body 56 that calculates a correction value based on the related value, the second related value, and the measured value of the first light intensity signal.
補正値及び各関連値について説明する。ヘモグロビン濃度は、第2光強度信号の値に基づいて算出されるが、この第2光強度信号の値は、免疫試薬を含む第2試料を用いて測定されるので、免疫試薬の影響を受けてしまう。従って、その免疫試薬の影響の大きさを示す値である補正値を、前記第2光強度信号の値から差し引いて、前記第2光強度信号の値を補正するようにしている。前記補正値は、免疫試薬そのものの影響の大きさを示す第1補正値と、免疫試薬と第2試料中のCRPとの免疫反応の影響の大きさを示す第2補正値との和である。 The correction value and each related value will be described. The hemoglobin concentration is calculated based on the value of the second light intensity signal, but the value of the second light intensity signal is measured using the second sample containing the immunoreagent, and is affected by the immune reagent. End up. Therefore, the value of the second light intensity signal is corrected by subtracting a correction value, which is a value indicating the magnitude of the influence of the immunoreagent, from the value of the second light intensity signal. The correction value is the sum of a first correction value indicating the magnitude of the influence of the immune reagent itself and a second correction value indicating the magnitude of the immune reaction between the immune reagent and the CRP in the second sample. .
第1補正値は、予め定められた第1関連値に基づいて算出される値であり、ここでは第1関連値に等しい。第1関連値は、ヘモグロビン濃度等の測定に先立って、前記希釈液によって所定倍率に希釈した(ここでは前記第2試料と概略同じ所定倍率に希釈してある)前記免疫試薬を生成し、前記セル10に収容した免疫試薬に対し、第2光源70から光を照射したときの透過光強度に関連する値(ここでは透過光強度を示す値)である。 The first correction value is a value calculated based on a predetermined first related value, and here is equal to the first related value. Prior to measurement of hemoglobin concentration or the like, the first related value is generated at a predetermined magnification with the diluent (here, diluted to approximately the same predetermined magnification as the second sample), and generates the immune reagent, This is a value related to the transmitted light intensity when light is irradiated from the second light source 70 to the immunoreagent contained in the cell 10 (here, a value indicating the transmitted light intensity).
一方、第2補正値は、全血中のCRP濃度に依存することが本願発明者の鋭意検討により見いだされており、全血中のCRP濃度を変数とする検量線に、全血中のCRP濃度を代入して算出される。前記第2関連値は前記検量線を示す値(ここでは多項式である検量線の係数)である。より詳しくは、第2関連値は、ヘモグロビン濃度等の測定に先立って全血中のCRP濃度が既知であり、その濃度が互いに異なる複数種類の全血に、溶血試薬及び免疫試薬を供給して複数種類の基準試料を生成し、セル10に収容した各基準試料に対し、前記第2光源から光をそれぞれ照射したときの複数の透過光強度に関連する値であり、ここでは、前記複数の透過光強度を示す値に基づいて算出した、透過光強度と全血中のCRP濃度との関係を示す検量線を示す値である。 On the other hand, the present inventors have found that the second correction value depends on the CRP concentration in whole blood, and the inventors have found that the second correction value depends on the CRP concentration in whole blood. Calculated by substituting the concentration. The second related value is a value indicating the calibration curve (here, the coefficient of the calibration curve which is a polynomial). More specifically, the second related value is obtained by supplying a hemolytic reagent and an immunological reagent to a plurality of types of whole blood whose blood concentrations are different from each other, in which the CRP concentration in the whole blood is known prior to measurement of the hemoglobin concentration or the like. It is a value related to a plurality of transmitted light intensities when a plurality of types of reference samples are generated and each reference sample accommodated in the cell 10 is irradiated with light from the second light source. It is a value indicating a calibration curve indicating the relationship between the transmitted light intensity and the CRP concentration in whole blood, calculated based on the value indicating the transmitted light intensity.
また、第2関連値はこれに限られるものではなく、第2関連値を検量線を示す値とした場合の他の例について言えば、第2関連値記憶部55が、前記複数の透過光強度を示す値を第2関連値として記憶し、補正値算出部本体56が、その複数の値から全血中のCRP濃度に応じて1つの値を選び出し、その値を第2補正値として算出するようにしたものを挙げることができる。 In addition, the second related value is not limited to this. For another example in which the second related value is a value indicating a calibration curve, the second related value storage unit 55 includes the plurality of transmitted lights. The value indicating the intensity is stored as a second related value, and the correction value calculation unit main body 56 selects one value from the plurality of values according to the CRP concentration in the whole blood, and calculates the value as the second correction value. You can list what you do.
Hgb算出部本体53は、第2光検出手段80から受け付けた第2光強度信号の値と、前記補正値との差分を算出して、第2光強度信号の値を補正する。また、Hgb算出部本体53は、ヘモグロビン濃度が既知である全血を用いて予め算出しておいた、前記ヘモグロビン濃度と前記差分との関係を示す検量線を記憶しており、その検量線に算出した差分を代入して、ヘモグロビン濃度を算出する。 The Hgb calculation unit main body 53 calculates the difference between the value of the second light intensity signal received from the second light detection means 80 and the correction value, and corrects the value of the second light intensity signal. In addition, the Hgb calculation unit main body 53 stores a calibration curve indicating the relationship between the hemoglobin concentration and the difference, which has been calculated in advance using whole blood having a known hemoglobin concentration, and the calibration curve is included in the calibration curve. The calculated difference is substituted to calculate the hemoglobin concentration.
Hct換算部57は、前記Hgb算出部51で算出したヘモグロビン濃度を、予め定められた換算式を用いてヘマトクリット値に換算するものである。 The Hct conversion unit 57 converts the hemoglobin concentration calculated by the Hgb calculation unit 51 into a hematocrit value using a predetermined conversion formula.
次に、この血液分析装置100の動作手順について図2のフローチャートを参照しながら説明する。まず、前記全血供給ノズルの先端に前記採血容器中の全血が浸かるように、前記採血容器を近づけた状態で、オペレータが測定開始スイッチを入れると(ステップS1)、前記制御部からの指令を受けて、前記全血供給ノズルが、所定量の全血をセル10に供給する(ステップS2)。次に、試薬供給手段20が、セル10に収容された全血に溶血試薬、緩衝試薬、及び免疫試薬を順次供給して第1試料を生成する(ステップS3)。さらに、第1光源30が前記第1試料に光を照射し(ステップS4)、第1光検出手段40が、第1試料を透過した光の強度を示す第1光強度信号を測定して出力する(ステップS5)。 Next, the operation procedure of the blood analyzer 100 will be described with reference to the flowchart of FIG. First, when the operator turns on the measurement start switch with the blood collection container approaching so that the whole blood in the blood collection container is immersed in the tip of the whole blood supply nozzle (step S1), a command from the control unit In response, the whole blood supply nozzle supplies a predetermined amount of whole blood to the cell 10 (step S2). Next, the reagent supply means 20 sequentially supplies a hemolysis reagent, a buffer reagent, and an immune reagent to the whole blood stored in the cell 10 to generate a first sample (step S3). Further, the first light source 30 irradiates the first sample with light (step S4), and the first light detection means 40 measures and outputs a first light intensity signal indicating the intensity of the light transmitted through the first sample. (Step S5).
さらに、前記制御部からの指令により、前記セル10の排出口から第1試料の一部を排出して、前記セル10に所定量の第1試料を残す(ステップS6)。希釈手段60は、セル10に残された第1試料に所定量の希釈液を供給して、前記第1試料を所定倍率に希釈し、第2試料を生成する(ステップS7)。 Further, according to a command from the control unit, a part of the first sample is discharged from the discharge port of the cell 10 to leave a predetermined amount of the first sample in the cell 10 (step S6). The diluting means 60 supplies a predetermined amount of diluent to the first sample remaining in the cell 10, dilutes the first sample at a predetermined magnification, and generates a second sample (step S7).
前記制御部からの指令により、第2光源70が前記第2試料に光を照射し(ステップS8)、第2光検出手段80が、第2試料を透過した光の強度を示す第2光強度信号を測定して出力する(ステップS9)。 In response to a command from the control unit, the second light source 70 irradiates the second sample with light (step S8), and the second light detection means 80 indicates the second light intensity indicating the intensity of the light transmitted through the second sample. The signal is measured and output (step S9).
CRP算出部50は、前記第1光強度信号の値の時間変化量を、予め算出しておいた検量線に代入して全血中のCRP濃度を算出する(ステップS10)。補正値算出部52の補正値算出部本体56は、全血中のCRP濃度を、第2関連値記憶部55が記憶している第2関連値を係数とする検量線に代入して、前記第2補正値を算出する一方、第1関連値記憶部54が記憶している第1関連値を、前記第1補正値として受け付け、第1補正値と第2補正値との和である補正値を算出する(ステップS11)。Hgb算出部本体53は、前記第2光検出手段80から受け付けた前記第2光強度信号の値と、前記補正値との差分を算出し、その差分を予め算出しておいた検量線に代入して、ヘモグロビン濃度を算出する(ステップS12)。 The CRP calculating unit 50 calculates the CRP concentration in whole blood by substituting the time change amount of the value of the first light intensity signal into a previously calculated calibration curve (step S10). The correction value calculation unit main body 56 of the correction value calculation unit 52 substitutes the CRP concentration in whole blood into a calibration curve having the second related value stored in the second related value storage unit 55 as a coefficient, and While calculating the second correction value, the first related value stored in the first related value storage unit 54 is accepted as the first correction value, and the correction is the sum of the first correction value and the second correction value. A value is calculated (step S11). The Hgb calculation unit main body 53 calculates a difference between the value of the second light intensity signal received from the second light detection means 80 and the correction value, and substitutes the difference into a previously calculated calibration curve. Then, the hemoglobin concentration is calculated (step S12).
Hct換算部57は、Hgb算出部51で算出した前記ヘモグロビン濃度を、予め定められた換算式を用いてヘマトクリット値に換算する(ステップS13)。CRP算出部50は、前記全血中のCRP濃度及びヘマトクリット値に基づいて、血漿中のCRP濃度を算出する(ステップS14)。プリンタのような出力手段が、算出されたヘモグロビン濃度や血漿中のCRP濃度を出力する(ステップS15)。 The Hct conversion unit 57 converts the hemoglobin concentration calculated by the Hgb calculation unit 51 into a hematocrit value using a predetermined conversion formula (step S13). The CRP calculating unit 50 calculates the CRP concentration in plasma based on the CRP concentration and hematocrit value in the whole blood (step S14). An output means such as a printer outputs the calculated hemoglobin concentration and plasma CRP concentration (step S15).
本実施形態に係る血液分析方法によって補正した第2光強度信号の値(前記差分)を用いて算出した吸光度と、ヘモグロビン濃度との相関性を示すグラフを図3に示す。相関係数の平均値は0.988であり、相関性は十分高く、本実施形態に係るヘモグロビン濃度の測定方法は十分に精度が高いことが分かる。 A graph showing the correlation between the absorbance calculated using the value of the second light intensity signal corrected by the blood analysis method according to the present embodiment (the difference) and the hemoglobin concentration is shown in FIG. The average value of the correlation coefficient is 0.988, the correlation is sufficiently high, and it can be seen that the hemoglobin concentration measuring method according to the present embodiment is sufficiently accurate.
本実施形態によれば、CRP濃度の測定に用いた後の第1試料を希釈して第2試料を生成し、その第2試料を用いてヘモグロビン濃度を測定するようにしているので、試薬等の供給回数及び供給に用いるノズルの洗浄回数を減らすことができ、測定時間を短縮できるとともに、手間を軽減することができる。また、ヘモグロビン測定用の試料と、CRP測定用の試料とを別々に一定量以上確保しなくとも良いので、測定精度を担保しながらも、試薬の使用量を減らしてランニングコストを低減できる。また、血液の採取量を減らして血液を採取される被験者の負担を軽減することも可能である。 According to the present embodiment, the second sample is generated by diluting the first sample used for measuring the CRP concentration, and the hemoglobin concentration is measured using the second sample. The number of times of supply and the number of times of cleaning the nozzle used for supply can be reduced, the measurement time can be shortened, and labor can be reduced. In addition, since it is not necessary to secure a certain amount or more separately for the hemoglobin measurement sample and the CRP measurement sample, it is possible to reduce the amount of reagent used and reduce the running cost while ensuring the measurement accuracy. It is also possible to reduce the burden on the subject who collects blood by reducing the amount of blood collected.
また、全血に免疫試薬を供給すると、例えば全血中のCRPと免疫試薬中の免疫成分とが免疫反応するので、この反応物を利用してCRP濃度が測定される。一方、前記反応物は、ヘモグロビン濃度の測定においては測定の妨げとなってしまうという問題がある。これに対し、第1試料を所定倍率に希釈して第2試料を生成してあるので、例えば前記反応物のような免疫試薬の影響を可及的に低減して、ヘモグロビン濃度を精度良く測定することができる。 Further, when an immunoreagent is supplied to whole blood, for example, CRP in whole blood and an immune component in the immunoreagent undergo an immunoreaction, and the CRP concentration is measured using this reaction product. On the other hand, there is a problem that the reaction product hinders measurement in measuring hemoglobin concentration. On the other hand, since the second sample is produced by diluting the first sample at a predetermined magnification, for example, the influence of an immune reagent such as the reaction product is reduced as much as possible to accurately measure the hemoglobin concentration. can do.
また、Hgb測定及びCRP測定に同一のセル10を用いているので、測定の種類ごとに異なるセルを設ける必要がなく、製造コストを抑えることができる。さらに、全血をセル10に供給する際には、前記全血供給ノズルに、前記採血容器中の全血を短時間接触させるだけでよいので、前記採血容器を保持しておくホルダ等を省略することができる。 Moreover, since the same cell 10 is used for Hgb measurement and CRP measurement, it is not necessary to provide different cells for each type of measurement, and the manufacturing cost can be suppressed. Further, when whole blood is supplied to the cell 10, the whole blood in the blood collection container only needs to be brought into contact with the whole blood supply nozzle for a short time, so that a holder or the like for holding the blood collection container is omitted. can do.
また、全血を用いた測定では、血漿中のCRP濃度を算出するために、ヘマトクリット値を用いる必要がある。従来、ヘマトクリット値は、電気抵抗法により算出されているため、電極等を設ける必要があり、製造コストがかかってしまう。これに対し、本発明の発明者は鋭意検討により、前記ヘモグロビン濃度からヘマトクリット値を精度良く換算できることを見出した。この換算を本実施形態の血液分析装置100で用いているため、電極等を省略でき、製造コストを抑えることができる。 In the measurement using whole blood, it is necessary to use a hematocrit value in order to calculate the CRP concentration in plasma. Conventionally, since the hematocrit value has been calculated by the electric resistance method, it is necessary to provide an electrode or the like, which increases manufacturing costs. On the other hand, the inventors of the present invention have found that hematocrit values can be accurately converted from the hemoglobin concentration by intensive studies. Since this conversion is used in the blood analyzer 100 of the present embodiment, electrodes and the like can be omitted, and the manufacturing cost can be reduced.
加えて言えば、CRP測定に用いられた第1試料全てを希釈するのではなく、第1試料の一部を希釈して第2試料を生成するようにしているので、希釈液の消費を抑えることができ、ランニングコストを抑えることができる。 In addition, not all of the first sample used for CRP measurement is diluted, but a part of the first sample is diluted to generate the second sample, so that consumption of the diluent is suppressed. Running costs can be reduced.
なお、本発明はこれらの実施形態に限られるものではない。例えば、CRP測定に用いられた第1試料全てを希釈して、第2試料を生成するようにしてもよい。 The present invention is not limited to these embodiments. For example, all the first samples used for CRP measurement may be diluted to generate the second sample.
また、ヘモグロビン濃度からヘマトクリット値を算出し、ヘマトクリット値及び全血中のCRP濃度に基づいて、血漿中のCRP濃度を算出するようにしたが、ヘマトクリット値を算出するという工程を経ずに、ヘモグロビン濃度及び全血中のCRP濃度に基づいて、血漿中のCRP濃度を算出するようにしてもよい。また、ヘモグロビン濃度を算出せず、第1光強度信号の値及び第2光強度信号の値から血漿中のCRP濃度を算出するようにしてもよい。 Further, the hematocrit value is calculated from the hemoglobin concentration, and the CRP concentration in the plasma is calculated based on the hematocrit value and the CRP concentration in the whole blood. However, without the step of calculating the hematocrit value, the hemoglobin is calculated. The CRP concentration in plasma may be calculated based on the concentration and the CRP concentration in whole blood. Alternatively, the CRP concentration in plasma may be calculated from the value of the first light intensity signal and the value of the second light intensity signal without calculating the hemoglobin concentration.
また、第1光強度信号の値の時間変化量から、全血中のCRP濃度を算出するようにしたが、第1光強度信号の値から算出するようにしてもよい。同様に、第2光強度信号の値からヘモグロビン濃度を算出するようにしたが、第2光強度信号の値の時間変化量から算出するようにしてもよい。 Further, the CRP concentration in the whole blood is calculated from the time change amount of the value of the first light intensity signal, but it may be calculated from the value of the first light intensity signal. Similarly, the hemoglobin concentration is calculated from the value of the second light intensity signal, but may be calculated from the amount of time change of the value of the second light intensity signal.
さらに、試薬供給手段についていえば、1つの試薬供給ノズルによって、各試薬を第1セルに供給するようにしてもよいし、各試薬に対応する複数の試薬供給ノズルを設けて、各試薬を供給するようにしてもよい。また、溶血試薬供給手段と、緩衝試薬供給手段と、免疫試薬供給手段とは一体で設けられるものとしたが、それぞれ別体で設けてもよい。同様に、試薬供給手段と希釈手段とは一体で設けても良いし、別体で設けても良い。 Further, regarding reagent supply means, each reagent may be supplied to the first cell by one reagent supply nozzle, or a plurality of reagent supply nozzles corresponding to each reagent are provided to supply each reagent. You may make it do. In addition, the hemolytic reagent supply unit, the buffer reagent supply unit, and the immunoreagent supply unit are provided integrally, but they may be provided separately. Similarly, the reagent supply unit and the diluting unit may be provided integrally or separately.
第1光源及び第2光源はLEDのようなピークを有する光を射出する単波長光源としたが、例えばXeランプのような連続スペクトル光を射出する連続スペクトル光源と、所定の波長範囲の光だけを透過させ、その他の波長範囲の光を遮光する光学フィルタとを具備する光源装置であってもよい。また、同一の連続スペクトル光源に対して、異なる光学フィルタを用いることにより、第1光源及び第2光源を構成してもよい。 The first light source and the second light source are single-wavelength light sources that emit light having a peak such as an LED, but only a continuous spectrum light source that emits continuous spectrum light such as an Xe lamp and light in a predetermined wavelength range. And a light source device including an optical filter that blocks light in other wavelength ranges. Moreover, you may comprise a 1st light source and a 2nd light source by using a different optical filter with respect to the same continuous spectrum light source.
また、第1光検出手段及び第2光検出手段は別体で設けられるものとしたが、一体で設けられてもよい。 Moreover, although the 1st light detection means and the 2nd light detection means shall be provided separately, you may provide integrally.
前記第1関連値は、前記第2試料と同じ希釈倍率(以下、基準倍率ともいう)に希釈した免疫試薬及びヘモグロビン測定に用いるセル(以下、このセルのセル長を基準セル長ともいう)を用いて測定した透過光強度を示す値としたが、基準倍率とは異なる希釈倍率に希釈した前記免疫試薬や、基準セル長とは異なるセル長のセルを用いて測定した透過光強度を示す値としてもよい。その場合、第1補正値は、第1関連値に所定値αを乗じた値とすればよく、その所定値αは、基準倍率に対する希釈倍率の比率や、基準セル長に対するセル長の比率に応じて定めた値(例えば、各比率が1である場合はα=1)とすればよい。 The first related value includes an immunoreagent diluted to the same dilution factor as the second sample (hereinafter also referred to as a reference magnification) and a cell used for hemoglobin measurement (hereinafter, the cell length of this cell is also referred to as a reference cell length). A value indicating the transmitted light intensity measured using the immunoreagent diluted to a dilution ratio different from the reference magnification or a cell having a cell length different from the reference cell length. It is good. In that case, the first correction value may be a value obtained by multiplying the first related value by a predetermined value α, and the predetermined value α is a ratio of the dilution ratio to the reference magnification or a ratio of the cell length to the reference cell length. A value determined accordingly (for example, α = 1 when each ratio is 1) may be used.
さらに、複数の希釈倍率やセル長が選択できる場合には、複数の希釈倍率に希釈した免疫試薬及び複数のセル長のセルを用いて透過光強度をそれぞれ測定し、測定した複数の透過光強度を示す値を第1関連値として記憶しておき、その中から前記選択に応じて1つを選び出し、第1補正値としてもよい。 Furthermore, when multiple dilution ratios and cell lengths can be selected, the transmitted light intensity is measured using immunoreagents diluted to multiple dilution ratios and cells with multiple cell lengths, and the measured multiple transmitted light intensities are measured. May be stored as a first related value, and one of them may be selected according to the selection, and used as the first correction value.
また、例えば複数の選択肢から希釈倍率やセル長を選ぶのではなく、所定範囲内の任意の希釈倍率やセル長を選択することができる場合には、検量線を用いることが望ましい。具体的には、複数の希釈倍率に希釈した免疫試薬及び複数のセル長のセルを用いて透過光強度をそれぞれ測定し、透過光強度と、前記セル長又は希釈倍率との関係を示す検量線を算出し、その検量線を示す値(例えば多項式である検量線の係数)を第1関連値とする。そして、前記セル長及び希釈倍率を、第1関連値を係数とする検量線に代入して、第1補正値を算出すればよい。 For example, it is desirable to use a calibration curve when an arbitrary dilution rate and cell length within a predetermined range can be selected instead of selecting a dilution rate and cell length from a plurality of options. Specifically, each of the transmitted light intensity is measured using an immunoreagent diluted to a plurality of dilution ratios and a cell having a plurality of cell lengths, and a calibration curve showing the relationship between the transmitted light intensity and the cell length or the dilution ratio. And a value indicating the calibration curve (for example, a coefficient of the calibration curve which is a polynomial) is set as the first related value. Then, the first correction value may be calculated by substituting the cell length and the dilution factor into a calibration curve having the first related value as a coefficient.
第2関連値についても、第1関連値と同様に、希釈倍率やセル長を考慮した値としてもよい。例えば希釈倍率やセル長に応じて、透過光強度と全血中のCRP濃度の関係を示す検量線(具体的には多項式である検量線の係数)を選び出すものを挙げることができる。より具体的には、上述した第1関連値と同様に、複数組の係数を第2関連値として第2関連値記憶部に記憶しておき、その複数組の係数から希釈倍率及びセル長の選択に応じて1組を選び出し、前記検量線の係数としてもよい。また、希釈倍率又はセル長と、検量線の係数との関係式を算出しておき、その関係式の係数を第2関連値として第2関連値記憶部に記憶しておいてもよい。 Similarly to the first related value, the second related value may be a value in consideration of the dilution rate and the cell length. For example, a calibration curve (specifically, a coefficient of a calibration curve that is a polynomial) showing the relationship between the transmitted light intensity and the CRP concentration in whole blood can be cited according to the dilution factor and the cell length. More specifically, similarly to the first related value described above, a plurality of sets of coefficients are stored as second related values in the second related value storage unit, and the dilution factor and cell length are determined from the plurality of sets of coefficients. One set may be selected according to the selection and used as the coefficient of the calibration curve. Further, a relational expression between the dilution factor or cell length and the coefficient of the calibration curve may be calculated, and the coefficient of the relational expression may be stored in the second related value storage unit as the second related value.
また、各関連値又は各補正値は、希釈倍率やセル長だけではなく、各試薬や希釈液の種類、各試薬及び希釈液の供給量、各試薬や希釈液同士の比率等に応じて算出されるものとしてもよい。 In addition, each related value or each correction value is calculated based not only on the dilution factor and cell length, but also on the type of each reagent and diluent, the amount of each reagent and diluent supplied, the ratio between each reagent and diluent, etc. It is good also as what is done.
一方、全血中のCRP濃度があまり変動しないことが見込まれる場合のような、全血中のCRP濃度が第2補正値に与える影響が実質的に変化しない場合には、第2補正値を、例えば全血中のCRP濃度が所定値(例えば平均値)である全血に、溶血試薬及び免疫試薬を供給して生成した基準試料に対し、前記第2光源から光を照射したときの透過光強度を示す値を第2関連値としてもよい。 On the other hand, when the influence of the CRP concentration in the whole blood on the second correction value does not substantially change, such as when the CRP concentration in the whole blood is expected not to fluctuate so much, the second correction value is set. For example, transmission when light is irradiated from the second light source to a reference sample generated by supplying a hemolyzing reagent and an immune reagent to whole blood in which the CRP concentration in the whole blood is a predetermined value (for example, an average value) A value indicating the light intensity may be set as the second related value.
前記各関連値は、第2光源を用いて得た透過光強度に関連する値としたが、例えば第2光源からの光の波長域を含む光を射出する光源のような、前記第2光源と同等の光源を用いて得た透過光強度に関連する値としてもよい。また、各関連値は、透過光強度、光透過率又は吸光度を示す値であってもよい。 Each of the related values is a value related to the transmitted light intensity obtained by using the second light source. For example, the second light source such as a light source that emits light including a wavelength range of light from the second light source. It is good also as a value relevant to the transmitted-light intensity | strength obtained using the light source equivalent to. Further, each related value may be a value indicating transmitted light intensity, light transmittance, or absorbance.
前記制御部は、この血液分析装置100の各部が、測定開始から所定時間経過後に動作するように、指令を出力するものとしたが、免疫試薬や希釈液の供給のような所定動作から所定時間経過後に、前記各部が動作するように指令を出力するものとしてもよい。その他、本発明はその趣旨を逸脱しない範囲で種々変形が可能である。 The control unit outputs a command so that each unit of the blood analyzer 100 operates after a predetermined time has elapsed from the start of measurement. However, the control unit outputs a command for a predetermined time from a predetermined operation such as supply of an immune reagent or a diluent. It is good also as what outputs a command so that each above-mentioned part may operate after progress. In addition, the present invention can be variously modified without departing from the spirit of the present invention.
100・・・血液分析装置
10・・・セル
20・・・試薬供給手段
30・・・第1光源
40・・・第1光検出手段
50・・・CRP算出部
51・・・Hgb算出部
60・・・希釈手段
70・・・第2光源
80・・・第2光検出手段
DESCRIPTION OF SYMBOLS 100 ... Blood analyzer 10 ... Cell 20 ... Reagent supply means 30 ... 1st light source 40 ... 1st light detection means 50 ... CRP calculation part 51 ... Hgb calculation part 60 ... Dilution means 70 ... Second light source 80 ... Second light detection means
Claims (5)
前記第1試料に光を照射する第1光源と、
前記第1光源から射出されて前記第1試料を透過した光を受光し、その強度を示す第1光強度信号を出力する第1光検出手段と、
前記第1試料に希釈液を供給して、前記第1試料を所定倍率に希釈し、第2試料を生成する希釈手段と、
前記第2試料に光を照射する第2光源と、
前記第2光源から射出されて前記第2試料を透過した光を受光し、その強度を示す第2光強度信号を出力する第2光検出手段と、
前記第2光強度信号の値及び免疫試薬の影響の大きさを示す値である補正値に基づいて、ヘモグロビン濃度を算出するHgb算出部と、
前記第1光強度信号の値及び前記ヘモグロビン濃度に基づいて前記全血における血漿中のC−反応性蛋白質濃度を算出するCRP算出部とを具備することを特徴とする血液分析装置。 A reagent supply means for generating a first sample by supplying a hemolysis reagent and an immune reagent to whole blood to be measured;
A first light source for irradiating the first sample with light;
First light detection means for receiving light emitted from the first light source and transmitted through the first sample, and outputting a first light intensity signal indicating the intensity;
Dilution means for supplying a diluent to the first sample, diluting the first sample at a predetermined magnification, and generating a second sample;
A second light source for irradiating the second sample with light;
Second light detection means for receiving light emitted from the second light source and transmitted through the second sample, and outputting a second light intensity signal indicating the intensity;
An Hgb calculator that calculates a hemoglobin concentration based on a correction value that is a value indicating the magnitude of the influence of the second light intensity signal and the immunoreagent ;
A blood analyzer comprising: a CRP calculating unit that calculates a C-reactive protein concentration in plasma of the whole blood based on the value of the first light intensity signal and the hemoglobin concentration.
前記Hgb算出部が、前記第1関連値及び前記第2光強度信号の値に基づいて、ヘモグロビン濃度を算出するものである請求項1記載の血液分析装置。 Related to the transmitted light intensity when the immunoreagent diluted at a predetermined magnification with the diluent is irradiated with light from the second light source or a light source that emits light including a wavelength range of light from the second light source. A first related value storage unit that stores a first related value that is a value;
The blood analyzer according to claim 1, wherein the Hgb calculation unit calculates a hemoglobin concentration based on the first related value and the value of the second light intensity signal.
前記Hgb算出部が、第2関連値と、前記第1光強度信号の値と、前記第2光強度信号の値とに基づいて、ヘモグロビン濃度を算出するものである請求項1記載の血液分析装置。 The wavelength range of light from the second light source or the second light source with respect to a reference sample generated by supplying a hemolysis reagent and an immunoreagent to whole blood with a known C-reactive protein concentration in the whole blood. A second related value storage unit that stores a second related value that is a value related to the transmitted light intensity when light is emitted from a light source that emits light,
The blood analysis according to claim 1, wherein the Hgb calculation unit calculates a hemoglobin concentration based on a second related value, a value of the first light intensity signal, and a value of the second light intensity signal. apparatus.
前記Hgb算出部が、該補正値及び前記第2光強度信号の値に基づいてヘモグロビン濃度を算出するものである請求項3記載の血液分析装置。 The correction value is calculated from the second related value and the C-reactive protein concentration in whole blood calculated from the value of the first light intensity signal,
The blood analyzer according to claim 3, wherein the Hgb calculating unit calculates a hemoglobin concentration based on the correction value and the value of the second light intensity signal.
前記第1試料に光を照射し、前記第1試料を透過した光を受光し、その強度を示す第1光強度を測定する第1光強度測定ステップと、
前記第1試料に希釈液を供給して、前記第1試料を所定倍率に希釈し、第2試料を生成する希釈ステップと、
第2試料に光を照射し、前記第2試料を透過した光を受光し、その強度を示す第2光強度を測定する第2光強度測定ステップと、
前記第2光強度及び免疫試薬の影響の大きさを示す値である補正値に基づいて、全血中のヘモグロビン濃度を算出するHgb算出ステップと、
前記第1光強度及び前記ヘモグロビン濃度に基づいて血漿中のC−反応性蛋白質濃度を算出するCRP算出ステップとを具備することを特徴とする血液分析方法。
A reagent supplying step of supplying a hemolysis reagent and an immune reagent to whole blood to generate a first sample;
A first light intensity measuring step of irradiating the first sample with light, receiving light transmitted through the first sample, and measuring a first light intensity indicating the intensity;
A dilution step of supplying a diluent to the first sample, diluting the first sample at a predetermined magnification, and generating a second sample;
A second light intensity measuring step of irradiating the second sample with light, receiving the light transmitted through the second sample, and measuring a second light intensity indicating the intensity;
An Hgb calculating step of calculating a hemoglobin concentration in whole blood based on a correction value which is a value indicating the magnitude of the influence of the second light intensity and the immune reagent ;
A blood analysis method comprising: a CRP calculating step of calculating a C-reactive protein concentration in plasma based on the first light intensity and the hemoglobin concentration.
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