JP2010032447A - Immunochromatography measuring device - Google Patents

Abstract

<P>PROBLEM TO BE SOLVED: To provide an immunochromatography measuring device capable of starting measurement properly and improving the reliability of a measured result without useless human manpower. <P>SOLUTION: The immunochromatography measuring device (hereafter abbreviated as a measuring device) includes an adding state detecting unit 102 for detecting that blood is added to the adding section 12 of a chromatography testpiece 15 (hereafter abbreviated as a testpiece) attached to the measuring device, and a controller 110 for starting the measurement to the testpiece 15 by a measuring unit 103 from the information that the blood is added by the adding-state detecting unit 102 and displaying the measured result on a display section 104, as the measured result outputting unit. With this configuration, addition is performed such as, by dotting blood to the adding section 12 of the testpiece 15 in the state that the testpiece 15 is attached to the measuring device, and measurement to the developing channel and the immobilization reacting section of the testpiece 15 is started by the detection of the added state automatically and the measured result is output. <P>COPYRIGHT: (C)2010,JPO&INPIT

Description

  The present invention relates to an immunochromatography measuring apparatus for analyzing an analyte in blood using immunochromatography.

  In recent years, with the improvement of home medical care and regional medical care such as clinics and clinics, as well as the early diagnosis and the increase in urgent clinical tests, even if you are not a clinical laboratory specialist, There has been a demand for an analyzer that can perform highly accurate measurement simply and quickly. For this reason, a small analyzer for POCT (Point of Care Testing), which can perform highly reliable measurement in a short time without complicated operations, is in the spotlight.

  POCT is a general term for tests performed in “close to patients” such as practitioners, specialists' examination rooms, wards, and clinics for outpatients. It is a method that has been attracting attention as a great help in improving the quality of medical care by performing various treatments and performing treatment processes and even prognostic monitoring. Compared to inspections in the central laboratory, such small analyzers can reduce the cost of sample transport, equipment, and unnecessary inspections, reducing total inspection costs. The POCT market is said to be possible, and is rapidly expanding in the US, where hospital management rationalization is progressing, and is expected to become a growth market in Japan and other countries.

  Test specimens as dry analytical elements such as immunochromatographic sensors do not require reagent adjustment, and simple operations such as dropping a liquid sample such as blood or urine to be measured onto the specimen. As a representative of POCT, it is possible to analyze the analyte contained in the liquid sample only, and it is very useful for analyzing the analyte in the liquid sample easily and quickly. Today, many are being put to practical use in various clinics, general outpatients, wards, emergency outpatients, and emergency sites.

  In immunochromatographic test strips using antigen-antibody reactions (hereinafter abbreviated as chromatographic test strips), the sensing reaction is performed with a high degree of specificity and a strong binding force. Therefore, in the analysis of physiologically active substances present at extremely low concentrations, Excellent characteristics than other test pieces. Today, using this principle, many diagnostic agents such as pregnancy diagnostic agents, cancer marker diagnostic agents, and myocardial marker diagnostic agents are commercially available and used in the medical field.

  An example of a general configuration of the chromatographic test piece is shown in FIGS. As shown in FIGS. 8A to 8C, the general configuration of the chromatographic test piece is composed of a porous carrier such as nitrocellulose or glass fiber filter paper on a substrate 1 such as a PET sheet, and the analyte. A developing flow channel 2 in which an immobilization reaction part 3 in which a reagent that specifically reacts with the immobilization reagent is immobilized, and a labeling reagent labeled with a reagent that specifically reacts with the analyte and the immobilization reagent are liquid A reaction reagent carrying part 4 held in a liquid permeable material so as to be easily eluted by permeation of the sample, and a liquid disposed on the reaction reagent carrying part 4 or upstream of the reaction reagent carrying part 4 in the chromatographic flow direction. A sample addition region 5 to which a sample is added and a water absorption part 18 for absorbing the developed liquid sample in the downstream region in the chromatographic flow direction are provided. Then, on the substrate 1, the upstream end of the reaction reagent carrier 4 is brought into contact with the downstream end of the sample addition region 5 in order from the upstream side in the chromatographic flow direction, and the development flow channel 2 is connected to the downstream end of the reaction reagent carrier 4. Are arranged so that the upstream end of the water absorption part 18 is in contact with the downstream end of the development flow path 2. Here, the test piece constituent members other than the substrate 1 (the sample addition region 5, the reaction reagent holding part 4, the development flow path 2 and the water absorption part 18) are all made of a liquid-permeable material. In many cases, as shown in FIG. 9, this chromatographic test piece is provided with a sample addition portion 23 and a result confirmation window 22 so that a part of the immobilized reaction portion 3 and the sample addition region 5 are exposed to the outside. It is comprised in the state accommodated in the inside of the hollow casing 21 which consists of the obtained liquid-impermeable material.

  The flow and measurement principle of a liquid sample such as blood in the chromatographic test strip will be described. First, a liquid sample is added to the sample addition unit 23. The added liquid sample spreads over the entire sample addition region 5 and develops while being absorbed by capillarity due to the constituent material of the test piece. The liquid sample that has developed from the sample addition region 5 and has reached the reaction reagent carrier 4 is further developed in the downstream direction while eluting the labeling reagent. , And further expands to the downstream region and is absorbed by the water absorption part 18. Here, when an analysis object is included in the liquid sample, the analysis object first reaches the reaction reagent carrying part 4 and then, by a specific binding reaction with the labeling reagent, “labeling reagent-analysis”. Forming a complex of objects. This “labeling reagent-analyte complex” is developed into the development flow path 2 together with the liquid sample, and further reaches the immobilization reaction section 3. In the immobilization reaction unit 3, the “labeling reagent-analyte complex” undergoes a specific binding reaction with the immobilization reagent to form a “labeling reagent-analyte-immobilization reagent complex”. In the immobilization reaction unit 3, the color reaction derived from the labeling reagent according to the concentration of the analysis object can be confirmed from the result confirmation window 22. General chromatographic specimens represented by this configuration are widely distributed in the market, such as for hospitals and general households. Here, as an example of the immune reaction, the measurement principle has been described by taking the sandwich reaction forming the “labeling reagent-analyte-immobilization reagent complex” as an example, but a competitive reaction is often used.

  On the other hand, although not an immunochromatographic measurement method, what is currently positioned as the ultimate POCT is blood glucose measurement self-monitoring (SMBG). This is a system that measures blood glucose levels of diabetic patients anytime, anywhere easily. A doctor or the patient himself punctures a fingertip to produce a small amount of blood and to a test piece set (mounted) on the measuring device. The blood glucose level can be measured in a short time only by the operation of spotting.

  In Patent Document 1 and Patent Document 2, as a method for measuring the glucose concentration in the blood, a blood addition part (capillary chamber) capable of holding 1 μL or less of blood and a blood addition part are provided. A test piece comprising an electrode, a reagent layer containing at least an enzyme in contact with a working electrode and a mediator is disclosed, and when blood is applied to the blood addition part of the test piece, the blood is contained in the blood addition part. A method has been reported in which the glucose concentration in blood is quantified by measuring the amount of electrons generated by the oxidation-reduction reaction after 10 seconds after being held and rapidly reacting with the reagent in the reagent layer.

According to this method, it can be seen that the glucose concentration in the blood using the electrode can be easily and rapidly measured with a small amount of blood.
However, this method cannot be applied to chromatographic test pieces. This is because in the case of measuring the glucose concentration in blood using an electrode, the blood remains held at a predetermined location on the electrode and has a structure with the electrode, so that the blood is relatively easily placed on the electrode. While it can be detected that it has been added (spotted) at a predetermined location, in the case of a chromatographic test strip, the added blood does not continue to be retained in part, but is quickly developed in the development flow path. Therefore, the conventional structure cannot detect the timing at which blood is added (spotted) to the chromatographic test piece. Further, it is difficult to accurately count the time since blood is actually added without detecting the timing at which blood is added (spotted).

  If the chromatographic test strip is mounted in advance on the measuring device before spotting blood on the chromatographic test strip, a start button is provided on the measuring device to start the measurement after mounting the chromatographic test strip. It is necessary to add the liquid sample (blood) to the chromatographic test piece and simultaneously press the start button. In addition, when the liquid sample is added to the chromatographic test piece and this chromatographic test piece is attached to the measuring device, the measurement of the measurement time is started from the timing when the chromatographic test piece is attached to the measuring device. Some errors occur from the timing of addition. For these reasons, use of a simple measurement means such as Patent Documents 1 and 2 using an immunochromatographic sensor without an electrode causes an error in measurement timing, which in turn results in an error in measurement results. It will not be suitable for.

  As a conventional simple immunoassay method, Patent Document 3 describes a test element holder for positioning a test element, a test element having a sample addition zone and a detection zone, an irradiation device, a sensor array, a transducer, and a digital signal. A quantitative analysis evaluation system for a test element comprising an evaluation unit and a display device for displaying an evaluation result is disclosed.

  In this quantitative analysis and evaluation system, an immunochromatographic sensor (chromatographic test piece) is positioned while being inserted into a holder, and measurement is performed using a transducer evaluation unit while irradiating light from the irradiation device to the immunochromatographic sensor. In addition, it is described that quantitative analysis and evaluation can be performed by displaying the result using a display device.

  Patent Document 4 discloses at least one body fluid sample measuring instrument including a housing, a logic circuit arranged in the housing, a visual display arranged in the housing, and a measurement system arranged in the housing. A cartridge with a lateral flow assay test strip is disclosed. The lateral flow assay test strip includes a lateral flow transport matrix, a specific binding assay zone on the transport matrix for receiving a fluid sample and performing a specific binding assay to generate a detectable response; a fluid And a general chemical assay zone on the transport matrix for receiving a general sample and performing a general chemical assay to generate a detectable response. The cartridge is also dimensioned so that it can be received in a body fluid analyte meter and the measurement system is positioned to detect responses in the specific binding assay zone and the general chemical assay zone in the lateral flow assay test strip. A bodily fluid sample measuring instrument is included, and these constitute a combined system of the bodily fluid sample measuring instrument and the cartridge.

According to this composite system, it is described that an assay capable of measuring a specific binding reaction and a general chemical assay can be measured more accurately by using a body fluid sample measuring instrument and a cartridge.
US Pat. No. 7,276,146 US Pat. No. 7,276,147 Special table 2000-507353 Special table 2007-528005

  However, in any of the quantitative analysis and evaluation system disclosed in Patent Document 3 and the composite system disclosed in Patent Document 4, the test element and the cartridge are set in the measurement system and the body fluid sample measuring instrument. There is no suggestion about the description of the means for starting the measurement or the specific operation method at the start of the measurement.

  That is, in the quantitative analysis / evaluation system disclosed in Patent Document 3 and the composite system disclosed in Patent Document 4, measurement is started by adding a specimen such as blood and simultaneously pressing the start button. If the structure is used, for accurate measurement, it is necessary to make the addition of the blood sample and the timing to press the start button constant every time. Forgetting to press this start button In such a case, the measurement time becomes unknown, and the time required for measurement cannot be accurately observed, so that the accuracy of the measurement result is also lacking. In some cases, when the test element is measured, the test element may not be suitable for measurement. In this case, there is a possibility that the measurement may become impossible. Must be tested.

  In addition, as described above, after adding a liquid sample to the chromatographic test piece, in the case of adopting a configuration in which this chromatographic test piece is attached to the measuring device, in order to start counting the measurement time from the timing attached to the measuring device, Some error occurs from the timing of actually adding the liquid sample.

  The present invention solves the above-mentioned problems, and in an immunochromatography measuring apparatus for qualitatively or quantitatively analyzing an analyte in blood using immunochromatography, the measurement can be started satisfactorily without bothering humans. Thus, an object of the present invention is to provide an immunochromatography measuring apparatus capable of improving the reliability of measurement results.

  In order to solve the above-mentioned problems, an immunochromatography measuring device of the present invention can be equipped with a chromatographic test piece having an addition part to which blood is added, a development channel, and an immobilization reaction part. An immunochromatography measuring device that qualitatively or quantifies an analyte in blood using chromatography, and that blood has been added to the addition part of a chromatographic test piece attached to the immunochromatography measuring device And a control for starting measurement on the chromatographic test piece by the measuring means based on the information that the blood is added by the adding state detecting means and outputting the measurement result to the measurement result outputting means. Means.

  With this configuration, with the chromatographic test piece attached to the immunochromatography measuring device, this addition state is detected by adding blood by, for example, spotting blood to the addition portion of the chromatographic test piece, and automatically Thus, the measurement of the development flow path and the immobilized reaction part of the chromatographic test piece is started, and the measurement result is output. This allows the start button for starting measurement to be performed when blood is spotted on the addition portion of the chromatography test piece while the chromatography test piece is mounted on an immunochromatography measurement device as has been conventionally done. Forgetting to press it will not cause the inaccuracy of the measurement result, or the problem of having to collect blood again and re-measure. In addition, in order to monitor the measurement state from the timing of mounting on the immunochromatography measurement device and start counting the measurement time, after adding blood to the chromatographic test strip, a configuration in which this chromatographic test strip is mounted on the measurement device was adopted. As in the case, there is no problem that some error occurs from the timing when blood is actually added. As a result, it is possible to reliably eliminate a measurement error that has occurred due to variations in measurement time, and to realize highly accurate measurement.

  The chromatographic test piece shown here is a test piece that can be chromatographed from a liquid sample, which is made of any material or structure that can move the liquid by capillary force, and is formed in a fine space, for example. And any liquid permeable material such as a porous membrane or glass fiber filter paper, but preferably the development channel is a single layer. The chromatographic test piece may be formed using anything such as a membrane filter typified by nitrocellulose, a fine fiber channel formed of glass fiber filter paper, cellulose filter paper, liquid impermeable material, or the like.

  In addition, the immunochromatography measuring device of the present invention is characterized by comprising a mounting state detecting means for detecting that a chromatographic test piece is mounted on the immunochromatographic measuring device.

  With this configuration, it is possible to perform an addition state detection operation for detecting that blood has been added to the addition part after the chromatographic test piece is mounted on the immunochromatography measurement device, so the measurement time can be accurately measured. Therefore, not only high-precision measurement is possible, but also power saving can be achieved.

In addition, the immunochromatography measuring device of the present invention is characterized in that the addition state detection means optically detects that blood has been added to the addition portion.
With this configuration, it is possible to satisfactorily detect that blood has been added to the adding portion.

  Further, the immunochromatography measuring apparatus of the present invention recognizes the addition state of blood to the addition portion of the chromatography test piece detected by the addition state detection means, and determines whether or not the added blood is an appropriate amount Means are provided.

  With this configuration, it is possible to determine whether or not an appropriate amount of blood has been added to the addition part, and the measurement is performed despite the lack of blood, and a measurement result with low reliability is output. Can be prevented and reliability can be improved.

Moreover, the immunochromatography measuring apparatus of the present invention is characterized in that the addition volume of the addition part is 10 μL or less.
In addition, the immunochromatography measuring apparatus of the present invention is characterized in that it can detect a result of qualitative or quantitative analysis of an analyte in blood within 5 minutes after blood is added to the adding part.

In addition, the immunochromatography measuring device of the present invention is characterized in that the blood added to the adding part is fingertip blood.
In addition, the immunochromatography measuring device of the present invention has an addition state detecting means disposed inside the housing part, and an opening for adding blood in the addition part when the chromatography test piece is attached is provided in the housing part. The chromatographic test piece is mounted so that the portion that is exposed to the outside and detects the addition state in the addition portion is located inside the casing that can be detected by the addition state detection means.

  With this configuration, when blood is added, blood can be added without any trouble from the opening exposed to the outside of the casing, and the addition state detecting means disposed inside the casing allows the casing to be added. The part which detects the addition state in the addition part located in the inside of a body part can be detected favorably.

  As described above, according to the present invention, the addition state detection means for detecting that blood is added to the addition portion of the chromatographic test piece attached to the immunochromatography measuring device, and the blood by this addition state detection means Equipped with a control means for starting measurement on a chromatographic test piece based on the information that the sample is added by the measurement means and outputting the measurement result to the measurement result output means. By simply adding blood to the addition part of the chromatographic test piece, it is automatically detected that blood has been added to the addition part. Information on the state of the reaction and the degree of reaction in the immobilized reaction part are automatically collected, and the analyte is qualitatively or quantitatively measured. As described above, it is possible to automatically perform immunoassay only by adding blood, and simple and rapid measurement can be performed.

  Moreover, unlike the conventional case, there is no problem that the measurement start result is forgotten to be missed and the result of measurement is not accurate or the blood must be collected again to be measured again. As a result, the reliability is improved, and the time and effort for pressing the start button can be saved, so that the usability is also improved. In addition, after adding blood to the chromatographic test piece, there is a problem that some error occurs from the timing when the liquid sample is actually added, as in the case of adopting a configuration in which the chromatographic test piece is attached to the measuring device. Therefore, it is possible to reliably eliminate the measurement error that has occurred due to the variation in the measurement time, and to realize highly accurate measurement.

  In addition, according to the present invention, the chromatographic test strip is mounted on the immunochromatography measuring device by providing the mounting state detecting means for detecting that the chromatographic test strip is mounted on the immunochromatographic measuring device. Therefore, it is possible to perform an addition state detection operation for detecting that blood has been added to the addition unit, and not only can accurately detect that blood has been added to the test piece, but also save power in the measuring device. Can be planned.

  Further, according to the present invention, there is provided a determination means for recognizing the addition state of the blood to the addition portion of the chromatography test piece detected by the addition state detection means and determining whether or not the added blood is an appropriate amount. Therefore, it is possible to determine whether or not an appropriate amount of blood has been added to the addition part, and it is possible to prevent the occurrence of problems such as outputting unreliable measurement results despite the lack of blood. Reliability can be improved.

  In addition, when the addition state detecting means is arranged inside the housing part and the chromatographic test piece is attached, an opening for adding blood in the addition part is exposed to the outside of the housing part, and the addition in the addition part The portion for detecting the state is arranged so that the chromatographic test piece is mounted so as to be located inside the case that can be detected by the addition state detecting means. Blood can be added from the opening exposed to the outside without any trouble, and the addition state in the addition portion located inside the housing portion is detected by the addition state detection means disposed inside the housing portion The portion can be detected well.

  Hereinafter, an immunochromatography measuring apparatus according to the present invention will be described in detail with reference to the drawings. In addition, embodiment shown here is an example to the last, Comprising: It is not necessarily limited to this embodiment.

  FIG. 1 shows a state in which a chromatographic test piece 15 is attached to an immunochromatography measuring apparatus 100 according to an embodiment of the present invention, and the chromatographic test piece 15 can be freely attached to the immunochromatographic measuring apparatus 100. It is configured.

  First, a chromatographic test piece (hereinafter abbreviated as a test piece) 15 attached to the immunochromatography measuring apparatus 100 of the present invention will be described with reference to FIGS. The configuration of the test piece 15 is not limited to the following structure. The test piece 15 includes the addition section 12, the development flow path 2, and the immobilization reaction section 3, and is subjected to analysis in blood using immunochromatography. Anything that measures the presence or concentration of an object may be used.

  As shown in FIGS. 6A to 6C, the test piece 15 includes an addition part (spotting part) 12 to which blood as a liquid sample (specimen) is added (spotting), and a reaction that reacts with blood. A reagent 14, a development channel 2 that develops blood mixed with the reaction reagent 14 or blood that has reacted with the reaction reagent, and a substrate 1 as a support that supports the addition unit 12 and the development channel 2; The presence or concentration of the analyte in the blood is measured using immunochromatography. The addition part 12 is configured by surrounding a fine addition space 9 with a space forming material 8 made of a liquid impermeable material. A reaction reagent 14 containing a labeling reagent is held at a position facing the addition space 9 of the space forming material 8 in the addition section 12 in a state where it can be dissolved in the blood added to the addition space 9. In addition to the labeling reagent, the reaction reagent 14 includes a cell contraction agent that contracts cell components such as blood cells, but is not limited thereto.

  A part of the development flow path 2 is provided with an immobilization reaction part 3 in which a specific protein is immobilized and also used as a measurement region. In addition, the surface of the development flow channel 2 is from the chromatographic upstream region to the chromatographic downstream region including at least the immobilized reaction unit 3 except for the open portion 10 in the downstream end region in the chromatographic flow direction (also referred to as the chromatographic downstream end). It is covered with a liquid-impermeable sheet 7 made of a liquid-impermeable material. In the upstream area of the chromatograph, an addition portion 12 configured by surrounding the minute addition space 9 with the above-described space forming material 8 made of a liquid impermeable material is provided. As shown in FIG. 6B, the addition space 9 is a space corresponding to the upstream end of the chromatograph for aspirating a certain amount of the liquid sample (in this embodiment, a certain amount of the liquid sample is aspirated by capillary action). The tip of the addition space 9 is an opening 11 for supplying a liquid sample to the biosensor. In addition, an air hole 13 for promoting a capillary force to the addition space 9 is formed by being opened at an upper surface portion at one end portion (a chromatographic downstream region) of the space forming material 8 forming the addition space 9. .

  Note that the space forming material 8 that forms the addition portion 12 and the liquid-impermeable sheet 7 that covers the surface of the development flow path 2 are both made of a light-transmitting material, and will be described later. The detection operation that blood is added to the addition part 12 of the test piece 15 and the measurement operation for the development flow path 2 and the immobilized reaction part 3 of the test piece 15 are performed favorably. In this embodiment, the auxiliary substrate 1 that functions as a spacer for adjusting the thickness dimension of the addition space 9 on the substrate 1 that forms the bottom surface portion (support) of the test piece 15 only in the chromatographic upstream region of the test piece 15. The case where 'is overlapped is shown, but the present invention is not limited to this.

  Next, the development state of blood on the test piece 15 will be described with reference to FIGS. FIGS. 7A to 7E are cross-sectional views each showing a development state of the liquid sample in the test piece 15 when blood is added to the test piece 15 according to the embodiment of the present invention.

  As shown in FIG. 7A, when blood A is spotted (added) into the opening 11 of the adding portion 12 (Step 1), a certain amount is added to the adding space 9 as shown in FIG. 7B. The blood is sucked by capillary action, and the addition space 9 is filled with blood (Step 2). When blood is sucked into the addition space 9, the reagent of the reaction reagent 14 (labeling reagent and cell contracting agent) comes into contact with the blood and starts to dissolve quickly. When the addition space 9 is filled with blood, the dissolved labeling reagent and cell contraction agent (hereinafter simply referred to as labeling reagent etc.) react with the blood and diffuse throughout the addition space 9, while FIG. ), The blood develops into the development flow path 2 (Step 3).

  The blood that develops in the development channel 2 develops in a state of reacting with the labeling reagent and the like, and passes through after reaching the immobilization reaction section 3 as shown in FIG. 7 (d) (Step 4). When reaching the immobilization reaction unit 3, when an analyte is present in the blood, a specific reaction is performed between the labeling reagent and the analyte and the immobilization reagent. Color reaction of origin occurs. In the region where the blood further developed through the development flow path 2 is covered with the liquid impermeable sheet 7 in the development flow path 2, moisture evaporation from the surface is prevented by the action of the liquid impermeable sheet 7. Water evaporation begins only after reaching the opening 10 that is not covered by the liquid-impermeable sheet 7 (see FIG. 7E). This drying process assists the movement of the liquid sample and promotes blood development from the addition section 12 to the opening section 10. The addition unit 12 is a fine space composed of a liquid-impermeable material, and moves in the downstream direction of the chromatography by the blood development movement without being held in the fine space (Step 5). By detecting the reaction of the labeling reagent that has appeared in the immobilization reaction part 3 through these processes using immunochromatography, the presence or concentration of the analyte in the blood can be confirmed.

The immunochromatography measuring apparatus 100 to which the test piece 15 is attached is configured as follows.
As shown in FIGS. 1 to 3, the immunochromatography measuring device 100 includes a mounting state detection switch 101 as a mounting state detection unit that detects that the test piece 15 is mounted on the immunochromatography measuring device 100, An addition state imaging sensor 102 as an addition state detection means for detecting the addition of blood to the addition portion 12 of the test piece 15 attached to the immunochromatography measuring apparatus 100, and the development flow path 2 of the test piece 15 The measurement unit 103 including a CCD for measuring the immobilized reaction unit 3, the display unit 104 as a measurement result output unit for displaying the measurement result, and information from the addition state imaging sensor 102 and the measurement unit 103 are displayed. And a control unit 110 for inputting and displaying the measurement result on the display unit 104. The control unit 110 is composed of a microcomputer and the like, and has a counter function such as a timer and a storage unit function for storing various data (not shown).

  When the test piece 15 is attached to the housing part (case part) 105 of the immunochromatography measuring apparatus 100, only the addition part 12 of the test piece 15 is exposed and protrudes to the outside. In addition, the blood A can be directly added (spotted) to the adding portion 12 of the test piece 15. Further, an addition portion irradiation means 106 made of an LED or the like that irradiates light to the addition portion 12 at a position facing the addition portion 12 outside the casing portion 105, and the addition portion irradiated with light by the addition portion irradiation means 106 An addition state imaging sensor 102 that detects 12 addition states is provided.

  Furthermore, the development flow path irradiation which consists of LED etc. which irradiate light so that it may face toward the fixed reaction part 3 in the development flow path 2 of the test piece 15 inside the housing | casing part 105 of the immunochromatography measuring device 100. FIG. Means 107 and the measurement means 103 are arranged. Note that the addition state imaging sensor 102 and the measuring unit 103 are not limited to the above-described configuration, and may be anything that can output an image such as an image sensor or a photodiode or can recognize brightness.

  As shown in FIG. 1, the immunochromatography measuring apparatus 100 is portable, small in size, and lightweight so that it can be placed on the palm. Therefore, it is of a size that can be stored in a desk drawer, bag, or pocket, etc., and can be carried to the desk side in the clinic, home visits, emergency medical treatment sites, health examination venues, travel destinations, etc. Anyone can measure anytime, anywhere.

  The control operation of the control unit 110 in the measurement process by the immunochromatography measuring apparatus 100 in the above configuration will be described with reference to FIG. When the test piece 15 is attached to the immunochromatography measuring apparatus 100 (Step 11), the attachment state detection switch 101 is turned on, and the blood (specimen) detection operation in the adding unit 12 is started (Step 12). In addition, when the test piece to be measured is not properly mounted, such as when the measurement is not possible, a display may be made to prompt the user to remount the test piece.

  When blood is added to the addition part 12 of the test piece 15 attached to the immunochromatography measuring apparatus 100, blood is sucked and held in the addition space 9 of the addition part 12 by capillary flow. The control unit 110 monitors the state in which blood is sucked into the addition space 9 of the addition unit 12 via the addition state imaging sensor 102 (Step 13), and is necessary for measuring the amount of added blood. When the amount has not been reached, it is determined that the addition amount is insufficient (NG), and an instruction is given to redo the addition of blood to the addition unit 12 (Step 14). For example, this redo instruction is displayed on the display unit 104 as “Please reapply blood”. If the amount of blood held in the adding unit 12 is sufficient for measurement, it is determined that the necessary constant amount of blood has been held (OK), and the next step of performing measurement (Step 15) Proceed to Although the details of the method for determining the addition amount will be described later, if a sufficient amount of blood is not added even after a predetermined time has passed, the display unit 104 is displayed with the message “Reattach another test piece to remove blood. Re-measurement with another test piece 15 may be promoted by displaying, for example, “Please reapply”.

  When it is determined that the addition amount is OK (sufficient amount), the time from blood addition is automatically counted simultaneously with the good determination (Step 15), and when the measurement start time is reached, from Step 16 Proceeding to Step 17, based on an algorithm necessary for performing the measurement, which is stored in advance in the storage unit of the control unit 110, arbitrary information is collected at an arbitrary timing and a measurement operation is performed. The collected information is further processed based on an algorithm for analysis (Step 18), and the concentration of the analyte in blood or the presence or absence of the analyte is displayed (Step 19).

  In FIG. 2, the addition part 12 of the test piece 15 and the addition state imaging sensor 102 are configured to exist outside the casing part 105, but a part of the addition part 12 There is no problem even if the addition state imaging sensor 102 is configured to exist inside the housing unit 105. That is, the addition state imaging sensor 102 as the addition state detection means is disposed inside the housing portion 105, and the opening for adding blood in the addition portion 12 when the test piece 15 is attached to the immunochromatography measuring apparatus 100. The part 11 is exposed to the outside of the housing part 105, and the part where the addition state in the addition part 12 is detected (the downstream part of the chromatography in the addition part 12, for example, the vicinity of the air hole 13) can be detected by the addition state imaging sensor 102. The mounting position of the test piece 15 may be arranged so as to be located inside the casing 105.

  Here, FIG. 5 is a diagram simply showing the blood volume detection operation of the adding section 12 in the measurement operation. An example of the blood volume detection operation will be described with reference to FIG. When the state of the test piece 15 attached to the immunochromatography measuring apparatus 100 is monitored by the addition state imaging sensor 102 as the addition state detection means, the state of the addition unit 12 is constantly updated from the state where blood is not added. The signal change of the brightness that is collected (see FIG. 5B) and processed in the brightness state is input to the control unit 110. In addition, the signal change of the brightness of the addition part 12 in case blood is not added is made into the reference value. When a sufficient amount of blood A is added to the addition part 12, the signal change of the lightness of the addition part 12 is greatly different from the reference value when blood A is not added (FIG. 5A). reference). From the difference from the reference value, the control unit 110 determines that a sufficient amount of blood is retained (added) in the adding unit 12, and starts counting the measurement time. On the other hand, when the blood volume is insufficient, in the signal change of the lightness of the addition part 12, a part having a large difference compared to the reference value and a part having no difference are generated (see FIG. 5C). In this case, since the signal change in brightness at the reference position where a sufficient amount of blood A is to be held does not change compared to the reference value, the control unit 110 determines that the blood volume is insufficient, and is insufficient. Is displayed on the display unit 104 to instruct further blood addition or replacement of the test piece 15.

  Thus, according to the embodiment of the present invention, blood is tested in a state where the test piece 15 shown in FIGS. 6 and 7 is attached to the immunochromatography measuring apparatus 100 as shown in FIGS. By adding to the addition part 12 of the piece 15, a measurement is automatically performed and an analysis result is displayed. Thereby, it is possible to automatically perform immunochromatographic measurement only by adding blood to the adding part 12, and it is possible to measure easily and quickly.

  Moreover, unlike the conventional case, there is no problem that the measurement start result is forgotten to be missed and the result of measurement is not accurate or the blood must be collected again to be measured again. As a result, the reliability is improved, and the time and effort for pressing the start button can be saved, so that the usability is also improved.

  In addition, there is no problem that a slight error occurs from the timing when blood is actually added, as in the case of adopting the conventional configuration in which blood is added to the test piece and then the test piece is attached to the measuring device. Therefore, it is possible to reliably eliminate the measurement error that has occurred due to the variation in the measurement time, and it is possible to realize highly accurate measurement.

Note that the blood volume detection method based on the difference in brightness in the above embodiment is merely an example, and there is no problem even if the blood volume is detected using any other method.
In the above-described embodiment, the case of the immunochromatography measuring apparatus 100 that requires mounting (setting) a new test piece 15 on the immunochromatographic measuring apparatus 100 when measuring is described. This is not a limitation. In other words, the immunochromatography measurement device adopts a configuration in which at least one test piece is built in, or a configuration in which a test piece holder in which the test piece is built in is incorporated in the immunochromatography measurement device, Add blood to the test piece addition part by inserting a finger through the insertion hole etc. into the test piece built in the immunochromatography measurement device, or add one of the test piece addition part from the test piece holder. Mounted on the measuring device so that the part can be measured, only the opening, which is the part where blood is actually added in the addition part, jumps out of the housing part of the measuring device, and blood is added to the addition part of the test piece There is no problem even if the measurement is automatically started by any method, such as by performing a calculation process from collecting information for determining the concentration or presence of the analyte by the measurement means. For of ways, there is no problem using any method.

  In addition, as described above, when the test piece 15 is built in, or when the portion other than the opening 11 in the addition portion 12 of the test piece 15 is located inside the housing portion 105, As described above, the addition state detection means and the measurement means may be provided separately. However, the present invention is not limited to this, and the addition state detection means and the measurement means are shared by one means, and the detection or measurement thereof is performed. It is possible to change the direction to be the range to be changed (or to move the test piece), and when detecting the addition state, the state of the addition unit 12 is detected, and thereafter, the addition is detected. Later, the addition state detection means (measurement means) or the test piece may be relatively moved so that the immobilization reaction part 3 can be measured. According to this, the addition state detection means and the measurement means can be used together. Because you can As compared with the case of separately providing, it is possible to further reduce the manufacturing cost.

  The immunochromatography measuring device of the present invention prepares a test strip, a measuring device, and a specimen (blood) when using a test strip using an immune reaction, detects an analyte in the blood, and determines or qualifies When measuring, it is useful as a measuring apparatus and measuring method for POCT capable of realizing simple, rapid, highly sensitive and highly accurate measurement.

BRIEF DESCRIPTION OF THE DRAWINGS FIG. 1 is a perspective view schematically showing a state in which blood is spotted (added) on a chromatographic test piece mounted on an immunochromatography measuring apparatus according to an embodiment of the present invention. Partial cutaway perspective view of the immunochromatography measuring device The block diagram which shows the principal part of the same immunochromatography measuring device Flow chart showing control operation of the immunochromatography measuring apparatus (A)-(c) is a top view of the addition part which concerns on the same immunochromatography measuring device, respectively, and the figure which shows the light-dark state of this location, (a) is a state with sufficient blood volume, (b) is blood Is not spotted (not added), (c) is insufficient blood (A)-(c) are the perspective view, exploded perspective view, and sectional drawing of a chromatographic test piece used for the immunochromatography measuring apparatus (A)-(e) is sectional drawing which shows the expansion | deployment state of the blood in each chromatography test piece, respectively (A)-(c) is a perspective view which shows the structure of the conventional chromatography test piece, an exploded perspective view, and sectional drawing (A) And (b) is the top view and sectional drawing which show the state which accommodated the conventional chromatography test piece in the inside of a hollow casing

Explanation of symbols

DESCRIPTION OF SYMBOLS 1 Substrate 2 Development flow path 3 Immobilization reaction part 8 Space formation material 9 Addition space 11 Opening part 12 Addition part 14 Reaction reagent 15 Chromatography test piece (test piece)
DESCRIPTION OF SYMBOLS 100 Immunochromatography measuring apparatus 101 Wearing state detection switch 102 Addition state imaging sensor 103 Measuring means 104 Display part (measurement result output means)
105 Case 106 Addition Unit Irradiation Means 107 Deployment Channel Irradiation Means 110 Control Unit

Claims (8)

An immunochromatography that can be fitted with a chromatographic test piece having an addition part to which blood is added, a development flow path, and an immobilization reaction part, and qualitatively or quantifies an analyte in blood using immunochromatography. A lithographic measuring device,
An addition state detection means for detecting that blood is added to the addition portion of the chromatographic test piece attached to the immunochromatography measuring device,
And a control means for starting measurement on the chromatographic test piece by the measurement means based on the information that the blood is added by the addition state detection means and outputting the measurement result to the measurement result output means. To perform immunochromatography measurement.   The addition state detecting means optically detects that blood has been added to the adding portion, and is an immunochromatographic measuring device.   The immunochromatography measuring device according to claim 1 or 2, further comprising a mounting state detecting means for detecting that the chromatographic test piece is mounted on the immunochromatographic measuring device.   A determination means for recognizing the addition state of blood to the addition portion of the chromatographic test strip detected by the addition state detection means and determining whether or not the added blood is an appropriate amount is provided. The immunochromatography measuring apparatus according to any one of 1 to 3.   The immunochromatography measuring apparatus according to any one of claims 1 to 4, wherein an addition volume of the addition part is 10 µL or less.   The detection result of qualitative or quantitative analysis of the analyte in the blood within 5 minutes after adding the blood to the adding part can be detected. Immunochromatographic measuring device.   The immunochromatography measuring device according to any one of claims 1 to 6, wherein the blood added to the adding part is fingertip blood.   When the addition state detection means is arranged inside the housing part and the chromatographic test piece is mounted, the opening for adding blood in the addition part is exposed to the outside of the housing part, and the addition state in the addition part is determined. The immunity according to any one of claims 1 to 7, wherein a chromatographic test piece is mounted so that the portion to be detected is located inside the casing that can be detected by the addition state detection means. Chromatographic measuring device.

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