CN110967307A - Hematocrit measuring device - Google Patents

Hematocrit measuring device Download PDF

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Publication number
CN110967307A
CN110967307A CN201911162996.5A CN201911162996A CN110967307A CN 110967307 A CN110967307 A CN 110967307A CN 201911162996 A CN201911162996 A CN 201911162996A CN 110967307 A CN110967307 A CN 110967307A
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light
detection
hematocrit
light source
instant
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李锐
储强平
徐嘉兴
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Ningbo Ziyuan Medical Instrument Co ltd
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    • GPHYSICS
    • G01MEASURING; TESTING
    • G01NINVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N21/00Investigating or analysing materials by the use of optical means, i.e. using sub-millimetre waves, infrared, visible or ultraviolet light
    • G01N21/17Systems in which incident light is modified in accordance with the properties of the material investigated
    • G01N21/25Colour; Spectral properties, i.e. comparison of effect of material on the light at two or more different wavelengths or wavelength bands
    • G01N21/31Investigating relative effect of material at wavelengths characteristic of specific elements or molecules, e.g. atomic absorption spectrometry
    • GPHYSICS
    • G01MEASURING; TESTING
    • G01NINVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N21/00Investigating or analysing materials by the use of optical means, i.e. using sub-millimetre waves, infrared, visible or ultraviolet light
    • G01N21/17Systems in which incident light is modified in accordance with the properties of the material investigated
    • G01N21/25Colour; Spectral properties, i.e. comparison of effect of material on the light at two or more different wavelengths or wavelength bands
    • G01N21/255Details, e.g. use of specially adapted sources, lighting or optical systems
    • GPHYSICS
    • G01MEASURING; TESTING
    • G01NINVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N21/00Investigating or analysing materials by the use of optical means, i.e. using sub-millimetre waves, infrared, visible or ultraviolet light
    • G01N21/62Systems in which the material investigated is excited whereby it emits light or causes a change in wavelength of the incident light
    • G01N21/63Systems in which the material investigated is excited whereby it emits light or causes a change in wavelength of the incident light optically excited
    • G01N21/64Fluorescence; Phosphorescence
    • G01N21/6428Measuring fluorescence of fluorescent products of reactions or of fluorochrome labelled reactive substances, e.g. measuring quenching effects, using measuring "optrodes"
    • GPHYSICS
    • G01MEASURING; TESTING
    • G01NINVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N21/00Investigating or analysing materials by the use of optical means, i.e. using sub-millimetre waves, infrared, visible or ultraviolet light
    • G01N21/75Systems in which material is subjected to a chemical reaction, the progress or the result of the reaction being investigated
    • G01N21/76Chemiluminescence; Bioluminescence
    • GPHYSICS
    • G01MEASURING; TESTING
    • G01NINVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N33/00Investigating or analysing materials by specific methods not covered by groups G01N1/00 - G01N31/00
    • G01N33/48Biological material, e.g. blood, urine; Haemocytometers
    • G01N33/50Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing
    • G01N33/53Immunoassay; Biospecific binding assay; Materials therefor

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  • Chemical & Material Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Immunology (AREA)
  • Biochemistry (AREA)
  • Analytical Chemistry (AREA)
  • General Health & Medical Sciences (AREA)
  • General Physics & Mathematics (AREA)
  • Pathology (AREA)
  • Engineering & Computer Science (AREA)
  • Spectroscopy & Molecular Physics (AREA)
  • Hematology (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Urology & Nephrology (AREA)
  • Molecular Biology (AREA)
  • Biomedical Technology (AREA)
  • Optics & Photonics (AREA)
  • Cell Biology (AREA)
  • Biotechnology (AREA)
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  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
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  • Investigating, Analyzing Materials By Fluorescence Or Luminescence (AREA)
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Abstract

The invention relates to a hematocrit detection device for an instant immunity detection system, which at least comprises one or more point light sources capable of emitting light rays with different wavelengths, one or more light ray receivers arranged on a light path and receiving the transmitted light rays, a sample container and a mounting base. And calculating the hematocrit of the whole blood sample by detecting the absorbance of the sample. A device for converting and reporting a plasma concentration of a detection index by a hematocrit value. The instant detection system comprises an instant fluorescence immunoassay system or an instant chemiluminescence immunoassay system, and is characterized in that the fluorescence immunoassay system and the chemiluminescence immunoassay system consist of a disposable immunoassay kit and a quantitative detection instrument matched with the kit.

Description

Hematocrit measuring device
Technical Field
The present invention relates to a hematocrit detection device. The instant hematocrit detecting device comprises at least one or more single-wavelength light emitting units and at least one or more specific-wavelength light intensity detecting units. Belongs to the field of medical biochemical inspection.
Background
The biochemical luminescence detection system in the traditional sense is mostly a desk type or vertical type instrument, is mostly placed in a clinical examination mechanism or a laboratory, and has the characteristics of large flux and large volume. The full-automatic chemiluminescence detection instrument frees experimenters from complicated manual operation, can obtain a plurality of test results in unit time, and is suitable for the current requirements of clinical examination. However, in some special occasions, such as instant detection at the bedside, the huge full-automatic system cannot meet the requirements, and at the moment, a portable instrument with quick detection and small volume is needed, so that the system is suitable for field detection at the bedside and the like.
In recent years, there have been studies and developments on a biochemical luminescence apparatus based on point-of-care testing (POCT). Although a whole blood sample can be adopted in the biochemical luminescence instrument based on POCT detection at home and abroad, the sample treatment is not needed, and the rapid and convenient detection can be realized compared with a large-scale instrument in a clinical examination mechanism or a laboratory, the measurement result is mostly influenced by the hematocrit in the whole blood sample, a linear fitting mode is basically adopted for achieving the purpose of reliable detection result, the method has the defects that the method is particularly prominent, and especially when the hematocrit difference is large, the deviation of the detection result after fitting can reach more than +/-20% compared with the measurement result of plasma or serum. Based on the above, the inventor proposes a device which is designed by a spectrophotometry method according to the characteristic that different hematocrits of a sample are correlated with the absorbance value of the sample at a specific wavelength, has a very small volume and can carry out instant hematocrit detection, and the detection result of the device can be consistent with the hematocrit measurement result of a clinical laboratory. When the biochemical luminescence instrument for POCT detection detects a whole blood sample, the hematocrit of the sample can be measured at the same time, and the influence of the hematocrit on the POCT detection result can be eliminated by recalculating the hematocrit and the POCT detection result.
Disclosure of Invention
The invention aims to solve the problems, and provides a method applied to an instant immunoassay system, which can eliminate the influence of hematocrit on a measurement result when a whole blood sample is measured, so that the instant immunoassay system does not need to process the sample in the detection process, and the result accuracy is consistent with the measurement result of blood plasma or blood serum.
Technical scheme of the invention
1. A hematocrit detection device characterized by being an instant hematocrit detection device; the detection device at least comprises one or more point light sources capable of emitting light rays with different wavelengths, one or more light ray receivers arranged on a light path and used for receiving transmitted light rays, a sample container and a mounting base; (ii) a The detection device is a hematocrit detection device which is matched with a disposable immunoassay kit with the functions of diluting and processing a whole blood sample; the detection device is characterized in that a light source with a specific wavelength passes through a whole blood sample solution at a certain light intensity, and the volume occupied by blood cells in the whole blood is calculated according to the light intensity attenuation.
2. The invention relates to a hematocrit detecting device, which is characterized in that the point light source of the device comprises one or more point light sources capable of emitting light rays with different wavelengths;
the light receiver is a sensor which is arranged on one or more than one light path and receives light;
the data processing integrated circuit comprises a light source regulating and controlling circuit and a transmission light ray detection and processing circuit;
the mounting base is a mechanical structure which can fix the light source, the receiver and the integrated circuit on the base and can be mounted on an instant detection system;
the sample container for detection is mainly characterized by comprising a transparent tip head, a cuvette, a kit and other sample containers.
3. The hematocrit detection device is characterized in that the light source can provide light with specific wavelength or wavelength band, the hematocrit detection device can adopt an LED lamp or a laser, and can also adopt one or more of a common light source and a grating or a combined lens, the selectable range of the wavelength is 400-800nm, preferably 410-625nm, and the diameter of a light spot is 2-5 mm;
the light receiver can adopt a photodiode, a light sensing IC, or one or more of the light sensing IC and a grating or a combined lens, and the wavelength selectable range is 400-;
the data processing integrated circuit can control and adjust the intensity of the light source, can obtain the value of the light intensity sensor, and can also process and analyze data.
Positive significance of the invention
The invention provides a hematocrit detection device, which takes a single-wavelength point light source as an irradiation light source and a photodiode as a receiver, and a movable or fixed sample container to quickly detect the hematocrit. The invention has the advantages of simple and compact structure, small volume, good external interference resistance, high sensitivity and high detection accuracy. The invention can also finish the detection of specific items by replacing point light sources with different wavelengths and replacing different sample containers, has strong practicability and wide applicability, and can be widely applied to various devices, thereby having great popularization and application values.
Drawings
Fig. 1 is a schematic cross-sectional view of the present invention, wherein 1 is a light source, 2 is a light outlet, 3 is a base, 4 is a sample container, 5 is a light inlet, and 6 is a light receiver.
Fig. 2 is a schematic diagram of a single-channel cross-sectional structure of the chemiluminescence instant detection system of the present invention, wherein 1 is an led light source, 2 is a light exit hole, 3 is a base, 5 is a light entrance hole, 6 is a photodiode, and 7 is a tip head.
FIG. 3 is a cross-sectional view of a blood sample testing structure of the chemiluminescent in-situ test system of the present invention, wherein 3 is a multi-channel test base structure and 7 is a tip sampling head.
FIG. 4 is a diagram of a data processing integrated circuit simulation.
Detailed description of the invention
The hematocrit detection device of the invention mainly uses a light source with specific wavelength to pass through a whole blood sample solution at a certain light intensity, and calculates the volume of blood cells in the whole blood according to the light intensity attenuation. The hematocrit detection device mainly comprises a light source (1), a light receiver (6), a data processing integrated circuit, a mounting base (3) and a sample container (4) for detection.
The light source (1) is mainly characterized by comprising one or more point light sources capable of emitting light rays with different wavelengths;
the light receiver (6) is mainly characterized by a sensor which is arranged on one or more light paths and receives transmitted light;
the data processing integrated circuit is mainly characterized by comprising a light source regulating and controlling circuit and a transmission light ray detection and processing circuit;
the mounting base (3) is mainly characterized in that the light source (1), the light receiver (6) and the data processing integrated circuit can be fixed on the base, and the mounting base can be mounted on a mechanical structure on an instant detection system;
the sample container (4) for detection is mainly characterized by comprising a transparent tip head (7), a cuvette, a kit and other sample containers.
The hematocrit detection device is mainly characterized in that the hematocrit detection device can be mainly used for various immunofluorescence analysis instruments or various chemiluminescence immunoassay analysis instruments, and is particularly used for small fluorescence immunoassay or chemiluminescence immunoassay detection instruments adopting whole blood samples in the POCT field.
Wherein:
1) a light source is characterized in that light with specific wavelength or wavelength band can be provided, an LED lamp or a laser can be adopted, one or more of a common light source and a grating or a combined lens can be adopted, the selectable range of the wavelength is 400-800nm, preferably 410-625nm, and the diameter of a light spot is 2-5 mm.
2) A light receiver is characterized in that a photodiode, a photosensitive IC, or one or more of a photosensitive IC plus a grating or a combined lens can be adopted, and the wavelength can be selected from the range of 400-.
3) A data processing integrated circuit is characterized in that the intensity of a light source can be controlled and adjusted, the value of a light intensity sensor can be obtained, and analysis data can be processed.
4) A mounting base structure is characterized in that a light source can be fixed, a parallel light outlet channel is provided, a sensor and an integrated circuit are fixed, a parallel light inlet channel is provided, the light outlet channel of interference light is cut off, a multi-path detection unit can be mounted on the whole base, and a mechanical structure is fixed on an instant detection system.
5) A container for detecting a sample is characterized by containing the sample, comprising a transparent tip head, a cuvette, a kit and the like, and being arranged in the middle of a parallel light path.
Examples
The present invention will be described in detail with reference to examples.
Example 1 hematocrit detecting device
The hematocrit detection device mainly comprises a light source (1), a light receiver (6), a data processing integrated circuit, a mounting base (3) and a sample container (4) for detection, wherein:
the light source can provide light with specific wavelength or wavelength range, and can adopt an LED lamp or a laser, or can adopt one or more of a common light source and a grating or a combined lens, wherein the wavelength range is 400-800nm, preferably 410-625nm, and the diameter of a light spot is 2-5 mm.
The light receiver can adopt a photodiode, a photosensitive IC, or one or more of the photosensitive IC and a grating or a combined lens, and the wavelength can be selected from the range of 400-.
The data processing integrated circuit includes a light source control circuit and a light detection and processing circuit, as shown in fig. 4.
The mounting base can fix the light source, provide parallel light outlet channel, fix the sensor and the integrated circuit, provide parallel light inlet channel, separate the light outlet channel of the interference light, and the whole base can be provided with a plurality of detection units and fixed on a mechanical structure of the instant detection system.
The detection sample container can contain a sample, comprises a transparent tip head, a cuvette, a kit and the like, and is arranged in the middle of the parallel light path.
Example 2 hematocrit test result comparison
The result of the hematocrit test device of the present invention was compared with the result of the clinical laboratory full-automatic hematology analyzer, and the results are shown in table 1.
TABLE 1 comparison of measurement results of the present invention (A) and the Beckmann DxH800 full-automatic blood cell analyzer (B)
Sample number (Whole blood) A(vol%) B(vol%) Sample number (Whole blood) A(vol%) B(vol%)
1 23.8 24.1 7 52.1 52.4
2 33.0 32.9 8 54.4 54.1
3 34.3 34.2 9 62.2 62.5
4 42.6 42.8 10 63.4 63.2
5 45.5 45.6 11 66.7 66.9
6 47.8 47.3 12 71.4 70.3
Example 3-comparison of the results of the measurement of NT-proBNP content in a sample using the instant chemiluminescence immunoassay system using the hematocrit detection device of the present invention and Roche cobas e411 type electrochemiluminescence immunoassay system.
The results of the measurement of whole blood samples by the instant chemiluminescence immunoassay system (A) using the hematocrit detection device of the present invention and the measurement of NT-proBNP of the plasma of the samples by the Roche cobas e411 type electrochemiluminescence immunoassay system (B) are shown in Table 2.
TABLE 2 results of NT-proBNP assay using two assay systems, A and B
Sample number A B Sample number A B Sample number A B
1 0.0183 0.0179 5 0.597 0.593 9 1.479 1.481
2 0.0785 0.0788 6 1.325 1.325 10 2.724 2.728
3 0.176 0.174 7 1.246 1.251 11 3.810 3.812
4 0.408 0.411 8 1.333 1.329 12 9.975 9.979
Example 4- -comparison of the results of the instant fluorescence immunoassay system using the hematocrit detecting device of the present invention and the results of the Roche cobas e411 type electrochemiluminescence immunoassay system for measuring the NT-proBNP content in the sample
The results of the measurement of whole blood samples by the instant fluorescence immunoassay system (A) using the hematocrit detection apparatus of the present invention and the measurement of NT-proBNP of the plasma of the samples by the Roche cobas e411 type electrochemical luminescence immunoassay system (B) are compared, and are shown in Table 3.
TABLE 3 results of NT-proBNP assay using both assay systems A and B
Sample number A B Sample number A B Sample number A B
1 0.0353 0.0349 5 0.879 0.877 9 3.478 3.481
2 0.0585 0.0588 6 1.551 1.555 10 4.723 4.725
3 0.346 0.347 7 1.862 1.857 11 5.710 5.712
4 0.613 0.611 8 2.333 2.329 12 25.779 25.785

Claims (4)

1. A hematocrit detection device characterized by being an instant hematocrit detection device; the detection device at least comprises one or more point light sources capable of emitting light rays with different wavelengths, one or more light ray receivers arranged on a light path and used for receiving transmitted light rays, a sample container and a mounting base; the detection device is a hematocrit detection device which is matched with a disposable immunoassay kit with the functions of diluting and processing a whole blood sample; the detection device is characterized in that a light source with a specific wavelength passes through a whole blood sample solution at a certain light intensity, and the volume of blood cells in the whole blood is calculated according to the light intensity attenuation so as to convert and report the plasma concentration of a detection index and a biomarker in the whole blood sample.
2. A hematocrit detection device according to claim 1, wherein the device comprises:
the point light sources comprise one or more point light sources capable of emitting light rays with different wavelengths;
the light receiver is a sensor which is arranged on one or more than one light path and receives light;
the data processing integrated circuit comprises a light source regulating and controlling circuit and a transmission light ray detection and processing circuit;
the mounting base is a mechanical structure which can fix the light source, the receiver and the integrated circuit on the base and can be mounted on an instant detection system;
the sample container for detection is mainly characterized by comprising a transparent tip head, a cuvette, a kit and other sample containers.
3. The hematocrit detecting device according to claims 1 and 2, wherein the light source is capable of providing light with specific wavelength or wavelength band, and the hematocrit detecting device is characterized in that one or more of an LED lamp or a laser, a common light source and a grating or a combined lens can be adopted, the wavelength can be selected from the range of 400-;
the light receiver can adopt a photodiode, a light sensing IC, or one or more of a light sensing IC and a grating or a combined lens, and the wavelength can be selected from the range of 400-800nm, preferably 410-625 nm;
the data processing integrated circuit can control and adjust the intensity of the light source, can obtain the value of the light intensity sensor and can also process and analyze data;
the mounting base structure is characterized in that a light source can be fixed, a parallel light outlet channel is provided, a sensor and an integrated circuit are fixed, a parallel light inlet channel is provided, an interference light outlet channel is cut off, a multi-path detection unit can be mounted on the whole base, and the whole base is fixed on a mechanical structure of an instant detection system.
4. A hematocrit test device according to claim 1 wherein each of the fluoroimmunoassay or chemiluminescent immunoassay instruments is used in particular in a miniaturized fluoroimmunoassay and chemiluminescent immunoassay point-of-care testing system using whole blood samples.
CN201911162996.5A 2019-11-22 2019-11-22 Hematocrit measuring device Pending CN110967307A (en)

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Cited By (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN115248323A (en) * 2021-04-26 2022-10-28 深圳市帝迈生物技术有限公司 Test stand and POCT blood cell analyzer
CN119846191A (en) * 2024-12-31 2025-04-18 深圳市新产业生物医学工程股份有限公司 Immunological detection method for to-be-detected object in whole blood sample

Citations (7)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US6064474A (en) * 1998-02-06 2000-05-16 Optical Sensors, Inc. Optical measurement of blood hematocrit incorporating a self-calibration algorithm
CN1914511A (en) * 2003-12-02 2007-02-14 扎芬纳股份公司 Hematocrit and analyte concentration determination
CN203595662U (en) * 2013-09-30 2014-05-14 江苏英诺华医疗技术有限公司 Photoelectric detection device with multiple detection positions
US20150118689A1 (en) * 2013-10-24 2015-04-30 Quidel Corporation Systems and methods for whole blood assays
US20160238521A1 (en) * 2013-10-16 2016-08-18 Institut National De La Sante Et De La Recherche Medical Simultaneous monitoring of fibrinogen and haematocrit in whole blood
CN108732134A (en) * 2018-07-18 2018-11-02 上海原科实业发展有限公司 A kind of scattering of multi-wavelength and transmittance opacimetry device
CN109975564A (en) * 2019-03-21 2019-07-05 厦门先明生物技术有限公司 A kind of integrated reagent automatic detection device of microfluid immunoassay

Patent Citations (7)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US6064474A (en) * 1998-02-06 2000-05-16 Optical Sensors, Inc. Optical measurement of blood hematocrit incorporating a self-calibration algorithm
CN1914511A (en) * 2003-12-02 2007-02-14 扎芬纳股份公司 Hematocrit and analyte concentration determination
CN203595662U (en) * 2013-09-30 2014-05-14 江苏英诺华医疗技术有限公司 Photoelectric detection device with multiple detection positions
US20160238521A1 (en) * 2013-10-16 2016-08-18 Institut National De La Sante Et De La Recherche Medical Simultaneous monitoring of fibrinogen and haematocrit in whole blood
US20150118689A1 (en) * 2013-10-24 2015-04-30 Quidel Corporation Systems and methods for whole blood assays
CN108732134A (en) * 2018-07-18 2018-11-02 上海原科实业发展有限公司 A kind of scattering of multi-wavelength and transmittance opacimetry device
CN109975564A (en) * 2019-03-21 2019-07-05 厦门先明生物技术有限公司 A kind of integrated reagent automatic detection device of microfluid immunoassay

Cited By (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN115248323A (en) * 2021-04-26 2022-10-28 深圳市帝迈生物技术有限公司 Test stand and POCT blood cell analyzer
CN119846191A (en) * 2024-12-31 2025-04-18 深圳市新产业生物医学工程股份有限公司 Immunological detection method for to-be-detected object in whole blood sample

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Application publication date: 20200407