CN113049800A - Immunoassay analyzer, detection method thereof and computer readable storage medium - Google Patents

Immunoassay analyzer, detection method thereof and computer readable storage medium Download PDF

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Publication number
CN113049800A
CN113049800A CN201911384361.XA CN201911384361A CN113049800A CN 113049800 A CN113049800 A CN 113049800A CN 201911384361 A CN201911384361 A CN 201911384361A CN 113049800 A CN113049800 A CN 113049800A
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sample
sensor
detection
detected
detection result
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王锐
覃桂贵
陆锋
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Shenzhen Dymind Biotechnology Co Ltd
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Shenzhen Dymind Biotechnology Co Ltd
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    • 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
    • G01N33/5302Apparatus specially adapted for immunological test procedures
    • 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
    • G01N33/5302Apparatus specially adapted for immunological test procedures
    • G01N33/5304Reaction vessels, e.g. agglutination plates
    • 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
    • G01N33/569Immunoassay; Biospecific binding assay; Materials therefor for microorganisms, e.g. protozoa, bacteria, viruses
    • G01N33/56966Animal cells
    • GPHYSICS
    • G16INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR SPECIFIC APPLICATION FIELDS
    • G16BBIOINFORMATICS, i.e. INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR GENETIC OR PROTEIN-RELATED DATA PROCESSING IN COMPUTATIONAL MOLECULAR BIOLOGY
    • G16B40/00ICT specially adapted for biostatistics; ICT specially adapted for bioinformatics-related machine learning or data mining, e.g. knowledge discovery or pattern finding

Abstract

The application discloses an immunoassay analyzer, a detection method thereof and a computer readable storage medium, wherein the detection method of the immunoassay analyzer comprises the following steps: obtaining a sample to be detected; if the sample to be detected is a serum sample or a plasma sample, inputting the sample to be detected into an immunoassay detection channel for detection, and obtaining a first immunoassay result; and if the sample to be detected is a whole blood sample, inputting the part of the sample to be detected into the immunoassay detection channel for detection to obtain a whole blood detection result, inputting the part of the sample to be detected into the HCT calculation channel to obtain a blood cell detection result, and calculating according to the whole blood detection result and the blood cell detection result to obtain a second immunoassay result. By the mode, equipment cost is saved, and detection efficiency is improved.

Description

Immunoassay analyzer, detection method thereof and computer readable storage medium
Technical Field
The present application relates to the field of immunoassay technologies, and in particular, to an immunoassay analyzer, a detection method thereof, and a computer-readable storage medium.
Background
The immunoassay detection equipment goes through several different development stages of radioimmunoassay, fluorescence immunoassay, enzyme-labeled immunoassay, chemiluminescence immunoassay and the like, and the full-automatic chemiluminescence immunoassay is a new stage of the current immunoassay detection development, has the characteristics of environmental protection, rapidness and accuracy, and is gradually widely accepted by the market.
The chemiluminescence immune analyzer is an in-vitro diagnostic instrument for carrying out immune analysis on a human body by detecting a serum sample. The common chemiluminescence immunoassay analyzer firstly separates a sample before detection, and after separation, a serum or plasma sample is used as a test object to start detection, and the type of the sample supported by the detection equipment is single.
Disclosure of Invention
In order to solve the above problems, the present application provides an immunoassay analyzer, a detection method thereof, and a computer-readable storage medium, which can save equipment cost and improve detection efficiency.
The technical scheme adopted by the application is as follows: provided is a detection method of an immunoassay analyzer, the method comprising: obtaining a sample to be detected; if the sample to be detected is a serum sample or a plasma sample, inputting the sample to be detected into an immunoassay detection channel for detection, and obtaining a first immunoassay result; and if the sample to be detected is a whole blood sample, inputting the part of the sample to be detected into the immunoassay detection channel for detection to obtain a whole blood detection result, inputting the part of the sample to be detected into the HCT calculation channel to obtain a blood cell detection result, and calculating according to the whole blood detection result and the blood cell detection result to obtain a second immunoassay result.
Wherein, before obtaining the sample to be detected, still include: judging whether a sample rack is detected; if yes, detecting the type of the sample container on the sample rack; and detecting the type of the sample to be detected in the corresponding sample container according to the type of the sample container.
Wherein detecting the type of sample container on the sample rack comprises: detecting whether a sample tube is arranged on the sample rack at a first height position by using a first sensor; detecting the height type of the sample tube on the sample rack at a second height position by using a second sample sensor, wherein the second height position is higher than the first height position; detecting the height type of the sample tube on the sample rack at a third height position by using a third sensor, wherein the third height position is higher than the second height position; and determining the type of the sample container on the sample rack according to the detection results of the first sensor, the second sensor and the third sensor.
Wherein, the method also comprises: determining the type of the sample tube on the sample rack at a fourth height position by using a fourth sensor in combination with the first sensor, the second sensor and the third sensor, wherein the fourth height position is lower than the first height position; determining the type of the sample container on the sample rack according to the detection results of the first sensor, the second sensor and the third sensor, including: and determining the type of the sample container on the sample rack according to the detection results of the first sensor, the second sensor, the third sensor and the fourth sensor.
Wherein, input the sample that will wait to detect to immunoassay detection channel detects to obtain first immunodetection result, include: adding a first reagent into the target reaction cup; adding a sample to be detected into a target reaction cup; carrying out uniform mixing operation, incubation operation and magnetic separation operation on the liquid in the target reaction cup in sequence; and detecting the liquid in the target reaction cup, and obtaining a first immune detection result.
Wherein, after carrying out mixing operation, incubation operation and magnetic separation operation in proper order to the liquid in the target reaction cup, still include: adding a second reagent into the target reaction cup; and carrying out uniform mixing operation, incubation operation and magnetic separation operation on the liquid in the target reaction cup in sequence for the second time.
Wherein, after carrying out mixing operation, incubation operation and magnetic separation operation to the liquid in the target reaction cup in proper order again, still include: adding a third reagent into the target reaction cup; and carrying out blending operation, incubation operation and magnetic separation operation on the liquid in the target reaction cup in sequence for the third time.
Wherein, carry out mixing operation, incubation operation and magnetic separation operation in proper order to the liquid in the target reaction cup, include: mixing the liquid in the target reaction cup; placing the target reaction cup in a set temperature environment for incubation operation and continuing for a set time length; and carrying out magnetic separation operation on the liquid in the target reaction cup.
Wherein, detect the liquid in the target reaction cup to obtain first immunodetection result, include: uniformly mixing the liquid in the target reaction cup; and inputting the liquid in the target reaction cup into the optical detection module so that the optical detection module detects the liquid and obtains a first immune detection result.
Wherein, inputting part of the sample to be detected into the HCT calculation channel, and obtaining the blood cell detection result, comprising: adding a diluent into an impedance detection cell; adding a sample to be detected into an impedance detection pool; uniformly mixing the liquid in the impedance detection cell; and detecting the liquid after the mixing operation in the impedance detection pool, and obtaining a blood cell detection result.
Wherein, to detect the liquid after the mixing operation in the impedance detection pond to obtain the blood cell testing result, include: detecting the number RBC and the average volume MCV of the red blood cells of a sample to be detected; the hematocrit HCT is calculated by the following formula and is used as a blood cell detection result: HCT ═ RBC MCV.
Wherein, calculating according to the whole blood detection result and the blood cell detection result to obtain a second immunity detection result, comprising: calculating by adopting the following formula to obtain a second immunodetection result;
Figure BDA0002343146660000031
wherein A is a whole blood detection result, and HCT is a blood cell detection result.
Wherein, the inputting the part of the sample to be detected into the colorimetric detection channel and obtaining the blood cell detection result comprises: adding a hemolytic agent into the impedance detection cell; adding the sample to be detected into the impedance detection cell; uniformly mixing the liquid in the impedance detection cell; and detecting the liquid after the uniform mixing operation in the impedance detection pool, and obtaining a blood cell detection result.
Wherein the pair of the impedance detectionDetecting the liquid after the mixing operation in the pool, and obtaining a blood cell detection result, wherein the method comprises the following steps: detecting the hemoglobin quantity HGB and the average hemoglobin concentration MCHC of the sample to be detected; the hematocrit HCT is calculated by the following formula and is used as a blood cell detection result:
Figure BDA0002343146660000032
wherein the calculating a second immunoassay result according to the whole blood test result and the blood cell test result comprises: calculating by adopting the following formula to obtain a second immunodetection result;
Figure BDA0002343146660000033
wherein A is a whole blood detection result, and HCT is a blood cell detection result.
Another technical scheme adopted by the application is as follows: an immunoassay analyzer is provided comprising a processor and a memory interconnected, the memory for storing program data, the processor for executing the program data to implement the method as described above.
Another technical scheme adopted by the application is as follows: there is provided a computer readable storage medium having stored therein program data for implementing the method as described above when executed by a processor.
The detection method of the immunoassay analyzer provided by the application comprises the following steps: obtaining a sample to be detected; if the sample to be detected is a serum sample or a plasma sample, inputting the sample to be detected into an immunoassay detection channel for detection, and obtaining a first immunoassay result; and if the sample to be detected is a whole blood sample, inputting the part of the sample to be detected into the immunoassay detection channel for detection to obtain a whole blood detection result, inputting the part of the sample to be detected into the HCT calculation channel to obtain a blood cell detection result, and calculating according to the whole blood detection result and the blood cell detection result to obtain a second immunoassay result. Through the mode, the immunoassay detection can be carried out on the serum sample, the plasma sample and the whole blood sample on the same immunoassay analyzer, the equipment cost is saved, and the detection efficiency is improved.
Drawings
In order to more clearly illustrate the technical solutions in the embodiments of the present application, the drawings needed to be used in the description of the embodiments are briefly introduced below, and it is obvious that the drawings in the following description are only some embodiments of the present application, and it is obvious for those skilled in the art to obtain other drawings based on these drawings without creative efforts. Wherein:
FIG. 1 is a first perspective view of the interior of a first embodiment of an immunoassay analyzer provided herein;
FIG. 2 is a second perspective view of the interior of the first embodiment of the immunoassay analyzer provided herein;
FIG. 3 is a schematic perspective view of an impedance cell assembly of a first embodiment of an immunoassay analyzer provided herein;
FIG. 4 is a schematic perspective view of a cuvette assembly according to a first embodiment of an immunoassay analyzer provided herein;
FIG. 5 is a schematic flow chart diagram of one embodiment of a detection method of the immunoassay analyzer provided herein;
fig. 6 is a schematic perspective view of an autoinjection device provided herein;
FIG. 7 is a schematic perspective view of a partial assembly of the autoinjector of FIG. 6;
FIG. 8 is a schematic perspective view of a partial assembly of the autoinjector of FIG. 6;
FIG. 9 is a schematic side view of various sample tubes;
FIG. 10 is a schematic diagram of a first flow chart of step 52 of FIG. 9;
FIG. 11 is a second schematic flow chart of step 52 of FIG. 9;
FIG. 12 is a third schematic flow chart of step 52 of FIG. 9;
FIG. 13 is a schematic flow chart diagram illustrating one embodiment of impedance detection provided herein;
FIG. 14 is a schematic flow diagram of one embodiment of colorimetric detection provided herein;
FIG. 15 is a schematic structural view of a second embodiment of the immunoassay analyzer provided herein;
FIG. 16 is a schematic structural diagram of an embodiment of a computer-readable storage medium provided in the present application.
Detailed Description
The technical solutions in the embodiments of the present application will be clearly and completely described below with reference to the drawings in the embodiments of the present application. It is to be understood that the specific embodiments described herein are merely illustrative of the application and are not limiting of the application. It should be further noted that, for the convenience of description, only some of the structures related to the present application are shown in the drawings, not all of the structures. All other embodiments, which can be derived by a person skilled in the art from the embodiments given herein without making any creative effort, shall fall within the protection scope of the present application.
The terms "first", "second", etc. in this application are used to distinguish between different objects and not to describe a particular order. Furthermore, the terms "include" and "have," as well as any variations thereof, are intended to cover non-exclusive inclusions. For example, a process, method, system, article, or apparatus that comprises a list of steps or elements is not limited to only those steps or elements listed, but may alternatively include other steps or elements not listed, or inherent to such process, method, article, or apparatus.
Reference herein to "an embodiment" means that a particular feature, structure, or characteristic described in connection with the embodiment can be included in at least one embodiment of the application. The appearances of the phrase in various places in the specification are not necessarily all referring to the same embodiment, nor are separate or alternative embodiments mutually exclusive of other embodiments. It is explicitly and implicitly understood by one skilled in the art that the embodiments described herein can be combined with other embodiments.
Referring to fig. 1 to 4 together, fig. 1 is a first schematic perspective view of the interior of a first embodiment of an immunoassay analyzer provided in the present application, fig. 2 is a second schematic perspective view of the interior of the first embodiment of the immunoassay analyzer provided in the present application, fig. 3 is a schematic perspective view of an impedance cell assembly of the first embodiment of the immunoassay analyzer provided in the present application, and fig. 4 is a schematic perspective view of a cuvette assembly of the first embodiment of the immunoassay analyzer provided in the present application.
The present application provides an immunoassay analyzer comprising a housing, a rack, a reaction disk assembly 410, a sample needle assembly 420, a reagent storage disk 430, a reagent needle assembly 440, a first washing well 442, an impedance well assembly 450 (or a cuvette assembly 550), a sample introduction mechanism, a cup loading mechanism 460, a stirring mechanism 470, a second washing well 472, a magnetic separation mechanism 480, an optical detection module, a measurement needle assembly 490, a cup grasping mechanism 492, a waste cup slide 494, and a waste cup magazine 496. The housing has been removed in fig. 1 and 2 in order to show the internal structure of the immunoassay analyzer.
The reaction tray assembly 410 is disposed on the frame and is used for loading and circulating the reaction cups 410.
The sample needle assembly 420 is disposed on the rack for reciprocating movement in a first direction for sampling and dispensing, and the sample needle assembly 420 is disposed above the reaction disk assembly 410 for dispensing to the reaction cup. The sample needle assembly 420 is provided with four stations, namely an open sample suction position, an impedance cell or colorimetric cell sample adding position, an automatic sample suction position and a reaction cup sample adding position, in the horizontal direction, wherein the open sample suction position can support an operator to directly hold a sample tube for the sample needle assembly 420 to suck samples, and the automatic sample suction position is a sampling position fixed on the sample mechanism and is positioned at the intersection point of the sample needle assembly 420 and the sample mechanism.
A reagent storage tray 430 is provided on the frame and on the side of the reaction tray assembly 410 for cold storage of reagents, which may be one, two or more. The reaction tray assembly 410 and the reagent storage tray 430 may be respectively located at the left and right sides of the immunoassay analyzer.
A reagent needle assembly 440 is swingably mounted on the frame between the reaction tray assembly 410 and the reagent storage tray 430 for taking and adding reagents to the reaction cuvette. The swing track of the reagent needle assembly 440 intersects with the reaction tray assembly 410 and the reagent storage tray 430. The reagent needle assembly 440 may have four positions, i.e., a first reagent position, a second reagent position, a cleaning position, and a reagent filling position, on the circumferential swing track.
The impedance cell assembly 450 (or the cuvette assembly 550) is disposed below the movement locus of the sample needle assembly 420.
Wherein, when the sample is a serum sample or a plasma sample, the reaction cup receives the sample needle assembly 420 for sampling, and when the sample is a whole blood sample, the reaction cup, the impedance cell assembly 450 (or the colorimetric cell assembly 550) receives the sample needle assembly 420 for sampling.
The cup feeding mechanism 460 is disposed on the frame and above the reaction tray assembly 410, and the cup feeding mechanism 460 is used for placing the reaction cups, shaping the reaction cups, and then conveying the reaction cups to the reaction tray assembly 410 in a preset posture.
The automatic sample introduction device is arranged on the front side of the rack and used for loading the sample rack so that the sample tubes on the sample rack pass through the sampling station one by one in the second direction, and the automatic sample introduction device specifically comprises a sample introduction mechanism 300, a first sensor 310, a second sensor 320, a third sensor 330, a fourth sensor 340, a code scanner, a rotating mechanism 100 and a shaking mechanism 350.
The sample introduction mechanism 300 is used to transport the sample rack through the sampling station, and the impedance cell assembly 450 (or the cuvette assembly 550) may be disposed on the sample introduction mechanism 300 or on the rack. The impedance cell assembly 450 (or the cuvette assembly 550) is arranged on the sample injection mechanism 300, so that the maintenance is convenient, and the impedance cell assembly 450 (or the cuvette assembly 550) is arranged on the frame, so that the structure of the immunoassay analyzer is more compact.
The first sensor 310 is disposed on the sample injection mechanism 300 for detecting whether there is a sample tube on the sample rack at a first height position.
And the second sensor 320 is arranged on the sample feeding mechanism 300 and used for detecting the height type of the sample tube on the sample rack at a second height position, wherein the second height position is higher than the first height position.
And the third sensor 330 is arranged on the sample feeding mechanism 300 and used for detecting the height type of the sample tube on the sample rack at a third height position, and the third height position is higher than the second height position.
Wherein the sampling station is located downstream of the first sensor 310, the second sensor 320, and the third sensor 330.
And the fourth sensor 340 is arranged on the sample feeding mechanism 300 and used for detecting the shape type of the sample tube on the sample rack at a fourth height position, the fourth height position is lower than the first height position, and the sampling station is positioned at the downstream of the fourth sensor 340.
The scanner is disposed on the gantry and below the sample needle assembly 420. The rotating mechanism 100 is arranged on the sampling mechanism 300 and located on the front side of the sampling station, the rotating mechanism 100 is used for rotating the sample tube, the rotating mechanism 100 comprises a transmission part and a driving motor, and the driving motor is used for driving the transmission part to rotate so as to link the sample tube to rotate based on the axis of the sample tube, so that the code scanner can shoot the identification code on the sample tube. The specific structure of the rotating mechanism 100 can refer to the foregoing embodiments.
The shaking-up mechanism 350 is arranged on the rack, the shaking-up mechanism 350 is used for grabbing the sampling sample tube and shaking up, and the shaking-up mechanism 350 is arranged between the third sensor 330 and the sampling station. Other specific structures of the automatic sample feeding device can refer to the aforementioned embodiments.
The reagent storage tray 430 is provided with a plurality of reagent stations on the swing track of the reagent needle assembly 440, or the reagent storage tray 430 can rotate a plurality of reagents to the reagent stations.
Reaction dish subassembly 410 includes heat preservation pot and carousel, and the heat preservation pot is used for providing constant temperature and incubates, and the carousel is equipped with a plurality of reaction cup hole sites in order to drive the circulation of reaction cup on the circumferencial direction.
The immunoassay analyzer further comprises a stirring mechanism 470, wherein the stirring mechanism 470 is arranged on the frame in a swinging manner and is positioned on the side edge of the reaction disc assembly 410 and used for uniformly mixing the sample liquid in the reaction cup, and the stirring mechanism 470 comprises one or more stirring paddles capable of swinging and rotating. The stirring paddle can be flat, and plays a role in stirring and uniformly mixing during rotation.
The first washing pool 442 is disposed at a side of the reagent storage tray 430 and located on a swing track of the reagent needle assembly 440 for washing the reagent needle after the reagent needle assembly 440 takes a reagent, and the second washing pool 472 is disposed at a side of the stirring mechanism 470 away from the reaction tray assembly 410 and located below the swing track of the stirring mechanism 470 for washing the stirring paddle after the stirring by the stirring paddle is completed.
The magnetic separation mechanism 480 is arranged on the rack and positioned on the side edge of the reaction disc component 410, and the magnetic separation mechanism 480 comprises a magnetic separation disc, a liquid injection mechanism and a liquid suction mechanism and is used for carrying out magnetic separation and cleaning on sample liquid to be detected.
The optical detection module (not shown in the figure) is arranged on the rack and erected above the reagent disk assembly, the measurement needle assembly 490 is erected above the magnetic separation mechanism 480, the measurement needle assembly 490 comprises a measurement blending mechanism and a measurement needle mechanism, the measurement blending mechanism is used for blending reacted sample liquid, and the measurement needle mechanism absorbs the blended sample liquid to the optical detection module for flow type fluorescence detection.
A cup grabbing mechanism 492, a waste cup slide 494 and a waste cup bin 496, wherein the cup grabbing mechanism 492 is arranged on the rack and is erected above the magnetic separation mechanism 480 and is used for taking out the reaction cup sampled by the measuring needle mechanism and placing the reaction cup on the waste cup slide into the waste cup bin 496.
As shown in fig. 3, the impedance cell assembly 450 includes a metal shield case 451, a counting cell, a syringe (not shown), and a pressure chamber (not shown).
The metal shield case 451 is provided with a sample inlet hole 452. The counting cell is arranged in the metal shielding box 451 and is aligned with the sample inlet hole. The injector is fixed by the frame and is used for inputting reagents into the counting cell or performing air inflation and uniform mixing. The pressure chamber is fixed by the frame and is used for providing negative pressure to enable the particles to be measured in the sample liquid to be measured in the counting cell to flow linearly.
Specifically, the impedance cell assembly 450 further includes a liquid injection tube 453, an isolation chamber 454, a metal shielding tube 456, a first cell body 457, a second cell body 458, a first electrode, and a second electrode.
The liquid pouring tube 453 penetrates the metal shield case 451, and is used to introduce a reagent into the cuvette. The isolation chamber 454 is arranged in the metal shielding box 451 and is located below the counting cell, the isolation chamber 454 has a certain volume for gas-liquid isolation, wherein the isolation chamber 454 is used for receiving the waste liquid after detection and is also used for transferring the gas for uniformly mixing the air bubbles.
The metal shielding tube 456 is connected to the metal shielding box 451 to form a grounding effect for switching the flexible reagent line, so as to prevent the sample liquid in the flexible reagent line from interfering with the electrical signal.
Specifically, the counting chamber includes a gem hole, a first chamber body 457, a second chamber body 458, a first electrode and a second electrode.
The jewel holes are used for allowing the particles to be measured to pass through one by one. A first cell body 457 is disposed on a first side of the gem well for receiving a reagent and a whole blood sample. Second cell body 458 is disposed on a second side of the gem hole and is communicated with first cell body 457 through the gem hole. The first electrode and the second electrode are arranged on the side edge of the gem hole and used for receiving an electric signal when the particles to be detected pass through. Specifically, a constant electric field is generated in the jewel holes of the first electrode and the second electrode, when the sample fluid in the first cell body 457 is pumped through the jewel holes by the negative pressure provided by the pressure chamber, pulse signals appear when the cell particles pass through the electric field, and RBC (red blood cell count) parameters and MCV (mean red blood cell volume) parameters can be obtained by analyzing the pulse size and the number, and then HCT (red blood cell volume) parameters are calculated by HCT-RBC-MCV.
When the sample is a serum sample or a plasma sample, the computer system analyzes the detection data of the optical detection module and directly reports the result, and the result is marked as A;
when a whole blood sample is obtained, the computer system analyzes and calculates the data of the optical detection module and the data of the impedance cell assembly 450 respectively, and reports the result, which is recorded as B. Wherein the content of the first and second substances,
Figure BDA0002343146660000101
as shown in fig. 4, the cuvette assembly 550 includes a metal shield case 551, a liquid pouring tube 553, and a cuvette 554.
The metal shielding box 551 is provided with a sample inlet 552, the liquid injection pipe 553 penetrates through the metal shielding box 551 and is used for inputting a reagent into the colorimetric pool 554, the colorimetric pool 554 is arranged in the metal shielding box 551 and is aligned with the sample inlet 552, and the optical detection assembly 555 is arranged in the metal shielding box 551 and is positioned at two sides of the colorimetric pool 554 for optical detection.
The HCT counting mode of the cuvette was:the HGB (hemoglobin) amount and MCHC (mean hemoglobin concentration) were determined by measuring the absorbance of the solution to a laser light having a wavelength of 554. + -.20 nm. By
Figure BDA0002343146660000102
HCT values can be obtained.
Referring to fig. 5, fig. 5 is a schematic flow chart of an embodiment of a detection method of the immunoassay analyzer provided in the present application, the method including:
step 51: and obtaining a sample to be detected.
Optionally, before step 51, the method further includes: judging whether a sample rack is detected; if yes, detecting the type of the sample container on the sample rack; and detecting the type of the sample to be detected in the corresponding sample container according to the type of the sample container.
The following method can be specifically adopted for detecting the types of the sample containers on the sample rack: detecting whether a sample tube is arranged on the sample rack at a first height position by using a first sensor; detecting the height type of the sample tube on the sample rack at a second height position by using a second sample sensor, wherein the second height position is higher than the first height position; detecting the height type of the sample tube on the sample rack at a third height position by using a third sensor, wherein the third height position is higher than the second height position; and determining the type of the sample container on the sample rack according to the detection results of the first sensor, the second sensor and the third sensor.
In addition, a fourth sensor may be provided, the fourth sensor may be used to detect the shape type of the sample tube on the sample rack at a fourth height position lower than the first height position, and the type of the sample container on the sample rack may be determined based on the detection results of the first sensor, the second sensor, the third sensor, and the fourth sensor.
Referring to fig. 6 to 9, fig. 6 is a schematic perspective view of an automatic sample feeding device provided in the present application; FIG. 7 is a schematic perspective view of a partial assembly of the autoinjector of FIG. 6; FIG. 8 is a schematic perspective view of a partial assembly of the autoinjector of FIG. 6; fig. 9 is a schematic side view of various sample tubes, and the present embodiment further provides a sample tube identification apparatus, which includes a first sensor 310, a second sensor 320, and a third sensor 330.
The first sensor 310 is used for detecting whether a sample tube is on the sample rack at a first height position, which may be slightly higher than the rack; the second sensor 320 is used for detecting the height type of the sample tube on the sample rack at a second height position, which is higher than the first height position; the third sensor 330 is used to detect the height type of the sample tube on the sample rack at a third height position, which is higher than the second height position. The second sensor 320 and the third sensor 330 can be used to identify whether the common sample tubes of two different heights (e.g., a sample tube 100mm high and a sample tube 75mm high) on the left side of fig. 12 are capped or not.
In an alternative embodiment, the sample tube identifying device further comprises a fourth sensor 340, the fourth sensor 340 being adapted to detect the type of shape of the sample tube on the sample rack at a fourth height position, the fourth height position being lower than the first height position. The fourth sensor 340 may be used to identify the particular sample tube on the right side of fig. 12. If the fourth sensor 340 is not arranged, the information of the instrument can be input through a software interface of the instrument for identification, and the fourth sensor 340 and the software interface can be arranged for judgment at the same time, so that the reliability is improved.
In the embodiment of the present invention, the second sensor 320 and the third sensor 330 are correlation sensors. Specifically, the second sensor 320 and the third sensor 330 may adopt optical couplers, each of which includes a transmitting end and a receiving end, and whether the sample tube is capped or not may be determined according to a light receiving state of the receiving end.
In an actual product, the first sensor 310, the second sensor 320, the third sensor 330 and the fourth sensor 340 are aligned in a vertical direction to make the product compact.
The first sensor 310, the second sensor 320, the third sensor 330 and the fourth sensor 340 can also be arranged in a deviating mode in the vertical direction to form a plurality of identification stations in linear distribution, and maintenance is facilitated.
As shown in fig. 7, the second sensor 320 and the third sensor 330 are aligned in the vertical direction. The first sensor 310 and the fourth sensor 340 are disposed on the left and right sides of the second sensor 320 and the third sensor 330.
As shown in fig. 7, the sample tube identification apparatus further includes a first mounting bracket 301, which may have an arch shape and includes two mounting arms spaced apart from each other, and the second sensor 320 and the third sensor 330 are disposed at different height positions of the mounting arms.
As shown in fig. 8, the sample tube identifying apparatus further includes a second mounting bracket 302, and the first sensor 310 and/or the fourth sensor 340 are disposed on the second mounting bracket 302.
The invention also provides an automatic sample introduction device which comprises the sample tube identification device.
The automatic sampling device further comprises a rotating mechanism and a code scanner, the rotating mechanism is used for rotating the sample tube, the rotating mechanism comprises a transmission part and a driving motor, and the driving motor is used for driving the transmission part to rotate so as to link the sample tube to rotate based on the axis of the sample tube, so that the code scanner can shoot the identification code on the sample tube. The specific structure of the rotating mechanism can be referred to the rotating mechanism 100 in the foregoing embodiment.
The present application further provides an automatic sample introduction device, which includes a sample introduction mechanism 300, a first sensor 310, a second sensor 320, and a third sensor 330.
The sample injection mechanism 300 is used for conveying the sample rack to pass through the sampling station 123, the sample injection mechanism 300 comprises an X-direction sample injection mechanism and a Y-direction sample injection mechanism, the X-direction sample injection mechanism is responsible for conveying the sample rack placed on the sample injection mechanism 300 to a Y-direction sample injection channel, and the Y-direction sample injection mechanism is responsible for conveying the sample rack to each operation station in sequence along the Y-direction sample injection channel according to fixed steps. The middle area of the X-direction sample injection mechanism is provided with a correlation sensor (also can be a side area, and also can be a sensor in other forms), and the starting position of the Y-direction sample injection channel is provided with a switch or a sensor; the first sensor 310 is used for detecting whether a sample tube is on the sample rack at a first height position, which may be slightly higher than the rack; the second sensor 320 is used for detecting the height type of the sample tube on the sample rack at a second height position, which is higher than the first height position; the third sensor 330 is used for detecting the height type of the sample tube on the sample rack at a third height position, the third height position is higher than the second height position, the second sensor 320 and the third sensor 330 can be used for identifying the common sample tube and the cap-free condition at two different heights (for example, the sample tube with the height of 100mm and the sample tube with the height of 75 mm) at the left side in the figure 7; wherein the sampling station 123 is located downstream of the first sensor 310, the second sensor 320, and the third sensor 330, i.e., identification of the sample tubes is done prior to sampling.
In an alternative embodiment, the sample tube identifying device further comprises a fourth sensor 340, the fourth sensor 340 being adapted to detect the type of shape of the sample tube on the sample rack at a fourth height position, the fourth height position being lower than the first height position. The fourth sensor 340 may be used to identify the particular sample tube on the right side of fig. 7. If the fourth sensor 340 is not arranged, the information of the instrument can be input through a software interface of the instrument for identification, and the fourth sensor 340 and the software interface can be arranged for judgment at the same time, so that the reliability is improved.
In the embodiment of the present invention, the second sensor 320 and the third sensor 330 are correlation sensors. Specifically, the second sensor 320 and the third sensor 330 may adopt optical couplers, each of which includes a transmitting end and a receiving end, and whether the sample tube is capped or not may be determined according to a light receiving state of the receiving end
In an actual product, the first sensor 310, the second sensor 320, the third sensor 330 and the fourth sensor 340 are aligned in a vertical direction to make the product compact.
The first sensor 310, the second sensor 320, the third sensor 330 and the fourth sensor 340 can also be arranged in an offset manner in the vertical direction to form a plurality of identification stations which are linearly distributed, so that the maintenance is convenient.
As shown in fig. 7, the second sensor 320 and the third sensor 330 are aligned in the vertical direction. The first sensor 310 and the fourth sensor 340 are disposed on the left and right sides of the second sensor 320 and the third sensor 330.
As shown in fig. 7, the sample tube identification apparatus further includes a first mounting bracket 301, which may have an arch shape and includes two mounting arms spaced apart from each other, and the second sensor 320 and the third sensor 330 are disposed at different height positions of the mounting arms.
As shown in fig. 7, the sample tube identifying apparatus further includes a second mounting bracket 302, and the first sensor 310 and/or the fourth sensor 340 are disposed on the second mounting bracket 302.
The automatic sample introduction device further comprises a rotating mechanism and a code scanner, and the rotating mechanism is used for rotating the sample tube. The rotating mechanism comprises a transmission piece and a driving motor, and the driving motor is used for driving the transmission piece to rotate so as to link the sample tube to rotate based on the axis of the sample tube, so that the code scanner can shoot the identification code on the sample tube. The specific structure of the rotating mechanism can be referred to the rotating mechanism 100 in the foregoing embodiment.
In addition, the automatic sample introduction device further comprises a shaking mechanism 350, the shaking mechanism 350 is used for grabbing the sample tube and shaking the sample tube uniformly, and the shaking mechanism 350 is arranged between the third sensor 330 and the sampling station 123 and can be arranged at the same station with the fourth sensor 340.
In the embodiment of the present invention, the shaking mechanism 350 can be eliminated, and the rotating mechanism 100 can rotate at a high speed to achieve the effect of uniform mixing. Alternatively, the rotation mechanism 100 may be eliminated, and the identification codes of the sample tubes may be placed on the sample rack in a uniform orientation so as to be captured by the scanner.
The control flow of the automatic sample introduction device provided by the embodiment of the invention is as follows:
when a correlation sensor (or other sensors) arranged on the X-direction sample injection mechanism detects that a sample rack enters, the X-direction sample injection mechanism conveys a sample to be detected to the Y-direction sample injection channel along the X direction, and when the sample rack touches or approaches a switch or a sensor at the starting position of the Y-direction sample injection channel, the Y-direction sample injection mechanism starts to start.
The Y-direction sample introduction mechanism conveys the sample rack to a sample tube detecting station along the Y-direction sample introduction channel, and the first sensor 310 performs first-step detection on the type of the sample tube on the sample rack.
The Y-direction sample introduction mechanism conveys the sample rack to a high-low sample tube detection station along the Y-direction sample introduction channel, and a second sensor 320 and a third sensor 330 which are respectively arranged at an upper position and a lower position carry out second-step detection on the sample tube.
The Y-direction sample injection mechanism conveys the sample rack to a code scanning station along the Y-direction sample injection channel, the rotating mechanism drives the sample tube to rotate, and a scanner (not shown) arranged at the station scans and identifies sample information on the sample tube. If the rotating mechanism is not arranged, the step is cancelled, and correspondingly, the sample tubes are required to be regularly placed so that the identification codes are opposite to the code scanner.
And the Y-direction sample feeding mechanism conveys the sample rack to a shaking station along the Y-direction sample feeding channel, the X-direction movement mechanism of the shaking mechanism 350 moves along the X direction, after the sample tube is clamped, the Z-direction movement mechanism of the shaking mechanism 350 lifts the clamped sample tube to the shaking station along the Z direction, and the shaking mechanism shakes the sample to be detected uniformly. After mixing, the sample tube was returned to the original position. If the shaking mechanism 350 is not arranged, the step is cancelled, and correspondingly, the rotating mechanism rotates at a high speed to achieve the effect of uniformly mixing.
The Y-direction sampling mechanism conveys the sample rack to the automatic sampling station 123 along the Y-direction sampling channel, a sample needle assembly (not shown) arranged right above the Y-direction sampling mechanism horizontally moves to the automatic sampling station 123, and then the sample needle sampling mechanism descends to a sample sucking position along the vertical direction to suck samples. And after the sample is sucked, the sample needle sampling mechanism returns to the initial position in the vertical direction to prepare for the next operation.
And the Y-direction sample injection mechanism conveys the sample rack to the exit area along the Y-direction sample injection channel, and when the sample rack touches or approaches the tail end switch or the sensor of the Y-direction sample injection channel, the sample rack is ejected out by the swinging mechanism.
The sample tube identification device provided by the invention has a simple structure, can conveniently identify various sample tubes, and solves the problem that medical staff need to regularly arrange the similar sample tubes.
Step 52: and if the sample to be detected is a serum sample or a plasma sample, inputting the sample to be detected into an immunoassay detection channel for detection, and obtaining a first immunoassay result.
Optionally, as shown in fig. 10, fig. 10 is a first flowchart of step 52 in fig. 9, and step 52 may specifically include:
step 52a 1: adding a first reagent into the target reaction cup.
In conjunction with fig. 1 and 2, the reagent needle assembly 440 is controlled to move to the first reagent station of the reagent storage tray 430, aspirate the first reagent from the first reagent station, and then rotate to the reagent filling station of the reaction tray assembly 410 to fill the first reagent into the target reaction cup in the reaction tray assembly 410.
Step 52a 2: adding a sample to be detected into the target reaction cup.
With reference to fig. 1 and 2, the cuvette with the first reagent loaded in the cuvette assembly 410 rotates with the cuvette assembly 410 to the loading position, the sample needle assembly 420 moves to the auto-injector assembly aspirating position, and after aspirating a predetermined amount of the sample from the sample tube, the cuvette moves to the loading position of the cuvette assembly 410 for loading.
Step 52a 3: and (3) carrying out uniform mixing operation, incubation operation and magnetic separation operation on the liquid in the target reaction cup in sequence.
Combining fig. 1 and fig. 2 above:
and (3) uniformly mixing: the cuvette with the first reagent and the sample in the cuvette assembly 410 rotates with the cuvette assembly 410 to the stirring station, and the stirring mechanism 470 stirs and mixes the reagents.
And (3) incubation operation: the reaction mixture in the reaction tray assembly 410 is incubated at 37 ℃ or a predetermined target temperature for a certain period of time, and then the reaction cup carrying the first stage reaction is transferred to the magnetic separation mechanism 480 by the cup grasping mechanism 492.
Magnetic separation operation: the magnetic separation mechanism 480 magnetically separates reactants in the reaction cup, the target cup position rotates to the liquid injection station after the magnetic separation is carried out for a certain time, the liquid injection mechanism injects cleaning liquid into the reaction cup, then the turntable drives the target cup position to rotate to the liquid absorption station, the liquid absorption mechanism moves out supernatant of the reaction cup after the magnetic separation is carried out for a certain time (the process can be carried out only once or for multiple times according to actual requirements), the turntable drives the target cup position to rotate to the liquid injection station for measuring solution, quantitative solution is injected into the target cup position by the liquid injection needle special for measuring solution, finally the turntable drives the target cup position to rotate to the cup discharge station of the magnetic separation disc, and the cup position is transferred to the measuring and mixing mechanism by the cup grabbing mechanism 492.
Step 52a 4: and detecting the liquid in the target reaction cup, and obtaining a first immune detection result.
Specifically, uniformly mixing the liquid in the target reaction cup; and inputting the liquid in the target reaction cup into the optical detection module so that the optical detection module detects the liquid and obtains a first immune detection result.
Optionally, as shown in fig. 11, fig. 11 is a second flowchart of step 52 in fig. 9, and step 52 may specifically include:
step 52b 1: adding a first reagent into the target reaction cup.
Step 52b 2: adding a sample to be detected into the target reaction cup.
Step 52b 3: and (3) carrying out uniform mixing operation, incubation operation and magnetic separation operation on the liquid in the target reaction cup in sequence.
The foregoing steps are similar to the first embodiment described above, except that: since the reagent is added for the second time, after the magnetic separation, the turntable drives the target cup position to rotate to the cup outlet position of the magnetic separation mechanism 480, and the cup grabbing mechanism 492 transfers the target cup position back to the reaction disk assembly 410.
Step 52b 4: adding a second reagent into the target reaction cup.
Step 52b 5: and carrying out uniform mixing operation, incubation operation and magnetic separation operation on the liquid in the target reaction cup in sequence for the second time.
Step 52b 6: and detecting the liquid in the target reaction cup, and obtaining a first immune detection result.
Optionally, as shown in fig. 12, fig. 12 is a third flow chart of step 52 in fig. 9, where step 52 may specifically include:
step 52c 1: adding a first reagent into the target reaction cup.
Step 52c 2: adding a sample to be detected into the target reaction cup.
Step 52c 3: and (3) carrying out uniform mixing operation, incubation operation and magnetic separation operation on the liquid in the target reaction cup in sequence.
The foregoing steps are similar to the first embodiment described above, except that: since the reagent is added for the second time, after the magnetic separation, the turntable drives the target cup position to rotate to the cup outlet position of the magnetic separation mechanism 480, and the cup grabbing mechanism 492 transfers the target cup position back to the reaction disk assembly 410.
Step 52c 4: adding a second reagent into the target reaction cup.
Step 52c 5: and carrying out uniform mixing operation, incubation operation and magnetic separation operation on the liquid in the target reaction cup in sequence for the second time.
After the second magnetic separation, the turntable drives the target cup position to be transferred to the cup outlet station of the magnetic separation mechanism 480, and the cup grabbing mechanism 492 transfers the target cup position back to the reaction disk assembly 410.
Step 52c 6: and adding a third reagent into the target reaction cup.
Step 52c 7: and carrying out blending operation, incubation operation and magnetic separation operation on the liquid in the target reaction cup in sequence for the third time.
Step 52c 8: and detecting the liquid in the target reaction cup, and obtaining a first immune detection result.
It is understood that the above three embodiments correspond to a one-step method, a two-step method and a three-step method, respectively, and different step flows can be performed in actual operation according to the types of reagents or manual selection.
Step 53: and if the sample to be detected is a whole blood sample, inputting the part of the sample to be detected into the immunoassay detection channel for detection to obtain a whole blood detection result, inputting the part of the sample to be detected into the HCT calculation channel to obtain a blood cell detection result, and calculating according to the whole blood detection result and the blood cell detection result to obtain a second immunoassay result.
Wherein, the part of the sample to be detected is input into the immunoassay detection channel for detection, and the detection steps of the obtained whole blood detection result on the serum sample or the plasma sample are consistent, which is not described herein again.
Referring to fig. 13, fig. 13 is a schematic flowchart of an embodiment of impedance detection provided in the present application, where the method includes:
step 131: and adding a diluent into the impedance detection cell.
Step 132: adding a sample to be detected into the impedance detection cell.
Step 133: and (4) uniformly mixing the liquid in the impedance detection cell.
Step 134: and detecting the liquid after the mixing operation in the impedance detection pool, and obtaining a blood cell detection result.
Specifically, step 134 may specifically be: detecting the number RBC and the average volume MCV of the red blood cells of a sample to be detected; the hematocrit HCT is calculated by the following formula and is used as a blood cell detection result:
HCT=RBC*MCV。
wherein, calculating according to the whole blood detection result and the blood cell detection result to obtain a second immunity detection result, which specifically comprises the following steps: calculating by adopting the following formula to obtain a second immunodetection result;
Figure BDA0002343146660000181
wherein A is a whole blood detection result, and HCT is a blood cell detection result.
Referring to fig. 14, fig. 14 is a schematic flow chart of an embodiment of colorimetric detection provided in the present application, where the method includes:
step 141: adding hemolytic agent into the colorimetric detection pool.
Step 142: and adding a sample to be detected into the colorimetric detection pool.
Step 143: and uniformly mixing the liquid in the contrast color detection pool.
Step 144: and detecting the liquid after the mixing operation in the contrast color detection pool, and obtaining a blood cell detection result.
Specifically, step 134 may specifically be: detecting the hemoglobin quantity HGB and the average hemoglobin concentration MCHC of a sample to be detected; the hematocrit HCT is calculated by the following formula and is used as a blood cell detection result:
Figure BDA0002343146660000182
wherein, calculating according to the whole blood detection result and the blood cell detection result to obtain a second immunity detection result, which specifically comprises the following steps: calculating by adopting the following formula to obtain a second immunodetection result;
Figure BDA0002343146660000183
wherein A is a whole blood detection result, and HCT is a blood cell detection result.
Different from the prior art, the detection method of the immunoassay analyzer provided by the application comprises the following steps: obtaining a sample to be detected; if the sample to be detected is a serum sample or a plasma sample, inputting the sample to be detected into an immunoassay detection channel for detection, and obtaining a first immunoassay result; and if the sample to be detected is a whole blood sample, inputting the part of the sample to be detected into the immunoassay detection channel for detection to obtain a whole blood detection result, inputting the part of the sample to be detected into the HCT calculation channel to obtain a blood cell detection result, and calculating according to the whole blood detection result and the blood cell detection result to obtain a second immunoassay result. Through the mode, the immunoassay detection can be carried out on the serum sample, the plasma sample and the whole blood sample on the same immunoassay analyzer, the equipment cost is saved, and the detection efficiency is improved.
Referring to fig. 15, fig. 15 is a schematic structural diagram of a second embodiment of an immunoassay analyzer provided in the present application, the immunoassay analyzer includes a processor 151 and a memory 152, wherein the memory 152 stores program data, and the processor 151 is configured to execute the program data to implement the following methods:
obtaining a sample to be detected; if the sample to be detected is a serum sample or a plasma sample, inputting the sample to be detected into an immunoassay detection channel for detection, and obtaining a first immunoassay result; and if the sample to be detected is a whole blood sample, inputting the part of the sample to be detected into the immunoassay detection channel for detection to obtain a whole blood detection result, inputting the part of the sample to be detected into the HCT calculation channel to obtain a blood cell detection result, and calculating according to the whole blood detection result and the blood cell detection result to obtain a second immunoassay result.
Referring to fig. 16, fig. 16 is a schematic structural diagram of an embodiment of a computer-readable storage medium provided in the present application, the computer-readable storage medium 160 stores program data 161, and the program data 161 is used for implementing the following method steps when being executed by a processor:
obtaining a sample to be detected; if the sample to be detected is a serum sample or a plasma sample, inputting the sample to be detected into an immunoassay detection channel for detection, and obtaining a first immunoassay result; and if the sample to be detected is a whole blood sample, inputting the part of the sample to be detected into the immunoassay detection channel for detection to obtain a whole blood detection result, inputting the part of the sample to be detected into the HCT calculation channel to obtain a blood cell detection result, and calculating according to the whole blood detection result and the blood cell detection result to obtain a second immunoassay result.
In an embodiment of the above immunoassay analyzer and computer readable storage medium, the program data, when executed by the processor, is further for implementing the steps of:
judging whether a sample rack is detected; if yes, detecting the type of the sample container on the sample rack; and detecting the type of the sample to be detected in the corresponding sample container according to the type of the sample container.
Optionally, the method is further used for implementing: detecting whether a sample tube is arranged on the sample rack at a first height position by using a first sensor; detecting the height type of the sample tube on the sample rack at a second height position by using a second sample sensor, wherein the second height position is higher than the first height position; detecting the height type of the sample tube on the sample rack at a third height position by using a third sensor, wherein the third height position is higher than the second height position; and determining the type of the sample container on the sample rack according to the detection results of the first sensor, the second sensor and the third sensor.
Optionally, the method is further used for implementing: determining the type of the sample tube on the sample rack at a fourth height position by using a fourth sensor in combination with the first sensor, the second sensor and the third sensor, wherein the fourth height position is lower than the first height position; determining the type of the sample container on the sample rack according to the detection results of the first sensor, the second sensor and the third sensor, including: and determining the type of the sample container on the sample rack according to the detection results of the first sensor, the second sensor, the third sensor and the fourth sensor.
Optionally, the method is further used for implementing: adding a first reagent into the target reaction cup; adding a sample to be detected into a target reaction cup; carrying out uniform mixing operation, incubation operation and magnetic separation operation on the liquid in the target reaction cup in sequence; and detecting the liquid in the target reaction cup, and obtaining a first immune detection result.
Optionally, the method is further used for implementing: adding a second reagent into the target reaction cup; and carrying out uniform mixing operation, incubation operation and magnetic separation operation on the liquid in the target reaction cup in sequence for the second time.
Optionally, the method is further used for implementing: adding a third reagent into the target reaction cup; and carrying out blending operation, incubation operation and magnetic separation operation on the liquid in the target reaction cup in sequence for the third time.
Optionally, the method is further used for implementing: mixing the liquid in the target reaction cup; placing the target reaction cup in a set temperature environment for incubation operation and continuing for a set time length; and carrying out magnetic separation operation on the liquid in the target reaction cup.
Optionally, the method is further used for implementing: uniformly mixing the liquid in the target reaction cup; and inputting the liquid in the target reaction cup into the optical detection module so that the optical detection module detects the liquid and obtains a first immune detection result.
Optionally, the method is further used for implementing: adding a diluent into an impedance detection cell; adding a sample to be detected into an impedance detection pool; uniformly mixing the liquid in the impedance detection cell; and detecting the liquid after the mixing operation in the impedance detection pool, and obtaining a blood cell detection result.
Optionally, the method is further used for implementing: detecting the number RBC and the average volume MCV of the red blood cells of a sample to be detected; the hematocrit HCT is calculated by the following formula and is used as a blood cell detection result: HCT ═ RBC MCV.
Calculating by adopting the following formula to obtain a second immunodetection result;
Figure BDA0002343146660000201
wherein A is a whole blood detection result, and HCT is a blood cell detection result.
Optionally, the method is further used for implementing: adding a hemolytic agent into the impedance detection cell; adding the sample to be detected into the impedance detection cell; uniformly mixing the liquid in the impedance detection cell; and detecting the liquid after the uniform mixing operation in the impedance detection pool, and obtaining a blood cell detection result.
Optionally, the method is further used for implementing: detecting the hemoglobin quantity HGB and the average hemoglobin concentration MCHC of the sample to be detected; the hematocrit HCT is calculated by the following formula and is used as a blood cell detection result:
Figure BDA0002343146660000211
optionally, the method is further used for implementing: calculating by adopting the following formula to obtain a second immunodetection result;
Figure BDA0002343146660000212
wherein A is a whole blood detection result, and HCT is a blood cell detection result.
In the several embodiments provided in the present application, it should be understood that the disclosed method and apparatus may be implemented in other manners. For example, the above-described device embodiments are merely illustrative, and for example, the division of the modules or units is only one logical division, and other divisions may be realized in practice, for example, a plurality of units or components may be combined or integrated into another system, or some features may be omitted, or not executed.
The units described as separate parts may or may not be physically separate, and parts displayed as units may or may not be physical units, may be located in one place, or may be distributed on a plurality of network units. Some or all of the units can be selected according to actual needs to achieve the purpose of the embodiment.
In addition, functional units in the embodiments of the present application may be integrated into one processing unit, or each unit may exist alone physically, or two or more units may be integrated into one unit. The integrated unit can be realized in a form of hardware, and can also be realized in a form of a software functional unit.
The above description is only for the purpose of illustrating embodiments of the present application and is not intended to limit the scope of the present application, and all modifications of equivalent structures and equivalent processes, which are made according to the content of the present specification and the accompanying drawings, or which are directly or indirectly applied to other related technical fields, are also included in the scope of the present application.

Claims (17)

1. A method of testing an immunoassay analyzer, the method comprising:
obtaining a sample to be detected;
if the sample to be detected is a serum sample or a plasma sample, inputting the sample to be detected into an immunoassay detection channel for detection, and obtaining a first immunoassay result;
and if the sample to be detected is a whole blood sample, inputting a part of the sample to be detected into the immunoassay detection channel for detection to obtain a whole blood detection result, inputting a part of the sample to be detected into the HCT calculation channel to obtain a blood cell detection result, and calculating according to the whole blood detection result and the blood cell detection result to obtain a second immunoassay result.
2. The method of claim 1,
before the sample to be detected is obtained, the method further comprises the following steps:
judging whether a sample rack is detected;
if so, detecting the type of the sample container on the sample rack;
and detecting the type of the sample to be detected in the corresponding sample container according to the type of the sample container.
3. The method of claim 2,
the detecting the type of the sample container on the sample rack comprises:
detecting whether a sample tube is on the sample rack at a first height position by using a first sensor; and
detecting the height type of the sample tube on the sample rack at a second height position by using a second sample sensor, wherein the second height position is higher than the first height position;
detecting a height type of a sample tube on the sample rack at a third height position with a third sensor, the third height position being higher than the second height position;
determining the type of the sample container on the sample rack according to the detection results of the first sensor, the second sensor and the third sensor.
4. The method of claim 3,
the method further comprises the following steps:
identifying a type of sample tube on the sample rack at a fourth elevation position using a fourth sensor in combination with the first sensor, the second sensor, and the third sensor, the fourth elevation position being lower than the first elevation position;
the determining the type of the sample container on the sample rack according to the detection results of the first sensor, the second sensor and the third sensor comprises:
determining the type of the sample container on the sample rack according to the detection results of the first sensor, the second sensor, the third sensor and the fourth sensor.
5. The method of claim 1,
the step of inputting the sample to be detected into an immunoassay detection channel for detection and obtaining a first immunoassay result comprises the following steps:
adding a first reagent into the target reaction cup;
adding the sample to be detected into the target reaction cup;
carrying out uniform mixing operation, incubation operation and magnetic separation operation on the liquid in the target reaction cup in sequence;
and detecting the liquid in the target reaction cup, and obtaining a first immune detection result.
6. The method of claim 5,
after carrying out blending operation, incubation operation and magnetic separation operation in proper order to the liquid in the target reaction cup, still include:
adding a second reagent into the target reaction cup;
and carrying out uniform mixing operation, incubation operation and magnetic separation operation on the liquid in the target reaction cup in sequence for the second time.
7. The method of claim 6,
after the blending operation, the incubation operation and the magnetic separation operation are sequentially performed on the liquid in the target reaction cup again, the method further comprises the following steps:
adding a third reagent into the target reaction cup;
and carrying out blending operation, incubation operation and magnetic separation operation on the liquid in the target reaction cup in sequence for the third time.
8. The method according to any one of claims 5 to 7,
the liquid in the target reaction cup is sequentially subjected to blending operation, incubation operation and magnetic separation operation, and the method comprises the following steps:
mixing the liquid in the target reaction cup in sequence;
placing the target reaction cup in a set temperature environment for incubation operation and continuing for a set time length;
and carrying out magnetic separation operation on the liquid in the target reaction cup.
9. The method of claim 5,
the detecting the liquid in the target reaction cup and obtaining a first immunity detection result comprises:
uniformly mixing the liquid in the target reaction cup;
and inputting the liquid in the target reaction cup into an optical detection module so that the optical detection module detects the liquid and obtains a first immune detection result.
10. The method of claim 1,
the inputting of the part of the sample to be detected into the HCT calculation channel and obtaining the blood cell detection result comprises:
adding a diluent into an impedance detection cell;
adding the sample to be detected into the impedance detection cell;
uniformly mixing the liquid in the impedance detection cell;
and detecting the liquid after the uniform mixing operation in the impedance detection pool, and obtaining a blood cell detection result.
11. The method of claim 10,
the liquid after the mixing operation in the impedance detection pool is detected, and a blood cell detection result is obtained, which comprises the following steps:
detecting the number RBC and the average volume MCV of the red blood cells of the sample to be detected;
the hematocrit HCT is calculated by the following formula and is used as a blood cell detection result:
HCT=RBC*MCV。
12. the method of claim 10,
the calculating according to the whole blood detection result and the blood cell detection result to obtain a second immune detection result comprises:
calculating by adopting the following formula to obtain a second immunodetection result;
Figure FDA0002343146650000041
wherein A is a whole blood detection result, and HCT is a blood cell detection result.
13. The method of claim 1,
the inputting of the part of the sample to be detected into the colorimetric detection channel to obtain the blood cell detection result comprises:
adding a hemolytic agent into the impedance detection cell;
adding the sample to be detected into the impedance detection cell;
uniformly mixing the liquid in the impedance detection cell;
and detecting the liquid after the uniform mixing operation in the impedance detection pool, and obtaining a blood cell detection result.
14. The method of claim 13,
the liquid after the mixing operation in the impedance detection pool is detected, and a blood cell detection result is obtained, which comprises the following steps:
detecting the hemoglobin quantity HGB and the average hemoglobin concentration MCHC of the sample to be detected;
the hematocrit HCT is calculated by the following formula and is used as a blood cell detection result:
Figure FDA0002343146650000042
15. the method of claim 13,
the calculating according to the whole blood detection result and the blood cell detection result to obtain a second immune detection result comprises:
calculating by adopting the following formula to obtain a second immunodetection result;
Figure FDA0002343146650000043
wherein A is a whole blood detection result, and HCT is a blood cell detection result.
16. An immunoassay analyzer comprising an interconnected processor and memory for storing program data, the processor being configured to execute the program data to implement the method of any one of claims 1 to 15.
17. A computer-readable storage medium, in which program data are stored which, when being executed by a processor, are adapted to carry out the method of any one of claims 1 to 15.
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CN114460320A (en) * 2022-04-14 2022-05-10 深圳市帝迈生物技术有限公司 Sample analyzer and sample detection process thereof
CN114660279A (en) * 2022-05-23 2022-06-24 深圳市帝迈生物技术有限公司 Sample detection method and sample analyzer

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