CN114184799A - Test method based on chemiluminescence reaction and sample analysis device - Google Patents

Test method based on chemiluminescence reaction and sample analysis device Download PDF

Info

Publication number
CN114184799A
CN114184799A CN202010962126.2A CN202010962126A CN114184799A CN 114184799 A CN114184799 A CN 114184799A CN 202010962126 A CN202010962126 A CN 202010962126A CN 114184799 A CN114184799 A CN 114184799A
Authority
CN
China
Prior art keywords
type
signal
reaction
luminous
reaction cup
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Pending
Application number
CN202010962126.2A
Other languages
Chinese (zh)
Inventor
瞿振
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Shenzhen Mindray Bio Medical Electronics Co Ltd
Original Assignee
Shenzhen Mindray Bio Medical Electronics Co Ltd
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Shenzhen Mindray Bio Medical Electronics Co Ltd filed Critical Shenzhen Mindray Bio Medical Electronics Co Ltd
Priority to CN202010962126.2A priority Critical patent/CN114184799A/en
Publication of CN114184799A publication Critical patent/CN114184799A/en
Pending legal-status Critical Current

Links

Images

Classifications

    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N35/00—Automatic analysis not limited to methods or materials provided for in any single one of groups G01N1/00 - G01N33/00; Handling materials therefor
    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N21/00—Investigating or analysing materials by the use of optical means, i.e. using sub-millimetre waves, infrared, visible or ultraviolet light
    • G01N21/75—Systems in which material is subjected to a chemical reaction, the progress or the result of the reaction being investigated
    • G01N21/76—Chemiluminescence; Bioluminescence
    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N33/00—Investigating or analysing materials by specific methods not covered by groups G01N1/00 - G01N31/00
    • G01N33/48—Biological material, e.g. blood, urine; Haemocytometers
    • G01N33/50—Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing
    • G01N33/53—Immunoassay; Biospecific binding assay; Materials therefor
    • G01N33/5302—Apparatus specially adapted for immunological test procedures
    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N33/00—Investigating or analysing materials by specific methods not covered by groups G01N1/00 - G01N31/00
    • G01N33/48—Biological material, e.g. blood, urine; Haemocytometers
    • G01N33/50—Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing
    • G01N33/58—Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing involving labelled substances
    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N35/00—Automatic analysis not limited to methods or materials provided for in any single one of groups G01N1/00 - G01N33/00; Handling materials therefor
    • G01N35/00584—Control arrangements for automatic analysers
    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N35/00—Automatic analysis not limited to methods or materials provided for in any single one of groups G01N1/00 - G01N33/00; Handling materials therefor
    • G01N35/00584—Control arrangements for automatic analysers
    • G01N35/00594—Quality control, including calibration or testing of components of the analyser
    • G01N35/00613—Quality control
    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N35/00—Automatic analysis not limited to methods or materials provided for in any single one of groups G01N1/00 - G01N33/00; Handling materials therefor
    • G01N35/02—Automatic analysis not limited to methods or materials provided for in any single one of groups G01N1/00 - G01N33/00; Handling materials therefor using a plurality of sample containers moved by a conveyor system past one or more treatment or analysis stations
    • G01N35/025—Automatic analysis not limited to methods or materials provided for in any single one of groups G01N1/00 - G01N33/00; Handling materials therefor using a plurality of sample containers moved by a conveyor system past one or more treatment or analysis stations having a carousel or turntable for reaction cells or cuvettes
    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N35/00—Automatic analysis not limited to methods or materials provided for in any single one of groups G01N1/00 - G01N33/00; Handling materials therefor
    • G01N35/02—Automatic analysis not limited to methods or materials provided for in any single one of groups G01N1/00 - G01N33/00; Handling materials therefor using a plurality of sample containers moved by a conveyor system past one or more treatment or analysis stations
    • G01N35/04—Details of the conveyor system
    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N35/00—Automatic analysis not limited to methods or materials provided for in any single one of groups G01N1/00 - G01N33/00; Handling materials therefor
    • G01N35/10—Devices for transferring samples or any liquids to, in, or from, the analysis apparatus, e.g. suction devices, injection devices
    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N35/00—Automatic analysis not limited to methods or materials provided for in any single one of groups G01N1/00 - G01N33/00; Handling materials therefor
    • G01N35/10—Devices for transferring samples or any liquids to, in, or from, the analysis apparatus, e.g. suction devices, injection devices
    • G01N35/1004—Cleaning sample transfer devices
    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N35/00—Automatic analysis not limited to methods or materials provided for in any single one of groups G01N1/00 - G01N33/00; Handling materials therefor
    • G01N2035/00346—Heating or cooling arrangements
    • G01N2035/00356—Holding samples at elevated temperature (incubation)
    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N35/00—Automatic analysis not limited to methods or materials provided for in any single one of groups G01N1/00 - G01N33/00; Handling materials therefor
    • G01N35/02—Automatic analysis not limited to methods or materials provided for in any single one of groups G01N1/00 - G01N33/00; Handling materials therefor using a plurality of sample containers moved by a conveyor system past one or more treatment or analysis stations
    • G01N35/04—Details of the conveyor system
    • G01N2035/0439—Rotary sample carriers, i.e. carousels

Abstract

A test method based on chemiluminescence reaction and a sample analysis device are provided, a first type luminescence signal containing a luminescence signal of a lower layer reaction liquid and a second type luminescence signal containing a luminescence signal of an upper layer reaction liquid are obtained, and whether the test is abnormal or not is judged according to the first type luminescence signal and the second type luminescence signal. The invention provides a scheme for judging whether the test is abnormal or not.

Description

Test method based on chemiluminescence reaction and sample analysis device
Technical Field
The invention relates to a test method based on chemiluminescence reaction and a sample analysis device.
Background
A sample analyzer, not exemplified by an immunoassay analyzer, is a high-sensitivity and high-specificity analyzer, and is often used in clinical laboratories to detect various analysis indexes of blood, urine or other body fluids. There are many implementation principles of conventional immunoassays, such as chemiluminescence, electrochemiluminescence, and the like. Taking a heterogeneous chemiluminescence immunoassay analyzer as an example, please refer to fig. 1, which mainly works according to the following principle: when a component in a sample needs to be measured, a corresponding antibody/antigen can be coated on a magnetic bead to form a magnetic bead reagent, and a specific label is labeled on the antibody to form a labeled reagent (a reagent for measuring an analysis item generally has multiple components, such as a magnetic bead reagent component, a labeled reagent component, and the like, and different components of the same item can be contained in different reagent containers or different cavities of the same reagent container). In the testing process, a sample containing an object to be tested is mixed with a magnetic bead reagent, a labeling reagent and other reagents in sequence to form a sample reagent reaction solution (reaction solution for short), and incubation reaction is carried out under certain conditions to form a reaction complex; then, removing unbound labels, other reagents and sample components in the reaction system by a washing-separation (Bound-free, generally referred to as B/F) technology; then adding a signal reagent, and reacting the label on the reaction complex with the signal reagent (or catalyzing the signal reagent) to emit light, wherein the signal reagent can be one or more of luminescent substrate solution, pre-excitation solution, luminescence enhancement solution and the like. Specific coating cleaning methods are also various, and in addition to the above-mentioned magnetic bead cleaning method, there are other methods such as coating the antibody on the reaction vessel wall and plastic beads.
Reliability of test results and the like have been pursued by the skilled person.
Disclosure of Invention
The present invention provides a test method and a sample analyzer based on a chemiluminescent reaction, which will be described in detail below.
According to a first aspect, there is provided in one embodiment a chemiluminescent reaction based test method comprising:
controlling to add a sample to be detected and a reagent into the reaction cup to prepare a reaction solution;
controlling the reaction liquid in the reaction cup to be incubated, magnetically separated and cleaned;
controlling to add a signal reagent into the reaction liquid in the reaction cup subjected to magnetic separation and cleaning so as to enable the reaction liquid to emit light;
acquiring a first type of luminescent signal containing a luminescent signal of a lower layer reaction liquid;
obtaining a second type of luminescent signal containing a luminescent signal of the upper layer reaction liquid, wherein the second type of luminescent signal is different from the first type of luminescent signal;
and judging whether the test is abnormal or not according to the first type of luminous signals and the second type of luminous signals.
In one embodiment, the test method further obtains a third type of luminescence signal of the whole reaction solution in the reaction cup.
In one embodiment:
acquiring a luminescent signal of a lower layer reaction liquid in the reaction cup to serve as the first type of luminescent signal;
and acquiring a luminescent signal of the upper layer reaction liquid in the reaction cup to serve as the second type luminescent signal.
In one embodiment:
after the third type of light-emitting signals are obtained, controlling to absorb the upper layer reaction liquid in the reaction cup and discharge the upper layer reaction liquid into a new reaction cup;
acquiring a luminescence signal of the whole reaction liquid in the new reaction cup to serve as the second type of luminescence signal;
and acquiring a luminescent signal of the residual reaction liquid in the original reaction cup to serve as the first type of luminescent signal.
In one embodiment, when the test is determined to be normal according to the first type of light-emitting signal and the second type of light-emitting signal, the test result is calculated according to the third type of light-emitting signal.
In one embodiment, a luminescence signal of the whole reaction liquid in the reaction cup is obtained to serve as the second type luminescence signal; and acquiring a luminescent signal of the lower layer reaction liquid in the reaction cup to serve as the first type luminescent signal.
In one embodiment, after the second type of luminescent signal is obtained, the upper layer reaction liquid in the reaction cup is controlled to be sucked and removed;
and acquiring a luminescent signal of the residual reaction liquid in the original reaction cup to serve as the first type of luminescent signal.
In one embodiment, when the test is determined to be normal according to the first type of light-emitting signal and the second type of light-emitting signal, the test result is calculated according to the second type of light-emitting signal.
In one embodiment, a luminescence signal of the whole reaction liquid in the reaction cup is obtained to serve as the first type of luminescence signal; and acquiring a luminescent signal of the upper layer reaction liquid in the reaction cup to serve as the second type luminescent signal.
In one embodiment:
after the first type of luminescent signals are obtained, controlling to absorb the upper layer reaction liquid in the reaction cup and discharge the upper layer reaction liquid into a new reaction cup;
and acquiring a luminescence signal of the whole reaction liquid in the new reaction cup to serve as the second type of luminescence signal.
In one embodiment, when the test is determined to be normal according to the first type of light-emitting signal and the second type of light-emitting signal, the test result is calculated according to the first type of light-emitting signal.
In an embodiment, the determining whether the test is abnormal according to the first type of light emitting signal and the second type of light emitting signal includes:
judging whether the test is abnormal or not according to the ratio of the first type of luminous signals to the second type of luminous signals;
when the ratio is larger than a threshold value, judging that the test is abnormal;
otherwise, the test is judged to be normal
According to a second aspect, there is provided in an embodiment a sample analysis device comprising:
a reaction cup loading mechanism for supplying and carrying empty reaction cups;
the sample introduction part is used for supplying a sample to be detected;
the sample dispensing mechanism is used for sucking and discharging a sample into the reaction cup;
a reagent component for carrying a reagent;
a reagent dispensing mechanism for sucking and discharging a reagent into the reaction cup;
the reaction part comprises a plurality of position holes for placing the reaction cups; the reaction component is used for incubating a reaction liquid formed by a sample and a reagent in the reaction cup;
the magnetic separation component is used for carrying out magnetic separation and cleaning on the reaction liquid in the reaction cup;
a measuring unit for measuring a reaction solution to be measured;
the transfer mechanism is used for scheduling the reaction cups;
the processor is used for controlling the sample dispensing mechanism and the reagent dispensing mechanism to add a sample to be detected and a reagent into the reaction cup to prepare a reaction liquid, controlling the reaction component to incubate the reaction liquid in the reaction cup, controlling the magnetic separation component to carry out magnetic separation cleaning on the reaction liquid in the reaction cup, and then controlling the sample dispensing mechanism to add a signal reagent into the reaction liquid in the reaction cup after the magnetic separation cleaning so as to enable the reaction liquid to emit light; the processor acquires a first type of luminous signal containing a luminous signal of the lower-layer reaction liquid and a second type of luminous signal containing a luminous signal of the upper-layer reaction liquid, and judges whether the test is abnormal or not according to the first type of luminous signal and the second type of luminous signal; wherein the second type of luminescent signal is different from the first type of luminescent signal.
In one embodiment, the processor further controls the measuring part to obtain a third type of luminescent signal of the whole reaction liquid in the reaction cup; after the third type of luminescent signal is obtained, the processor controls the sample dispensing mechanism to suck the upper layer reaction liquid in the reaction cup and discharge the upper layer reaction liquid into a new reaction cup, controls the measuring component to obtain a luminescent signal of the whole reaction liquid in the new reaction cup to be used as the second type of luminescent signal, and controls the measuring component to obtain a luminescent signal of the residual reaction liquid in the original reaction cup to be used as the first type of luminescent signal; when the test is judged to be normal according to the first type of luminous signals and the second type of luminous signals, the processor calculates a test result according to the third type of luminous signals; alternatively, the first and second electrodes may be,
the processor controls the measuring part to obtain a luminescence signal of the whole reaction liquid in the reaction cup to serve as the second type luminescence signal; after the second type of luminescent signals are obtained, the processor controls the sample dispensing mechanism to suck and remove the upper layer reaction liquid in the reaction cup, and controls the measuring component to obtain the luminescent signals of the residual reaction liquid in the original reaction cup to be used as the first type of luminescent signals; when the test is judged to be normal according to the first type of luminous signals and the second type of luminous signals, the processor calculates a test result according to the second type of luminous signals; alternatively, the first and second electrodes may be,
the processor controls the measuring part to obtain a luminous signal of the whole reaction liquid in the reaction cup to serve as the first type of luminous signal; after the first type of luminescent signals are obtained, the processor controls the sample dispensing mechanism to suck the upper layer reaction liquid in the reaction cup and discharge the upper layer reaction liquid into a new reaction cup, and controls the measuring component to obtain the luminescent signals of the whole reaction liquid in the new reaction cup to be used as the second type of luminescent signals; and when the test is judged to be normal according to the first type of luminous signals and the second type of luminous signals, the processor calculates a test result according to the first type of luminous signals.
In one embodiment, the sample analysis device further comprises a receiver capable of acquiring an optical signal;
the processor controls the receiver to recognize and receive the luminous signals of the lower layer reaction liquid in the reaction cup as the first type of luminous signals, and recognize and receive the luminous signals of the upper layer reaction liquid in the reaction cup as the second type of luminous signals; the processor controls the measuring part to obtain a third type of luminous signals of the whole reaction liquid in the reaction cup; when the test is judged to be normal according to the first type of luminous signals and the second type of luminous signals, the processor calculates a test result according to the third type of luminous signals; alternatively, the first and second electrodes may be,
the processor controls the receiver to identify and receive a luminous signal of the lower layer reaction liquid in the reaction cup as the first type of luminous signal; the processor controls the measuring part to obtain a luminescence signal of the whole reaction liquid in the reaction cup as the second type luminescence signal; when the test is judged to be normal according to the first type of luminous signals and the second type of luminous signals, the processor calculates a test result according to the second type of luminous signals; alternatively, the first and second electrodes may be,
the processor controls the receiver to identify and receive a luminous signal of the upper layer reaction liquid in the reaction cup as the second type luminous signal; the processor controls the measuring part to obtain a luminous signal of the whole reaction liquid in the reaction cup as the first type of luminous signal; and when the test is judged to be normal according to the first type of luminous signals and the second type of luminous signals, the processor calculates a test result according to the first type of luminous signals.
In one embodiment:
the sample analysis device also comprises a receiver capable of acquiring an optical signal, wherein the receiver is arranged on the sample analysis device in a manner of limiting a luminous signal for receiving the lower reaction liquid in the reaction cup; the processor controls the receiver to receive a luminous signal of the lower layer reaction liquid in the reaction cup to serve as the first type of luminous signal; the processor controls the measuring part to obtain a luminescence signal of the whole reaction liquid in the reaction cup as the second type luminescence signal; when the test is judged to be normal according to the first type of luminous signals and the second type of luminous signals, the processor calculates a test result according to the second type of luminous signals; alternatively, the first and second electrodes may be,
the sample analysis device also comprises a receiver capable of acquiring an optical signal, wherein the receiver is arranged on the sample analysis device in a mode of limiting a luminous signal for receiving the reaction liquid on the upper layer in the reaction cup; the processor controls the receiver to receive a luminous signal of the upper layer reaction liquid in the reaction cup as the second type luminous signal; the processor controls the measuring part to obtain a luminous signal of the whole reaction liquid in the reaction cup as the first type of luminous signal; when the test is judged to be normal according to the first type of luminous signals and the second type of luminous signals, the processor calculates a test result according to the first type of luminous signals;
the sample analysis device also comprises two receivers capable of light signals, wherein one receiver is arranged on the sample analysis device in a manner of limiting the luminous signal for receiving the lower layer reaction liquid in the reaction cup, and the other receiver is arranged on the sample analysis device in a manner of limiting the luminous signal for receiving the upper layer reaction liquid in the reaction cup; the processor controls the two receivers to respectively receive the luminous signals of the lower layer reaction liquid in the reaction cup as the first type of luminous signals and receive the luminous signals of the upper layer reaction liquid in the reaction cup as the second type of luminous signals; the processor controls the measuring part to obtain a third type of luminous signals of the whole reaction liquid in the reaction cup; and when the test is judged to be normal according to the first type of luminous signals and the second type of luminous signals, the processor calculates a test result according to the third type of luminous signals.
In one embodiment, the reaction part comprises a first hole site and/or a second hole site; the first hole is shielded on the upper half part, so that only the luminous signal of the lower layer reaction liquid in the reaction cup placed in the first hole is allowed to be transmitted out through the lower unshielded half part of the first hole; the second hole is covered on the lower half part, so that only the luminous signal of the upper reaction liquid in the reaction cup placed in the second hole is allowed to be transmitted out through the second hole by the uncovered upper half part;
the processor controls the measuring part to obtain a luminescence signal of the whole reaction liquid in the reaction cup as the second type luminescence signal; the processor controls the transfer mechanism to dispatch the reaction cup to the first position hole, and acquires a luminescent signal of a lower layer reaction liquid in the reaction cup as the first type luminescent signal through the measuring part; when the test is judged to be normal according to the first type of luminous signals and the second type of luminous signals, the processor calculates a test result according to the second type of luminous signals; alternatively, the first and second electrodes may be,
the processor controls the measuring part to obtain a luminous signal of the whole reaction liquid in the reaction cup as the first type of luminous signal; the processor controls the transfer mechanism to dispatch the reaction cup to the second position hole, and obtains a luminous signal of the reaction liquid on the upper layer in the reaction cup as the second type of luminous signal through the measuring part; when the test is judged to be normal according to the first type of luminous signals and the second type of luminous signals, the processor calculates a test result according to the first type of luminous signals; alternatively, the first and second electrodes may be,
the processor controls the measuring part to obtain a third type of luminous signals of the whole reaction liquid in the reaction cup; the processor controls the transfer mechanism to dispatch the reaction cup to the first position hole, and acquires a luminescent signal of a lower layer reaction liquid in the reaction cup as the first type luminescent signal through the measuring part; the processor controls the transfer mechanism to dispatch the reaction cup to the second position hole, and obtains a luminous signal of the reaction liquid on the upper layer in the reaction cup as the second type of luminous signal through the measuring part; and when the test is judged to be normal according to the first type of luminous signals and the second type of luminous signals, the processor calculates a test result according to the third type of luminous signals.
In one embodiment, the reaction part is arranged in a disc-shaped structure, and the reaction part can rotate and drive the reaction cup placed in the hole position to rotate; the sample analysis device further comprises a movable shielding window;
the processor controls the measuring part to obtain a luminescence signal of the whole reaction liquid in the reaction cup as the second type luminescence signal; the processor controls the shielding window to move to a preset position, so that a luminous signal of a lower layer reaction liquid in the reaction cup is obtained through the measuring part and is used as the first type of luminous signal; when the test is judged to be normal according to the first type of luminous signals and the second type of luminous signals, the processor calculates a test result according to the second type of luminous signals; alternatively, the first and second electrodes may be,
the processor controls the measuring part to obtain a luminous signal of the whole reaction liquid in the reaction cup as the first type of luminous signal; the processor controls the shielding window to move to a preset position so as to obtain a luminous signal of the upper layer reaction liquid in the reaction cup as the second type luminous signal through the measuring part; when the test is judged to be normal according to the first type of luminous signals and the second type of luminous signals, the processor calculates a test result according to the first type of luminous signals; alternatively, the first and second electrodes may be,
the processor controls the measuring part to obtain a third type of luminous signals of the whole reaction liquid in the reaction cup; the processor controls the shielding windows to move to different positions respectively, so that the luminous signals of the lower layer reaction liquid in the reaction cup are obtained through the measuring part and are used as the first type luminous signals, and the luminous signals of the upper layer reaction liquid in the reaction cup are used as the second type luminous signals; and when the test is judged to be normal according to the first type of luminous signals and the second type of luminous signals, the processor calculates a test result according to the third type of luminous signals.
According to a third aspect, an embodiment provides a computer readable storage medium comprising a program executable by a processor to implement a method as described in any of the embodiments herein.
According to the chemiluminescence reaction-based test method, the sample analysis device and the computer-readable storage medium of the embodiments, a scheme for judging whether the test is abnormal is provided, for example, a first type luminescence signal including a luminescence signal of a lower layer reaction solution and a second type luminescence signal including a luminescence signal of an upper layer reaction solution are obtained, and whether the test is abnormal is judged according to the first type luminescence signal and the second type luminescence signal.
Drawings
FIG. 1 is a schematic view of the testing principle of an immunoassay analyzer according to an embodiment;
FIG. 2 is a graph of data from an experiment of an embodiment;
FIG. 3 is a schematic structural diagram of a sample analyzer according to an embodiment;
FIG. 4 is a schematic diagram of an implementation apparatus for acquiring different types of luminescence signals according to an embodiment;
FIG. 5 is a schematic diagram of an implementation apparatus for acquiring different types of luminescence signals according to another embodiment;
FIG. 6 is a schematic diagram of an implementation apparatus for acquiring different types of luminescence signals according to yet another embodiment;
FIG. 7 is a schematic diagram of an implementation apparatus for acquiring different types of luminescence signals according to yet another embodiment;
FIG. 8 is a schematic diagram of an implementation apparatus for obtaining different types of luminescence signals according to yet another embodiment;
FIG. 9 is a schematic diagram of an implementation apparatus for acquiring different kinds of luminescence signals according to yet another embodiment;
FIG. 10 is a schematic diagram of an implementation apparatus for obtaining different kinds of luminescence signals according to yet another embodiment;
FIG. 11 is a flow chart of a chemiluminescence reaction-based test method according to an embodiment;
FIG. 12 is a flow chart of a chemiluminescent reaction based test method according to another embodiment;
FIG. 13 is a flow chart of a chemiluminescent reaction based test method according to yet another embodiment;
FIG. 14 is a flow chart of a chemiluminescence reaction-based test method according to yet another embodiment;
FIG. 15 is a flow chart of a chemiluminescence reaction-based test method according to still another embodiment;
FIG. 16 is a flow chart of a chemiluminescence reaction-based test method according to yet another embodiment;
FIG. 17 is a flow chart of a chemiluminescent reaction based test method according to yet another embodiment.
Detailed Description
The present invention will be described in further detail with reference to the following detailed description and accompanying drawings. Wherein like elements in different embodiments are numbered with like associated elements. In the following description, numerous details are set forth in order to provide a better understanding of the present application. However, those skilled in the art will readily recognize that some of the features may be omitted or replaced with other elements, materials, methods in different instances. In some instances, certain operations related to the present application have not been shown or described in detail in order to avoid obscuring the core of the present application from excessive description, and it is not necessary for those skilled in the art to describe these operations in detail, so that they may be fully understood from the description in the specification and the general knowledge in the art.
Furthermore, the features, operations, or characteristics described in the specification may be combined in any suitable manner to form various embodiments. Also, the various steps or actions in the method descriptions may be transposed or transposed in order, as will be apparent to one of ordinary skill in the art. Thus, the various sequences in the specification and drawings are for the purpose of describing certain embodiments only and are not intended to imply a required sequence unless otherwise indicated where such sequence must be followed.
The numbering of the components as such, e.g., "first", "second", etc., is used herein only to distinguish the objects as described, and does not have any sequential or technical meaning. The term "connected" and "coupled" when used in this application, unless otherwise indicated, includes both direct and indirect connections (couplings).
The applicant researches and discovers that in the immunoassay testing process, if heterogeneous substances such as a sample or a reagent are introduced to precipitate, particulate matters and magnetic bead aggregates of magnetic bead adhesion fibrin and lipid are formed and often wrap interferents causing luminescence, and abnormal luminescence values can be caused in luminescent substrates/excitation liquid of each system, and the test result is often abnormal. If such false results are not recognized, they may directly result in the clinical laboratory sending a false clinical report, causing a medical accident.
However, the above-mentioned problems are not recognized by the manufacturers at present, let alone the measures for identifying anomalies in the measured values due to particles or the corresponding devices. From the clinical practice, it is currently only the highly experienced physicians who have the ability to determine the patient's test results based on the patient's specific clinical presentation and to retest the patient's sample if the patient's test results are not perceived as matching the patient's clinical presentation.
The present invention is directed to the problem, and provides a test method and a sample analyzer based on chemiluminescence reaction, to determine the advisability of the current test result, and determine whether the current test result is abnormal in luminescence value due to the introduction of the above-mentioned interferents, so that the test result is also abnormal.
Specifically, the particles can settle at the bottom of the reaction cup within a short time, for example, 1 to 5 seconds after being added with the substrate and mixed uniformly, and the particles settled at the bottom can continuously catalyze the peripheral substrate to emit light, so that the light-emitting signal of the lower-layer substrate is higher than that of the upper-layer substrate. For example, FIG. 2 shows the data obtained by the inventors' experiment, in the left and right panels, the solid line shows the value of the luminescence signal of the lower substrate, and the dotted line shows the value of the luminescence signal of the upper substrate; specifically, the left graph shows a graph of luminescence signals of the sample particulate matter with the strong jump value, and it can be seen that the difference between the luminescence signals of the upper substrate and the lower substrate is relatively large, and the right graph shows a graph of luminescence signals of the sample particulate matter with the weak jump value or the non-jump value, and it can be seen that the luminescence signals of the upper substrate and the lower substrate are relatively close. Therefore, the applicant proposes that the difference of the luminescence values of the upper substrate and the lower substrate is analyzed and compared, so that the jump value can be pre-judged, and the misjudgment of clinical tests caused by the occurrence of false results is avoided.
The present invention is explained below.
Referring to fig. 3, a sample analyzer according to some embodiments of the present invention includes a cuvette loading mechanism 1, a sample injection unit 33, a sample dispensing mechanism 3, a reagent unit 5, a reagent dispensing mechanism 6, a reaction unit 4, a measurement unit 10, a magnetic separation unit 91, a transfer mechanism, and a processor 99, which will be described in detail below. A
The cuvette loading mechanism 1 is used for supplying and carrying empty cuvettes, for example, for supplying and carrying cuvettes to the cup dispensing position. In one embodiment, the cup separating position is used for the transfer mechanism to dispatch the reaction cup to the sample adding position. In one embodiment, the reaction cup loading mechanism 1 comprises a bin 101, a picking mechanism 102, a reversing mechanism 103 and a transferring mechanism 104. The magazine 101 is used for storing reaction cups. The picking mechanism 102 is used to pick up, transfer and unload the reaction cups. The reversing mechanism 103 is connected behind the picking mechanism 102, and the reversing mechanism 103 has a conveying groove which is arranged obliquely downwards from one side of the picking mechanism 102, the conveying groove has a size which allows the lower part of the reaction cup to extend into, the width of the conveying groove is smaller than that of the hanging part on the reaction cup, the conveying groove at least has a first groove bottom wall at one end close to the picking mechanism 102, and the distance from the first groove bottom wall to the upper edge of the conveying groove is smaller than that from the bottommost part of the reaction cup to the hanging part. The transfer mechanism 104 is connected to the outlet of the reaction cup of the conveying tank, and the transfer mechanism 104 has at least one reaction cup position for storing the reaction cup for placing the reaction cup; the transfer mechanism 104 has the above-described cup separation position, and for example, one of the reaction cup positions on the transfer mechanism 104 is set as the cup separation position. In one embodiment, the transfer mechanism 104 may be a disk-type structure.
The sample introduction part 33 is used for supplying a sample to be measured. For example, the Sample introduction part 33 may be implemented by a Sample Delivery Module (SDM) and a front end rail.
The sample dispensing mechanism 3 is used to suck and discharge a sample into a reaction cup, for example, a reaction cup at a sample application position. In one embodiment, the sample dispensing mechanism 3 may be implemented by a single sample needle. In one embodiment, the whole operation flow of the sample dispensing mechanism 3 for completing one sample adding or dispensing is as follows: the sample is sucked by moving to the sample sucking position, then the sample is moved to the corresponding cleaning position to clean the outer wall, then the sample is discharged to the reaction cup positioned at the sample adding position by moving to the sample adding position, and finally the sample is moved to the corresponding cleaning position to clean the inner wall and the outer wall, for example, the cleaning of the sample dispensing mechanism 3 can be carried out at the sample needle cleaning unit 32.
The reagent component 5 is used to carry reagents. In one embodiment, the reagent part 5 is arranged in a disc-shaped structure, the reagent part 5 has a plurality of positions for carrying reagent containers, and the reagent part 5 can rotate and drive the reagent containers carried by the reagent part to rotate so as to rotate the reagent containers to a reagent sucking position for the reagent dispensing mechanism 6 to suck reagents. In one embodiment, the reagent part 5 is one, which can be separately disposed outside the reaction part 4.
The reagent dispensing mechanism 6 is used to suck and discharge a reagent into a reaction cuvette, for example, a reagent is sucked and discharged into a reaction cuvette at a reagent addition site. In one embodiment, the reagent dispensing mechanism 6 may be implemented by a reagent needle, and the number of the reagent needles may be one. In one embodiment, the whole operation flow of the reagent dispensing mechanism 6 for completing one reagent adding or dispensing is as follows: moving to a reagent sucking position to suck the reagent, then moving to a corresponding cleaning position to clean the outer wall, then moving to a reagent adding position to discharge the sucked reagent to a reaction cup positioned at the reagent adding position, and finally moving to the corresponding cleaning position to clean the inner wall and the outer wall. In one embodiment, when the reagent needle is set to continuously suck a plurality of reagents and then discharge the reagents together, the reagent needle is controlled to continuously perform a plurality of reagent sucking operations to suck a required plurality of reagents; wherein in the process of aspirating the required multiple reagents, after one reagent aspirating operation is completed and before the next reagent aspirating operation is started, the reagent needle is subjected to outer wall cleaning, for example, cleaning at the reagent needle cleaning cell unit 61.
The reaction part 4 comprises a plurality of position holes or position positions for placing reaction cups; the reaction unit 4 is used for incubating a reaction solution formed by a sample and a reagent in the reaction cup. In some embodiments, the reaction component 4 is disposed in a disc-shaped structure, and has a plurality of holes or positions for placing the reaction cups, and the reaction component 4 can rotate and drive the reaction cups in the positions to rotate, so as to schedule the reaction cups in the reaction component 4 and incubate the reaction solution in the reaction cups. In one embodiment, the reaction member 4 comprises an inner race portion and an outer race portion that are independently rotatable or rotatable together; the inner ring part comprises one or more circles of tracks, and each circle of tracks is provided with a plurality of placing positions for incubating the reaction cup and scheduling the reaction cup among the placing positions of the inner ring part; the outer ring part comprises one or more circles of tracks, and each circle of tracks is provided with a plurality of placing positions for scheduling the reaction cups among the placing positions of the outer ring part. In fig. 3 is shown an outer ring portion with one turn of track 4a, and an inner ring portion with three turns of track 4b, 4c, 4 d. In one embodiment, there is one reaction part 4.
In one embodiment, the reaction part 4 has a positioning and/or waste suction level; the measuring positions are used for the measuring part 10 to measure the reaction cups, namely the measuring part 10 measures the reaction cups scheduled to the measuring positions, and in one embodiment, when the measuring part 10 is an optical measuring unit, the measuring positions are optical measuring positions; the reaction cuvette having completed the measurement is subjected to waste liquid suction at the waste liquid suction position. In one embodiment, the position and the waste liquid absorption position are disposed on the outer portion of the reaction component 4, for example, both the position and the waste liquid absorption position are a placement position or a hole position on the outer portion of the reaction component 4, such as the position 414 and the waste liquid absorption position 415 in fig. 3. The reaction cup after the measurement is used for absorbing waste liquid at the waste liquid absorbing level, and in one embodiment, the sample analyzer further includes a waste liquid absorbing unit 11 for absorbing the reaction liquid in the reaction cup after the measurement is completed, wherein the waste liquid absorbing unit 11 includes a waste liquid absorbing needle, and a movement track of the waste liquid absorbing needle passes through the waste liquid absorbing level. In one embodiment, the reagent addition site is located within the reaction part 4, i.e., the reaction part 4 has a reagent addition site, and in one embodiment, the reagent addition site is located at an outer circumferential portion of the reaction part 4, such as reagent addition site 412 in FIG. 3; in one embodiment, the sample application site is disposed inside or outside the reaction member 4, for example, a sample application site 31 disposed outside the reaction member 4 is shown in FIG. 3.
The measuring unit 10 is used for measuring a reaction solution to be measured. In one embodiment, the measuring unit 10 is an optical measuring unit, for example, for detecting the light emission intensity of the reaction solution to be measured, and calculating the concentration of the component to be measured in the sample by, for example, a calibration curve. In one embodiment, the measuring part 10 is separately provided outside the reaction part 4. In one embodiment, the measurement unit 10 is provided separately from the magnetic separation unit 91. The measuring position may be provided in the reaction part 4 or may be provided outside the reaction part 4.
The magnetic separation member 91 is used for magnetically separating and cleaning the reaction solution in the reaction cup. In an embodiment, the magnetic separation part 91 comprises a magnetic separation disc arranged in a disc-shaped structure, the magnetic separation disc is provided with one or more circles of tracks which independently or simultaneously move, each track comprises a plurality of placing positions for placing reaction cups, and the magnetic separation disc can rotate and drive the reaction cups in the placing positions to rotate and is used for scheduling the reaction cups in the magnetic separation disc to the liquid injection position and the liquid suction position to complete magnetic separation cleaning. In one embodiment, the magnetic separating member 91 is separately disposed outside the reaction member 4.
The transfer mechanism is used to transfer the cuvettes, for example, at least among the cuvette loading mechanism 1, the reaction unit 4, and the magnetic separation unit 91.
A cooperation of the above-described mechanisms, units, components, etc. is not described by taking a one-step test item as an example. Under the control of the processor 99, the transfer mechanism transfers one cuvette from the cuvette-dividing position of the cuvette loading mechanism 1 to the sample application position, and the sample dispensing mechanism 3 sucks a sample from the sample application member 33 and discharges the sample into the cuvette at the sample application position, wherein the sample application position may be set in the reaction member 4, that is, the sample application position is one of the reaction members 4, and the sample application position may be set outside the reaction member 4. When the sample addition position is outside the reaction member 4, the transfer mechanism transfers the cuvette, which is positioned at the sample addition position and the sample addition is completed, to the reaction member 4, the cuvette discharges a reagent and is incubated in the reaction member 4 by the reagent dispensing mechanism 6, after the incubation of the cuvette is completed, the cuvette is transferred from the reaction member 4 to the magnetic separation member 91 by the transfer mechanism to be magnetically separated and cleaned, and after the magnetic separation and cleaning of the cuvette is completed, the cuvette is transferred from the magnetic separation member 91 by the transfer mechanism to be finally measured. In one embodiment, the reaction member 4 can have a photometric location, and if the measuring member 10 is a photometric cell, the reaction member 4 accordingly has a photometric location. In this case, the cuvette is returned from the magnetic separator 91 to the reaction unit 4 by the transfer mechanism after completion of the magnetic separation washing, and the photometric means optically measures the cuvette when the reaction unit 4 returns the cuvette 4 to the photometric position.
For the scheduling of the reaction cup in the whole testing process, several positions related to the scheduling can be set in the reaction part 4, and these positions can be placement positions or hole positions in the reaction part 4. In one embodiment, the reaction member 4 has a reagent loading position at the outer ring portion, a first front operating position, a first rear operating position, and a second rear operating position at the inner ring portion, as described in detail below.
When the sample addition position is located in the reaction component 4, the first front operation position is used for receiving the transfer mechanism to transfer the reaction cups from the sample division position to the reaction component 4, and when the sample addition position is located outside the reaction component 4, the first front operation position is used for receiving the reaction cups transferred from the sample addition position to the reaction component 4 by the transfer mechanism. The first rear operating position is for receiving the reaction cup transferred by the transfer mechanism from the magnetic separating unit 91 to the reaction unit 4. The second post-operation position is used for the transfer mechanism to dispatch the reaction cup to the magnetic separation unit 91 or to receive the reaction cup dispatched by the transfer mechanism from the kneading mechanism to the reaction unit 4. Of course, the functions of the operation positions may have other variations, and may be changed and set according to actual situations in specific implementations.
In order to coordinate the respective scheduling-related positions etc. in the reaction parts 4, the transfer mechanism may comprise, in an embodiment, a first cup gripper 2 and a second cup gripper 7. In one embodiment, the first cup grasping hand 2 is configured such that the movement locus passes through the cup separating position and the first front operation position, and when the sample addition position is located outside the reaction component 4, the movement locus of the first cup grasping hand 2 also passes through the sample addition position. The second cup grabber 7 is arranged such that the movement trajectory passes through the first post-operation position, the second post-operation position and the magnetic separation member 91. In one embodiment, the first cup grasping hand 2 is a three-dimensional moving structure or a rotating structure, and the second cup grasping hand 7 is a three-dimensional moving structure or a rotating structure. The scheduling between the positions can also be set on the motion track of the corresponding cup grabbing hand according to the actual situation.
When the sample addition site is located in the reaction member 4, the sample addition site may be the same site as the first front operation site or may be a different site; when the sample addition site is located outside the reaction member 4, the sample addition site and the first previous operation site may be the same site or different sites.
It is not to be construed that the reagent addition site and the first previous operation site are not the same site when the reagent addition site is located outside the reaction part 4, for example, FIG. 3 illustrates the scheduling and coordination between the sites from the viewpoint of the test flow of a one-step test item.
Under the control of the processor 99, the first cup grasping hand 2 indexes one reaction cup from the cup dividing position of the reaction cup loading mechanism 1 to the sample adding position 31, and after the sample is absorbed from the sample injecting component 33 by the sample injecting mechanism 3, the absorbed sample is discharged to the reaction cup on the sample adding position 31; the first cup grasping hand 2 dispatches the reaction cup after sample addition from the sample addition position 31 to the first front operation position 411 in the reaction part 4, the reaction part 4 dispatches the reaction cup from the first front operation position 411 to the reagent addition position 412, and the reagent dispensing mechanism sucks the reagent from the reagent sucking position of the reagent unit 5 and discharges the reagent into the reaction cup at the reagent addition position 412; the reaction part 4 dispatches the reaction cup to the first post-operation position 413, and the second cup grasping hand 7 incubates the reaction cup from the second post-operation position 42 dispatched to the reaction part 4; after the incubation is finished, when the reaction cup is not located at the second post-operation position 42, the reaction part 4 schedules the reaction cup in the reaction part 4, the reaction cup is scheduled to the second post-operation position 42, and then the second cup grabbing hand 7 schedules the reaction cup from the second post-operation position 42 to the magnetic separation part 91 for magnetic separation and cleaning; after the magnetic separation and cleaning is finished, the second cup grabbing hand 7 dispatches the reaction cup from the magnetic separation part 91 to the first post-operation position 413 of the reaction part 4; thereafter, within a predetermined substrate incubation time, the reaction component 4 can just dispatch the reaction cup to the assay position 414 for the assay component 10 to perform an assay; then, the reaction part 4 dispatches the reaction cup from the measurement position 414 to the waste liquid suction position 415, the waste liquid suction unit 11 sucks the waste liquid in the reaction cup on the waste liquid suction position 415, the reaction part 4 dispatches the reaction cup from the waste liquid suction position 415 to the first front operation position 411, the first cup grabbing hand 2 throws the reaction cup, for example, the first cup grabbing hand 2 discards the first front operation position 411 of the reaction cup to one of the cup throwing holes 201, 202, the cup throwing hole 201 is communicated with a containing device for containing the discarded cup, such as a waste bin, 202 is also connected to a waste cup holding device, the processor 99 can control the first cup grasping hand 2 to discard the reaction cups to be discarded from the first front operation position 411 to the cup throwing hole 201, when the receptacle for the waste cup, which is in communication with the cup throwing hole 201, is filled, the processor 99 notifies the user to replace the receptacle, and controls the first cup grasping hand 2 to discard the cuvette to be discarded from the first front operation position 411 to the cup disposal hole 202. The magnetic separation of the reaction cup after cleaning is performed with a substrate for the determination, and in one embodiment, the substrate can be performed in the magnetic separation part 91, and in one embodiment, the substrate can be performed in the reaction part 4, and accordingly, a substrate loading position can be provided in the reaction part 4.
The above are some of the descriptions of the sample analyzing apparatus.
In some embodiments of the present invention, two types of light emitting signals are obtained to determine whether the test is abnormal. For example, in some embodiments, the processor 99 is configured to control the sample dispensing mechanism 3 and the reagent dispensing mechanism 6 to add a sample and a reagent to be tested to a reaction cup to prepare a reaction solution, control the reaction component 4 to incubate the reaction solution in the reaction cup, control the magnetic separation component 91 to perform magnetic separation cleaning on the reaction solution in the reaction cup, and control the sample dispensing mechanism 6 to add a signal reagent to the reaction solution in the reaction cup after the magnetic separation cleaning, so that the reaction solution emits light — in some examples, the signal reagent may be a light-emitting substrate solution, a pre-excitation solution, an excitation solution, a light-emitting enhancement solution, and the like; the processor 99 obtains a first kind of light-emitting signal including the light-emitting signal of the lower layer reaction solution, and obtains a second kind of light-emitting signal including the light-emitting signal of the upper layer reaction solution, the second kind of light-emitting signal being different from the first kind of light-emitting signal, and judges whether the test is abnormal or not according to the first kind of light-emitting signal and the second kind of light-emitting signal.
The first type of luminescent signal and the second type of luminescent signal may be in a variety of cases; for example, in one case, the first type of luminescent signal is a luminescent signal of a lower layer of reaction liquid in the reaction cup, and the second type of luminescent signal is a luminescent signal of an upper layer of reaction liquid in the reaction cup; for another example, in one case, the first type of luminescent signal is a luminescent signal of a lower layer reaction solution in the reaction cup, and the second type of luminescent signal is a luminescent signal of the whole reaction solution in the reaction cup; for another example, in one case, the first type of luminescent signal is a luminescent signal of the whole reaction solution in the reaction cup, and the second type of luminescent signal is a luminescent signal of the upper layer reaction solution in the reaction cup; the following describes in detail how to obtain the first type of luminescence signal and the second type of luminescence signal.
In some cases, the above two types of signals can be obtained by a cup separation method.
In some embodiments, the processor 99 further controls the measuring component 10 to obtain a third kind of luminescence signal of the whole reaction solution in the reaction cup; the third type of light emitting signal may be used to calculate the test result, and the third type of light emitting signal may be a light emitting signal at a specific time or a light emitting signal at specific multiple times. After obtaining the third kind of light emitting signals, the processor 99 controls the sample dispensing mechanism 3 to suck the upper layer reaction solution in the reaction cup and discharge the upper layer reaction solution into a new reaction cup, controls the measuring component 10 to obtain the light emitting signals of the whole reaction solution in the new reaction cup as the second kind of light emitting signals, and controls the measuring component 10 to obtain the light emitting signals of the remaining reaction solution in the original reaction cup as the first kind of light emitting signals. When the test is normal according to the first type of light-emitting signal and the second type of light-emitting signal, the processor 99 calculates the test result according to the third type of light-emitting signal.
In some embodiments, the processor 99 controls the measuring part 10 to obtain the luminescence signal of the whole reaction solution in the reaction cup as the second type luminescence signal; after the second type of luminescent signal is obtained, the processor 99 controls the sample dispensing mechanism 3 to suck and remove the upper layer reaction solution in the reaction cup, and controls the measuring component 10 to obtain the luminescent signal of the residual reaction solution in the original reaction cup as the first type of luminescent signal; when the test is judged to be normal according to the first type of light-emitting signal and the second type of light-emitting signal, the processor 99 calculates the test result according to the second type of light-emitting signal — understandably, since the second type of light-emitting signal is the light-emitting signal of the whole reaction liquid in the reaction cup, the second type of light-emitting signal can be multiplexed as the light-emitting signal for calculating the test result in addition to being used as the light-emitting signal for judging the test to be normal in the embodiment.
In some embodiments, the processor 99 controls the measuring part 10 to obtain the luminescence signal of the whole reaction solution in the reaction cup as the first type luminescence signal; after acquiring the first type of light emitting signal, the processor 99 controls the sample dispensing mechanism 3 to suck the upper layer reaction solution in the reaction cup and discharge the upper layer reaction solution into a new reaction cup, and controls the measuring component 10 to acquire the light emitting signal of the whole reaction solution in the new reaction cup as a second type of light emitting signal; when the test is judged to be normal according to the first type of light-emitting signal and the second type of light-emitting signal, the processor 99 calculates the test result according to the first type of light-emitting signal — understandably, since the first type of light-emitting signal is the light-emitting signal of the whole reaction liquid in the reaction cup, the first type of light-emitting signal can be multiplexed as the light-emitting signal for calculating the test result in addition to being used as the light-emitting signal for judging the test to be normal in the embodiment.
In some cases, the above two types of signals can be obtained by a non-cup separation method.
In some embodiments, the luminescent signal of the upper and lower substrates can be identified by introducing a receiver 12 capable of obtaining the light signal, such as a photomultiplier tube PMT; fig. 4 is an example.
In some embodiments, the processor 99 controls the receiver 12 to recognize and receive the light-emitting signal of the lower layer of the reaction liquid in the reaction cup as a first type of light-emitting signal, and to recognize and receive the light-emitting signal of the upper layer of the reaction liquid in the reaction cup as a second type of light-emitting signal; the processor 99 controls the measuring part 10 to obtain a third type of luminescence signal of the whole reaction liquid in the reaction cup; when the test is normal according to the first type of light-emitting signal and the second type of light-emitting signal, the processor 99 calculates the test result according to the third type of light-emitting signal.
In some embodiments, the processor 99 controls the receiver 12 to recognize and receive the light-emitting signal of the lower layer reaction liquid in the reaction cup as the first type light-emitting signal; the processor 99 controls the measuring part 10 to obtain the luminescence signal of the whole reaction liquid in the reaction cup as the second type luminescence signal; when the test is judged to be normal according to the first type of light-emitting signal and the second type of light-emitting signal, the processor 99 calculates the test result according to the second type of light-emitting signal — understandably, since the second type of light-emitting signal is the light-emitting signal of the whole reaction liquid in the reaction cup, the second type of light-emitting signal can be multiplexed as the light-emitting signal for calculating the test result in addition to being used as the light-emitting signal for judging the test to be normal in the embodiment.
In some embodiments, the processor 99 controls the receiver 12 to recognize and receive the light-emitting signal of the upper reaction liquid in the reaction cup as the second type of light-emitting signal; the processor 99 controls the measuring part 10 to obtain the luminescence signal of the whole reaction liquid in the reaction cup as a first type luminescence signal; when the test is judged to be normal according to the first type of light-emitting signals and the second type of light-emitting signals, the processor calculates the test result according to the first type of light-emitting signals — understandably, because the first type of light-emitting signals are light-emitting signals of the whole reaction liquid in the reaction cup, the first type of light-emitting signals can be multiplexed into light-emitting signals for calculating the test result besides being used as light-emitting signals for judging the test to be normal in the embodiment.
Some embodiments, such as fig. 5, can be achieved by introducing a receiver 13 capable of acquiring an optical signal, wherein the receiver 13 is disposed on the sample analysis apparatus in a manner that defines a luminescence signal for receiving the reaction solution in the lower layer of the reaction cup. The processor 99 controls the receiver 13 to receive the light-emitting signal of the lower layer reaction liquid in the reaction cup as a first type light-emitting signal; the processor 99 controls the measuring part 10 to obtain the luminescence signal of the whole reaction liquid in the reaction cup as a second type luminescence signal; when the test is judged to be normal according to the first type of light-emitting signal and the second type of light-emitting signal, the processor 99 calculates the test result according to the second type of light-emitting signal — understandably, since the second type of light-emitting signal is the light-emitting signal of the whole reaction liquid in the reaction cup, the second type of light-emitting signal can be multiplexed as the light-emitting signal for calculating the test result in addition to being used as the light-emitting signal for judging the test to be normal in the embodiment.
Some embodiments, such as FIG. 6, may be implemented by introducing a receiver 14 capable of acquiring an optical signal, which is disposed on the sample analysis apparatus in a manner defining a luminescence signal for receiving the reaction solution in the upper layer of the cuvette. The processor 99 controls the receiver 14 to receive the light-emitting signal of the upper layer reaction liquid in the reaction cup as the second type light-emitting signal; the processor 99 controls the measuring part 10 to obtain a luminescence signal of the whole reaction liquid in the reaction cup as a first type luminescence signal; when the test is judged to be normal according to the first type of light-emitting signal and the second type of light-emitting signal, the processor 99 calculates the test result according to the first type of light-emitting signal — understandably, since the first type of light-emitting signal is the light-emitting signal of the whole reaction liquid in the reaction cup, the first type of light-emitting signal can be multiplexed as the light-emitting signal for calculating the test result in addition to being used as the light-emitting signal for judging the test to be normal in the embodiment.
Some embodiments, such as fig. 7, can be achieved by introducing two receivers 13 and 14 capable of optical signals, wherein one receiver 13 is disposed on the sample analysis apparatus in a manner of defining a luminescent signal for receiving a lower layer of reaction liquid in the reaction cup, and the other receiver 14 is disposed on the sample analysis apparatus in a manner of defining a luminescent signal for receiving an upper layer of reaction liquid in the reaction cup; the processor controls the two receivers 13 and 14 to respectively receive the light-emitting signals of the lower layer reaction liquid in the reaction cup as a first type of light-emitting signals and the light-emitting signals of the upper layer reaction liquid in the reaction cup as a second type of light-emitting signals-in some examples, the two receivers 13 and 14 can perform synchronous photometry; the processor 99 controls the measuring part 10 to obtain a third type of luminescence signal of the whole reaction liquid in the reaction cup; when the test is normal according to the first type of light-emitting signal and the second type of light-emitting signal, the processor 99 calculates the test result according to the third type of light-emitting signal.
In some schemes, different kinds of light-emitting signals can be obtained by shielding the upper half part or the lower half part of the hole position.
In some embodiments, reaction member 4 includes a first aperture location and/or a second aperture location; the first hole is shielded on the upper half part, so that only the luminous signal of the lower layer reaction liquid in the reaction cup placed in the first hole is allowed to be transmitted out through the lower unshielded half part of the first hole; the second hole is blocked at the lower part, so that only the luminous signal of the upper reaction liquid in the reaction cup placed in the second hole is allowed to be transmitted out through the unblocked upper part of the second hole. For example, FIG. 8 shows an example of a first hole site, a second hole site, and a normal hole site.
In some embodiments, the processor 99 controls the measuring part 10 to obtain the luminescence signal of the whole reaction solution in the reaction cup as the second type luminescence signal; the processor 99 controls the transfer mechanism to dispatch the reaction cup to the first position hole, and obtains a luminescent signal of the lower layer reaction liquid in the reaction cup as a first type luminescent signal through the measuring part 10; when the test is judged to be normal according to the first type of light-emitting signals and the second type of light-emitting signals, the processor calculates the test result according to the second type of light-emitting signals — understandably, since the second type of light-emitting signals are light-emitting signals of the whole reaction liquid in the reaction cup, the second type of light-emitting signals can be multiplexed into light-emitting signals for calculating the test result besides being used as light-emitting signals for judging the test to be normal in the embodiment.
In some embodiments, the processor 99 controls the measuring part 10 to obtain the luminescence signal of the whole reaction liquid in the reaction cup as the first type luminescence signal; the processor 99 controls the transfer mechanism to dispatch the reaction cup to the second position hole, and obtains a luminescence signal of the upper layer reaction liquid in the reaction cup as a second type luminescence signal through the measuring part 10; when the test is judged to be normal according to the first type of light-emitting signal and the second type of light-emitting signal, the processor 99 calculates the test result according to the first type of light-emitting signal — understandably, since the first type of light-emitting signal is the light-emitting signal of the whole reaction liquid in the reaction cup, the first type of light-emitting signal can be multiplexed as the light-emitting signal for calculating the test result in addition to being used as the light-emitting signal for judging the test to be normal in the embodiment.
The processor 99 controls the measuring part 10 to obtain a third type of luminescent signal of the whole reaction liquid in the reaction cup; the processor 99 controls the transfer mechanism to dispatch the reaction cup to the first position hole, and obtains a luminescent signal of the lower layer reaction liquid in the reaction cup as a first type luminescent signal through the measuring part 10; the processor 99 controls the transfer mechanism to dispatch the reaction cup to the second position hole, and obtains a luminescence signal of the upper layer reaction liquid in the reaction cup as a second type luminescence signal through the measuring part 10; when the test is normal according to the first type of light-emitting signal and the second type of light-emitting signal, the processor 99 calculates the test result according to the third type of light-emitting signal.
In some embodiments, different types of signals may be acquired through a movable shutter window. For example, fig. 9 is an example, the shielding window includes a normally complete window through which a light emitting signal of the entire reaction solution in the reaction cup can be transmitted, an upper window through which a light emitting signal of the upper reaction solution in the reaction cup can be transmitted, and a lower window through which a light emitting signal of the lower reaction solution in the reaction cup can be transmitted. The obscuration window in figure 9 can be rotationally displaced in the manner of the arrow shown, so that there is a normally complete window, upper window or lower window between the receiver or assay part 10 and the cuvette, so that the receiver or assay part 10 receives a different luminescence signal. FIG. 10 is another example, in which the shielding window comprises a half window, and the light-emitting signal of the upper reaction solution in the reaction cup can be transmitted through the half window while the light-emitting signal of the lower reaction solution in the reaction cup is shielded by moving the shielding window up and down; when the half window faces the lower layer reaction liquid in the reaction cup, the luminous signal of the lower layer reaction liquid in the reaction cup can be transmitted out through the half window, and the luminous signal of the upper layer reaction liquid in the reaction cup is shielded; in some examples, when the shielding window is moved upward so that the shielding window does not shield the cuvette at all, a luminescence signal of the entire reaction solution in the cuvette can be obtained by, for example, the measurement section 10.
In some embodiments, the processor 99 controls the measuring part 10 to obtain the luminescence signal of the whole reaction solution in the reaction cup as the second type luminescence signal; the processor 99 controls the shielding window to move to a predetermined position to obtain a luminescence signal of the lower layer reaction liquid in the reaction cup as a first type luminescence signal through, for example, the measuring part 10; when the test is judged to be normal according to the first type of light-emitting signal and the second type of light-emitting signal, the processor 99 calculates the test result according to the second type of light-emitting signal — understandably, since the second type of light-emitting signal is the light-emitting signal of the whole reaction liquid in the reaction cup, the second type of light-emitting signal can be multiplexed as the light-emitting signal for calculating the test result in addition to being used as the light-emitting signal for judging the test to be normal in the embodiment.
In some embodiments, the processor 99 controls the measuring part 10 to obtain the luminescence signal of the whole reaction liquid in the reaction cup as the first type luminescence signal; the processor 99 controls the shielding window to move to a predetermined position to acquire a luminescence signal of the upper layer reaction liquid in the cuvette as a second type luminescence signal by, for example, the measuring part 10; when the test is judged to be normal according to the first-type light-emitting signal and the second-type light-emitting signal, the processor 99 calculates the test result according to the first-type light-emitting signal — understandably, since the first-type light-emitting signal is a light-emitting signal of the whole reaction liquid in the reaction cup, the first-type light-emitting signal can be multiplexed as a light-emitting signal for calculating the test result besides being used as a light-emitting signal for judging the test to be normal in the embodiment.
In some embodiments, the processor 99 controls the measuring part 10 to obtain a third kind of luminescence signal of the whole reaction solution in the reaction cup; the processor 99 controls the shielding windows to move to different positions respectively, so as to obtain the luminescent signals of the lower layer reaction liquid in the reaction cup as a first type luminescent signal and the luminescent signals of the upper layer reaction liquid in the reaction cup as a second type luminescent signal respectively through the measuring part 10; when the test is normal according to the first type of light-emitting signal and the second type of light-emitting signal, the processor 99 calculates the test result according to the third type of light-emitting signal.
In some embodiments described above, the processor 99 may determine whether the test is normal according to the first type of light emitting signal and the second type of light emitting signal: and judging whether the test is normal or not according to the ratio of the first type of luminous signals to the second type of luminous signals, and judging that the test is abnormal when the ratio is greater than a threshold value. The threshold value may be a certain value or may be a range value. For example, when the first type of luminescent signal is a luminescent signal of the lower layer reaction solution and the second type of luminescent signal is a luminescent signal of the upper layer reaction solution, the threshold value may be in a range of 1.05 to 1.2.
The above is a description of the sample analyzer according to some embodiments of the present invention, and a test method based on a chemiluminescence reaction is further disclosed in some embodiments of the present invention, which is described in detail below.
Referring to fig. 11, some embodiments of the chemiluminescence-based test method include the following steps:
step 1000: and controlling to add a sample to be detected and a reagent into the reaction cup to prepare a reaction solution.
Step 1100: and controlling the reaction liquid in the reaction cup to be incubated and washed by magnetic separation.
Step 1200: and controlling to add a signal reagent into the reaction liquid in the reaction cup subjected to magnetic separation and cleaning so as to enable the reaction liquid to emit light. In some examples, the signaling agent can be a luminescent substrate solution, a pre-excitation solution, an excitation solution, a luminescence enhancement solution, and the like.
Step 2100: acquiring a first type of luminescent signal containing a luminescent signal of a lower layer reaction liquid;
step 2200: and acquiring a second type of luminescent signal containing the luminescent signal of the upper layer reaction liquid, wherein the second type of luminescent signal is different from the first type of luminescent signal.
Step 2300: and judging whether the test is abnormal or not according to the first type of luminous signals and the second type of luminous signals.
In some embodiments, step 2300 can determine whether the test is normal according to the first type of emission signal and the second type of emission signal: and judging whether the test is normal or not according to the ratio of the first type of luminous signals to the second type of luminous signals, and judging that the test is abnormal when the ratio is greater than a threshold value. The threshold value may be a certain value or may be a range value. For example, when the first type of luminescent signal is a luminescent signal of the lower layer reaction solution and the second type of luminescent signal is a luminescent signal of the upper layer reaction solution, the threshold value may be in a range of 1.05 to 1.2.
The first type of light emitting signal and the second type of light emitting signal may be specifically various cases; for example, in one case, the first type of luminescent signal is a luminescent signal of a lower layer of reaction liquid in the reaction cup, and the second type of luminescent signal is a luminescent signal of an upper layer of reaction liquid in the reaction cup; for another example, in one case, the first type of luminescent signal is a luminescent signal of a lower layer reaction solution in the reaction cup, and the second type of luminescent signal is a luminescent signal of the whole reaction solution in the reaction cup; for another example, in one case, the first type of luminescent signal is a luminescent signal of the whole reaction solution in the reaction cup, and the second type of luminescent signal is a luminescent signal of the upper layer reaction solution in the reaction cup; the following describes in detail how to obtain the first type of luminescence signal and the second type of luminescence signal.
The following description will first explain a scheme in which the first type of luminescent signal is a luminescent signal of a lower layer reaction solution in the reaction cup, and the second type of luminescent signal is a luminescent signal of an upper layer reaction solution in the reaction cup.
Referring to fig. 12, the method for testing based on chemiluminescence reaction of some embodiments further includes step 2000, obtaining a third type of luminescence signal of the entire reaction solution in the reaction cup. The third type of light emitting signal may be used to calculate the test result, and the third type of light emitting signal may be a light emitting signal at a specific time or a light emitting signal at specific multiple times. The first type of luminescence signal and the second type of luminescence signal can be obtained in the same reaction cup, for example, for step 2100, the luminescence signal of the lower layer of reaction solution in the reaction cup can be obtained as the first type of luminescence signal; for step 2200, the luminescence signal of the upper reaction solution in the reaction cup can be obtained as the second type luminescence signal. In some embodiments, when the step 2300 determines that the test is normal according to the first type of light emitting signal and the second type of light emitting signal, the step 2400 calculates the test result according to the third type of light emitting signal.
Or a cup division scheme can be adopted to obtain different kinds of luminous signals. For example, referring to fig. 13, after the third type of light-emitting signal is obtained in step 2000, step 2010, controlling to suck the upper layer reaction solution in the reaction cup and discharge the upper layer reaction solution into a new reaction cup; step 2200 is to obtain a luminescence signal of the whole reaction solution in the new reaction cup as a second type luminescence signal; in step 2100, a luminescence signal of the remaining reaction solution in the original cuvette is obtained as a first type of luminescence signal. In some embodiments, when the step 2300 determines that the test is normal according to the first type of light emitting signal and the second type of light emitting signal, the step 2400 calculates the test result according to the third type of light emitting signal.
The following is a description of a scheme in which the first type of luminescent signal is a luminescent signal of a lower layer reaction solution in the reaction cup, and the second type of luminescent signal is a luminescent signal of the whole reaction solution in the reaction cup.
Referring to fig. 14, in some embodiments, step 2100 may obtain a luminescence signal of a lower layer reaction solution in the reaction cup as a first type luminescence signal; step 2200 may be obtaining a luminescence signal of the whole reaction solution in the reaction cup as a second type luminescence signal. In some embodiments, when the step 2300 judges that the test is normal according to the first type of light emitting signal and the second type of light emitting signal, the step 2400 calculates the test result according to the second type of light emitting signal. Since the second type of luminescence signal is the luminescence signal of the whole reaction solution in the reaction cup, the second type of luminescence signal can be multiplexed as the luminescence signal for calculating the test result, in addition to being the luminescence signal for judging the test is normal in the embodiment.
Referring to fig. 15, in some embodiments, step 2200 may be obtaining a luminescence signal of the entire reaction solution in the reaction cup as a second type luminescence signal; after the second type luminescence signal is obtained in the step 2200, controlling to suck and remove the upper layer reaction liquid in the reaction cup in the step 2020; step 2100 may be to obtain a luminescence signal of the remaining reaction solution in the original reaction cup as a first type luminescence signal. In some embodiments, when the step 2300 judges that the test is normal according to the first type of light emitting signal and the second type of light emitting signal, the step 2400 calculates the test result according to the second type of light emitting signal. Since the second type of luminescence signal is the luminescence signal of the whole reaction solution in the reaction cup, the second type of luminescence signal can be multiplexed as the luminescence signal for calculating the test result, in addition to being the luminescence signal for judging the test is normal in the embodiment.
The following is a description of a scheme in which the first type of luminescent signal is a luminescent signal of the whole reaction solution in the reaction cup, and the second type of luminescent signal is a luminescent signal of the upper layer reaction solution in the reaction cup.
Referring to fig. 16, in some embodiments, step 2100 may be obtaining a luminescence signal of the entire reaction solution in the reaction cup as a first type of luminescence signal; step 2200 may be obtaining a luminescence signal of the upper reaction solution in the reaction cup as a second type luminescence signal. In some embodiments, when the step 2300 judges that the test is normal according to the first type of light emitting signal and the second type of light emitting signal, the step 2400 calculates the test result according to the first type of light emitting signal. Since the first type of luminescence signal is the luminescence signal of the whole reaction solution in the reaction cup, the first type of luminescence signal can be multiplexed into a luminescence signal for calculating the test result, in addition to being used as the luminescence signal for judging the test is normal in the embodiment.
Referring to fig. 17, in some embodiments, step 2100 may be obtaining a luminescence signal of the entire reaction solution in the reaction cup as a first type of luminescence signal; after the first type of light emitting signal is obtained in step 2100, step 2030 controls to suck the upper layer reaction liquid in the reaction cup and discharge the upper layer reaction liquid into a new reaction cup; step 2200 may be obtaining the luminescence signal of the whole reaction solution in the new reaction cup as the second type luminescence signal. In some embodiments, when the step 2300 judges that the test is normal according to the first type of light emitting signal and the second type of light emitting signal, the step 2400 calculates the test result according to the first type of light emitting signal. Since the first type of luminescence signal is the luminescence signal of the whole reaction solution in the reaction cup, the first type of luminescence signal can be multiplexed into a luminescence signal for calculating the test result, in addition to being used as the luminescence signal for judging the test is normal in the embodiment.
It is some description of the chemiluminescent reaction based assay method of the present invention.
According to some embodiments of the invention, abnormal luminescence of the reaction liquid caused by introduction of an interfering substance can be predicted in advance, and sending of a wrong clinical report is avoided.
Reference is made herein to various exemplary embodiments. However, those skilled in the art will recognize that changes and modifications may be made to the exemplary embodiments without departing from the scope hereof. For example, the various operational steps, as well as the components used to perform the operational steps, may be implemented in differing ways depending upon the particular application or consideration of any number of cost functions associated with operation of the system (e.g., one or more steps may be deleted, modified or incorporated into other steps).
In the above embodiments, the implementation may be wholly or partially realized by software, hardware, firmware, or any combination thereof. Additionally, as will be appreciated by one skilled in the art, the principles herein may be reflected in a computer program product on a computer readable storage medium, which is pre-loaded with computer readable program code. Any tangible, non-transitory computer-readable storage medium may be used, including magnetic storage devices (hard disks, floppy disks, etc.), optical storage devices (CD-to-ROM, DVD, Blu-Ray discs, etc.), flash memory, and/or the like. These computer program instructions may be loaded onto a general purpose computer, special purpose computer, or other programmable data processing apparatus to produce a machine, such that the instructions which execute on the computer or other programmable data processing apparatus create means for implementing the functions specified. These computer program instructions may also be stored in a computer-readable memory that can direct a computer or other programmable data processing apparatus to function in a particular manner, such that the instructions stored in the computer-readable memory produce an article of manufacture including means for implementing the function specified. The computer program instructions may also be loaded onto a computer or other programmable data processing apparatus to cause a series of operational steps to be performed on the computer or other programmable apparatus to produce a computer implemented process such that the instructions which execute on the computer or other programmable apparatus provide steps for implementing the functions specified.
While the principles herein have been illustrated in various embodiments, many modifications of structure, arrangement, proportions, elements, materials, and components particularly adapted to specific environments and operative requirements may be employed without departing from the principles and scope of the present disclosure. The above modifications and other changes or modifications are intended to be included within the scope of this document.
The foregoing detailed description has been described with reference to various embodiments. However, one skilled in the art will recognize that various modifications and changes may be made without departing from the scope of the present disclosure. Accordingly, the disclosure is to be considered in an illustrative and not a restrictive sense, and all such modifications are intended to be included within the scope thereof. Also, advantages, other advantages, and solutions to problems have been described above with regard to various embodiments. However, the benefits, advantages, solutions to problems, and any element(s) that may cause any element(s) to occur or become more pronounced are not to be construed as a critical, required, or essential feature or element of any or all the claims. As used herein, the terms "comprises," "comprising," or any other variation thereof, are intended to cover a non-exclusive inclusion, such that a process, method, article, or apparatus that comprises a list of elements does not include only those elements but may include other elements not expressly listed or inherent to such process, method, system, article, or apparatus. Furthermore, the term "coupled," and any other variation thereof, as used herein, refers to a physical connection, an electrical connection, a magnetic connection, an optical connection, a communicative connection, a functional connection, and/or any other connection.
Those skilled in the art will recognize that many changes may be made to the details of the above-described embodiments without departing from the underlying principles of the invention. Accordingly, the scope of the invention should be determined only by the claims.

Claims (19)

1. A chemiluminescent reaction based assay method comprising:
controlling to add a sample to be detected and a reagent into the reaction cup to prepare a reaction solution;
controlling the reaction liquid in the reaction cup to be incubated, magnetically separated and cleaned;
controlling to add a signal reagent into the reaction liquid in the reaction cup subjected to magnetic separation and cleaning so as to enable the reaction liquid to emit light;
acquiring a first type of luminescent signal containing a luminescent signal of a lower layer reaction liquid;
obtaining a second type of luminescent signal containing a luminescent signal of the upper layer reaction liquid, wherein the second type of luminescent signal is different from the first type of luminescent signal;
and judging whether the test is abnormal or not according to the first type of luminous signals and the second type of luminous signals.
2. The test method of claim 1, wherein: and obtaining a third type of luminescent signal of the whole reaction liquid in the reaction cup.
3. The test method of claim 2, wherein:
acquiring a luminescent signal of a lower layer reaction liquid in the reaction cup to serve as the first type of luminescent signal;
and acquiring a luminescent signal of the upper layer reaction liquid in the reaction cup to serve as the second type luminescent signal.
4. The test method of claim 2, wherein:
after the third type of light-emitting signals are obtained, controlling to absorb the upper layer reaction liquid in the reaction cup and discharge the upper layer reaction liquid into a new reaction cup;
acquiring a luminescence signal of the whole reaction liquid in the new reaction cup to serve as the second type of luminescence signal;
and acquiring a luminescent signal of the residual reaction liquid in the original reaction cup to serve as the first type of luminescent signal.
5. The test method according to any one of claims 2 to 4, wherein when the test is judged to be normal based on the first type of light emission signal and the second type of light emission signal, a test result is calculated based on the third type of light emission signal.
6. The test method according to claim 1, wherein a luminescence signal of the entire reaction solution in the reaction cuvette is obtained as the second type luminescence signal; and acquiring a luminescent signal of the lower layer reaction liquid in the reaction cup to serve as the first type luminescent signal.
7. The test method of claim 6, wherein:
after the second type of luminescent signals are obtained, controlling to suck and remove the upper layer reaction liquid in the reaction cup;
and acquiring a luminescent signal of the residual reaction liquid in the original reaction cup to serve as the first type of luminescent signal.
8. The test method according to claim 6 or 7, wherein when the test is judged to be normal based on the first type of light emission signal and the second type of light emission signal, a test result is calculated based on the second type of light emission signal.
9. The test method according to claim 1, wherein a luminescence signal of the entire reaction solution in the reaction cup is obtained as the first type luminescence signal; and acquiring a luminescent signal of the upper layer reaction liquid in the reaction cup to serve as the second type luminescent signal.
10. The test method of claim 9, wherein:
after the first type of luminescent signals are obtained, controlling to absorb the upper layer reaction liquid in the reaction cup and discharge the upper layer reaction liquid into a new reaction cup;
and acquiring a luminescence signal of the whole reaction liquid in the new reaction cup to serve as the second type of luminescence signal.
11. The test method according to claim 9 or 10, wherein when the test is judged to be normal based on the first type of light emission signal and the second type of light emission signal, a test result is calculated based on the first type of light emission signal.
12. The method according to any one of claims 1 to 11, wherein the determining whether the test is abnormal according to the first type of the light-emitting signal and the second type of the light-emitting signal comprises:
judging whether the test is abnormal or not according to the ratio of the first type of luminous signals to the second type of luminous signals;
when the ratio is larger than a threshold value, judging that the test is abnormal;
otherwise, the test is judged to be normal.
13. A sample analysis apparatus, comprising:
a reaction cup loading mechanism for supplying and carrying empty reaction cups;
the sample introduction part is used for supplying a sample to be detected;
the sample dispensing mechanism is used for sucking and discharging a sample into the reaction cup;
a reagent component for carrying a reagent;
a reagent dispensing mechanism for sucking and discharging a reagent into the reaction cup;
the reaction part comprises a plurality of position holes for placing the reaction cups; the reaction component is used for incubating a reaction liquid formed by a sample and a reagent in the reaction cup;
the magnetic separation component is used for carrying out magnetic separation and cleaning on the reaction liquid in the reaction cup;
a measuring unit for measuring a reaction solution to be measured;
the transfer mechanism is used for scheduling the reaction cups;
the processor is used for controlling the sample dispensing mechanism and the reagent dispensing mechanism to add a sample to be detected and a reagent into the reaction cup to prepare a reaction liquid, controlling the reaction component to incubate the reaction liquid in the reaction cup, controlling the magnetic separation component to carry out magnetic separation cleaning on the reaction liquid in the reaction cup, and then controlling the sample dispensing mechanism to add a signal reagent into the reaction liquid in the reaction cup after the magnetic separation cleaning so as to enable the reaction liquid to emit light; the processor acquires a first type of luminous signal containing a luminous signal of the lower-layer reaction liquid and a second type of luminous signal containing a luminous signal of the upper-layer reaction liquid, and judges whether the test is abnormal or not according to the first type of luminous signal and the second type of luminous signal; wherein the second type of luminescent signal is different from the first type of luminescent signal.
14. The sample analyzing apparatus as recited in claim 13, wherein: the processor also controls the measuring part to obtain a third type of luminous signals of the whole reaction liquid in the reaction cup; after the third type of luminescent signal is obtained, the processor controls the sample dispensing mechanism to suck the upper layer reaction liquid in the reaction cup and discharge the upper layer reaction liquid into a new reaction cup, controls the measuring component to obtain a luminescent signal of the whole reaction liquid in the new reaction cup to be used as the second type of luminescent signal, and controls the measuring component to obtain a luminescent signal of the residual reaction liquid in the original reaction cup to be used as the first type of luminescent signal; when the test is judged to be normal according to the first type of luminous signals and the second type of luminous signals, the processor calculates a test result according to the third type of luminous signals; alternatively, the first and second electrodes may be,
the processor controls the measuring part to obtain a luminescence signal of the whole reaction liquid in the reaction cup to serve as the second type luminescence signal; after the second type of luminescent signals are obtained, the processor controls the sample dispensing mechanism to suck and remove the upper layer reaction liquid in the reaction cup, and controls the measuring component to obtain the luminescent signals of the residual reaction liquid in the original reaction cup to be used as the first type of luminescent signals; when the test is judged to be normal according to the first type of luminous signals and the second type of luminous signals, the processor calculates a test result according to the second type of luminous signals; alternatively, the first and second electrodes may be,
the processor controls the measuring part to obtain a luminous signal of the whole reaction liquid in the reaction cup to serve as the first type of luminous signal; after the first type of luminescent signals are obtained, the processor controls the sample dispensing mechanism to suck the upper layer reaction liquid in the reaction cup and discharge the upper layer reaction liquid into a new reaction cup, and controls the measuring component to obtain the luminescent signals of the whole reaction liquid in the new reaction cup to be used as the second type of luminescent signals; and when the test is judged to be normal according to the first type of luminous signals and the second type of luminous signals, the processor calculates a test result according to the first type of luminous signals.
15. The sample analyzing apparatus of claim 13, further comprising a receiver capable of acquiring the optical signal;
the processor controls the receiver to recognize and receive the luminous signals of the lower layer reaction liquid in the reaction cup as the first type of luminous signals, and recognize and receive the luminous signals of the upper layer reaction liquid in the reaction cup as the second type of luminous signals; the processor controls the measuring part to obtain a third type of luminous signals of the whole reaction liquid in the reaction cup; when the test is judged to be normal according to the first type of luminous signals and the second type of luminous signals, the processor calculates a test result according to the third type of luminous signals; alternatively, the first and second electrodes may be,
the processor controls the receiver to identify and receive a luminous signal of the lower layer reaction liquid in the reaction cup as the first type of luminous signal; the processor controls the measuring part to obtain a luminescence signal of the whole reaction liquid in the reaction cup as the second type luminescence signal; when the test is judged to be normal according to the first type of luminous signals and the second type of luminous signals, the processor calculates a test result according to the second type of luminous signals; alternatively, the first and second electrodes may be,
the processor controls the receiver to identify and receive a luminous signal of the upper layer reaction liquid in the reaction cup as the second type luminous signal; the processor controls the measuring part to obtain a luminous signal of the whole reaction liquid in the reaction cup as the first type of luminous signal; and when the test is judged to be normal according to the first type of luminous signals and the second type of luminous signals, the processor calculates a test result according to the first type of luminous signals.
16. The sample analysis apparatus of claim 13, wherein:
the sample analysis device also comprises a receiver capable of acquiring an optical signal, wherein the receiver is arranged on the sample analysis device in a manner of limiting a luminous signal for receiving the lower reaction liquid in the reaction cup; the processor controls the receiver to receive a luminous signal of the lower layer reaction liquid in the reaction cup to serve as the first type of luminous signal; the processor controls the measuring part to obtain a luminescence signal of the whole reaction liquid in the reaction cup as the second type luminescence signal; when the test is judged to be normal according to the first type of luminous signals and the second type of luminous signals, the processor calculates a test result according to the second type of luminous signals; alternatively, the first and second electrodes may be,
the sample analysis device also comprises a receiver capable of acquiring an optical signal, wherein the receiver is arranged on the sample analysis device in a mode of limiting a luminous signal for receiving the reaction liquid on the upper layer in the reaction cup; the processor controls the receiver to receive a luminous signal of the upper layer reaction liquid in the reaction cup as the second type luminous signal; the processor controls the measuring part to obtain a luminous signal of the whole reaction liquid in the reaction cup as the first type of luminous signal; when the test is judged to be normal according to the first type of luminous signals and the second type of luminous signals, the processor calculates a test result according to the first type of luminous signals;
the sample analysis device also comprises two receivers capable of light signals, wherein one receiver is arranged on the sample analysis device in a manner of limiting the luminous signal for receiving the lower layer reaction liquid in the reaction cup, and the other receiver is arranged on the sample analysis device in a manner of limiting the luminous signal for receiving the upper layer reaction liquid in the reaction cup; the processor controls the two receivers to respectively receive the luminous signals of the lower layer reaction liquid in the reaction cup as the first type of luminous signals and receive the luminous signals of the upper layer reaction liquid in the reaction cup as the second type of luminous signals; the processor controls the measuring part to obtain a third type of luminous signals of the whole reaction liquid in the reaction cup; and when the test is judged to be normal according to the first type of luminous signals and the second type of luminous signals, the processor calculates a test result according to the third type of luminous signals.
17. The sample analysis device of claim 13, wherein the reaction feature comprises a first aperture site and/or a second aperture site; the first hole is shielded on the upper half part, so that only the luminous signal of the lower layer reaction liquid in the reaction cup placed in the first hole is allowed to be transmitted out through the lower unshielded half part of the first hole; the second hole is covered on the lower half part, so that only the luminous signal of the upper reaction liquid in the reaction cup placed in the second hole is allowed to be transmitted out through the second hole by the uncovered upper half part;
the processor controls the measuring part to obtain a luminescence signal of the whole reaction liquid in the reaction cup as the second type luminescence signal; the processor controls the transfer mechanism to dispatch the reaction cup to the first position hole, and acquires a luminescent signal of a lower layer reaction liquid in the reaction cup as the first type luminescent signal through the measuring part; when the test is judged to be normal according to the first type of luminous signals and the second type of luminous signals, the processor calculates a test result according to the second type of luminous signals; alternatively, the first and second electrodes may be,
the processor controls the measuring part to obtain a luminous signal of the whole reaction liquid in the reaction cup as the first type of luminous signal; the processor controls the transfer mechanism to dispatch the reaction cup to the second position hole, and obtains a luminous signal of the reaction liquid on the upper layer in the reaction cup as the second type of luminous signal through the measuring part; when the test is judged to be normal according to the first type of luminous signals and the second type of luminous signals, the processor calculates a test result according to the first type of luminous signals; alternatively, the first and second electrodes may be,
the processor controls the measuring part to obtain a third type of luminous signals of the whole reaction liquid in the reaction cup; the processor controls the transfer mechanism to dispatch the reaction cup to the first position hole, and acquires a luminescent signal of a lower layer reaction liquid in the reaction cup as the first type luminescent signal through the measuring part; the processor controls the transfer mechanism to dispatch the reaction cup to the second position hole, and obtains a luminous signal of the reaction liquid on the upper layer in the reaction cup as the second type of luminous signal through the measuring part; and when the test is judged to be normal according to the first type of luminous signals and the second type of luminous signals, the processor calculates a test result according to the third type of luminous signals.
18. The sample analyzer of claim 13, wherein the reaction member is configured as a disk-shaped structure, and the reaction member is capable of rotating and rotating the reaction cup placed at the hole; the sample analysis device further comprises a movable shielding window;
the processor controls the measuring part to obtain a luminescence signal of the whole reaction liquid in the reaction cup as the second type luminescence signal; the processor controls the shielding window to move to a preset position, so that a luminous signal of a lower layer reaction liquid in the reaction cup is obtained through the measuring part and is used as the first type of luminous signal; when the test is judged to be normal according to the first type of luminous signals and the second type of luminous signals, the processor calculates a test result according to the second type of luminous signals; alternatively, the first and second electrodes may be,
the processor controls the measuring part to obtain a luminous signal of the whole reaction liquid in the reaction cup as the first type of luminous signal; the processor controls the shielding window to move to a preset position so as to obtain a luminous signal of the upper layer reaction liquid in the reaction cup as the second type luminous signal through the measuring part; when the test is judged to be normal according to the first type of luminous signals and the second type of luminous signals, the processor calculates a test result according to the first type of luminous signals; alternatively, the first and second electrodes may be,
the processor controls the measuring part to obtain a third type of luminous signals of the whole reaction liquid in the reaction cup; the processor controls the shielding windows to move to different positions respectively, so that the luminous signals of the lower layer reaction liquid in the reaction cup are obtained through the measuring part and are used as the first type luminous signals, and the luminous signals of the upper layer reaction liquid in the reaction cup are used as the second type luminous signals; and when the test is judged to be normal according to the first type of luminous signals and the second type of luminous signals, the processor calculates a test result according to the third type of luminous signals.
19. A computer-readable storage medium, characterized by comprising a program executable by a processor to implement the method of any one of claims 1 to 12.
CN202010962126.2A 2020-09-14 2020-09-14 Test method based on chemiluminescence reaction and sample analysis device Pending CN114184799A (en)

Priority Applications (1)

Application Number Priority Date Filing Date Title
CN202010962126.2A CN114184799A (en) 2020-09-14 2020-09-14 Test method based on chemiluminescence reaction and sample analysis device

Applications Claiming Priority (1)

Application Number Priority Date Filing Date Title
CN202010962126.2A CN114184799A (en) 2020-09-14 2020-09-14 Test method based on chemiluminescence reaction and sample analysis device

Publications (1)

Publication Number Publication Date
CN114184799A true CN114184799A (en) 2022-03-15

Family

ID=80539314

Family Applications (1)

Application Number Title Priority Date Filing Date
CN202010962126.2A Pending CN114184799A (en) 2020-09-14 2020-09-14 Test method based on chemiluminescence reaction and sample analysis device

Country Status (1)

Country Link
CN (1) CN114184799A (en)

Similar Documents

Publication Publication Date Title
US5846491A (en) Device for automatic chemical analysis
US9341640B2 (en) Apparatus for multiple automatic analysis of biosamples, method for autoanalysis, and reaction cuvette
CN111033263B (en) Automatic analysis device and working method thereof
US11754580B2 (en) Sample measurement method and sample measurement device
CN210090481U (en) Chemiluminescence immunoassay appearance
EP2733494B1 (en) Specimen analyzer
WO2017047240A1 (en) Automated analysis device
CN111033265A (en) Automatic analysis device and working method thereof
US11400455B2 (en) Sample measuring system and sample measuring method
CN114184799A (en) Test method based on chemiluminescence reaction and sample analysis device
JP2018080980A (en) Measuring mechanism equipped with reaction unit and optical detection unit
JP2020101465A (en) Specimen measurement device and specimen measurement method
CN111033266B (en) Automatic analysis device and working method thereof
JP5286299B2 (en) Analysis equipment
US20200309801A1 (en) Sample measurement device and sample measurement method
JP6886952B2 (en) Specimen measuring device and sample measuring method
CN217688992U (en) Sample analyzer
US11953511B2 (en) Sample measurement system and method of transporting racks

Legal Events

Date Code Title Description
PB01 Publication
PB01 Publication
SE01 Entry into force of request for substantive examination
SE01 Entry into force of request for substantive examination