CN111413328A

CN111413328A - Dual-mode instant detection system

Info

Publication number: CN111413328A
Application number: CN202010347516.9A
Authority: CN
Inventors: 吴勇; 严志伟; 李颖; 胡恒龙
Original assignee: Shijiazhuang Dihong Biotechnology Co ltd; Zhongshan Taihui Biotechnology Co ltd; Shanghai Taihui Biotechnology Co ltd
Current assignee: Shijiazhuang Dihong Biotechnology Co ltd; Zhongshan Taihui Biotechnology Co ltd; Shanghai Taihui Biotechnology Co ltd
Priority date: 2020-04-28
Filing date: 2020-04-28
Publication date: 2020-07-14
Anticipated expiration: 2040-04-28
Also published as: CN111413328B

Abstract

The application discloses a dual-mode instantaneous detection system. The dual-mode point-of-care detection system comprises: the reagent strip rotating table comprises a rotating disc and a supporting frame for supporting the rotating disc, the rotating disc comprises a plurality of reagent strip seats for receiving and holding reagent strips, and the supporting frame is provided with a turbidimetric detection station and a photochemical luminescence detection station; and the detection device is arranged adjacent to the reagent strip rotating table and comprises an excitation light source, a turbidimetric detection assembly and a photochemical luminescence detection assembly, the excitation light source and the turbidimetric detection assembly are arranged on the turbidimetric detection station in a mutually opposite mode, and the photochemical luminescence detection assembly is arranged on the photochemical luminescence detection station. According to the dual-mode instant detection system, the two detection modes are integrated into one detection instrument, the structural design is reasonable, the detection efficiency is improved, and the economic cost, the time cost and the space cost are saved.

Description

Dual-mode instant detection system

Technical Field

The present disclosure relates to the field of in vitro diagnostic and detection immunoassay, and more particularly to a dual-mode real-time detection system.

Background

Infectious diseases are today one of the major diseases facing humans. Antibiotics control many bacterial infections and effectively reduce the mortality of various bacterial infections, but the problems of antibiotic abuse and resistance are also increasing. At present, the control strength of reasonably using antibiotics is increased in China. The early and rapid differential diagnosis of infectious diseases has important significance for the reasonable use of antibiotics and the treatment of diseases.

The clinical diagnosis method for infectious diseases comprises a relatively short immunoassay method, a relatively short fluorescence immunoassay method, a relatively high fluorescence immunoassay method, a relatively short fluorescence immunoassay method, a relatively high fluorescence immunoassay sensitivity, a relatively high fluorescence immunoassay method for efficiently detecting the detection sensitivity of early infection, a relatively high fluorescence detection sensitivity of a relatively short fluorescence detection time, a relatively high fluorescence detection time, a relatively short fluorescence immunoassay method for identifying the relatively short fluorescence immunoassay method for infectious diseases, a relatively high fluorescence immunoassay method, a relatively high fluorescence detection time, a relatively short fluorescence detection time, a relatively high fluorescence detection sensitivity for relatively high fluorescence detection time, a relatively high fluorescence detection sensitivity for relatively short fluorescence detection time, a relatively high fluorescence detection time.

Chemiluminescence can be classified into two major types, labeled immunoassay and unlabeled immunoassay, depending on whether it is labeled or not. Since a label is required and it is inevitably necessary to solve the problem of separating an antigen or antibody bound to the label and an antigen or antibody not bound to the label in the test, the labeled immunoassay is classified into a conventional heterogeneous immunoassay and a homogeneous immunoassay according to whether the separation is performed or not. The heterogeneous immunoassay method needs to remove free proteins and microspheres which do not participate in reaction through multiple steps of operations such as embedding, elution, separation and the like, and because the sample pretreatment process is complex and tedious and relates to a full-automatic instrument, the detection equipment is expensive, the detection time is long, the requirements on the instrument and reagents are high, false positive or false negative results are easy to appear due to improper operation, and the missed detection and false detection are caused. In addition, chemiluminescence does not meet the requirements for rapid detection and diagnosis, and is not suitable for application scenarios such as emergency treatment. In contrast, homogeneous chemiluminescence is a method based on the effect of microsphere-to-microsphere or particle-to-particle proximity and is used for target analyte detection. By detecting the intensity of the optical signal, the existence of the target analyte in the actual detection sample is judged or the concentration information of the target analyte is further obtained. The homogeneous phase luminescence immunoassay method effectively avoids complicated steps such as elution and separation, can complete a series of steps from incubation to detection in a short time by matching with the high-affinity antibody, and greatly improves the detection efficiency and the cost performance while realizing high-sensitivity detection.

Under the condition that the in vitro detection is in scale and package nowadays, the joint detection of a plurality of projects can greatly improve the detection efficiency, so that the method is suitable for the detection of the in vitro detection. However, due to the different contents of different analytes in the sample, the detection sensitivity and linear range technical requirements of different items are also different. Due to the technical conditions of homogeneous phase immunoassay, it is difficult to perform joint detection on multiple antigens or antibodies with large content difference (the content difference is more than 100 times) in a single sample. As for the above-mentioned measurement of CRP, SAA and PCT, CRP and SAA are substances at a level of mg, and PCT is a substance at a level of pg. The immunoturbidimetric detection method is limited by detection sensitivity, and is difficult to detect a target substance at a low concentration level. Therefore, it is difficult to simultaneously detect a plurality of items by using a homogeneous luminescence detection method alone or an immunoturbidimetric detection method alone. In addition, conventional assays use essentially serum or plasma samples, and do not detect whole blood samples. This is due to the complex matrix of the whole blood sample and the high number of disturbing factors. This necessitates the pretreatment of the sample, and the detection procedure becomes more complicated and takes a longer time.

Therefore, the method can detect the indexes simultaneously, can perform auxiliary diagnosis on the infectious diseases more quickly and simply, and reduce the medical burden of the patient, thereby effectively avoiding the risk of missed detection of the patient in the window period due to insufficient sensitivity of the in-vivo antibody, and improving the sensitivity and specificity of clinical diagnosis. In addition, the detection advantage is not only limited to inflammation markers, but also can be applied to the aspects of liver and kidney functions, myocardial infarction indexes and the like. Further improving the application value of the homogeneous phase luminescence technology.

Disclosure of Invention

It is an object of the present disclosure to provide a dual mode point-of-care detection system that overcomes at least one of the deficiencies of the prior art.

The subject technology of the present disclosure is illustrated in accordance with aspects described below. For convenience, various examples of aspects of the subject technology are described as clauses (1, 2, 3, etc.) of the reference numerals. These terms are provided as examples and do not limit the subject technology of the present disclosure.

1. A dual-mode real-time detection system configured to perform immunoturbidimetry and/or photochemiluminescence detection on the same sample, wherein the dual-mode real-time detection system comprises:

the reagent strip rotating table comprises a rotating disc and a supporting frame for supporting the rotating disc, the rotating disc comprises a plurality of reagent strip seats for receiving and holding reagent strips, and the supporting frame is provided with a turbidimetric detection station and a photochemical luminescence detection station; and

the detection device is arranged adjacent to the reagent strip rotating table and comprises an excitation light source, a turbidimetric detection assembly and a photochemical luminescence detection assembly, the excitation light source and the turbidimetric detection assembly are arranged on the turbidimetric detection station in a mutually opposite mode, and the photochemical luminescence detection assembly is arranged on the photochemical luminescence detection station;

the rotating disc can rotate on the supporting frame around the central axis of the rotating disc so as to sequentially move the reagent strips in the reagent strip seat to a turbidimetric detection station and a photochemical luminescence detection station at the downstream of the turbidimetric detection station, wherein when the reagent strips move to the turbidimetric detection station, the excitation light source, the reagent strips and the turbidimetric detection component can establish a turbidimetric detection light path for immune turbidimetric detection; when the reagent strip moves to the photochemical luminescence detection station, the reagent strip and the photochemical luminescence detection assembly can establish a photochemical detection light path for photochemical luminescence detection.

2. The dual-mode point-of-care detection system of clause 1, wherein the excitation light source is configured to simultaneously provide illumination light for immunoturbidimetric detection and excitation light for photochemical luminescence detection.

3. The dual-mode point-of-care detection system of clause 1, wherein the turbidimetric detection assembly comprises a transmitted light turbidimetric detection assembly and a scattered light turbidimetric detection assembly,

the transmission light turbidimetry detection component is arranged opposite to the excitation light source and is positioned in the light emission direction of the excitation light source, so that a transmission light turbidimetry detection light path can be established by the transmission light turbidimetry detection component, the excitation light source and the reagent strip positioned between the transmission light turbidimetry detection component and the excitation light source;

the scattered light turbidimetric detection assembly is arranged opposite to the excitation light source and forms an included angle with the light emission direction of the excitation light source, so that a scattered light turbidimetric detection light path can be established by the scattered light turbidimetric detection assembly, the excitation light source and the reagent strip positioned between the scattered light turbidimetric detection assembly and the excitation light source.

4. The dual mode instantaneous test system of clause 3, wherein the included angle ranges from 10 ° to 60 °.

5. The dual mode instantaneous detection system of any of clauses 1-4, wherein the turbidimetric detection assembly includes a turbidimetric detector, an attenuation panel, and a filter panel.

6. The dual mode instantaneous detection system of clause 5, wherein the turbidimetric detector is selected from one or more of the following group: photon counter, photomultiplier, silicon photocell, photometry integrating sphere.

7. A dual mode point-of-care detection system as described in any of clauses 1-4 wherein the photo-chemical luminescence detection assembly comprises a photo-chemical luminescence detector and a filter.

8. The dual-mode point-of-care detection system of clause 7, wherein the photo-chemical luminescence detector is selected from one or more of the following group: photon counter, photomultiplier, silicon photocell, photometry integrating sphere.

9. The dual-mode point-of-care system of clause 7, wherein the photo-chemical detection assembly comprises a first photo-chemical detection assembly and a second photo-chemical detection assembly adjacent to each other, the first photo-chemical detection assembly comprises a first filter, the second photo-chemical detection assembly comprises a second filter different from the first filter, and the photo-chemical emission detection station comprises a first photo-chemical emission detection station and a second photo-chemical emission detection station;

the first photochemical luminescence detection assembly is arranged on the first photochemical luminescence detection station, and the first photochemical luminescence detection station is arranged at the downstream of the turbidimetric detection station along the rotation direction of the rotating disc; when the reagent strip moves to the first photochemical luminescence detection station, the first photochemical luminescence detection assembly and the reagent strip can establish a first photochemical detection light path for first-time photochemical luminescence detection;

the second photochemical luminescence detection assembly is arranged on the second photochemical luminescence detection station, and the second photochemical luminescence detection station is arranged at the downstream of the first photochemical luminescence detection station along the rotation direction of the rotating disc; when the reagent strip moves to the second photochemical luminescence detection station, the second photochemical luminescence detection assembly and the reagent strip can establish a second photochemical detection light path for second photochemical luminescence detection.

10. The dual mode instantaneous detection system of any of clauses 1-4, wherein the rotating disc comprises an annular bottom wall and one or two side walls projecting vertically upward from an inner and/or outer periphery of the bottom wall.

11. The dual-mode instant testing system of clause 10, wherein the reagent strip holder comprises a through-hole in the bottom wall and a sidewall projecting vertically upward from the bottom wall around a periphery of the through-hole, and wherein a cross-sectional shape of the reagent strip holder matches a cross-sectional shape of the reagent strip.

12. The dual mode point-of-care testing system of clause 11, wherein the top of the sidewall of the reagent strip holder is provided with a recess recessed inwardly from the outer surface thereof, the recess configured for insertion of a finger of an operator.

13. The dual mode point-of-care detection system of any of clauses 1-4, wherein the plurality of reagent strip holders abut one another in a circumferential direction of the rotating disk.

14. The dual mode point-of-care detection system of any of clauses 1-4, wherein the plurality of reagent strip holders are equally spaced, or not equally spaced, in the circumferential direction of the rotating disk.

15. The dual mode instantaneous test system of any of clauses 1-4, wherein the central cavity of the rotating disc has a drive shaft secured thereto.

16. The dual-mode point-of-care testing system of any of clauses 1-4, wherein the support frame comprises an annular bottom wall, and a reagent strip slide disposed on the bottom wall.

17. The dual-mode point-of-care detection system of clause 16, wherein the reagent strip slide includes radially inner and outer sidewalls that extend vertically upward from the bottom wall and are spaced apart, and the radially inner and outer sidewalls are spaced apart a radial distance that is slightly greater than or greater than a radial dimension of the reagent strip.

18. The dual-mode instant testing system of clause 17, wherein the reagent strip slide is provided with a first pair of opposing mounting slots and a second pair of opposing mounting slots on a radially inner side wall and a radially outer side wall thereof, and the excitation light source and the turbidimetric testing assembly are removably mounted in the first pair of opposing mounting slots, and the actinic luminescence testing assembly is removably mounted in the second pair of opposing mounting slots.

19. The dual mode instantaneous detection system of clause 17, wherein the plurality of posts are disposed immediately radially outward of the radially outer sidewall, project vertically upward from the bottom wall, and have a height greater than the radially outer sidewall.

20. The dual-mode point-of-care testing system of any of clauses 1-4, wherein the reagent strip carousel further comprises a rotating disk cover that overlies the rotating disk to provide a dark room environment for the reagent strip suitable for testing.

21. The dual mode point of care detection system of clause 20, wherein the rotating disc cover comprises an annular cover body, and the cover body comprises a top wall and one or two side walls projecting vertically downward from an inner and/or outer periphery of the top wall.

22. The dual-mode point-of-care detection system of clause 21, wherein the support frame comprises an annular bottom wall and a plurality of columns extending vertically upward from the bottom wall, and the cover is secured to the plurality of columns.

23. The dual-mode point-of-care detection system of clause 21, wherein the reagent opening is provided on a top wall of the cover to provide access for the pipetting device to the reagent strip interior cavity.

24. The dual-mode point-of-care testing system of clause 21, wherein the sample placement window is disposed on the top wall of the cover to provide access to the reagent strip holder for the reagent strip.

25. The dual mode point-of-care detection system of clause 24, wherein the rotating tray cover further comprises a sample placement window cover that can slide back and forth over the cover along a guide rail on the top wall of the cover to open or close the sample placement window.

26. The dual-mode point-of-care testing system of clause 15, wherein the reagent strip carousel further comprises a drive mechanism configured to drive the carousel to rotate on the support frame.

27. The dual mode point-of-care detection system of clause 26, wherein the drive mechanism comprises a motor and an electrically conductive slip ring, an output shaft of the motor being connected to the electrically conductive slip ring by a drive belt, and an output shaft of the electrically conductive slip ring being connected to a drive shaft of the rotating disc.

28. The dual mode real time detection system of clause 27, wherein the drive mechanism comprises a stop collar located below the rotatable disk and having a notch, and a zero position sensor for determining the initial position of the rotatable disk by detecting the notch of the stop collar.

29. The dual mode point of care detection system of clause 28, wherein the stop collar is disposed at a lower end of the output shaft of the conductive slip ring.

30. The dual-mode instant testing system of any of clauses 1-4, wherein the reagent strip carousel further comprises an incubation mechanism configured to provide a suitable temperature for an immune reaction in the reagent strip.

31. The dual-mode point-of-care detection system of clause 30, wherein the incubation mechanism is disposed on the rotary disk, on the support frame, or on both the rotary disk and the support frame.

32. The dual-mode point-of-care detection system of clause 31, wherein the incubation mechanism comprises a heating membrane.

33. The dual-mode point-of-care testing system of any of clauses 1-4, wherein the reagent strip is configured to contain a sample and one or more solvents.

34. The dual-mode point-of-care detection system of clause 33, wherein the reagent strip comprises a reaction cup for holding the sample, one or more solvent compartments for holding one or more solvents, and a pipette tip compartment for holding a pipette tip to be mounted on the pipette device.

35. The dual-mode point-of-care detection system of clause 34, wherein the cuvette is configured to be transparent to allow light emitted by the excitation light source and light emitted by the sample to pass therethrough.

36. The dual-mode point-of-care detection system of clause 34, wherein the reaction cup is removably or non-removably secured in the reagent strip.

37. The dual-mode point-of-care detection system of clause 34, wherein the openings of the reaction cup, the solvent chamber, and the pipette tip chamber are all disposed on top and are sealed with a sealing membrane.

38. The dual-mode point-of-care detection system of clause 34, wherein the dual-mode point-of-care detection system further comprises a pipetting device configured for transferring the one or more solvents into the sample, the pipetting device disposed radially outward of the reagent strip carousel.

39. The dual-mode instant testing system of clause 38, wherein the pipetting device comprises a vertical shuttle and a pipetting gun secured to the vertical shuttle, wherein the vertical shuttle is capable of moving the pipetting gun in a vertical reciprocating motion and cooperating with the rotation of the reagent strip carousel to transfer the one or more solvents into the reaction cuvette of the reagent strip.

40. The dual mode point-of-care detection system of clause 39, wherein the pipette is provided with a level sensor for detecting the liquid level.

41. The dual-mode real-time detection system of clause 39, wherein the vertical reciprocating mechanism comprises a vertical plate, and a driving rotating shaft, a driven rotating shaft and a synchronous belt arranged on the vertical plate, one end of the synchronous belt is wound on the driving rotating shaft, the other end of the synchronous belt is wound in the driven rotating shaft, and the pipette is fixed on the synchronous belt.

42. The dual-mode point-of-care detection system of clause 18, wherein the detection device further comprises a turbidimetric detection carrier and a chemiluminescent detection carrier, wherein the turbidimetric detection carrier is configured to carry the excitation light source and the turbidimetric detection assembly, and the chemiluminescent detection carrier is configured to carry the chemiluminescent detection assembly.

43. The dual-mode real-time detection system of clause 42, wherein the turbidimetric detection carrier comprises a bottom wall and vertical arms extending vertically upward from both ends of the bottom wall, the bottom wall of the turbidimetric detection carrier is fixed to the bottom wall of the support frame between the first pair of mounting slots, and the two vertical arms respectively carry the excitation light source and the turbidimetric detection assembly.

44. The dual-mode real-time inspection system of clause 42, wherein the photo-chemical luminescence inspection carrying seat comprises a bottom wall and vertical arms vertically extending upwards from two ends of the bottom wall, the bottom wall of the turbidimetric inspection carrying seat is fixed to the bottom wall between the second pair of mounting grooves of the supporting frame, and one of the vertical arms carries the photo-chemical luminescence inspection assembly.

45. The dual mode real time detection system of any of clauses 1-4, wherein the dual mode real time detection system further comprises an operator interface, wherein a user sets parameters, display data, and analysis data of the dual mode real time detection system through the operator interface.

46. The dual-mode point-of-care detection system of any of clauses 1-4, wherein the dual-mode point-of-care detection system comprises a controller electrically connected to and controlling the operation of the reagent strip carousel, pipetting device, and detection device.

47. A dual-mode point-of-care detection method performed by a dual-mode point-of-care detection system configured for immunoturbidimetric detection and/or photochemical luminescence detection of the same sample, wherein the method comprises the steps of:

adding a collected sample into a reaction cup of a reagent strip, wherein the reagent strip is packaged with a photochemical luminescence detection reagent and a turbidimetric detection reagent;

placing the reagent strip into a rotating disc of a reagent strip rotating table;

the rotating disc drives the reagent strips to rotate to reach a station of the liquid transferring device, and the liquid transferring device adds a photochemical luminescence detection reagent and a turbidimetric detection reagent in the reagent strips into a collected sample of the reaction cup through the rotation matching of the reagent strip rotating table to obtain a sample to be detected;

the rotating disc drives the reagent strip to rotate to reach a turbidimetric detection station of the liquid transferring device, the excitation light source simultaneously provides illumination light for immunoturbidimetric detection and excitation light for photochemical luminescence detection after the immunoturbidimetric detection, and the turbidimetric detection assembly detects a turbidity value Z of the sample;

the rotating disc drives the reagent strip to rotate to reach a photochemical luminescence detection station at the downstream of a turbidimetric detection station of the liquid transferring device, and the photochemical luminescence detector detects a photochemical luminescence signal value F of the sample;

substituting the photochemical luminescence signal value F into a photochemical luminescence detection object concentration-photochemical luminescence signal value standard curve to obtain the concentration of the photochemical luminescence detection object in the sample to be detected; and

and (4) bringing the turbidity value Z into a turbidity detection substance concentration-turbidity value standard curve to obtain the concentration of the turbidity detection substance in the sample to be detected.

48. The method of clause 47, wherein the turbidimetric analyte concentration-turbidity value standard curve comprises a plurality of turbidimetric analyte concentration-turbidity value standard curves corresponding to the plurality of actinic luminescence signal values F1, … Fn, respectively,

if the photochemical luminescence signal value F is one of F1 and … Fn, substituting the turbidity value Z into a corresponding turbidimetric test substance concentration-turbidity value standard curve to obtain a turbidimetric test substance concentration value;

if the photochemical luminescence signal value F is not one of F1 and … Fn, selecting two values which are adjacent to F from F1 and … Fn, obtaining two turbidimetric detection substance concentration-turbidity value standard curves corresponding to the two values, obtaining a turbidimetric detection substance concentration-turbidity value standard curve corresponding to the photochemical luminescence signal value F from the two turbidimetric detection substance concentration-turbidity value standard curves according to a linear interpolation method and a L orit model, and substituting the turbidity value Z into the turbidimetric detection substance concentration-turbidity value standard curve corresponding to the photochemical luminescence signal value F to obtain a turbidimetric detection substance concentration value.

49. The method of clause 47, wherein the method further comprises establishing a standard curve of the concentration of the chemiluminescent detector versus the value of the chemiluminescent signal.

50. The method of clause 47, wherein the method further comprises establishing a plurality of turbidimetric analyte concentration-turbidity value standard curves, wherein the plurality of turbidimetric analyte concentration-turbidity value standard curves correspond to different values of the actinic luminescence signal.

51. The method of any of clauses 47-50, wherein the pipetting device removes and assembles the disposable pipette tip from the reagent strip prior to the pipetting device adding the chemiluminescent detection reagent and the turbidimetric detection reagent to the sample in the cuvette.

52. The method of any of clauses 47-50, wherein the sample and the reagent are homogenized by one or more pipetting operations of the pipetting device while the photochemiluminescence detection reagent and the turbidimetric detection reagent in the reagent strip are added to the sample in the cuvette by the pipetting device.

53. The method of any of clauses 47-50, wherein the incubation mechanism incubates the cuvette for an appropriate time after the pipetting device adds the chemiluminescent detection reagent and the turbidimetric detection reagent in the reagent strip to the sample in the cuvette.

Additional features and advantages of the disclosed subject technology will be set forth in the description which follows, and in part will be obvious from the description, or may be learned by practice of the disclosed subject technology. The advantages of the subject technology of the present disclosure will be realized and attained by the structure particularly pointed out in the written description and claims hereof as well as the appended drawings.

It is to be understood that both the foregoing general description and the following detailed description are exemplary and explanatory and are intended to provide further explanation of the subject technology of the present disclosure as claimed.

Drawings

Various aspects of the disclosure will be better understood upon reading the following detailed description in conjunction with the drawings in which:

FIGS. 1 and 2 illustrate assembled and exploded perspective views, respectively, of a dual mode point of care detection system according to a first embodiment of the present disclosure;

FIG. 3 illustrates a perspective view of the rotary plate, support frame and rotary plate cover of the dual mode instant detection system of FIGS. 1 and 2;

FIG. 3A illustrates a close-up view of the dual mode instantaneous detection system of FIG. 3;

FIG. 4 illustrates a perspective view of the drive mechanism of the dual mode instant detection system of FIGS. 1 and 2;

FIG. 5 illustrates a perspective view of a reagent strip of the dual-mode point-of-care testing system of FIGS. 1 and 2;

FIG. 6 shows a perspective view of the pipetting device of the dual mode instant detection system of FIGS. 1 and 2;

FIGS. 7 and 8 show perspective views of the detection device of the dual mode point-of-care detection system of FIGS. 1 and 2;

FIG. 9 shows a schematic of a standard curve of turbidimetric assay concentration versus turbidity values.

Detailed Description

The present disclosure will now be described with reference to the accompanying drawings, which illustrate several embodiments of the disclosure. It should be understood, however, that the present disclosure may be embodied in many different forms and should not be construed as limited to the embodiments set forth herein; rather, the embodiments described below are intended to provide a more complete disclosure of the present disclosure, and to fully convey the scope of the disclosure to those skilled in the art. It is also to be understood that the embodiments disclosed herein can be combined in various ways to provide further additional embodiments.

It should be understood that like reference numerals refer to like elements throughout the several views. In the drawings, the size of some of the features may be varied for clarity.

It is to be understood that the terminology used in the description is for the purpose of describing particular embodiments only, and is not intended to be limiting of the disclosure. All terms (including technical and scientific terms) used in the specification have the meaning commonly understood by one of ordinary skill in the art unless otherwise defined. Well-known functions or constructions may not be described in detail for brevity and/or clarity.

As used in this specification, the singular forms "a", "an" and "the" include plural referents unless the content clearly dictates otherwise. The terms "comprising," "including," and "containing" when used in this specification specify the presence of stated features, but do not preclude the presence or addition of one or more other features. The term "and/or" as used in this specification includes any and all combinations of one or more of the associated listed items. The terms "between X and Y" and "between about X and Y" as used in the specification should be construed to include X and Y. The term "between about X and Y" as used herein means "between about X and about Y" and the term "from about X to Y" as used herein means "from about X to about Y".

In the description, when an element is referred to as being "on," "attached" to, "connected" to, "coupled" to, or "contacting" another element, etc., another element may be directly on, attached to, connected to, coupled to, or contacting the other element, or intervening elements may be present. In contrast, when an element is referred to as being "directly on," "directly attached to," directly connected to, "directly coupled to," or "directly contacting" another element, there are no intervening elements present. In the description, one feature is disposed "adjacent" another feature, and may mean that one feature has a portion overlapping with or above or below an adjacent feature.

In the specification, spatial relations such as "upper", "lower", "left", "right", "front", "rear", "high", "low", and the like may explain the relation of one feature to another feature in the drawings. It will be understood that the spatial relationship terms are intended to encompass different orientations of the device in use or operation in addition to the orientation depicted in the figures. For example, features originally described as "below" other features may be described as "above" other features when the device in the figures is inverted. The device may also be otherwise oriented (rotated 90 degrees or at other orientations) and the relative spatial relationships may be interpreted accordingly.

The systems described herein may also utilize one or more controllers to receive information and transform the received information to generate output. The controller may comprise any type of computing device, computing circuitry, or any type of processor or processing circuitry capable of executing a series of instructions stored in a memory. The controller may include multiple processors and/or multi-core Central Processing Units (CPUs) and may include any type of processor, such as a microprocessor, digital signal processor, microcontroller, or the like. The controller may also include a memory to store data and/or algorithms to execute a series of instructions.

Any of the methods, programs, algorithms or code described herein may be converted to or expressed as a programming language or computer program, "programming language" and "computer program" are any language used to specify instructions to a computer, and include, but are not limited to, assembly language, Basic, batch files, BCP L, C, C +, C + +, Delphi, Fortran, Java, JavaScript, machine code, operating system command language, Pascal, Perl, P L1, scripting language, Visual Basic, meta-languages that specify programs themselves, and first, second, third, fourth and fifth generation computer languages.

Any of the methods, programs, algorithms, or code described in this specification can be embodied on one or more machine-readable media or memories. The term "memory" may include a mechanism that provides (e.g., stores and/or transmits) information in a form readable by a machine, such as a processor, computer, or digital processing device. For example, the memory may include Read Only Memory (ROM), Random Access Memory (RAM), magnetic disk storage media, optical storage media, flash memory devices, or any other volatile or non-volatile storage device. The code or instructions contained thereon may be represented by carrier wave signals, infrared signals, digital signals, and other similar signals.

Fig. 1 and 2 show an assembled perspective view and an exploded perspective view, respectively, of a dual mode point of care detection system 1 according to a first embodiment of the present disclosure. The dual-mode instant detection system 1 can be used for the combined detection of immunoturbidimetry and photochemical luminescence in the same immune reaction system. As shown, the dual-mode instant assay system 1 includes a reagent strip carousel 10, a pipetting device 20, and an assay device 30. The reagent strip rotating platform 1 is used for moving the reagent strip 40 filled with the sample to the work station of the pipetting device 20 and the work station of the detection device 30 in sequence. The pipetting device 20 is disposed adjacent the reagent strip carousel 10 and is configured to transfer a solvent (e.g., a detection reagent, a buffer, a diluent, etc.) into the sample of the reagent strip 40 in coordination with the rotation of the reagent strip carousel 10. The detection device 30 is disposed near the reagent strip rotation stage 10 and is used for detecting a turbidity value and/or a photo-chemical luminescence signal value in a sample of the reagent strip 40.

Referring to fig. 1 and 2, the reagent strip rotation stand 10 includes a rotation disk 110 that rotates about its central axis, a support frame 120 that supports the rotation disk 110, and a driving mechanism 130 that drives the rotation disk 110 to rotate. As shown in fig. 3, the rotating disc 110 includes a bottom wall, and one or two side walls 112 vertically protruding upward from an inner circumference and/or an outer circumference of the bottom wall. The bottom wall may be annular.

The rotating disk 110 further includes a plurality of reagent strip holders 113 disposed on the bottom wall. The reagent strip holder 113 is for receiving and holding a reagent strip 40. The reagent strip holder 113 includes a through hole in the bottom wall, and a side wall 114 projecting vertically upward from the bottom wall around the periphery of the through hole. The cross-sectional shape of the reagent strip holder 113 and the cross-sectional shape of the reagent strip 40 are matched so that the reagent strip 40 can be placed on the support rack 120 below through the through-hole and stably held in a vertical position by the side wall 114. The reagent strip holder 113 may be arcuate in cross-section, with the arcuate shape being concentric with the annular bottom wall. In other embodiments, the cross-section of the reagent strip holder 113 may have other suitable shapes, such as rectangular, etc. The plurality of reagent strip holders 113 may be adjacent to each other in the circumferential direction of the rotary disk 110. In other embodiments, the plurality of reagent strip holders 113 may also be equally spaced, or not equally spaced, in the circumferential direction of the rotating disk 110. The number of the reagent strip seats 113 can be set according to needs, and twelve reagent strip seats 113 are arranged in the embodiment, so that the test needs are met, and the carrying is convenient.

As shown in the enlarged partial view of FIG. 3A, the top of the side wall 114 of the reagent strip holder 113 is provided with a recess 116 recessed inward from the outer surface thereof to facilitate insertion of the fingers of the operator for inserting and removing the reagent strips 40.

A drive shaft 115 (see fig. 4) is fixed to a central cavity of the rotating disc 110 for connection to an output shaft of the driving mechanism 130. The driving mechanism 130 drives the rotary disk 110 to rotate, so as to sequentially move the reagent strips 40 in the reagent strip holders 113 to different stations, such as a station of the pipetting device 20 and a station of the detection device 30.

The support bracket 120 is disposed under the rotary disk 110 and serves to support the rotary disk 110 to rotate. The rack 120 includes a bottom wall 121, and a reagent strip slide 122 disposed on the bottom wall 121. The bottom wall 121 may be annular.

The reagent strip slide 122 allows the reagent strip 40 to slide therein to different stations, such as the station of the pipetting device 20 and the station of the detection device 30. The reagent strip slide 122 includes a radially inner side wall 123 and a radially outer side wall 124 that project vertically upward from the bottom wall 121 and are spaced apart. The radially inner and

outer side walls

123, 124 are annular and concentric with the bottom wall of the rotating disc 110. The radially inner and

outer side walls

123, 124 are spaced apart a radial distance slightly greater than or equal to the radial dimension of the reagent strip 40 to facilitate sliding of the received reagent strip 40 therein. The rotary disk 110 is placed on the support bracket 120, and either the radially inner side wall 123 or the radially outer side wall 124 may be used to support the rotary disk 110, or both the radially inner side wall 123 and the radially outer side wall 124 may be used to support the rotary disk 110. The through-hole of the reagent strip holder 113 is located at a radial position between the radially inner side wall 123 and the radially outer side wall 124, thereby facilitating the reagent strip 40 to be placed in the reagent strip slide 122 through the through-hole of the reagent strip holder 113 and stably held in an upright state by the side wall 114 of the reagent strip holder 113.

The reagent strip slide 122 is provided with a first pair of opposed mounting slots 125 and a second pair of opposed mounting slots 126 on its radially inner 123 and radially outer 124 side walls. The excitation light source 310 and turbidimetric detection assembly 320 (described in detail below) of the detection device 30 are removably mounted in the mounting slot 126 to form a turbidimetric detection station of the stations of the detection device 30. A chemiluminescent detection assembly 330 (described in detail below) of detection apparatus 30 is removably mounted in mounting slot 125 to form a chemiluminescent detection station of the stations of detection apparatus 30.

In some embodiments, a plurality of posts 127 are disposed immediately radially outward of the radially outer sidewall 124 of the reagent strip chute 122 and are evenly distributed circumferentially to prevent the rotating disk 110 from deviating from the rotational path as the rotating disk 110 rotates on the support frame 120. The post 127 may protrude vertically upward from the bottom wall 121 and have a height greater than the radially outer side wall 124 so as to block the deflection of the rotating disc 110.

In some embodiments, the support stand 120 is further provided with a plurality of support legs 128 (see fig. 2) to support the support stand 120 on the base plate 41 of the dual-mode real-time detection system 1 and above the driving device 20. The support legs 128 may extend vertically downward from the bottom wall 121 of the support bracket 120.

The reagent strip rotation station 10 may also include a rotation tray cover 140. The rotary disk cover 140 covers the rotary disk 110 to provide a dark room environment suitable for testing to the reagent strip 40. The rotating disk cover 140 includes a cover body 141. The cover 141 is annular and includes a top wall 142, and one or two side walls 143 projecting vertically downward from an inner periphery and/or an outer periphery of the top wall 142. The top wall 142 and the side wall 143 of the cover 141, the side wall 112 of the rotating disk 110, and the

side walls

123 and 124 and the bottom wall 121 of the support frame 120 cooperate to provide a dark room environment for the reagent strip 40. The top wall 142 of the cover 141 may be placed over the post 127 of the support bracket 120 and secured to the post 127 by screwing, snap-fitting, welding, gluing, etc.

A reagent opening 144 may be provided in the top wall 142 of the cover 141 to provide access to the interior of the reagent strip 40 by the pipetting device 20. A sample placement window 145 may also be provided in the top wall 142 of the cover 141 to provide access for reagent strips 40 to and from the reagent strip holders 113 of the rotating disk 110. The sampling window cover 146 can be used to cover the sampling window 145. The placement window cover 146 can slide back and forth on the cover 141 along rails on the top wall 142 to open or close the placement window 145. In other embodiments, the placement window cover 146 can also be removed directly from over the placement window 145. In other embodiments, the entire cover 141 of the rotary disk cover 140 can be removed directly from above the rotary disk 110 to place the reagent strip 40 into the reagent strip holder 113 of the rotary disk 110 without providing an additional sample placement window 145 in the cover 141.

The driving mechanism 130 is used for driving the rotating disc 110 to rotate on the supporting frame 120. As shown in fig. 4, the drive mechanism 130 includes a motor 131 as a drive source. The motor 131 may be, for example, a stepper motor, and may be applied to a digital program control system to achieve automatic control. The motor 131 may be fixed on the substrate 41. The drive mechanism 130 may also include an electrically conductive slip ring 132 that transmits electrical energy and/or electrical signals from the stationary structure to the rotating structure during unlimited continuous rotation. An output shaft of the motor 131 is connected to the conductive slip ring 132 through a transmission belt, and an upper end of the output shaft of the conductive slip ring 132 is connected to the driving shaft 115 of the rotating disk 110, thereby driving the rotating disk 110 to rotate.

In some embodiments, the output shaft of the motor 131 may be connected to a reduction mechanism by a transmission belt, and the reduction mechanism is connected to the drive shaft 115 of the rotating disc 110. In some embodiments, the output shaft of the motor 131 may be connected to the drive shaft 115 of the turn disc 110 by a drive belt. In some embodiments, the output shaft of the motor 131 may be fixedly connected directly to the drive shaft 115 of the turn disc 110 without a belt.

The drive mechanism 130 may also include a stop collar 133 and a null sensor 134. The stopper ring 133 is disposed below the rotating disc 110 and is provided with a notch. The null sensor 134 is provided on the base plate 41. The null sensor 134 determines an initial position of the rotary disk 110 by detecting a gap of the retainer ring 133 and resets the rotary disk 110. In some embodiments, a stop collar 133 may be provided at the lower end of the output shaft of the conductive slip ring 132.

As shown in FIGS. 2 and 3, the reagent strip carousel 10 may also include an incubation mechanism 150 to provide an appropriate temperature for the immune reaction in the reagent strip 40. The incubation mechanism 150 may be disposed on the rotating disk 110, on the support shelf 120, or on both the rotating disk 110 and the support shelf 120. The incubation mechanism 150 may be a heating membrane. The heating film can be formed by using a polyester film as a substrate, using conductive ink as a heating body, using silver paste and a conductive metal bus bar as a conductive lead and finally performing hot-pressing compounding. The heating film generates heat in a radiation mode and has penetrability. The shape of the heating film can be customized as desired. In one embodiment, the heating film is ring-shaped and is disposed on an inner side of the rotating disk 110, such as an inner side of the bottom wall or an inner side of the side wall 112.

The reagent strip 40 is used for accommodating a sample to be detected, a solvent, and the like, and is moved to different stations by the reagent strip rotation table 10, such as a station of the pipetting device 20 and a station of the detection device 30. As shown in FIG. 5, the reagent strip 40 has a cylindrical shape. The cross section of the reagent strip 40 is arc-shaped to match the cross section of the reagent strip holder 113; the height of the reagent strip 40 is slightly less than or equal to the sum of the internal heights of the reagent strip holder 113 and the reagent strip slide 122 so that the reagent strip 40 can be placed in the reagent strip slide 122 through the through hole of the reagent strip holder 113 and stably held in an upright position by the reagent strip holder 113.

The reagent strip 40 includes a reaction cup 410 for holding a sample to be tested, and one or more solvent chambers 420 for holding various solvents (e.g., detection reagents, buffers, diluents, etc.). The cuvette 410 is transparent to allow light from the excitation light source 310 and light from the sample to pass through. Reaction cup 410 may be removably or non-removably secured within reagent strip 40. The reagent strip 40 may also include a pipette tip compartment 430 to accommodate a disposable pipette tip to be mounted on a pipette gun 210 (described in detail below) of the pipetting device 20. This has avoided moving liquid at every turn and all need taking a liquid-transfering gun head from liquid-transfering gun head big packing, has improved operating efficiency.

The openings of the reaction cup 410, the solvent chamber 420 and the pipette head chamber 430 are all disposed on top and may be sealed with a disposable sealing film (e.g., aluminum foil). This avoids contamination of the pipette tips and reagents, improving the reliability of the detection. The reaction cup 410, the solvent chamber 420 and the pipette tip chamber 430 can be recycled by cleaning and other processes. The number of cuvettes 410, solvent chambers 420 and pipette tip chambers 430 in the reagent strip 40 can be set as desired, for example, one cuvette 410, three solvent chambers 420 and one pipette tip chamber 430 are provided in this embodiment.

The pipetting device 20 is arranged radially outside the reagent strip rotation stage 10 and is used to transfer various solvents into the sample of the reagent strip 40. As shown in fig. 6, the pipetting device 20 includes a vertical reciprocating mechanism 220, and a pipette gun 210 fixed to the vertical reciprocating mechanism 220. The pipette gun 210 is used to aspirate or spit out the detection reagents or other solvents (e.g., buffers, diluents, etc.) in the one or more solvent chambers 420 of the reagent strip 40. The vertical reciprocating mechanism 220 drives the pipette gun 210 to reciprocate along the vertical direction, and cooperates with the rotation of the reagent strip rotating platform 10 to transfer the detection reagent or other solvents into the reaction cup of the reagent strip 40, so as to complete the pipetting operation.

The pipette gun 210 may be an air pump automatic pipette gun for a digital program control system. The pipette 210 may be provided with a level sensor that detects the liquid level. The level sensor can sense the level position and feed information back to the pipette gun 210 to allow the pipette gun 210 to automatically complete the pipetting action. In some embodiments, pipette gun 210 may perform multiple "spitting" motions to accomplish the mixing of the liquid. The number of times of the "sucking and spitting" action can be set as required.

The vertical reciprocating mechanism 220 includes a vertical plate 221, and a driving rotation shaft 222, a driven rotation shaft 223, and a timing belt 224 provided on the vertical plate 221. The driving rotation shaft 222 and the driven rotation shaft 223 extend in a horizontal direction, and are spaced apart and aligned in a vertical direction. One end of the timing belt 224 is wound around the driving rotation shaft 222 and the other end is wound around the driven rotation shaft 223. The pipette gun 210 is fixed to the timing belt 224 by a mechanism such as a slider. An output shaft of a driver of the vertical reciprocating mechanism 220 is connected to the driving rotating shaft 222 and drives the driving rotating shaft 222 to rotate, thereby driving the synchronous belt 224 and the pipette gun 210 to reciprocate in the vertical direction. The drive may be, for example, an air cylinder, a motor, or the like, such as a closed loop motor for a digital program control system.

The detecting device 30 is disposed on the supporting frame 120 and is used for detecting a turbidity value and/or a photo-chemical luminescence signal value in a sample of the reagent strip 40. As shown in fig. 7 and 8, the detection device 30 includes an excitation light source 310, a turbidimetric detection assembly 320, and a chemiluminescent detection assembly 330. The excitation light source 310 is used to provide illumination light for immunoturbidimetric assay and excitation light for photochemical luminescence assay simultaneously. Turbidimetric detection component 320 is configured to detect a turbidity value of a sample. The chemiluminescence detection assembly 330 is used for detecting the value of the chemiluminescence signal of the sample.

The turbidimetric detection assembly 320 is positioned in the turbidimetric detection station opposite the excitation light source 310. Turbidimetry detection assembly 320 may include a transmitted light turbidimetry detection assembly. The transmitted light turbidimetry detection assembly includes a turbidimetry detector for detecting turbidity of the sample, and may further include an attenuation sheet for attenuating the intensity of the light, and/or a filter sheet for filtering certain bands of light. The transmitted-light turbidimetry detection assembly is disposed opposite the excitation light source 310 and in the light emission direction of the excitation light source 310 such that the transmitted-light turbidimetry detection assembly, the excitation light source 310, and the reagent strip 40 form a transmitted-light turbidimetry detection light path. In some embodiments, turbidimetric detection assembly 320 may also include a scattered light turbidimetric detection assembly. The scattered light turbidimetry detection assembly comprises a turbidimetry detector and may further comprise an attenuation and/or filter segment. The scattered light turbidimetry detection assembly is positioned opposite the excitation light source 310 and at an angle (e.g., about 10 to about 60) to the light emission direction of the excitation light source 310 such that the scattered light turbidimetry detection assembly, the excitation light source 310, and the reagent strip 40 form a scattered light turbidimetry detection light path.

The actinic radiation detection assembly 330 includes an actinic radiation detector for detecting the actinic radiation signal of the sample. In some embodiments, the actinic light detection assembly 330 may also include filters for filtering certain bands of light. The photoluminescence detection component 330 is disposed in a photoluminescence detection station of the detection apparatus 30. The photochemistry detection station is located downstream of the turbidimetric detection station and the rotating disc 110 can rotate past the turbidimetric detection station and then past the photochemistry detection station.

The turbidimetric detector of turbidimetric detection assembly 320 and the chemiluminescent detector of the chemiluminescent detection assembly 330 may be selected from the group consisting of a photon counter, a photomultiplier tube, a silicon photocell, a photometric integrating sphere, and the like.

The detecting device 30 further comprises a turbidimetric detection carrier 340 and a photochemical luminescence detection carrier 350. The turbidimetric detection carrier 340 is configured to carry the excitation light source 310 and the turbidimetric detection assembly 320. The turbidimetric test carrier 340 is mounted in the first pair of mounting slots 126 of the support bracket 120. Turbidimetric test carrier 340 may be U-shaped and include a bottom wall and vertical arms extending vertically upward from both ends of the bottom wall. The bottom wall of the turbidimetric assay carrier 340 is removably secured (e.g., by screws or the like) to the bottom wall 121 between the first pair of mounting slots 126, while the two vertical arms carry the excitation light source 310 and the turbidimetric assay module 320, respectively, and the excitation light source 310 and the turbidimetric assay module 320 protrude from the radially inner side wall 123 and the radially outer side wall 124 of the reagent strip slide 122 of the support rack 120 through the mounting slots 126. The reagent strip 40 can be rotated by the rotating disk 110 about the central axis of the rotating disk 110 and rests above the bottom wall between the two vertical arms to form a turbidimetric detection light path with the excitation light source 310 and the turbidimetric detection assembly 320.

The chemiluminescence detection bearing seat 350 is used for bearing the photochemical luminescence detection assembly 330. The chemiluminescent detection bearing seats 350 are mounted in the second pair of mounting slots 125 of the support frame 120. The photoluminescence measurement carrier 350 may be U-shaped and include a bottom wall and vertical arms extending vertically upward from both ends of the bottom wall. The bottom wall of the turbidimetric assay carrier 340 is removably fixed (e.g., by screws or the like) to the bottom wall 121 between the second pair of mounting slots 125, and one of the vertical arms carries the photo-luminescent assay component 330, and the photo-luminescent assay component 330 protrudes from the radially inner sidewall 123 or the radially outer sidewall 124 of the reagent strip slide 122 of the support frame 120 through the mounting slot 125. Reagent strip 40 is rotatable about the central axis of rotary disk 110 by rotary disk 110 and rests above the bottom wall between the two vertical arms to form a photochemically active light detection path with photochemically active light detecting assembly 330.

The dual mode point-of-care detection system 1 may also include an operator interface and a controller (not shown). The user can set parameters, display data and analysis data of the dual-mode instantaneous detection system 1 through the operation interface and send commands to the controller. The controller is electrically connected to the reagent strip rotary table 10, the pipetting device 20, and the detection device 30. The controller receives the command and outputs a trigger signal to the reagent strip rotary table 10, the pipetting device 20, the detection device 30, and the like, thereby realizing automatic control.

The dual mode point-of-care detection system 1 also includes a power supply 50 and a general integration board 60. The total integrated board 60 integrates the switches, information transfer interfaces of the system, and temperature display screens of the incubation assembly, etc., as shown in fig. 1 and 2.

The dual-mode instant detection system 1 can be used for the combined detection of immunoturbidimetry and photochemical luminescence in the same immune reaction system. Adding turbidimetric-photochemical luminescence joint detection reagent into the same sample to be detected to form an immunoreaction system. The turbidimetric-photochemical luminescence joint detection reagent is a single-sample homogeneous joint detection reagent developed by the inventor and comprises a turbidimetric reagent donor component I, a luminescent reagent donor component II and a luminescent reagent receptor component III. The turbidity reagent donor component I is a substance which is connected with the latex microsphere and can be specifically combined with the turbidimetric biomarker. Turbidity reagent donor component I can immunoreact with a turbidimetric biomarker in the sample, causing an increase in turbidity of the sample. The luminescent reagent donor component II is a substance which is connected with an energy donor microsphere and can be specifically combined with the photochemical biological marker, and the energy donor microsphere can generate singlet oxygen under the excitation of light. The luminescent reagent receptor component III is a substance which is connected with the energy receptor microsphere and can be specifically combined with the photochemical biological marker. The luminescent reagent donor component II and the luminescent reagent receptor component III can form specific immunoreaction with the photochemical biological marker in the sample, and the energy receptor microsphere can react with singlet oxygen to generate a photochemical luminescent signal.

That is, the chemiluminescent detection reagent of the turbidimetric-chemiluminescent joint detection reagent comprises luminescent reagent donor component II and luminescent reagent acceptor component III, while the turbidimetric detection reagent comprises turbidity reagent component I. The luminescent reagent donor component II and the luminescent reagent receptor component III can be specifically combined with a photochemical biological marker (also called a photochemical luminescent detector) in a sample to be detected and can generate a luminescent signal under an excitation state for detecting a photochemical luminescent item. The turbidity reagent component I can be specifically combined with a turbidimetric marker (also called a turbidimetric detector) in a sample to be detected to form a complex, so that the turbidity of the system is increased, and the turbidity reagent component I can be used for detecting turbidity items.

By combining with the turbidimetric-photochemical luminescence joint detection reagent, the dual-mode instant detection system 1 can simultaneously complete the detection of a turbidimetric item and a photochemical luminescence item, and can be used for analyzing a plurality of objects to be detected in the same immunoreaction. The rotating disc 110 of the reagent strip rotating table 10 rotates to the turbidimetric detection station of the detection device 30, the excitation light source 310 of the detection device 30 excites the photochemical luminescence reactant in the reagent strip 40 and simultaneously performs the immunoturbidimetric detection, and when the rotating disc 110 continues to rotate to the photochemical luminescence detection station of the detection device 30, the photochemical luminescence detection is performed.

The operation of the dual mode instantaneous detection system 1 according to the disclosed embodiment is described below. The operation process comprises a preparation phase and a test phase. The preparation stage is used for establishing a standard curve of the concentration of the photochemical luminescence detection object-the value of the photochemical luminescence signal and a standard curve of the concentration of the turbidimetric detection object-the value of the turbidimetric property. The testing stage is used for detecting a sample to be tested, and calculating a concentration value of the photochemical luminescent detection object and a concentration value of the turbidimetric detection object in the sample to be tested according to the standard curve of the concentration of the photochemical luminescent detection object-the photochemical luminescent signal value and the standard curve of the concentration of the turbidimetric detection object-the turbidimetric value. The preparation phase and the test phase may be performed sequentially or separately.

In the preparation stage, a standard curve of the concentration of the photochemical luminescence detection object-the value of the photochemical luminescence signal and a standard curve of the concentration of the turbidimetric detection object-the value of the turbidimetric value need to be established respectively. The standard curve of the concentration of the photochemical luminescence detection object-the photochemical luminescence signal value can be established firstly, and then the standard curve of the concentration of the turbidimetric detection object-the turbidimetric value can be established, or the standard curve of the concentration of the turbidimetric detection object-the turbidimetric value can be established firstly, and then the standard curve of the concentration of the photochemical luminescence detection object-the photochemical luminescence signal value can be established.

The establishment of a standard curve of the concentration of the chemiluminescent detection substance versus the value of the chemiluminescent signal is first described. Before this, it is necessary to add the chemiluminescent detection reagent, the turbidimetric detection reagent, the diluent, and the pipette tip into each of the solvent chamber 420 and pipette tip chamber 430 of the single aliquot strip 40 and seal them with a disposable sealing film.

First, the chemiluminescent assay is diluted with a diluent to 9 parts of chemiluminescent assay solution with increasing concentrations, and the 9 parts of chemiluminescent assay solution are added to the reaction cups 410 of the 9 single-person reagent strips 40, respectively.

Each reagent strip 40 is placed in the reagent strip holder 113 of the rotary disk 110 of the dual mode instant messaging system 1 such that the bottom of the reagent strip 40 rests on the reagent strip slide 122 of the support shelf 120 and the upper portion is stably held by the side walls 114 of the reagent strip holder 113.

The rotating disk 110 is driven by a drive mechanism 130 to rotate to a station of the pipetting device 20. The pipette tip 210 of the pipetting device 20 is configured to take out and set up a disposable pipette tip from the pipette tip chamber 430 of the reagent strip 40 in accordance with the rotation of the rotary disk 110, and then take out the photo-luminescent detection reagent, the turbidimetric detection reagent, and other solvents from the solvent chamber 420 and add them to the sample in the cuvette 410. The pipetting operation of pipette gun 210 mixes the sample with various solvents. The sample and the photo-luminescent and turbidimetric detection reagents are immunologically reacted in the cuvette 410, and the incubation mechanism 150 provides a suitable temperature for the immunological reaction. In the process, under the control of the controller, the turn disc 210 rotates, and the pipette gun 210 moves only in the vertical direction. The pipette tips are then discarded by the pipette gun 210 to the pipette tip chamber 430.

The rotary disk 110 is driven by the drive mechanism 130 and sequentially rotated to reach the turbidimetric detection station and the photochemical luminescence detection station of the pipetting device 20. At the turbidimetric detection station, the excitation light source 310 provides excitation light to the sample, and after excitation is completed, the sample generates a photochemical luminescence signal. At the photochemistry detection station, the photochemistry detector detects the photochemistry signal of the sample, so as to obtain 9 photochemistry signal values F1, F2, F3, F4, F5, F6, F7, F8 and F9, respectively. And combining the concentrations of the 9 parts of the photochemical luminescence detection object solution, fitting to obtain a photochemical luminescence detection object concentration-photochemical luminescence signal value standard curve, and storing the standard curve in a controller.

The establishment of a standard curve of concentration versus turbidity values for turbidimetric test substances is described below, it is noted that the sample of the test strip 40, after adding a chemiluminescent test reagent and a turbidimetric test reagent and carrying out an immunoreaction, produces a chemiluminescent test substance and a turbidimetric test substance at the same time, the chemiluminescent test substance itself has a turbidity, and the greater the concentration, the greater the turbidity, therefore, the turbidity of the turbidimetric test substance is measured taking into account the concentration factor of the chemiluminescent test substance.

First, the chemiluminescent analyte and the turbidimetric analyte were diluted with a diluent to 9 portions of a chemiluminescent-turbidimetric analyte solution in which the concentrations of the chemiluminescent analyte and the turbidimetric analyte were increased in order, wherein the concentration of the chemiluminescent analyte was a constant value CF 1. 9 parts of the chemiluminescent-turbidimetric assay solution were added to the reaction cuvette 410 of each of the 9 single-aliquot reagent strips 40.

Each single-aliquot reagent strip 40 is placed in the reagent strip holder 113 of the rotary disk 110 of the dual-mode instant test system 1 such that the bottom of the reagent strip 40 is placed on the reagent strip slide 122 of the support frame 120 and the upper portion of the reagent strip 40 is stably held by the side wall 114 of the reagent strip holder 113.

The rotating disk 110 is driven by a drive mechanism 130 to rotate to a station of the pipetting device 20. The pipette tip 210 of the pipetting device 20 is configured to take out and set up a disposable pipette tip from the pipette tip chamber 430 of the reagent strip 40 in accordance with the rotation of the rotary disk 110, and then take out the photo-luminescent detection reagent, the turbidimetric detection reagent, and other solvents from the solvent chamber 420 and add them to the sample in the cuvette 410. The pipetting operation of pipette gun 210 mixes the sample with various solvents. The sample and the photo-luminescent and turbidimetric detection reagents are immunologically reacted in the cuvette 410, and the incubation mechanism 150 provides a suitable temperature for the immunological reaction. In this process, under the control of the controller, the turn disc 210 rotates and the pipette gun 210 moves only in the vertical direction. The pipette tips are then discarded by the pipette gun 210 to the pipette tip chamber 430.

The rotating disc 110 is driven by the driving mechanism 130 to sequentially rotate to reach a turbidimetric detection station and a photochemical emission detection station of the pipetting device 20, in the turbidimetric detection station, the excitation light source 310 provides excitation light for a sample, and the turbidimetric detector detects the turbidity of the sample, so that 9 turbidity values Z1, Z2, Z3, Z4, Z5, Z6, Z7, Z8 and Z9. are respectively obtained, the photochemical emission detector detects the photochemical emission signal value F1 of the sample, since the concentration of the photochemical emission detector is a fixed value CF1, 9 photochemical emission signal values F1 are theoretically the same, but the difference of the testing environment causes a little difference of 9F 1 values, the average value of 9F 1 values can be taken, and a turbidimetric detection substance concentration-turbidity value standard curve CF 1-L1-OD 1 is obtained by fitting by combining the concentrations of 9 turbidimetric detection substance solutions, and the standard curve is stored in the controller.

The standard curves CF 2-L2-OD 2 and … CFn-L n-ODn were established in the same manner as the standard curves CF 1-L1-OD 1, wherein the concentrations of the photo-chemical luminescent analytes in the photo-chemical luminescence-turbidimetric analyte solution were respectively CF2 and … CFn, and the values of the photo-chemical luminescent signals detected by the photo-chemical luminescent detector module were respectively F2 and … Fn, as shown in fig. 9.

As described above, in the preparation stage, the establishment of the standard curve of the concentration of the chemiluminescent detection substance-the value of the chemiluminescent signal and the establishment of the standard curve of the concentration of the turbidimetric detection substance-the value of the turbidimetric detection substance are not in sequence, and only two standard curves need to be prepared before actual sample measurement.

The steps of the testing phase are described below. Various parameters of the dual-mode real-time detection system 1, such as stroke actions of various parts, sampling amount of a pipette and the like, are set through an operation interface. The single serve reagent strip 40 is removed, the disposable seal is torn off, and the collected sample is added to the cuvette 410 of the single serve reagent strip 40.

The reagent strip 40 is placed in the reagent strip holder 113 of the rotary disk 110 of the dual mode instant messaging system 1 such that the bottom of the reagent strip 40 is placed on the reagent strip slide 122 of the support rack 120 and the upper portion of the reagent strip 40 is stably held by the side wall 114 of the reagent strip holder 113.

The rotary disk 110 is driven by the drive mechanism 130 and sequentially rotated to reach the turbidimetric detection station and the photochemical luminescence detection station of the pipetting device 20. At the turbidimetric detection station, the excitation light source 310 provides excitation light to the sample, and the turbidimetric detector detects a turbidity value Z of the sample. And at the photochemical luminescence detection station, detecting the photochemical luminescence signal value F of the sample by a photochemical luminescence detector.

And substituting the photochemical luminescence signal value F into a photochemical luminescence detection object concentration-photochemical luminescence signal value standard curve to obtain the concentration of the photochemical luminescence detection object in the sample to be detected.

And (4) bringing the turbidity value Z into a turbidity detection substance concentration-turbidity value standard curve to obtain the concentration of the turbidity detection substance in the sample to be detected. Specifically, if the actinic light signal value F is one of F1, F2, F3, F4, the turbidity value Z is brought into the corresponding turbidimetric analyte concentration-turbidity value standard curve to obtain the turbidimetric analyte concentration. If the actinic light signal value F is not one of F1, F2, F3, F4, the calculation of the turbidimetric analyte concentration is performed according to the following steps:

1) if F1 is less than F < F2, linear interpolation is adopted in a CF 1-L1-OD 1 standard curve and a CF 2-L2-OD 2 standard curve group to obtain each turbidity value corresponding to each turbidimetric detection substance concentration point;

2) fitting the concentration points and the turbidity values of each turbidimetric test object according to an L ogit model to obtain a CF-L F-ODF standard curve;

3) the turbidity value Z was substituted into the CF-L F-ODF standard curve to obtain the turbidimetric assay concentration.

For example, in the case where F2 to F1 is 5Y and measured F is F1+2Y, a straight line (Y-axis direction) is drawn from a curve in which the photochemical emission signal is F1 to a curve in which the photochemical emission signal is F2 at the concentration points of 9 turbidimetric analytes, new concentration point values of 9 analytes are obtained at 2/5 of the straight line, a new CF-L F-ODF standard curve is fitted to each new 9Y values by L git-4p, and the turbidimetric analyte concentration is obtained by substituting the turbidity value Z CF-L F-ODF standard curve into the turbidimetric analyte concentration curve.

It should be noted that during the above operation, the used reagent strip 40 can be taken out from the rotating disk 110 and the next reagent strip 40 can be put in without interference, so as to save time.

A dual mode point-of-care detection system according to a second embodiment of the present disclosure is described below. The difference from the dual-mode point-of-care sensing system 1 is that it includes two photo-chemical luminescence sensing elements instead of one photo-chemical luminescence sensing element. The two photochemical luminescence detection assemblies comprise a first photochemical luminescence detection assembly and a second photochemical luminescence detection assembly. The first photochemical luminescence detection assembly and the second photochemical luminescence detection assembly are adjacently arranged on the support frame and are positioned at the downstream of the turbidimetric detection assembly. The first photochemical luminescence detection assembly is arranged at the first photochemical luminescence detection station and forms a first photochemical detection light path with the reagent strip. The second photochemical luminescence detection assembly is arranged at the second photochemical luminescence detection station and forms a second photochemical detection light path with the reagent strip.

The dual-mode instant detection system according to the second embodiment of the present disclosure can detect two chemiluminescent detectors (referred to as a chemiluminescent detector a and a chemiluminescent detector B, respectively) in the same sample. Different filters (respectively, a filter A and a filter B) are arranged in the first photochemical luminescence detection assembly and the second photochemical luminescence detection assembly. The filter A in the first photochemical luminescence detection assembly can only enable the luminescence signal corresponding to the photochemical luminescence detection object A to pass through, and the filter B in the second photochemical luminescence detection assembly can only enable the luminescence signal corresponding to the photochemical luminescence detection object B to pass through, so that the detection of the photochemical luminescence detection object A and the detection object B in the same sample can be realized.

The dual-mode point-of-care detection system according to the second embodiment of the present disclosure is used with a joint detection reagent developed by the present inventors. This combination test reagent differs from the combination test reagent of the first embodiment in that the luminescent reagent donor component II and the luminescent reagent acceptor component III are in two groups, respectively. The two groups of luminescent reagent donor components II and luminescent reagent acceptor components III are respectively as follows: a luminescent agent donor component II-A and a luminescent agent acceptor component III-A, and a luminescent agent donor component II-B and a luminescent agent acceptor component III-B. The luminescent reagent donor component II-A, II-B can generate singlet oxygen under the excitation of an excitation light source with the same excitation wavelength, the luminescent reagent donor component II-A and the luminescent reagent receptor component III-A form specific immunoreaction with the photochemical luminescence detector A, and the luminescent reagent donor component II-B and the luminescent reagent receptor component III-B form specific immunoreaction with the photochemical luminescence detector B. Under the irradiation of exciting light, the two immunoreactions form different luminescent wavelengths (marked as X-A and X-B), the filter A can allow the X-A to pass through, and the filter B can allow the X-B to pass through, so that the detection of the photochemical luminescent detection object A and the photochemical luminescent detection object B in the same sample can be realized.

It should be noted that three or more than three photochemical biomarkers in the same sample can be detected, as long as a suitable joint detection reagent is selected and the chemiluminescent detection assembly is continuously assembled on the detection device of the first embodiment or the second embodiment.

The dual-mode instant detection system according to the embodiment of the disclosure can be used in an immunoturbidimetric mode, a photochemical luminescence detection mode or a combination of the two modes to detect an object to be detected in an immunoreaction, so as to detect various objects to be detected more quickly and simply.

According to the dual-mode instant detection system disclosed by the embodiment of the disclosure, two detection modes are integrated into one detection instrument, the structural design is reasonable, the detection efficiency is improved, and the economic, time and space costs are saved.

The dual-mode instant detection system according to the embodiment of the disclosure is based on the turbidimetric-photochemical luminescence joint detection reagent designed by the inventor, and can detect a turbidimetric methodology marker and a photochemical luminescence methodology marker in a sample to be detected. Specifically, at a first detection station, an excitation light source is turned on, and the photochemical luminescence methodology marker can be excited and the turbidity can be detected at the same time; and then, a second detection station is carried out, and the photochemical luminescence detection assembly is used for detecting a luminescence signal.

The rotating disc of the dual-mode instant detection system according to the embodiment of the disclosure is circumferentially provided with a plurality of reagent strip seats, and each single-serving reagent strip is inserted into each reagent strip seat. The rotating disc drives each single-person reagent strip to rotate, and the rotating disc is matched with the liquid transfer device to complete the transfer and the uniform mixing of the solvent in the single-person reagent strips. The pipetting device only needs vertical reciprocating motion, so that the efficiency is improved, and the economic cost is saved.

According to the double-mode instant detection system disclosed by the embodiment of the disclosure, the pipette tip, the required reagent and the diluent can be packaged in advance by the single reagent strip, the efficiency is improved, the pollution of the pipette tip, the required reagent or the diluent can be avoided, and the detection reliability is improved.

Although exemplary embodiments of the present disclosure have been described, it will be understood by those skilled in the art that various changes and modifications can be made to the exemplary embodiments of the present disclosure without substantially departing from the spirit and scope of the present disclosure. Accordingly, all changes and modifications are intended to be included within the scope of the present disclosure as defined in the appended claims. The disclosure is defined by the following claims, with equivalents of the claims to be included therein.

Claims

1. A dual-mode real-time detection system configured to perform immunoturbidimetric detection and/or photochemical luminescence detection on the same sample, the dual-mode real-time detection system comprising:

2. The dual-mode real-time detection system of claim 1, wherein the excitation light source is configured to simultaneously provide illumination light for immunoturbidimetric detection and excitation light for photochemical luminescence detection.

3. The dual mode real-time detection system of claim 1, wherein the turbidimetry detection assembly comprises a transmitted light turbidimetry detection assembly and a scattered light turbidimetry detection assembly,

4. A dual mode instantaneous test system according to claim 3, characterized in that said included angle ranges from 10 ° to 60 °.

5. A dual mode real-time detection system according to any of claims 1 to 4, wherein the turbidimetric detection assembly comprises a turbidimetric detector, an attenuation block and a filter block.

6. The dual mode real-time detection system according to claim 5, wherein the turbidimetric detector is selected from one or more of the group consisting of: photon counter, photomultiplier, silicon photocell, photometry integrating sphere.

7. A dual mode real-time detection system according to any of claims 1-4, wherein the actinic radiation detection assembly comprises an actinic radiation detector and a filter.

8. A dual mode instantaneous detection system according to claim 7, characterized in that the photochemical luminescence detector is selected from one or more of the following group: photon counter, photomultiplier, silicon photocell, photometry integrating sphere.

9. The dual-mode real-time inspection system of claim 7, wherein the photo-chemical inspection assembly comprises a first photo-chemical inspection assembly and a second photo-chemical inspection assembly adjacent to each other, the first photo-chemical inspection assembly comprises a first filter, the second photo-chemical inspection assembly comprises a second filter different from the first filter, and the photo-chemical emission inspection station comprises a first photo-chemical emission inspection station and a second photo-chemical emission inspection station;

10. A dual mode real-time detection system according to any of claims 1 to 4, wherein the rotary disc comprises an annular bottom wall and one or two side walls projecting vertically upwards from the inner and/or outer peripheral edge of the bottom wall.