TWM632068U - Analysis system of immunomagnetic reduction - Google Patents

Abstract

An analysis system for immunomagnetic reduction, comprising a pipette; a storage device for collecting the sample and the reagent from the pipette, and obtaining a mixed solution by mixing; an analysis device with a measuring A space and an analysis module, the analysis device is used for receiving the mixed solution and analyzing to obtain a detection information; and a display device, receiving the detection information, and displaying an analysis result, wherein the analysis device is provided according to the type of the reagent. A standard curve is different, and the reagent contains an antibody and a magnetic bead that can be combined with the antibody, and the sample concentration is obtained by detecting the magnetic bead in the mixed solution to obtain a magnetic decrement signal. The purpose of this creation is to provide a stable standard curve, and it is not necessary to establish a standard curve frequently or every measurement.

Description

Analysis system of immunomagnetic reduction

This creation is an analysis system for immunomagnetic densification. Based on the surface protein of the target molecule, a magnetic particle with an antibody that can bind to the surface protein of the target molecule is established to obtain the magnetic decrement signal of the analyte. This concentration signal is converted to the true concentration of the sample through the analytical system for simple, fast and accurate results.

Traditional optical detection methods are usually accompanied by multiple tedious procedures, including coating with primary antibodies, first washing, adding samples, second washing, binding of secondary antibodies, multiple washings, and then successive color development and stopping. reaction and other multi-channel procedures.

In the process of executing the above multi-channel procedures, each procedure will affect the final measured optical signal, especially the step of color development and stop reaction, which is a signal at a certain moment under a floating dynamic signal (Dynamic Signal), in other words , as long as a slight difference in time may result in different optical signal strengths (OD).

The traditional optical detection method is not only the problem mentioned in the previous paragraph, but also the same sample, the results of different times of detection or the detection process of different people may be different because of the different degree of execution of multi-channel procedures, such as the number of washings. Changes, small changes in the amount of antibody binding each identified and added will result in different optical signal strengths.

Therefore, the purpose of this creation is to provide an immunomagnetic decrement analysis system, which can penetrate Through the analysis system, the concentration of the analyte can be converted back based on a stable standard curve, which is a fast, simple and stable analysis system.

The present invention provides an analysis system for immunomagnetic reduction, comprising a pipette for obtaining a sample or a reagent; a storage device for collecting the sample and the reagent from the pipette, and obtaining by mixing a mixed solution; an analysis device having a measuring space and an analysis module, the analysis device is used for receiving the mixed solution and analyzing to obtain a detection information; and a display device receiving the detection information and displaying an analysis As a result, the analysis device is provided with a different standard curve according to the type of the reagent, and the reagent contains an antibody and a magnetic bead that can bind to the antibody, and a magnetic bead is obtained by detecting the magnetic bead in the mixed solution. The decrement signal is compared with the standard curve corresponding to the reagent by the magnetic decrement signal, and the sample concentration is obtained by back-calculation.

The present invention is an analysis system for immunomagnetic reduction, wherein the pipette comprises a micropipette, a multi-channel automatic pipette, a pipette, a pipette or a pipette.

The present invention is an analysis system for immunomagnetic reduction, wherein the reagent comprises an antibody and magnetic beads that can be combined with the antibody.

The present invention is an analysis system for immunomagnetic reduction, wherein the magnetic beads are composed of Fe ₃ O ₄ and antibodies that specifically recognize biomarkers, and the diameter is 50-60 nm.

The present invention is an analysis system for immunomagnetic reduction, wherein the storage device is a glass container, an acrylic container, a plastic container, a centrifuge tube, and a microcentrifuge tube.

In one embodiment, the present invention is an analysis system for immunomagnetic decrement. The measurement space of the analysis device further includes at least one detection tube, and the mixed solution can be dropped into the at least one detection tube, and analyzed by the analysis system. A display panel on one of the devices lists after analysis by the analysis device the result.

In another embodiment, the present invention is an analysis system for immunomagnetic abatement, further comprising a quality control solution, wherein the quality control solution is used to determine whether the standard curve of the analysis device drifts.

The term "sample" described in this document generally refers to, but is not limited to, proteins, protein fragments, biomarkers, viruses, nucleic acids, bacteria, allergens, lipids, sugars, or small molecules; in some embodiments, a sample can be is Aβ42 or Aβ40.

100: Analysis system of immune magnetic decrement

1: Pipette

2: Storage device

3: Analysis device

4: Display device

Fig. 1 is a standard curve chart established by the present invention in Example Aβ42.

Figure 2 is the xy scatter diagram of the semi-annual data of the quality control fluid concentration.

Figure 3 is a block diagram of the created system.

The present invention provides an analysis system (100) for immunomagnetic reduction, which can not only achieve the purpose of detecting weak biomolecular signals by traditional optical detection methods in the past, but also improve the tedious procedures of optical detection methods and avoid excessive Many factors affect the final result.

The present invention provides an analysis system (100) for immunomagnetic reduction, comprising a pipette (1) for obtaining a sample or a reagent; a storage device (2) for collecting data from the pipette (1) The sample and the reagent are mixed to obtain a mixed solution; an analysis device (3) has a measurement space and an analysis module, and the analysis device (3) is used for receiving the mixed solution and performing analysis to obtain a detection information; and a display device (4) for receiving the detection information and displaying an analysis result, wherein the analysis device (3) is provided with a different standard curve according to the type of the reagent, and the reagent contains an antibody and A magnetic bead that can be combined with the antibody obtains a magnetic decrement signal by detecting the magnetic bead in the mixed solution, and the magnetic decrement signal corresponds to the standard curve of the reagent, and returns Push to obtain the sample concentration.

first embodiment

Take the system of magnetic immunoassay analyzer (XacPro-S series, Weibu Medical Instrument Co., Ltd. Yizi No. 005218 and DE/CA22/419-750.1-IVD) as an example, first prepare the "magnetic" immunomagnetic reduction detection reagent, product The tube liquid and the sample are returned to the state of room temperature, wherein the reagent contains magnetic beads (Fe ₃ O ₄ ) and the surface of the magnetic beads has an antibody that can bind to the sample, and then the reagent, the sample By oscillating for 5±2 seconds, a uniform effect is achieved, which is convenient for subsequent mixing.

Prepare a glass sample tube as a storage device (2), select 60μL or 40μL of sample or quality tube liquid through a pipette (1) (this is a micropipette), depending on the different biomarkers, draw the sample The amount will also vary.

Then, the pipette (1) adds 60 μL or 80 μL of the “magnetic volume” immunomagnetic reduction detection reagent to the storage device (2) according to the needs of the user to form a mixed solution containing the sample or the liquid in the quality control tube.

The storage device (2) can be mixed in about 5±2 seconds by using the shaking mode, and the unsealed reagent is stored at 2~8°C, and the sample or quality control solution is placed on ice first, and then recovered- Store at 80°C and -20°C.

Place the storage device (2) with the mixed solution in the measurement space of the analysis device (3) or drop the mixed solution into a detection tube of the measurement space via the pipette (1), and Through the analysis module, a detection information is obtained.

=函數曲線的中心、γ=曲線的斜率) When the antibody on the surface of the magnetic beads binds to the sample, the magnetic beads will aggregate into larger molecules, which reduces the magnetic induction generated by the magnetic beads under the external magnetic field. The analysis module has the equation listed in the following formula (I). The measured ImmunoMagnetic Reduction (IMR value) can be converted to the concentration of the target biomarker. (IMR=Magnetic Decrease, A=Initial Value, B=Final Value,

= the center of the function curve, γ = the slope of the curve)

=22742.16964以及γ=0.31207帶入上述之式(I)，即完成專門檢測Aβ42的標準曲線。 Taking Figure 1 as an example, this is the Aβ42 standard curve obtained by using the immunomagnetic decrement analysis system of this creation, and set A=1.61561, B=8.92,

=22742.16964 and γ=0.31207 are brought into the above formula (I), that is, the standard curve for the special detection of Aβ42 is completed.

When the analysis module completes the analysis, it obtains a detection information, and transmits the detection information to a display device (4) for the operator to judge the corresponding result, wherein the analysis system and the display device (4) are connected by a For the electrical connection, usually a blank sample will be placed as a background value correction during measurement, and the display device (4) displays "NaN", so when the analysis result of the clinical sample measurement is NaN10, it means that the measurement needs to be re-measured.

Wherein the display device (4) is a mobile device, a computer screen or other terminal devices that can be used for display.

In this example, the concentration of a standard with a concentration of 100 pg/ml measured by three different production batches of reagents on different days and the measurement results of immunomagnetic densification using the standard curve in Figure 1 are shown in Table 1 below. shown.

It is confirmed by the results measured in Table 1 above that the standard curve established by the immunomagnetic densification analysis system of this creation, even if the reagents prepared at different time points, under the condition of fixed concentration, will not be affected by different test times, Different batches of reagents result in very different concentrations, and the error is very small, which is completely different from the traditional optical detection method in the past.

On the other hand, the standard curve established by the immunomagnetic densification analysis system of the present invention will allow the control solution to measure the standard curve to determine whether there is a drift problem, because the analysis device (3) has different reagents according to the For the corresponding standard curve, in each measurement, you only need to use the quality control solution to match the reagents, and then use Westgard Multi-rules to monitor whether the standard curve of the machine deviates.

Taking Figure 2 as an example, from June 2019 to December 2019, a total of 68 drop points were observed for the concentration of the quality control fluid. It can be found that most of the drop points (45 values) fall within mean±SD. Within the range of Mean±2SD, the rest are within Mean±2SD, and none of the values exceed Mean±2SD, and the statistical results in Table 2 can be referred to together.

Facts have proved that this standard curve has a high reference value and significance under the results of the six-month monitoring. If the evaluation method of Westgard Multi-rules is applied, please refer to the table Third, unbiased results can be determined.

The foregoing has outlined rather broadly the features and technical advantages of the present disclosure in order that the detailed description of the present disclosure that follows may be better understood. Additional features and advantages of the present inventive disclosure will be described hereinafter, which form the novel subject of the claims. Those skilled in the art will appreciate that the conception and specific embodiment disclosed may be readily utilized as a basis for modifying or designing other structures for carrying out the same purposes as those disclosed in the present invention. Those skilled in the art should also understand that such equivalent constructions do not depart from the spirit and scope of the invention as set forth in the claims.

The novel features of the features believed to be authored in terms of organization and method of operation, together with other objects and advantages, will be better understood from the following description when considered in conjunction with the accompanying drawings. However, it must be specifically understood that each drawing is provided for the purpose of illustration and description only and is not intended as a definition of limitations of the present invention. Unless otherwise defined, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which this creation belongs. In case of conflict, the description will control.

100: Analysis system of immune magnetic decrement

1: Pipette

2: Storage device

3: Analysis device

4: Display device

Claims (10)

An analysis system for immunomagnetic reduction, comprising: a pipette for obtaining a sample or a reagent; a storage device for collecting the sample and the reagent from the pipette, and obtaining a mixture by mixing solution; an analysis device with a measurement space and an analysis module, the analysis device is used for receiving the mixed solution and analyzing to obtain a detection information; and a display device receiving the detection information and displaying an analysis result, The analysis device is provided with a different standard curve according to the type of the reagent, and the reagent contains an antibody and a magnetic bead that can be combined with the antibody, and a magnetic decrement signal is obtained by detecting the magnetic bead in the mixed solution , and the magnetic decrement signal is compared with the standard curve corresponding to the reagent, and the sample concentration is obtained by backtracking. According to the analysis system for immunomagnetic decrement according to claim 1, when the analysis result shows "NaN", it means that the measurement needs to be re-measured. The analysis system for immunomagnetic reduction according to claim 1, wherein the pipette comprises a micropipette, a multi-channel automatic pipette, a pipette, a pipette or a pipette. The analysis system for immunomagnetic decrement according to claim 1, wherein the material of the magnetic beads is Fe ₃ O ₄ . The analysis system for immunomagnetic decrement according to claim 4, wherein the diameter of the magnetic beads is 50-60 nm. The analysis system for immunomagnetic reduction according to claim 1, wherein the storage device is a glass container, an acrylic container, a plastic container, a centrifuge tube, or a microcentrifuge tube. According to the analysis system for immunomagnetic reduction according to claim 1, the measurement space of the analysis device further comprises at least one detection tube, and the mixed solution can be dropped into the at least one After testing the tube, obtain the testing information. The analysis system for immunomagnetic densification according to claim 1 further comprises a quality control fluid, and the analyzing device judges whether the standard curve drifts through the analysis result of the quality control fluid. The analysis system for immunomagnetic abatement according to claim 1, wherein the sample is protein, protein fragment, biomarker, virus, nucleic acid, bacteria, allergen, lipid, sugar or small molecule. The analysis system for immunomagnetic decrement according to claim 1, wherein the analysis device and the display device are electrically connected.

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