WO2015192327A1

WO2015192327A1 - Reagent kit and method for manufacturing same

Info

Publication number: WO2015192327A1
Application number: PCT/CN2014/080125
Authority: WO
Inventors: 王海; 朱星才; 蒋凯平
Original assignee: 深圳迈瑞生物医疗电子股份有限公司
Priority date: 2014-06-17
Filing date: 2014-06-17
Publication date: 2015-12-23
Also published as: CN105940302A; CN105940302B

Abstract

Provided is a reagent kit, comprising a case body, said case body being provided with a plurality of reagent positions used for holding reagents and a plurality of standard positions used for holding standards. Provided is a method for manufacturing a reagent kit; a plurality of reagent positions used for holding reagents are fabricated on a case body; at the same time, a plurality of standard positions used for holding standards are fabricated on said case body. The reagent and standard required for a test are arranged on a reagent kit, such that a client may use, in a disposable manner, the required reagent kit and standard for carrying out a machine operation, thus providing convenience to the client; the distance of movement when taking and placing reagents and standards is reduced.

Description

Kit and manufacturing method thereof

The present invention relates to a kit for nucleic acid extraction and a method of making the same. Background technique

In the nucleic acid extraction process, in order to detect the sample to be tested, it is necessary to provide a reagent and a standard and a reference product to be used therewith. During the test, the sample to be tested, the standard used and the reference product are first distributed to the respective reaction vessels, and then the reagents are distributed to the reaction vessels for mixing, incubation, and subsequent cleaning and separation, until all The sample containers are all subjected to a nucleic acid extraction operation, and the extracted products are each separately distributed to a subsequent test container for simultaneous testing. The standards and reference materials described herein refer to substances which are supplied by a reagent manufacturer and which give a certain sample of a certain concentration or negative information, and are collectively referred to as standards.

On automated instruments, reagents are placed in specialized reagent areas. Standards are usually printed as a special sample and placed in the sample area along with the sample to be tested. This requires the operator to manually process the standard and reference products, and Corresponding to the printed bar code - the operator's work steps are added, and more importantly, the introduction of the human operation is likely to cause a mismatch between the bar code information and the actual standard product, thereby causing serious consequences of the test result error. Summary of the invention

The invention provides a novel kit and a preparation method thereof.

The present invention provides a kit having a reagent site for carrying a reagent and a standard grade for carrying a standard.

There may be more than one reagent position and standard grade.

When there are multiple reagent sites, it can include at least one first reagent site for carrying a reagent container and at least one second reagent site for carrying a reagent pipette tip.

A kit is produced by making a plurality of reagent sites for carrying reagents on a cartridge; and at the same time, a plurality of standard grades for carrying standards are produced on the cartridge.

Further, a gear mechanism is formed on the casing.

Further, an identification code is created on the box. The beneficial effects of the invention are:

1) Arrange the reagents and standards required for a test project on one kit, so that the customer can complete the required kit and standard products on the machine at one time, which is convenient for the customer; The distance to move with the standard.

2) Since the reagent and the position information of the standard on the kit can be directly transmitted to the nucleic acid extractor by means of the identification code scanning, human intervention is avoided, and the result error caused by the error of the standard information can be avoided. DRAWINGS

Figure 1 is a schematic view showing the structure of a kit of the present embodiment;

Fig. 2 is a flow chart showing a test method of the nucleic acid extractor of the present embodiment. detailed description

As shown in Fig. 1, the kit of the present embodiment comprises a case 1 in which a plurality of reagent positions and standard grades are provided, a reagent position for carrying a reagent, and a standard grade for carrying a standard. The reagent level or standard grade can carry the reagent or standard directly, or carry a container containing the reagent or standard, or carry a liquid-absorbent head that can absorb the reagent or standard. A standard is a substance that is supplied by a reagent manufacturer and gives a similar sample of information or negative information.

Further, the side of the box may be provided with an identification code, and the identification code may carry information of reagents and standards. The identification code is like a barcode.

As shown in Figure 1, the kit of the present embodiment is capable of providing all of the reagents and standards required for a test item. The reagent may include a magnetic bead reagent, a lysate reagent, an eluent reagent,

PCR buffer and enzyme activator. There can be more than one standard.

The kit comprises a box body 1 , and the box body 1 is provided with a magnetic bead reagent container 2 . In order to avoid sedimentation of the magnetic bead particles, the box body 1 is provided with a gear mechanism 10 , and the gear mechanism 10 drives the magnetic bead reagent container 2 to rotate, so that the magnetic beads The reagents maintain a mixed hook state during the test. In order to facilitate mixing on the machine, the magnetic bead reagent container 2 is provided at the foremost end of the casing 1. Two first liquid suction head positions 3 are disposed behind the magnetic bead reagent container 2, and the two first liquid suction head positions 3 can respectively carry the magnetic bead reagent liquid suction head and the lysate reagent liquid absorption head. A lysate reagent container 4 is disposed behind the two first pipetting head positions 3. A plurality of standard containers 5 are provided behind the lysing reagent container 4. An eluent container 6 is provided behind the standard container 5. There are two second liquid suction head positions 7 at the rear of the eluent container 6, and the two second liquid suction head positions 7 can respectively carry the eluent reagent liquid suction head and subsequent PCR. Reagent suction head. The last end of the cartridge 1 is provided with two reagent containers 8 for accommodating a PCR buffer and an enzyme activator, respectively.

In the present embodiment, each container can be detached from the casing 1 for independent packaging to facilitate the filling operation during the production process.

In the present embodiment, the identification code 9 is attached to the side surface of the casing 1. The identification code includes test information such as the arrangement position of the reagent and the standard product, and the standard product concentration or the negative positivity information. The identification code can be a barcode. This information is imported into the extractor by a barcode scan on the nucleic acid extractor during the machine. Before the test is started, each batch of tests can be automatically added to the test of the standard by pre-setting, and the operator does not need to manually apply for the test operation required for each batch.

In the present invention, the reagents and standards required for a test item are arranged on one kit, so that the customer can simultaneously put the required kits and standards at the same time, and at the same time, the reagents and the standard products are in the kit. The arrangement position information on the arrangement can be directly transmitted to the nucleic acid extractor by means of preset or identification code identification, which not only facilitates the instrument to absorb reagents and standards, but also avoids human intervention, thereby avoiding the result error caused by the error of the standard product information. Even the pre-set calibration rules can be used to automatically add the standard test to the test, which can further reduce the workload of the operator and improve the reliability of the test results. The instrument can explain the filling volume of reagents and standards by means of identification code identification and other information transmission methods, which is convenient for the instrument to fix the liquid level, thereby reducing the dead volume of the liquid absorption process and avoiding the problem of insufficient liquid level detection sensitivity.

A kit is prepared by simultaneously preparing a plurality of reagent sites for carrying reagents and a plurality of standard grades for carrying standards on a cartridge. Further, a gear mechanism can be fabricated on the casing. Further, an identification code capable of identifying the reagent and the standard information can be produced on the casing.

A kit for a nucleic acid extractor, comprising a box body, wherein the box body is provided with a magnetic bead reagent position for carrying the magnetic bead reagent and at least one reagent position for carrying other reagents, and the box body is further provided with a standard for carrying the standard product. The grade, the magnetic bead reagent is located at the foremost part of the box body, and the magnetic bead reagent position is provided with a driving mechanism capable of driving the magnetic bead reagent container to rotate, and the box body is further provided with an identification code carrying the reagent information and the standard product information. There can be more than one reagent position and standard grade. The standard grade can be located in the middle of the box, ie the front and back of the box can be provided with reagent bits. Each reagent site and standard can contain reagents, standards, reagents, standard containers, or a tip. The drive mechanism is a gear mechanism. The identification code is like a barcode. As shown in FIG. 2, a method for testing a nucleic acid extractor, the method provides a nucleic acid extraction apparatus and provides a kit, the nucleic acid extractor comprising a sample dispensing mechanism, a reagent dispensing mechanism, and a control sample dispensing mechanism And a host of the reagent dispensing mechanism, the reagent box is provided with a reagent carrying reagent and a standard grade carrying the standard, the kit is further provided with an identification code, and during operation, the identification code on the reagent cartridge is read; The other 'J code determines the position of each reagent of the kit and the position of each standard; receives the test command; the host control reagent dispensing mechanism draws the reagent to the reagent position, and the host controls the sample dispensing mechanism to draw the standard product to the standard grade. Receiving test instructions is performed by manual input or according to predetermined rules. The predetermined rule may be executed in batch or on a daily basis. When the predetermined condition is met, the corresponding standard test command is generated by the host, and the nucleic acid extractor automatically starts to increase the nucleic acid extraction test of the standard during the routine test.

For the nucleic acid extractor, the host can determine the liquid level of each reagent and standard of the kit according to the identification code; the host control reagent dispensing mechanism and the sample dispensing mechanism are positioned to absorb the reagents and standards below the liquid level. Compared with the prior art, the liquid level is generally detected by the liquid level detection method to determine the liquid absorption position, thereby requiring a larger amount of liquid dead volume for generating the liquid level signal, and the method for directly determining the liquid level by the identification code in the embodiment. The dead volume can be reduced, which saves reagents and standards.

The above is a further detailed description of the present invention in connection with the specific embodiments, and the specific implementation of the invention is not limited to the description. For those skilled in the art to which the present invention pertains, a simple deduction or replacement can be made without departing from the inventive concept.

Claims

Rights request

A kit comprising a cartridge, wherein the cartridge is provided with a reagent bit for carrying a reagent and a standard grade for carrying a standard.

2. The kit according to claim 1, wherein the reagent bits are plural, comprising at least one first reagent position and at least one second reagent position, the first reagent position being used to carry a reagent a container, the second reagent position for carrying a reagent pipette tip.

The kit according to claim 1, wherein the cartridge body further comprises a gear mechanism, the reagent position comprises a magnetic bead reagent position, and the gear mechanism is disposed at the magnetic bead reagent position.

The kit according to any one of claims 1 to 3, wherein the cassette is provided with an identification code.

A method of manufacturing a kit, characterized in that

Making a plurality of reagent sites for carrying reagents on the cartridge;

A plurality of standard grades for carrying standards are produced on the box.

The method of manufacturing a kit according to claim 5, wherein a gear mechanism is formed on the casing.

The method of manufacturing a kit according to claim 5 or 6, wherein an identification code is created on the cartridge.

A kit for a nucleic acid extractor, comprising a cartridge, wherein the cartridge is provided with a magnetic bead reagent bit for carrying a magnetic bead reagent and at least one reagent bit for carrying other reagents, the cartridge The body is further provided with a standard grade for carrying a standard, the magnetic bead reagent is disposed at a front portion of the box, and the magnetic bead reagent position is provided with a driving mechanism capable of driving the rotation of the magnetic bead reagent container, The box is also provided with an identification code carrying reagent information and standard information.

A test method for a nucleic acid extractor, comprising a nucleic acid extractor comprising a sample dispensing mechanism, a reagent dispensing mechanism, and a host, and a kit, wherein the kit is provided for a reagent carrying reagent and a standard grade for carrying a standard, characterized in that

Read the identification code on the kit;

Determining a position of each reagent of the kit and a position of each standard according to the identification code;

Receiving test instructions; The host controls the reagent dispensing mechanism to draw a reagent to the reagent position, and the host controls the sample dispensing mechanism to draw a standard product to the standard grade.

10. The testing method according to claim 9, wherein receiving the test command is performed by manual input or according to a predetermined rule.

The test method according to claim 9 or 10, characterized in that

Determining a liquid level of each reagent and standard of the kit according to the identification code; the host controls the reagent dispensing mechanism and the sample dispensing mechanism to be positioned below the liquid level to absorb the reagent and Standard.