Kit for detecting mycoplasma pneumoniae

Abstract

The utility model discloses a kit for detecting mycoplasma pneumoniae, which belongs to the technical field of biochips and diagnostic reagents, and comprises a positive quality control reagent, a negative quality control reagent and a detection chip, the detection chip comprises an upper shell and a lower shell, the upper shell is connected with the lower shell in a clamping manner, the upper shell is provided with three sample introduction windows, and the lower shell is provided with three sample introduction openings. The upper shell and the lower shell are provided with three sample introduction windows, the three sample introduction windows are respectively a negative control port, a positive control port and a detection port, and a reaction film is arranged between the upper shell and the lower shell; a negative control area is arranged at the position, opposite to the negative control opening, of the reaction film, a positive control area is arranged at the position opposite to the positive control opening, and a detection area is arranged at the position opposite to the detection opening. The kit disclosed by the utility model can accurately verify whether the quality of the detection chip is qualified or not and whether manual operation is correct or not, so that the quality control of a product is enhanced, and the accuracy of a detection result is improved.

Description

TECHNICAL FIELD

[0001] The utility model relates to the technical field of biochip and diagnostic reagent, especially to a kit for mycoplasma pneumoniae detection. BACKGROUND

[0002] Mycoplasma pneumoniae is the pathogen of human mycoplasma pneumonia, and is the smallest microorganism found by people that can grow on solid culture medium in vitro and survive without relying on living cells. Its size is between viruses and bacteria. It is transmitted into the respiratory tract of humans through droplets and causes lung infection. If not treated in time, it can develop into severe pneumonia. Therefore, targeted treatment is very important.

[0003] The main diagnosis method of mycoplasma pneumoniae relies on isolation and culture and serological test. The sputum or throat swab of suspected patients can be used as a specimen for isolation and culture, and inoculated into agar culture medium containing serum or yeast extract. After 5-10 days, observe whether there are round roof-like colonies with a diameter of 30-100 um. After multiple passages, it can become a typical "pouch egg" colony and can adsorb various animal red blood cells, tracheal epithelial cells, HeLa cells, etc., and this adsorption can be inhibited by specific antibodies. However, the above culture method takes a long time, and the process of waiting for the results is easy to delay the disease, and is more suitable for laboratory use, but not suitable for rapid determination of pathogens in clinical practice.

[0004] Chinese patent CN 114397458 A discloses a detection box for mycoplasma pneumoniae antigen detection, and specifically discloses a detection box comprising a detection plate, an ID chip, and a sample diluent. The detection plate comprises a sealed and buckled upper cover and a lower cover. The upper cover is provided with a sample adding hole and a detection window. The lower cover is provided with a clamping groove. A test strip is placed in the clamping groove. The test strip comprises a PVC strip. The PVC strip is provided with a nitrocellulose membrane. One end of the nitrocellulose membrane away from the sample adding hole is provided with an absorbent paper. The other end of the nitrocellulose membrane is provided with a binding pad. The free end of the binding pad is provided with a sample adding pad. The position of the sample adding hole corresponds to that of the sample adding pad. The nitrocellulose membrane is coated with an antigen detection line and a quality control detection line. The antigen detection line is sprayed with mycoplasma pneumoniae monoclonal antibody P2. The quality control detection line is sprayed with sheep anti-mouse antibody IgG.

[0005] The above patent, like most chromatographic strips, has the disadvantage of only one sample adding hole, which can only add the sample to be tested. However, the quality control of the chromatographic strip detection result is not enough. In order to better control the accuracy of each detection result, positive and negative controls need to be added. UTILITY MODEL CONTENT

[0006] The utility model wants to solve the technical problem of designing a new type of kit for mycoplasma pneumoniae detection, the detection chip in it sets up quality control area, is used for verifying detection chip quality and operation accuracy, to enhance product quality control, improve detection result accuracy.

[0007] In order to solve the above technical problem, the utility model adopts the following technical scheme: a kit for mycoplasma pneumoniae detection, including positive quality control reagent, negative quality control reagent and detection chip, the detection chip includes upper shell and lower shell, the upper shell and lower shell snap connection, three sample windows are set up on the upper shell, and the three sample windows are negative control port, positive control port and detection port respectively;Reaction film is arranged between the upper shell and the lower shell, when the upper shell and the lower shell are engaged, the reaction film is arranged with negative control area opposite the negative control port, positive control area opposite the positive control port and detection area opposite the detection port;The negative control area, positive control area and detection area embed corresponding antigen or antibody respectively.

[0008] Further, the three sample windows all include sample channels, and the bottom of the sample channel is in abutment with the reaction film.

[0009] Further, the cross section of the sample channel is trapezoidal.

[0010] Further, the negative control area, positive control area and detection area all embed mycoplasma pneumoniae antigen.

[0011] Further, the positive quality control reagent is mycoplasma pneumoniae positive serum, and the negative quality control reagent is mycoplasma pneumoniae negative serum.

[0012] Further, the lower part of the reaction film is provided with a water absorption layer.

[0013] Further, the water absorption layer includes water absorption soft cotton and water absorption paperboard, the water absorption soft cotton is located in the lower part of the reaction film, and the water absorption paperboard is located in the lower part of the water absorption soft cotton. Beneficial effects

[0014] The application sets up three sample windows on the upper shell, each sample window is communicated with mycoplasma pneumoniae positive control area, negative control area and detection area respectively, and the positive control area, negative control area and detection area all embed mycoplasma pneumoniae antigen. During detection, only need to drop positive quality control reagent to positive control area, drop negative control reagent to negative control area and drop test reagent to detection area, and the desired result can be obtained.

[0015] The kit of the application can accurately verify whether the quality of the detection chip is qualified and whether the manual operation is correct by separately adding the sample and the control reagent, thereby enhancing the quality control of the product and improving the accuracy of the detection result. BRIEF DESCRIPTION OF DRAWINGS

[0016] Fig. 1 It is a top view of the detection window of the utility model.

[0017] Fig. 2 It is a sectional view of the detection window of the utility model.

[0018] Fig. 3 It is a structural schematic view of the detection chip of the utility model.

[0019] Wherein 1 is an upper shell, 2 is a lower shell, 3 is a negative control port, 4 is a positive control port, 5 is a detection port, 6 is a reaction film, 61 is a negative control area, 62 is a positive control area, 63 is a detection area, 7 is a water-absorbing cotton, 8 is a water-absorbing paperboard, and 9 is a sample inlet channel. DETAILED DESCRIPTION

[0020] In order to strengthen the understanding of the utility model, the utility model will be described in detail below in combination with examples and drawings, and the examples are only used to explain the utility model and do not constitute a limitation on the protection scope of the utility model.

[0021] As Figs. 1 to 3 shown is a structural schematic view of a detection chip in a kit for detecting mycoplasma pneumoniae, and specifically, the detection chip comprises an upper shell 1 and a lower shell 2, the upper shell 1 and the lower shell 2 can be connected by clamping or buckling, which is a conventional technical means and will not be described here.

[0022] Three sample inlet windows are arranged on the upper shell 1, which are a negative control port 3, a positive control port 4 and a detection port 5 respectively, and each sample inlet window is connected with a sample inlet channel 9 at the lower part. A reaction film 6 is arranged between the upper shell 1 and the lower shell 2, and when the upper shell 1 is clamped with the lower shell 2, the bottom of the sample inlet channel 9 abuts against the reaction film 6.

[0023] At this time, the reaction film 6 is provided with a negative control area 61 at the position opposite to the negative control port 3, a positive control area 62 at the position opposite to the positive control port 4 and a detection area 63 at the position opposite to the detection port 5, and the negative control area 61, the positive control area 62 and the detection area 63 respectively embed corresponding antigens or antibodies. The positions of the sample inlet windows and the control areas are not limited here and can be determined according to the types of the embedded antigens or antibodies.

[0024] According to one preferred embodiment of the utility model, the cross section of the sample inlet channel 9 is trapezoidal, which makes the sample liquid drop more concentrated in the reaction area, thereby saving the amount of sample liquid.

[0025] According to one preferred embodiment of the utility model, the negative control area 61, the positive control area 62 and the detection area 63 all embed mycoplasma pneumoniae antigens.

[0026] In use, the mycoplasma pneumoniae negative serum is dropped into the negative control port, the mycoplasma pneumoniae positive serum is dropped into the positive control port, and the sample to be tested is dropped into the detection port, and the required result is obtained according to the specific reaction of the antigen and antibody, thereby enhancing the quality control of the product and improving the accuracy of the product detection result.

[0027] According to one preferred embodiment of the utility model, the lower part of the reaction film 6 is provided with a water absorption layer. The water absorption layer comprises water absorption soft cotton 7 and water absorption paperboard 8, the water absorption soft cotton 7 is located in the lower part of the reaction film 6, and the water absorption paperboard 8 is located in the lower part of the water absorption soft cotton 7. This design can better absorb the waste liquid after reaction and prevent pollution caused by the waste liquid.

[0028] The embodiments of the utility model disclose preferred embodiments, but are not limited to this, and the person skilled in the art can easily understand the spirit of the utility model according to the above-mentioned embodiments and make different inferences and changes, as long as the spirit of the utility model is not deviated, and are within the protection scope of the utility model.

Claims

1. A kit for detection of Mycoplasma pneumoniae, comprising a positive quality control reagent, a negative quality control reagent and a detection chip, the detection chip comprising an upper shell (1) and a lower shell (2), the upper shell (1) and the lower shell (2) being snap-connected, characterized in that, Three sample injection windows are arranged on the upper shell (1), which are a negative control port (3), a positive control port (4) and a detection port (5) respectively. A reaction film (6) is arranged between the upper shell (1) and the lower shell (2), when the upper shell (1) and the lower shell (2) are clamped, a negative control area (61) is arranged at a position opposite to the negative control port (3), a positive control area (62) is arranged at a position opposite to the positive control port (4), and a detection area (63) is arranged at a position opposite to the detection port (5). The negative control area (61), the positive control area (62) and the detection area (63) respectively embed corresponding antigens or antibodies.

2. The kit for detection of Mycoplasma pneumoniae according to claim 1, characterized by, The three sample injection windows all include a sample injection channel (9), and the bottom of the sample injection channel is in contact with the reaction film (6).

3. The kit for detection of Mycoplasma pneumoniae according to claim 2, characterized by, The cross section of the sample injection channel (9) is trapezoidal.

4. The kit for detection of Mycoplasma pneumoniae according to claim 1, characterized by, The negative control area, the positive control area and the detection area all embed mycoplasma pneumoniae antigens.

5. The kit for detection of Mycoplasma pneumoniae according to claim 1, characterized by, The positive control reagent is mycoplasma pneumoniae positive serum, and the negative control reagent is mycoplasma pneumoniae negative serum.

6. The kit for detection of Mycoplasma pneumoniae according to claim 1, characterized in that, The lower part of the reaction film (6) is provided with a water absorption layer.

7. The kit for detection of Mycoplasma pneumoniae according to claim 6, characterized in that, The water absorption layer includes water absorption soft cotton (7) and water absorption paperboard (8), the water absorption soft cotton (7) is located at the lower part of the reaction film (6), and the water absorption paperboard (8) is located at the lower part of the water absorption soft cotton (7).

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