Mycoplasma pneumoniae antigen detection kit (colloidal gold )

[Product Name] Common Name: Mycoplasma pneumoniae antigen detection kit (colloidal gold)

【 Packaging Specifications 】 1 Test/Box, 2 Test/Box, 3 Test/Box, 5 Test/Box, 10 Test/Box, 20 Test/Box, 50 Test/Box, 100 Test/Box.

[Expected use] This product is used for qualitative detection of Mycoplasma pneumoniae antigen in throat swab samples of the population. Mycoplasma pneumoniae can cause upper and lower respiratory tract infections, mainly transmitted through direct contact and droplets. The incubation period is about 1-3 weeks, and carriers of the pathogen are contagious from the incubation period to several weeks of symptom relief. There are many cases in autumn and winter, and the incidence rate of children and young people is high. And local and epidemic infections occur worldwide, with a regional outbreak occurring approximately every 3-7 years. Mycoplasma pneumoniae can cause primary atypical pneumonia in humans and is the main pathogen of community-acquired pneumonia. Mycoplasma pneumoniae pneumonia has a relatively slow onset, complex and difficult to distinguish clinical manifestations, and a long course of illness. If not treated in a timely manner, it can cause other respiratory system diseases and various extrapulmonary complications, posing a great threat to the growth and development of children. In clinical practice, the main symptoms include bronchitis, cough, sputum production, asthma, irregular fever, etc., which are very similar to symptoms caused by other pathogens such as viruses or bacteria and are difficult to distinguish. P1 protein is a membrane protein that is sensitive to trypsin and has antigenicity and immunogenicity. It is located at the top of MP and is the main adhesion protein of MP, encoded by approximately 5000 base pairs and composed of 1627 amino acids. P1 protein antibodies can be detected in the serum of patients infected with Mycoplasma pneumoniae. Therefore, specific detection of P1 protein can effectively detect Mycoplasma pneumoniae infection. This product uses colloidal gold immunochromatography technology and is suitable for auxiliary diagnosis of Mycoplasma pneumoniae infection. The test results of this kit are for clinical reference only and should not be used as the sole criterion for clinical diagnosis. It is recommended to conduct a comprehensive analysis of the patient's condition based on their clinical manifestations and other laboratory tests.

【 Testing Principle 】 This product uses immunochromatography technology and employs a double antibody sandwich method to detect Mycoplasma pneumoniae antigen. During the detection process, drop the processed extract into the sample well of the test card. When the concentration of Mycoplasma pneumoniae antigen in the test sample is not lower than the minimum detection limit, the Mycoplasma pneumoniae antigen first reacts and complexes with the labeled antibody, and then moves forward along the nitrocellulose membrane under chromatography. The reaction complex will be captured by monoclonal antibodies against Mycoplasma pneumoniae nucleoprotein pre coated in the detection zone (T) on a nitrocellulose membrane. If a purple red reaction line appears in the detection area (T), the result is positive. Conversely, if no reaction line appears, the result is negative. Regardless of whether the sample contains Mycoplasma pneumoniae antigen, a purple red reaction line will always appear in the quality control area (C) to determine whether the chromatography process is normal and serve as the internal control standard for the reagent.

The reagent consists of a test card and a sample extraction tube (including sample extraction solution). The test cards and sample extraction tubes in different batch numbers of reagent kits cannot be interchanged. one The test card consists of a test strip and a plastic card. The main components on the test strip include: colloidal gold labeled Mycoplasma pneumoniae monoclonal antibody, NC membrane coated Mycoplasma pneumoniae monoclonal antibody, and quality control line sheep anti mouse IgG. two The main components of the sample extraction solution include Tris HCl buffer containing NaCl, NP40, Proclin 300 (preservative), etc. Required but not provided materials: clock or timer. Disposable sampling swabs from Yangzhou Xinghe Biotechnology Co., Ltd. (registration number: Suyang Mechanical Equipment 20220104; model: Type I). The disposable sampler of Bodi Tai (Xiamen) Biotechnology Co., Ltd. (registration number: Minxia Mechanical Equipment No. 20210279; model: OS001).

【 Storage conditions and shelf life 】 Stored at 4 ℃~30 ℃, with a shelf life of 18 months. After opening the aluminum foil bag, it is recommended to use the test card within 1 hour at 4 ℃~30 ℃ to avoid prolonged exposure to humid air (humidity ≥ 60%) that may affect the test results. Please use the sample extraction solution as soon as possible within 1 hour after opening. The production date and expiration date can be found on the outer packaging.