Treponema Pallidum (TP) IgM/IgG Antibody Rapid Test Kit Colloidal Gold

Treponema Pallidum (TP) IgM/IgG Antibody Rapid Test Kit

Description

It is suitable for the in vitro qualitative test of Treponema Pallidum (TP) IgM/IgG antibodies in human whole blood samples. Clinically, this kit can be used for the auxiliary diagnosis of syphilis. The kit uses immunochromatography technology to detect Treponema pallidum (TP) IgM/IgG antibody by double antigen sandwich method. This product is intended for clinical laboratory personnel who have received specialized instruction and training in the technical aspects of in vitro diagnostic procedures. This kit does not use an instrument and can produce results when used alone. The product is automatically produced and packaged in a 100,000-level purification workshop, and the shell is sterilized with 75% alcohol.

Specification

Picture details

CE Approved

All our rapid test kits have CE certifications that can be downloaded.

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This kit is applicable for in vitro qualitative tests of Treponema Pallidum (TP) IgM/IgG antibody in the sample of human whole blood. Clinically, this kit is applicable for auxiliary diagnosis of syphilis. The product is intended for use by qualified and trained clinical laboratory personnel specifically instructed and trained in the techniques of in vitro diagnostic procedures. Qualitative tests are used to screen for syphilis.

The positive rate is: 1 to 2 weeks after infection with Treponema pallidum is 76%, secondary syphilis is 95% to 100%, late syphilis is 70% to 95%, and the latent infection period is 70% to 80%. Qualitative tests can produce false positive reactions, which are found in neoplastic leprosy, malaria, SLE, scleroderma, yaws, relapsing fever, schistosomiasis, hydatid disease, mycoplasma pneumonia, infectious mononucleosis, tuberculosis, etc.

Yongyue Medical Technology (Kunshan) Co., Ltd. is a comprehensive high-tech enterprise integrating R&D, manufacturing, sales, and service, focusing on the third category of medical devices and biomedical consumables (IVD in vitro diagnostic systems). The company is located in the High-tech Zone of Kunshan City, Jiangsu Province, covering an area of ​​nearly 20,000 square meters and a building area of ​​12,000 square meters. The company has completely independent product development, mold making, parts production, and finished product assembly full-process capabilities; it has an independent research and development team, an independent microbiology laboratory, and a physical and chemical laboratory of 10,000 square meters; the production workshop has been built with 5000 square meters and 100,000 Level purification workshop is equipped with nearly 40 imported all-electric injection molding machines and multiple fully automated assembly lines. The company has passed the ISO13485:2016 quality system certification, and the products have passed the EU CE certification. Yongyue Medical Technology takes "caring for human health" as its original intention and "improving the quality of life" as its mission. Adhering to the corporate core values ​​of "caring for life, health-oriented; giving back to the society, cultural inheritance", we will wholeheartedly provide high-quality products and first-class services to the majority of users in the medical and health industry. Yongyue Medical is your partner worthy of trust.