Oropharyngeal 5pcs Covid 19 Rapid Test Kit ISO13485 Approval

Professional oropharyngeal Covid-19 Test Kit/SARS-Cov-2 Antigen Assay kit by Immunofluorescence Chromatography Method

Test Principle

The reagent forms an antigen-antibody conjugate with SARS-Cov-2 antigen and is detected by a fluorescence detector to achieve a semi-quantitative determination of the concentration of SARS-Cov-2 antigen in human nasopharyngeal swabs or oropharyngeal swabs, thereby achieving a qualitative interpretation of viral infection. After treatment, SARS-Cov-2 in the sample is added to the detection hole, antigen and latex labeled antibody (monoclonal antibody against SARS-Cov-2) form an immune complex. The complex moves with the liquid to the nitrocellulose membrane, and the detection area of the nitrocellulose membrane is coated with another one.

Test Result

When the monoclonal antibody is against SARS-Cov-2, the immune complex is captured by the antibody on nitrocellulose membrane, forming fluorescence signal: the result is positive. When the sample does not contain SARS-Cov-2 antigen or is lower than the minimum detection limit of this kit, fluorescence signal appears in the detection area: the result is negative.

STEPS

1. Specimen collection using either sterile nasopharynx swab or oropharyngeal swab
2. Sample extraction: insert swab into sample preservation tube after pricking. Immerse, rotate, and discard swab then insert dripper
3. Drop 80ul of mixed solution into test card. After 15 min, place test card into instrument and detect

ABOUT US

Sichuan Xincheng Biological Co.,LTD (Diacegene as brand for overseas market), founded in 2007, is a global leading bio-technical company, dedicating to develop and manufacture In Vitro Diagnostic (IVD) products, providing"Analyzers & Reagents" and "Products & Services".

Sichuan Xincheng Biological Co., Ltd.(referred to as Xincheng BIO and Diacegene as brand for overseas sale), was founded in 2007, located in Chengdu High-tech Zone, Sichuan Province, P.R. China. It's a high-tech enterprise combined with R&D, production, sales of in vitro diagnostic (IVD) "instrument & reagent ", and provide" products & services ".

As an in vitro diagnostic(IVD) products and services integrated program supplier, the future of Xincheng BIO will continue to adhere to the "customer-centered, teamwork, innovation, pragmatic, dedicated, progressive" core values, to be the innovator of IVD and the promoter of the general health care.