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Oropharyngeal 5pcs Covid 19 Rapid Test Kit ISO13485 Approval

Oropharyngeal 5pcs Covid 19 Rapid Test Kit ISO13485 Approval

  • Oropharyngeal 5pcs Covid 19 Rapid Test Kit ISO13485 Approval
  • Oropharyngeal 5pcs Covid 19 Rapid Test Kit ISO13485 Approval
Oropharyngeal 5pcs Covid 19 Rapid Test Kit ISO13485 Approval
Product Details:
Place of Origin: China
Brand Name: Diacegene
Certification: ISO13485
Model Number: SARS-CoV-2 Antigen Test
Payment & Shipping Terms:
Minimum Order Quantity: 20,000
Price: USD 2.5-USD 3.5 per test
Delivery Time: 3-15 business day
Payment Terms: T/T
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Detailed Product Description
Specification: 5 Or 25 Or 50 Tests/box Methodology: Immunofluorescence Chromatography Method
Components: Test Card, Dilution, Capillary Tube, Swab, ID Card Storage: Room Temperature Or Refrigerated (2-30℃)
Validity: 18 Months Sample Type: Nasopharynx/oropharyngeal Swab Collection
Instrument: YES, IFP-2000/IFP-3000 Device Type: IVD (In Vitro Diagnostic) Medical Device
High Light:

oropharyngeal Covid 19 Rapid Test Kit


5pcs Covid 19 Rapid Test Kit


ISO13485 fast test kit

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.



  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
Sample Type Nasopharynx/oropharyngeal swab collection
Components Test card, Dilution, Capillary Tube, Swab
Instrument YES, IFP-2000/IFP-3000

Room temperature or refrigerated (2-30℃)



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.


Oropharyngeal 5pcs Covid 19 Rapid Test Kit ISO13485 Approval 0Oropharyngeal 5pcs Covid 19 Rapid Test Kit ISO13485 Approval 1

Contact Details
Sichuan Xincheng Biological Co., Ltd.

Contact Person: Harvey Huang

Tel: +8615828328497

Send your inquiry directly to us
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