5pcs Antigen Rapid Test Cassette , 15mins POCT Diagnostic Testing Kit

 15 mins POCT Covid-19 Test Kit/SARS-Cov-2 Antigen Assay kit by Immunofluorescence Chromatography Method

Summary

This product can be used as a supplementary test indicator for suspected cases with negative nucleic acid test of SARS-Cov-2 or used in conjunction with nucleic acid testing in the diagnosis of suspected cases. It cannot be used as a basis for the diagnosis and exclusion of pneumonia caused by SARS-Cov-2 infection.

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 and 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. 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, no fluorescence signal appears in the detection area: the result is negative.

Reagents components

The reagent consists of test card, ID chip card, sample preservation solution (optional), dripper and swab (optional).
1. The test card consists of reagent strip and plastic case. The main components of the test strip are: fluorescence labeled SARS-Cov-2 nucleoprotein monoclone antibody and another nucleoprotein monoclone antibody coatted in the detection area of nitrocellulose membrane; anti mouse immunoglobulin G polyclonal antibody fixed in the quality control area of nitrocellulose membrane.
2. The main preservation solution was phosphate buffer (PBS, 50mm, ph7.2).

Applicable instrument

The models produced by Sichuan Xincheng Biological Co., LTD: IFP-2000, IFP-3000 fluorescent Immunoanalyzer.

Compatible Fluorescent Immunoanalyzers

IFP-2000/IFP-3000

• 10-second touchscreen operation
• Single-channel test: cards ejected automatically upon completion
• The instruments can also be used in conjunction with our other tests to detect a wide variety of other indications (PCT, CRP, SAA, IL6, Cardiac cTnl, NT-proBNP, cTnl / Myo / CKMB, D-dimer, beta-HCG, Prog, HbA1c, influenza A/B)
• Built-in printer supports automatic printing of test reports
• Built-in RS232, USB, LAN and other interfaces can be connected to LIS
  30 X 21.5 X 15cm, weight 3.1kg

Customer Focused

We herewith declare that the above mentioned products meet the provisions of the council directive 98/79/EC for in vitro diagnostic medical devices and is compliant with ISO 13485. We provide all-around service that guarantees satisfaction in the procurement process.

• Strong R&D capability
• Products outperform competitors
• Constantly innovating better and more competitor kits

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.