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2019-nCoV Ag Rapid Test Card

  • 2019-nCoV Ag Rapid Test Card
  • 2019-nCoV Ag Rapid Test Card

2019-nCoV Ag Rapid Test Card

    Min. Order: 10000 Piece/Pieces
    Packaging: export standard
    Productivity: 100,000,000 pcs/year
    Brand: Uni-medica
    Transportation: Ocean,Land,Air,Express
    Place of Origin: China
    Supply Ability: 100,000,000 pcs/year
    Certificate: CE/SGS
    HS Code: 38220090
    Port: Shenzhen,Guangzhou,Hongkong

Basic Info

Model No.: R041-01

Product Description

Product Name

SARS-CoV-2 Antigen Rapid Test Cassette (Colloidal Gold)

Alternative Name

COVID-19 Antigen Rapid Test Cassette (Colloidal Gold), also named 2019-nCoV Rapid Antigen Test Kit, New coronavirus Antigen Test Kit,etc.

Intended Usage

This Covid-19 Antigen Test Kit is used for the detection of novel coronavirus antigens in oropharyngeal swabs and nasopharyngeal swab samples of people suspected of being infected with pneumonia caused by novel coronavirus. Antigen testing is generally used in the acute infection period, that is, sample testing within 7 days of the onset of symptoms in a suspected population.

Antigen testing cannot be used alone for the diagnosis of new coronavirus infection. It should be combined with nucleic acid testing, imaging and other diagnostic information, medical history, and contact history to determine the status of infection.

Product Description

The novel coronaviruses belong to the β genus.COVID-19 is an acute respiratory

infectious disease. People are generally susceptible. Currently, the patients infected by novel coronavirus are the main source of infection; asymptomatic infected people can also be an infectious source.

Based on the current epidemiological investigation, the incubation periodis 1 to 14

days,mostly 3 to 7 days. The main manifestations include fever, fatigue and dry cough.

Nasal congestion, runny nose, sore throat, myalgia and diarrhea are found in a few cases.

Testing Principle

The Novel Coronavirus (SARS-CoV-2) Antigen Kit is composed of novel coronavirus monoclonal antibody 2 and goat anti- mouse IgG polyclonal antibody fixed in the nitrocellulose membrane and Novel Coronavirus monoclonal antibody 1 latex-labeled fixed in the release pad.The kit tests Novel Coronavirus SARS-CoV-2 N antigen in human nasopharyngeal swabs , oropharyngeal swabs ,saliva or nasal swabs with the principle of double antibody sandwich method by latex immunochromatography.

When a specimen is added to the sample well, the sample is first mixed with the colored latex-labeled novel coronavirus monoclonal antibody 1 on the release pad, and then migrate on the nitrocellulose membrane. If SARS-CoV-2 N protein antigen presents in the sample, these antigens will bind to coronavirus monoclonal antibody 1 labeled with color latex forming antigen antibodies complex. This complex migrates through nitrocellulose membrane by capillary action. When the complex is captured by the SARS-CoV-2 monoclonal antibody 2 to form a red colored band in the T line, which is a positive result. If no antigen presents in the sample, there will be no red band appearing in the testing region, this is a negative result. The internal control (C band) fixing with goat anti-mouse antibody should exhibit a red band regardless of whether antigen presents in the test.

Scope of Use

The rapid, accurate and easy-to-operate advantages of antigen detection will benefit many industries, including customs (personnel and import and export goods), hotels, airlines, restaurants, conferences, live concerts, sports events, etc. In addition, the operation of rapid antigen detection is very simple, and other medical staff besides professional medical technicians can also easily master it, and use it to provide patients with fast new coronavirus detection services, which can greatly reduce the overload of the medical system. The advent of rapid detection products for the new crown antigen is conducive to reducing the risk of virus transmission to a minimum and helping to promote countries around the world to achieve complete prevention and control of the epidemic.

Storage Conditions and Expiry Date

Store in a dry place at 2~30℃, valid for 12 months.

Product Features

1. Fast: It only takes 15-20 minutes to detect a sample, and quick on-site inspection can be done.

2. The operation is simple, without special equipment and personnel training;

3. Stable sensitivity: The immunological methods have relatively low requirements for samples, and the antigen protein is relatively stable, so the sensitivity of the antigen detection kit is stable.

Testing Results

Positive: Both the detection line (T line) and the quality control line (C line) appear colors.

Negative: The test line (T line) does not appear color, only the quality control line (C line) appears color

Invalid: The quality control line (C line) does not appear color, or both of the quality control line (C line) and the test line (T line) do not appear color, which means that the test is invalid and the test should be repeated.

Testing Results

Our advantage

1. Quick result: <5 minunites

2. High accuracy: >99%

3. High sensitivity: >99%

CE-antibody_1CE-antibody_2NMPA certificateMedical Device Production License_1Export White listDeclaration Letter Antigen Tesk Kit

Shenzhen Uni-medica Technology Co.,Ltd

 Shenzhen Uni-medica Technology Co., Ltd (Uni-medica) is a national high-tech enterprise. It has established cooperation and jointly performed a number of scientific research projects with the Hong Kong University of Science and Technology, Shenzhen University and Chinese Academy of Sciences. Uni-medica was also selected as one of the top 100 new Chinese innovative enterprises. The company takes the technical innovation of molecular detection methods as the core driving force, and focuses on the R&D and industrialization of molecular diagnostic products aiming at prevention and control of infectious diseases and genetic diseases. Uni-medica provides total solution of accurate diagnosis of infectious diseases and genetic diseases based on multi-omics technologies, including multiplex PCR, NGS technology and flow cytometry. Uni-medica is qualified by ISO 13485 and CFDA quality control system. The pathogen molecular detection products are daily used in hundreds of hospitals, Centers for Disease Control and Prevention and Quarantine Laboratories throughout the country, providing strong support for prevention and control of infectious diseases.

Company Info

  • Company Name: Shenzhen Uni-medica Technology Co.,Ltd
  • Representative: Wang yan Pin
  • Product/Service: Disposable virus sampling tube , Nucleic acid extraction kits , RT-PCR test kits , One-Step method test solution of COVID-19 , Automatic test solution of COVID-19 , Nucleic acid extractors
  • Capital (Million US $): 5,000,000
  • Year Established: 2011
  • Total Annual Sales Volume (Million US $): US$10 Million - US$50 Million
  • Export Percentage: 51% - 60%
  • Total Annual Purchase Volume (Million US $): US$5 Million - US$10 Million
  • No. of Production Lines: 5
  • No. of R&D Staff: 21 -30 People
  • No. of QC Staff: 5 -10 People
  • OEM Services Provided: yes
  • Factory Size (Sq.meters): 3,000-5,000 square meters
  • Factory Location: 2nd Floor, No.6 Building, Xili Liuxian Culture Park, Nanshan District, Shenzhen City, Guangdong Province, China
  • Contact Person: Mr. Jack
  • Tel: +86-755-86502782
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