Covid 19 Antigen Rapid Test

The SARS-CoV-2 Antigen Rapid Test (covid 19 antigen rapid test) is a rapid chromatographic immunoassay for the qualitative detection of novel coronavirus SARS-CoV-2 in human throat and nasal secretions.

Product Details

SARS-CoV-2 Antigen Rapid Test (covid 19 antigen rapid test)


A rapid test for the qualitative detection of antigens to the novel coronavirus SARS-CoV-2 in human throat and nasal secretions. For professional in vitro diagnostic use only.


INTENDED USE

The SARS-CoV-2 Antigen Rapid Test (covid 19 antigen rapid test) is a rapid chromatographic immunoassay for the qualitative detection of novel coronavirus SARS-CoV-2 in human throat and nasal secretions.


PRINCIPLE

The SARS-CoV-2 Antigen Rapid Test is for detection of SARS-CoV-2 antigens. Anti-SARS-CoV-2 monoclonal antibodies are coated in the test line and conjugated with the colloidal gold. During testing, the specimen reacts with the anti-SARS-CoV-2 antibodies conjugate in the test strip. The mixture then migrates upward on the membrane chromatographically by capillary action and reacts with another Anti-SARS-CoV-2 monoclonal antibodies in the test region. The complex is captured and forming a colored line in the Test line region. The SARS-CoV-2 Antigen Rapid Test contains anti-SARS-CoV-2 monoclonal antibodies conjugated particles and another anti-SARS-CoV-2 monoclonal antibodies are coated in the test line regions.


Materials Provided

1) Foil pouches, with test cassettes and desiccants

2) Assay buffer

3) Sterile swab and specimen collection tube

4) Instruction for use

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single packing

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20test packing


TEST PROCEDURE

Allow the test device, specimen, buffer, and/or controls to equilibrate to room temperature (15-30°C) prior to testing.

1. Bring the pouch to room temperature before opening. Remove the test device from the sealed pouch and use it as soon as possible.

2. Place the test device on a clean and horizontal surface. Reverse the specimen collection tube, extrude 3 drops of the prepared specimen into the specimen well (S) of the test cassette and start the timer.

See illustration below.

TEST PROCEDURE

3. Wait for the colored line(s) to appear. Read results at 10 minutes. Do not interpret the result after 15 minutes.


Features
1.Fast Test, get result within 10-15 minutes.
2.High sensitivity and specificity
3.Easy to operate, no need equipment, convenient and fast
4.Require little Specimens, few Nasal or throat swabs


Authorized certifications

Declaration of Conformity COVID-19 Ag_00


CE

Approve by German Ministry of Health


Approve by German Ministry of Health

China's white list approved COV 19 test kits manufacturer

China's white list approved COV 19 test kits manufacturer


PERFORMANCE CHARACTERISTICS
1. Sensitivity, Specificity and Accuracy 

The SARS-CoV-2 Antigen Rapid Test (covid 19 antigen rapid test)  has been compared with a commercial gold standard reagent (PCR). The result showed the relative sensitivity and specificity

sensitivity and specifityRelative Sensitivity: 90.00%(95%CI:79.49%~96.24%)
Relative Specificity: 100.00%(95%CI:98.48%~100.00%)
Accuracy: 98.33%(95%CI:96.32%~99.32%)
2. Cross-reactivity:
The SARS-CoV-2 Antigen Rapid Test (covid 19 antigen rapid test) is associated with parainfluenza virus antigen, influenza A virus antigen, influenza B virus antigen, Chlamydia pneumoniae antigen, Mycoplasma pneumoniae antigen, adenovirus antigen, respiratory syncytial virus antigen, hepatitis B surface antigen, Hepatitis C virus antigen, Treponema pallidum antigen, human immunodeficiency virus antigen, EB virus antigen, cytomegalovirus antigen, enterovirus 71 antigen, mumps antigen, chicken pox-zoster virus positive samples did not cross-react.
3.Interfering Substances:
The following compounds have been tested using The SARS-CoV-2 Antigen Rapid Test (covid 19 antigen rapid test)  and no interference was observed.

interfering substances


Company profile

Hangzhou Immuno Biotech Co., LTD., organized in 2014, is a high-tech enterprise dedicated to the research and development, service, sales, agency and integration of immunological reagent products.We have a strong r & D team, both experienced scholars, and not lack of active and agile young talent, they are our product quality assurance.Based on technology research and development and product innovation, through continuous technical investment, the R&D team has successfully developed a number of products widely praised by the market and customers.The company attaches great importance to technical cooperation. Through the cooperation with universities, research institutes, technical teams and other objects, we continuously expands and enriches our product line, hoping to provide our partners with high-quality and reliable raw materials for antigens and antibodies and test paper products.


immuno

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_MG_1704

warehouse



Certifications

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Our Service 

  1. Factory price,  reasonable and competitive

  2. OEM/ODM service, Not only packaging and brand customization, we have our own laboratory and R&D team, which can develop and customize proprietary products for customers

  3. Timly and quickly feedback, anytime and anywhere for customer service.

  4. Provide professional training and quality samples to help customers develop the market

  5. Flexible trading methods to meet customer and business needs


Logistics

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