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SALIVA Antigen IVD Kit SARS-CoV-2 Whitelist CE 5min Aging FDA

Basic Information
Place of Origin: China
Brand Name: REAGEN
Certification: CE,FDA,ANVISA
Model Number: RNS92048T
Minimum Order Quantity: 500 test
Price: Negotiable
Packaging Details: color packing
Delivery Time: 5-7 days
Payment Terms: T/T
Supply Ability: 500000 per day
Detail Information
Temperature: 4~30℃ Accuracy: 90%-99.0%
Aging: 5-15min Name: Antigen IVD Kit
Application: Vitro Qualitative Detection Collected Samples: Are Processed By The Sample Extract And Added
High Light:

SALIVA Antigen IVD Kit

,

5min Aging Antigen IVD Kit

,

FDA Antigen Rapid Test Kit


Product Description

SARS-CoV-2 Antigen IVD Kit SALIVA Whitelist CE Certification

Product Description

This kit is used for in vitro qualitative detection of COVID-19 antigen in human saliva samples.

Mechanism Of Reaction

This kit adopts the detection principle of double antibody sandwich method. The binding pad of the detection card contains colloidal gold-labeled mouse N protein monoclonal antibody I; the detection line (T line) of the nitrocellulose membrane is coated with mouse N protein monoclonal antibody II, quality control line (line C) is coated with goat anti-mouse antibody.
The collected samples are processed by the sample extract and added. During the test, when the extract containing the N protein of the COVID-19 is added to the sample hole of the test card, under the action of chromatography, the sample moves to the end of the absorbent paper and first passes through the binding pad. The N protein and colloidal gold labeled mice The source N protein monoclonal antibody I specifically binds and continues to move to the absorbent paper end. When the sample moves to the T line, the N protein bound to the labeled antibody specifically binds to the N protein monoclonal antibody II coated in the T line in a double antibody sandwich mode, and stays at the T line; the remaining liquid continues to absorb water The paper end moves. When it moves to the C line, the mouse N protein antibody I labeled with colloidal gold specifically binds to the goat anti-mouse antibody in the C line. The T line shows a red band, indicating that the COVID-19 antigen is positive. No matter whether the T line is colored or not, the C line should show red. If the C line is not colored, the test is invalid and the sample needs to be tested again.

 

Interpretation Of Results

Negative: A purple-red band, only the quality control line (C line) is colored.

Positive: Two purple-red strips, the detection line (T&A/B) and the quality control line (C line) are both colored .

Invalid results: The quality control line (line C) has no color development, and the test is invalid. It is recommended to take another test card to retest.

Precisio

The sensitivity of the test kit was 90%-95%, the specificity was 98%-99%, and the accuracy was between 95%-99%

 

 

Symbol
Symbol Meaning Symbol Meaning

 

SALIVA Antigen IVD Kit SARS-CoV-2 Whitelist CE 5min Aging FDA 0

In vitro diagnostic medical devicet

 

 

Storage temperature limit

 

 

Manufacturer

 

SALIVA Antigen IVD Kit SARS-CoV-2 Whitelist CE 5min Aging FDA 1

Authorized representative

in the European Community

  Date of Manufacture   Use by date
  Do not reuse   Consult instruction for use

 

 

Batch code

 

 

Meet the requirements of

EC Directive 98/79/EC

 

 

SALIVA Antigen IVD Kit SARS-CoV-2 Whitelist CE 5min Aging FDA 2

 

Contact Details
Nicole

Phone Number : 856-727-0250

WhatsApp : +8615361523839