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

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

Place of Origin USA
Brand Name REAGEN
Certification CE,FDA,ANVISA
Model Number RNS92048T
Product Details
Temperature:
4~30℃
Accuracy:
90%-99.0%
Aging:
5-15 Min
High Light: 

99.0% Accuracy IVD Kit

,

SARS-CoV-2 Antigen IVD Kit SALIVA

,

CE Certification IVD Kit

Payment & Shipping Terms
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
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

 

SARS-CoV-2 Antigen IVD Kit SALIVA Whitelist CE Certification 0

In vitro diagnostic medical devicet

SARS-CoV-2 Antigen IVD Kit SALIVA Whitelist CE Certification 1

 

Storage temperature limit

 

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

Manufacturer

 

SARS-CoV-2 Antigen IVD Kit SALIVA Whitelist CE Certification 3

Authorized representative

in the European Community

SARS-CoV-2 Antigen IVD Kit SALIVA Whitelist CE Certification 4 Date of Manufacture SARS-CoV-2 Antigen IVD Kit SALIVA Whitelist CE Certification 5 Use by date
SARS-CoV-2 Antigen IVD Kit SALIVA Whitelist CE Certification 6 Do not reuse SARS-CoV-2 Antigen IVD Kit SALIVA Whitelist CE Certification 7 Consult instruction for use

 

SARS-CoV-2 Antigen IVD Kit SALIVA Whitelist CE Certification 8

Batch code

 

SARS-CoV-2 Antigen IVD Kit SALIVA Whitelist CE Certification 9

Meet the requirements of

EC Directive 98/79/EC

 

 

 

 

Contact Us at Any Time

1-619-389-8888
7098 Miratech Dr Ste 110 San Diego CA 92121 USA
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