CE MSDS SARS-CoV-2 Antigen Self Test Kit 100.00% Specificity

Rapid Test Kit SARS-CoV-2 Antigen Rapid Test Kit Self Testing Antigen Detection Rapid Test Kit

Intend Use
This rapid test kit is intended for the qualitative detection of SARS-CoV-2 viral nucleocapsid antigens from human anterior nasal of secretion from individuals suspected of COVID-19.  Positive result of the antigen test can be used for early isolation of patients with suspected infection, but it cannot be used as diagnosis basis of SARS-CoV-2 infection. Negative results do not rule out SARS-CoV-2 infection and should not be used as the sole basis for treatment. Further nucleic acid detection should be carried out for suspected population whose antigen test result is positive or negative.
Product Details

Principle

This kit is an immunochromatography assay which detects SARS-CoV-2 nucleocapsid antigen in the samples with the help of the double antibody sandwich method. If there is virus antigen presence in the sample, it binds with the corresponding colloidal gold antibody. This complex “migrates” across the membrane and binds to the monoclonal antibody at the Test line (T). This creates a visible red line, which indicates a positive result. However, if the sample does not contain any antigen, then the complex cannot be formed and thus no reddish line forms in the Test line (T). Regardless of whether the sample contains antigen or not, a reddish line forms in the Control line (C).

Product  Feature

• At home use
• One Step Operation without extra instrument
• High accuracy, Specificity and Sensitivity, Specificity rate up to 100%
• Safety and reliable, CE and ISO13485 Certificated

 

Main Components

• 20 Test Cassettes
• 20 Sample tubes 
• 20 Extraction Buffer
• 20 Swabs
• 1 Tube stand
• 1 Instruction for use

Use Step

• Open the sealed pouch and remove the test casstette. Lay it face up on a clean, dry and flat surface.
• Unpack the sample extraction, add all of the sample extraction into the sample tube and then put the tube into tube stand.
• Gently, insert the entire absorbent tip of the swab (around 1.5 cm) into your nostril. Rotate walls of your nostril 5 times or more. Use the same swab to repeat steps in the other nostril.

• Insert the swab into the ssample tube with extraction buffer. Mix well. Mix well and squeeze the swab 10-15 times by compressing the walls of the tube against the swab. Roll the swab head against the inner wall of the tubes as you remove it.
• Close the cape of the sample tube. Add 3 full drops of the mixed solution vertically into the sample well(S) of the test cassette.
• Read the result 15-20minutes after adding the sample. Result got after 20 minutes is invalid.

 
Result Interpretation

• POSITIVE: Two colored bands appear on the membrane. One band appears in the control region (C) and another band appears in the test region (T).

• NEGATIVE: Only one colored band appears, in the control region (C). No apparent colored band appears in the test region (T).

• INVALID: If there is no Control line (C) or only a Test line (T) in the result window, the test did not run correctly and the results are not valid.

 

 
Virus Sources

 Advantage

• Rapid detection of new coronavirus in 10-15 minutes
• Antigen detection is the better tool for rapid tracking of new coronal infection
• Single rapid detection of nasopharyngeal swab can be detected
• Suitable for monitoring novel coronavirus pneumonia

Certificate