Rapid Diagnostic Test SARS-CoV-2 Antigen Rapid Test Kit Self Test Use Simple Operation CE Certificated 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. It's according to immunochromatography assay which detects SARS-CoV-2 nucleocapsid antigen in the samples with the help of the double antibody sandwich method.

Product Feature

• For home use
• Result in 15 minutes
• Store at 2-30℃
• Detected COVID-19 virus variants (UK. SA. Brazil. CA. NY. etc)

Diagnostic Accuracy

Product Feature

• Rapid detection of new COVID-19 virus in 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 navel coronavirus pneumonia

Main Components

• Test Cassette
• Sample tube with prefilled sample extraction buffer
• Swab
• Instruction for use

Use Step

• Wash and dry hands before you begin to perform the test.

• Please check the expiration date printed on the BOX. Do not use it beyond the expiration date. Lay all the supplied materials on a clean, dry and flat surface.

• Take sample tube with sample extraction buffer and remove the sealed film of the sample tube. Then place the tube in the tube stand (The tube stand is the outer box.)

• Open the sealed pouch and remove the test cassette. Lay it face up on a clean, dry and flat surface.

• Remove the swab from the container, being careful NOT to touch the soft end, which is the absorbent tip.

• Gently, insert the entire absorbent tip of the swab (around 1.5 cm) into your nostril. Slowly, rotate the swab in a circular against the inside walls of your nostril 5 times or more. Be sure to collect any nasal drainage that maybe present on the swab. Gently remove the swab. Use the same swab to repeat steps in the other nostril and slowly, take out the swab.

• Insert the swab into the sample tube with prefilled extraction buffer. 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. Try to release as much liquid as possible. Dispose of the used swab in accordance with applicable local regulations.

• Close the cap 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 15-20 minutes 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

Important Information

• This kit is a qualitative detection, which cannot determine the exact content of antigen.
• The test is intended for use outside the body only.
• Not to be taken internally. Avoid sample buffer contact with skin and eyes.
• Protect from sunlight, do not freeze. Store in a dry place between 2°C and 30°C. Do not use after the expiration date printed on the package.

Certificate

• CE cetificated
• Iceland registration
• Philipines certificated
• Germant BfArm List