SARS-CoV-2 IVD Reagent Rapid Antigen Self Test Kit Individual Labnovation Test

Product Specification

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

Intend Use

• The SARS-CoV-2 Anigen Rapid Test kit is for in vitro diagnostic use only
• The rapid test kit is for individual self testing use
• Immunochromatography assay
• 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.
• Test result 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

Product  Feature

• Results ready in 15minutes
• Accurate diagnostic tool
• Easy to administer and read results
• Affordable, no need for instrument, highly portable
• Single Pack  more protable and convenient
• Individual Self Testing At Home

 
Main Components

•   Test Cassette
•   Sample Tube 
•   Sample Extraction Buffer
•   Swab
•   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

Other 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.
• Keep out of the reach of children. Any child under age 18 shouldn’t perform the test without parental guidance, or professional aid.
• Not following the exact instructions can affect the outcome of the test. The final diagnosis must be confirmed by a physician.
• Do not use the test if the packaging is damaged. Do not use broken test components.
• All test components are only intended to be used for this test. Do not reuse the test or test components.
• The test should be carried out immediately or within one hour after opening the foil pouch (15-30°C, humidity <60%).
• Samples be processed as soon as possible after sample collection. If the test cannot be performed immediately, the sample should be stored in a sealed state, stored at 2~8°C for 8 hours, and stored below -20°C for 1 month.
• Long-term storage is not recommended.

Certificate