LABNOVATION® SARS-COV-2 Antigen-Schnelltest

LABNOVATION® SARS-COV-2 Antigen-Schnelltest
PURPOSE OF USE
This test is for the in vitro qualitative determination of SARS-CoV-2 antigen in human anterior nasal specimens. It serves as a rapid screening for suspected cases of novel coronavirus, but can also be used as a confirmatory method for nucleic acid detection in discharged cases. A positive test result indicates that the samples contain SARS-CoV-2 antigen. A negative test result does not rule out the possibility of infection.
This kit is intended for home use by non-laboratory lay people (such as a person's home or certain non-traditional locations such as offices, sporting events, airports, schools, etc.)
INGREDIENTS
1. SARS-CoV-2 antigen test cassette
2. Sample Extraction Buffer
3. Single-use virus specimen swab
4. Extraction tube stand
1. Sample collection:
Gently insert the entire soft tip of the swab into one nostril about 1.5cm until you feel some resistance.
Using medium pressure, slowly rub the swab in a circular motion around the inside wall of your nose 4 times for a total time of 15 seconds.
Repeat the same process with the same swab in the other nostril.
2. Sample treatment
The swab is soaked after sampling below the liquid level of the sample extraction buffer, twisted several times and pressed 3 times, the swab soaking time is at least 15 seconds.
The sampling tube is squeezed while the swab is removed
The collection tube is then sealed with the cap. The liquid in the tube is the post-treatment sample
3. Sample storage: The treated sample should be tested within 1 hour.
TEST PROCEDURE
Place the test cassette and sample extraction buffer at room temperature for 15~30 minutes and bring to room temperature (10~30℃).
Open the aluminum foil pouch of the test cassette and place the test cassette on a flat surface.
Add 4 drops of treated sample to the sample well of the test cassette (For chromatographic abnormalities, add an additional 1 to 2 drops of treated sample). Incubate at 10~30°C for 15 minutes.
Observe results after incubation at 10 to 30°C for 15 minutes. The result obtained after 30 minutes is invalid.
DISCARD SAMPLE AND CLEAN UP
Place the test cassette, specimen extraction buffer and disposable viral swab swab into the biohazard specimen bag and seal the bag.
Discard the remaining components of the sample kit.
Reapply hand sanitizer.
INTERPRETATION OF THE RESULT
Positive:
Two color bands show up in the observation window, i.e. a red or magenta line appears at the position of the quality control line (C line) and the detection line (T line) (as shown in result 1), indicating that the test result of SARS-CoV -2 antibody in the sample is positive.
Negative:
A red or magenta line appears at the position of the quality control line (C line) in the observation window and no line appears at the position of the test line (T line) (as shown in Result 2), indicating that the test results of the SARS CoV-2 antibodies in the sample are negative or the concentration is below the detection limit of the set.
Invalid:
No line appears at the position of the quality control line (Line C) in the observation window (as shown in Result 3), indicating the test is invalid and the sample should be collected and retested again.