For the qualitative in vitro determination of SARS-CoV-2 antigen in human anterior nasal samples
The set is used for the qualitative in vitro determination of SARS-CoV-2 antigen in human anterior nasal samples. It serves as a rapid examination in suspected cases of novel coronavirus, but can also be used as a confirmation method for the detection of nucleic acids 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 layperson's home use outside of the laboratory (such as a person's home or certain non-traditional locations such as offices, sporting events, airports, schools, etc.)
1. SARS-CoV-2 antigen test cassette
2. Sample extraction buffer
3. Disposable virus specimen swab
4. Trash bags for contaminated waste
Note: Components from different batches cannot be mixed.
1. Sample collection:
- Gently insert the entire soft tip of the swab into one nostril about 1.5 cm until you feel some resistance.
- Using medium pressure, slowly rub the swab in a circular motion around the inner wall of your nose 4 times for a total of 15 seconds.
- Repeat the same process with the same swab in the other nostril.
2. Sample handling
- After the sample has been taken, the smear is soaked below the liquid level of the sample extraction buffer, rotated several times and pressed 3 times, the soaking time of the smear is at least 15 seconds.
- The sampling tube is compressed while the swab is removed
- The collection tube is then closed with the cap. The liquid in the tube is the sample after the treatment
3. Sample storage: The treated sample should be tested within 1 hour.
- Insert the test cassette and sample extraction buffer for 15 ~ 30 minutes at room temperature and bring to room temperature (10 ~ 30)..
- Open the aluminum foil pouch of the test device and place the test device on a flat surface.
- Put 4 drops of the treated sample into the sample hole of the test cassette (in the case of chromatographic anomalies, add an additional 1 to 2 drops of the treated sample). Incubate for 15 minutes at 10 ~ 30C..
- Observe results after incubation at 10 to 30 C for 15 minutes. The result obtained after 30 minutes is invalid..
DISCARD THE SAMPLE AND CLEAN UP
- Place the test cassette, sample extraction buffer, and disposable virus specimen swab in the biohazard sample bag and seal the bag.
- Discard the remaining components of the sample kit.
- Reapply hand sanitizer.
INTERPRETATION OF THE RESULT
Two colored 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), which indicates that the test result of the SARS-CoV -2 antibody in the sample is positive.
A red or magenta line appears at the quality control line (C line) position in the observation window, and no line appears at the test line (T line) position (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.
No line appears at the position of the quality control line (line C) in the observation window (as shown in Result 3), indicating that the test is invalid and the sample should be recollected and retested.
Delivery time: 1-3 working days depending on volume and delivery address
Approval for self-application from the BfArm - TEST ID:5640-S-080/21