Description
SARS-CoV-2 Rapid Antigen Test Kit.
The rapid testing of the SARS-CoV-2 gene serves to qualitatively detect the N antigen of the novel coronavirus in the human anterior nostril. The kit is suitable for adults over 18 years old, minors under 18 require sampling from caretakers. Seniors and those who cannot operate independently must complete the test with guidance or professional assistance.

How to use
Allow the test device, sample, sponge to balance at ambient temperature (15-30 °C) before testing and use it as soon as possible.
1. Wash hands before starting the test.
2. Check all components for possible damage and all materials provided for the finite. Put all the materials provided to a clean, dry and flat surface.
3. Pinch the top of the test tube and shake it several times to drop the pad completely to the bottom of the test tube. Remove the aluminum foil seal from the extraction tube containing the buffer solution. (* Note: move away from the face).
4. Insert the extraction tube into the circular hole of the card holder.
5. Remove the test kit from the sealed sheet bag and place it to the clean, level surface.
6. Please remove the excessive mucous membrane in the nasal cavity before sampling with the swab.
7. Unpack the tampon, take care not to touch the soft end, i.e. the absorbent tip.
8. Gently insert the tampon into the 1-1.5 cm nasal cavity (in general 1cm for children 2-14 years old). Do not insert too much, avoid damage to your nostril. Slowly turn the tampon into the inner walls of the nostril 5 times or more to collect more nasal secretions. Repeat steps in the other nostril using the same stampon.
9. Insert the swab into the extraction tube with sponge, take the test tube from the card holder, and then turn the swab for 10-15 minutes to mix the collected sample with the sponge as much as possible.
10. Pull the breaking position of the tampon near the mouth of the extraction tube, pinch the swab head one hand on the outer wall of the extraction tube, and bend the swab to gently break it with the other hand.
11. Close the lid of the extraction tube and press it firmly.
12. Vertical add 2 drops of treated sample into the test box sample well. And start the stopwatch.
13. Read the result 15-20 minutes after adding the sample. The result decays after 20 minutes.
14. All used test components are put in the Biosafety bag, sealed and discarded. (According to the local garbage classifying standards)
* Note: After all steps are finished, wash hands with disinfectant.
POSITIVE: C and T bands are present, the test result is positive. The fuchsia test line would vary in nuance and intensity as a function of the antigen concentration detected. A bright or weak test line is also interpreted as a positive result.
NEGATIVE: The test result is negative if it has only the C band. Positive result means that SARS-CoV-2 antigen is detected in the sample, and SARS-CoV-2 infection is suspected, and the local epidemic control and prevention policy is followed for signaling and isolation, and corresponding medical care is required; Negative result means that no SARS-CoV-2 antigen is detected in the sample. However, a negative result cannot fully exclude the possibility of infection, and further inspections are carried out in accordance with the requirements of local policies on epidemic prevention and control when necessary.
Invalid result means that the test has failed, or the test kit is invalid. Incorrect sample volume or incorrect procedural techniques are the most possible reasons for the failure of control line. Carefully re-read the instructions on use and repeat the test with a new test device. If the problem persists, stop using the test device immediately and contact the local distributor immediately.

Warnings
-Only for qualitative diagnosis in vitro, carefully read the instructions before the test.
-For single use only. Test within the first 7 days of symptoms.
-Use in the valid period and preserved in strict accordance with the instructions.
-Follow the instructions strictly, do not mix different batches of test cassettes, extraction tubes with sponge etc.
-Incorrect test procedure or insufficient sample volume may compromise the test results-Do not use the test box in case of damaged bag or component leakage (such as shortage of desiccant etc.).
-Do not drink the sponge from the test tube with or without a swab, immediately seek medical advice/attention in case of incidental ingestion.
-Drying in the bag, do not take orally.
-Do not touch the test and sample area of the test box directly with your hands.
-Keep out of the reach of children. Children under 18 years old must perform the test with adult driving or professional assistance.
-It is recommended to use the kit within 1 hour after opening (15-30 °C, humidity <60%).
-In case of damage to the test tube or leakage of the solution after the mixture with the swab, dispose of it as medical waste and redo the sampling for retesting.
-The sponge contains a small condom content that would cause skin and eye irritation. If the sponge contacts the skin or eyes, wash/rinse with plenty of water, get medical advice/attention in case of irritation or rash.
-- Pay attention to safety measures during operation, washing or disinfection of hands before and after use.

1. The test kit is a qualitative diagnostic reagent in vitro. The test results merely serve the clinical auxiliary diagnosis and do not act as the sole basis for clinical diagnosis. The diagnosis is determined entirely on the basis of the clinical symptoms and other indicators of the test.
2. The test kit merely serves the qualitative detection of SARS-CoV-2 antigens present in the anterior nasal sample.
3. A positive result only indicates the possible presence of SARS-CoV-2 antigen, but it does not serve as the only standard for judging SARS-CoV-2 infection.
4. A negative result does not completely exclude SARS-CoV-2 infection, both for the viral level too low to detect and for other reasons of the false negative result.
5. Possible causes of the false positives include: (1) use of the samples and contaminated components; (2) other unverified factors that may affect the results.
6. Possible causes of the false negatives include: (1) the viral level in the sample is too low; (2) the genetic mutants of the target antigen location (nucleocapsid protein) to be tested; (3) other unverified factors that may affect outcomes.
7. The method of sampling and processing exerts a great influence on viral detection, and improper operation could lead to erroneous results.

storage
The product is stored in a dry place protected from direct sun at 2-30 °C. Do not use the expired product.
-The test cassette and sample sponge come as soon as possible within 1 hour of opening.
Validity with intact packaging: 24 months.

Format
Kit containing:
-1 test box;
-1 sterilized swab;
-1 extraction tube with sponge;
-1 biosafety bag;
-1 instruction manual;
-1 card holder.