Egens Rapid Antigen Test Covid-19

Covid-19 Rapid Antigen Test
The SARS-CoV-2 Rapid Antigen Test Kit is the lateral flow immunochromatographic test. It can qualitatively detect novel coronavirus antigen in human nasal swab samples. Add the sample to be tested into the well of the test cassette, if the sample contains the SARS-CoV-2 antigen, the viral antibody will be bound to the colloidal gold-labeled antibody to form a colloidal gold-labeled antibody complex. 'viral antigen'. The complex moves forward along the test cassette under capillary action and combines the antibody coated in the test area to form a red band (T line), indicating a positive result; if the sample does not contain SARS-CoV-2 antigen or the content is less than the detectable range, the T line is colorless.
Regardless of whether the sample contains SARS-CoV-2 antigens, the Mouse IgG labeled with colloidal gold will be bound to the sheep anti-mouse IgG coated on the control line, forming a red band (line C). Detection will fail if the C line does not appear.

How to use
Allow the test device, sample and sponge to equilibrate to room temperature (15 -30 °C) before the test and use it as soon as possible.
1. Wash your hands before starting the test.
2. Check all components for possible damage and all materials provided for the test. 'integrity. Place all supplied materials on a clean, flat surface. 3. Pinch the top of the extraction tube and shake it several times to completely drop the swab to the bottom of the tube. Remove the foil seal from the extraction tube containing the buffer solution.
Note: Move it 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 foil pouch and place it on the clean, level surface.
6. Remove excess mucosa in the nasal cavity before sampling with the swab.
7. Unpack the swab, take care not to touch the soft end, i.e. the absorbent tip.
8. Gently insert the swab into the nasal cavity by 1-1.5 cm (generally 1 cm for children aged 2-14 years).< br />Do not insert too much, to avoid damage to the nostril. Slowly roll the swab into the inner walls of the nostril 5 times or more to collect more nasal secretions. Repeat the steps in the other nostril using the same swab.
9. Insert the swab into the sponge extraction tube, gently take the tube from the paper holder, and then rotate the swab for 10-15 minutes to mix the sample collected with the sponge as much as possible.
10. Pull the break position of the swab close to the mouth of the extraction tube, pinch the swab head with 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. Add 2 drops of processed sample vertically into the sample well of the test cassette . 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 placed in the Biosafety bag, sealed and discarded.
Note: After completing all steps, wash your hands with disinfectant.< /p>

Interpretation of results
POSITIVE
The C and T bands are present, the test result is positive. The fuchsia test line would vary in shade and intensity depending on the antigen concentration detected. Even a bright or weak test line is interpreted as a positive result.
NEGATIVE
The test result is negative if only the C band is present. Positive result means that the SARS-CoV-2 antigen is detected in the sample, and SARS-CoV-2 infection is suspected, and the local epidemic prevention and control policy is followed for reporting 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 control line failure. Please re-read the instructions for use carefully and repeat the test with a new device. If the problem persists, immediately stop using the test device and contact your local distributor immediately.

Limitations
1. The test kit is a diagnostic reagent qualitative in vitro. The test results serve merely as an auxiliary clinical diagnosis and do not serve as the sole basis for the clinical diagnosis. The diagnosis is determined entirely based on 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 indicates only the possible presence of SARS-CoV-2 antigen, but does not serve as the sole standard for judging SARS-CoV-2 infection.
4. A negative result does not completely exclude l 'SARS-CoV-2 infection, either due to the viral level being too low to detect or other reasons for the false negative result.
5. Possible causes of false positives include: 
a. use of contaminated samples and components;
b. other unverified factors that may affect results.
6. Possible causes of false negatives include: 
a. the viral level in the sample is too low;
b. the genetic mutants of the target antigen locus (nucleocapsid protein) to be tested;
c. other unverified factors that may affect the results.
7. The sampling and processing method exerts a great influence on viral detection, and the improper operation may lead to the erroneous results.

Warnings
- For qualitative in vitro diagnosis only, read the instructions carefully before testing.
- For single use only. Test within the first 7 days of symptoms.
- Use within the valid period and stored in strict accordance with the instructions.
- Strictly follow the instructions, 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 cassette in case of damaged bag or loss of components (such as shortage of desiccant etc.).
- Do not drink the sponge from the test tube with or without swab, seek immediate medical advice/attention in case of accidental ingestion.
- Desiccant in the bag, do not take orally.
- Do not directly touch the test and sample area of the test cassette with your hands.
- Keep out of reach of children. Children under 18 years of age should perform the test with adult guidance 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 tube or leakage of the solution after mixing with the swab, dispose of it as medical waste and repeat the sampling for the new test.
- The sponge contains a small condom content which would cause skin and eye irritation. If the sponge comes into contact with skin or eyes, wash/rinse with plenty of water, obtain medical advice/attention in case of skin irritation or rash.
- Pay attention to safety measures when operation, washing or disinfection of hands before and after use.

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

Format
1 test cassette, 1 sterilized swab, 1 extraction tube with sponge, 1 biosafety bag, 1 instruction manual, 1 card holder.