Covid-19 Rapid Antigen Test

Rapid test for the qualitative detection of Protein antigens SARS-CoV-2 nucleocapsid present in nasal swab specimens.
For in vitro self-testing use only.
Single-use test kit intended to detect SARS-CoV-2 that causes COVID-19 in self-collected nasal swab samples.

The test is intended for use in symptomatic subjects who meet the case definition for COVID-19 as well as in asymptomatic subjects, limited to contacts of confirmed or probable cases of COVID-19 and to healthcare workers at risk.

Positive results indicate the presence of viral antigens, but clinical correlation with patient history and other diagnostic information is required to determine infection status .
Positive results are indicative of the presence of SARS-CoV-2.
Individuals who test positive should self-isolate and seek further care from their healthcare provider. Positive results do not exclude bacterial infection or coinfection with other viruses. Negative results do not rule out SARS-CoV-2 infection.
Individuals who test negative and continue to experience COVID-like symptoms should contact their healthcare provider.

How to use
Wash your hands with soap and water for at least 20 seconds before and after the test. If soap and water are not available, use a hand sanitizer with at least 60% alcohol. Remove the lid of the tube with the extraction swab and place the tube in the tube holder in the box.
Collecting the nasal swab sample
1. Remove the sterile swab from the pouch.
2. Insert the swab into the nostril until you feel a slight resistance (about 2 cm up the nose). Slowly rotate the swab, rubbing it along the inside of the nostril 5-10 times against the nasal wall.
Note
This can be annoying. Do not insert the swab deeper if you feel strong resistance or pain. When the nasal mucosa is damaged or bleeding, nasal swab collection is not recommended. If you are collecting swabs from others, please wear a face mask. With children, it may not be necessary to insert the swab as far into the nostril. For very young children, another person may need to hold the child's head still while taking the swab.
3. Gently remove the swab.
4. Using the same swab, repeat the step 2 in the other nostril.
5. Withdraw the swab.
Sample preparation
1. Place the swab into the extraction tube, make sure it touches the bottom and shake the swab to mix it well . Press the swab head against the tube and rotate the swab for 10-15 seconds. 2. Remove the swab by pressing the swab head against the inside of the extraction tube. Place the swab in the biosafety bag. 3. Close the cap or insert the tube tip onto the tube.
Test
1. Remove the test cassette from the sealed foil pouch and use it within one hour. The best results are obtained if the test is performed immediately after opening the foil pouch. Place the test cassette on a flat surface. 2. Invert the sample extraction tube and add 3 drops of the extracted sample to the well (S) of the test cassette and start the timer. Do not move the test cassette during test development. 3. Read the result at 15 minutes. Do not read the result after 20 minutes.
Note: At the end of the test, place all components in the biosafety plastic bag and dispose of according to local regulations.
Reading the results
Positive: * two colored lines appear. A colored line should appear in the control region (C) and another colored line should appear in the test region (T).
*Note: The intensity of the color in the test line region (T) varies depending on depending on the number of SARS-CoV-2 antigens present in the sample. Therefore the presence of any shade of color in the test region (T) must be interpreted as a positive result.
A positive result means that it is very likely that the person is infected with COVID-19, positive samples must be confirmed. Immediately self-isolate as required by local regulations and contact your doctor or health care district as instructed by local authorities. The test will be verified by a confirmatory molecular test (PCR) and instructions on the following steps will be provided.
Negative: Only one colored line appears in the control region (C) No colored lines appear in the test line region (T). It is unlikely that you have COVID-19. However, it is possible for this test to give an incorrect result (a false negative) in some people with COVID-19. This means that you may have contracted COVID-19 even if the test gave a negative result.
Also, you can repeat the test with a new kit.
If you suspect, repeat the test later 1-2 days, since the coronavirus cannot be determined at all stages of infection. Even with a negative result, the rules of distancing and hygiene must continue to be observed.
Invalid: the control line does not appear.
An insufficient volume of sample or incorrect procedural techniques are the most probable causes of the lack of control line. Review the procedure and repeat the test with a new kit or contact your doctor or a COVID-19 diagnosis center.

Warnings
For self-test only for in vitro self-diagnostic use. Do not use after the expiration date.
Do not eat, drink or smoke in the area where you handle specimens or kits.
Do not drink the swab liquid contained in the kit. Handle the swab with care and avoid it coming into contact with the skin or eyes, rinse immediately with plenty of running water in case of contact.
Store in a dry place at 2-30° C (36-86° F ), avoiding areas of excessive humidity. Please do not use if the foil pouch is damaged or has been opened.
This test kit should be used as a preliminary test only and repeatedly abnormal results should be discussed with a doctor or medical professional.
Strictly follow the indicated time.
Use the test only once. Do not disassemble and touch the test window of the test cassette.
The kit should not be frozen or used after the expiration date printed on the package.
Testing for children should be under the guidance of a adult.
Wash hands thoroughly before and after handling.
Please ensure that an adequate quantity of specimens is used for testing. Too much or too little sample may lead to biased results.

Limitations
- Performance was evaluated with nasal swab specimens only, using the procedures provided in this information leaflet.
- The Rapid Antigen Detection Test (Nasal Swab) for SARS-CoV-2 will only indicate the presence of SARS-CoV-2 antigens in the sample.
- If the test result is negative or non-reactive and the clinical symptoms persist, it is because the virus of very early infection may not be detected, it is recommended to retest with a new kit or test with a molecular diagnostic device to exclude infection in these individuals .
- Negative results do not exclude SARS-CoV-2 infection, particularly in those who have been in contact with the virus. Follow-up testing with molecular diagnostics should be considered to rule out infection in these individuals.
- Positive COVID-19 results may be due to infection with non-SARS-CoV-2 coronavirus strains or other interfering factors.
- Failure to follow these procedures may alter test performance.
- False negative results may occur if a specimen is collected or handled improperly.
- False negative results may occur if insufficient levels of virus are present in the specimen.

Storage
Store as packaged in the sealed pouch at room temperature or refrigerated (2-30 ° C).
The test is stable until the expiration date printed on the sealed pouch.
The test must remain in the sealed pouch until used. Do not freeze. Do not use beyond the expiry date.