Description
Rapid test for the qualitative detection of SARS-CoV-2 Protein Nucleocapside antigens present in nasal swab samples. For in vitro self-diagnostic use only.
Disposable Test Kit intended to detect COVID-19-causing SARS-CoV-2 in self-taken samples on nasal swab. The test is intended for use in symptomatic subjects that 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 health care professionals at risk. Positive results indicate the presence of viral antigens, but a clinical correlation with the patient's history and other diagnostic information is needed to determine the state of the infection. Positive results are indicative of the presence of SARS-CoV-2. Individuals who test positive should self-isolate themselves and seek further treatment from their health care provider. Positive results do not exclude bacterial infection or co-infection with other viruses. Negative results do not exclude infection with SARS-CoV-2. Individuals who test negative and who continue to experience symptoms similar to those of COVID should contact their health care provider.

How to use
Wash 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 tube lid with the extraction pad and place the test tube in the test tube holder in the box.
Collection of nasal swab sample
1. Remove the sterile swab from the envelope.
2. Insert the tampon into the nostril until you feel a slight resistance (about 2 cm up the nose). Rotate the tampon slowly, rubbing it along the inside of the nostril 5-10 times against the nasal wall.
Note
This can be annoying. Do not insert the tampon deeper if you feel strong resistance or pain. When the nasal mucosa is damaged or bleeding, the collection of the nasal swab is not recommended. If you are collecting tampons from others, please wear a face mask. With children, it may not be necessary to insert the tampon so thoroughly into the nostril. For very young children, another person may be needed to hold the baby's head still when picking the tampon.
3. Gently remove the tampon.
4. Using the same tampon, repeat step 2 in the other nostril.
5. Withdraw the tampon.
Sample preparation
1. Put the tampon in the extraction tube, make sure it touches the bottom and shake the tampon to mix well. Press the tampon head against the test tube and rotate the tampon for 10-15 seconds. 2. Remove the tampon by pressing the tampon head against the inside of the extraction tube. Put the tampon in the biosafety bag. 3. Close the cap or insert the tip of the tube on the tube.
Test
1. Remove the test box from the sealed aluminum bag and use it within an hour. The best results are obtained if the test is carried out immediately after opening the aluminum bag. Place the test box on a flat surface. 2. Reverse the sample extraction tube and add 3 drops of the extracted sample to the test box (S) and start the timer. Do not move the test box during test development. 3. Read the result at 15 minutes. Do not read the result after 20 minutes.
Note: After finishing the test, put all the components in the plastic biosafety bag and dispose of according to local regulations.
Reading results
Positive: * Two colored lines appear. A colored line should appear in the control zone (C), and another colored line should appear in the test region (T).
* Note: The color intensity in the test line region (T) varies depending on the number of SARS-CoV-2 antigens present in the sample. Then the presence of any color shade in the test region (T) should be interpreted as a positive result.
A positive result means that the person is very likely to be infected with COVID-19, positive samples must be confirmed. Immediately place yourself in self-isolation as prescribed by local regulations and contact your attending physician or health care district as instructed by local authorities. The test will be verified via a confirmation molecular test (PCR) and instructions will be given on the following steps.
Negative: Only one colored line appears in the control region (C) No colored line appears in the test line region (T). You are unlikely to have COVID-19. However, it is possible that this test will give an incorrect result (a false negative) in some people with COVID-19. This means that you may have contracted the COVID-19 even though the test gave a negative result.
In addition, you can repeat the test with a new kit.
In case of suspicion, repeat the test after 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 procedure techniques are the most likely causes of the lack of the control line. Review the procedure and retest 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 samples or kits are handled.
Do not drink the tampon liquid contained in the kit. Handle the swab carefully and prevent it from coming into contact with 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 excessive moisture areas. Please do not use if the aluminum packaging is damaged or has been opened.
This test kit should only be used as a preliminary test, 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 box window of the test box.
The kit should not be frozen or used after the expiration date printed on the packaging.
The test for children should be under the guidance of an adult.
Wash hands thoroughly before and after manipulation.
Please make sure that a proper amount of samples is used for testing. Too much or too little sample can lead to the deviation of the results.
Limitations
-Performance was evaluated only with nasal swab samples, using the procedures provided in this package insert.
-The Rapid Detection Antigen 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 the very early infection may not be detected, it is recommended that the test be performed again with a new kit or the test with a molecular diagnostic device to exclude infection in these individuals.
-Negative results do not rule out SARS-CoV-2 infection, particularly in those who have been in contact with the virus. Control tests with a molecular diagnostic should be considered to exclude infection in these individuals.
-Positive results from COVID-19 may be due to infection with non-SARS-CoV-2 coronavirus strains or other interference factors.
-- Failure to follow these procedures can alter test performance.
-False negative results may occur if a sample is improperly collected or handled.
-False negative results may occur if insufficient levels of viruses are present in the sample.

storage
Store as packaged in sealed bag at room temperature or chilled (2-30 °C). The test is stable until the expiration date printed on the sealed envelope. The test must remain in the sealed envelope until use. Do not freeze. Do not use beyond the expiration date.
Validity packaging intact: 24 months.

Format
Test box; package leaflet; sterile swab; extraction pad; biosafety bag.

Cod. HAB INCP-502H