CoV-19 Antigen Rapid Test All Test 1 Test

CoV-19 All Test Antigen Rapid Test - Medical Device

Rapid test for the qualitative detection of SARS-CoV-2 Nucleocapsid Protein antigens present in nasal swab samples. For in vitro self-diagnostic use only.
Disposable test kit intended to detect SARS-CoV-2 which causes COVID-19 in self-collected nasal swab specimens. The test is intended for use in symptomatic individuals who meet the case definition for COVID-19 as well as in asymptomatic individuals, limited to contacts of confirmed or probable cases of COVID-19 and healthcare professionals at risk. Positive results indicate the presence of viral antigens, but clinical correlation with patient history and other diagnostic information is required to determine the status of the infection. 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 rule out 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 buffer and place the tube in the tube holder in the box.
Nasal Swab Sample Collection

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 tampon deeper if you feel severe 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 that deeply into the nostril. For very young children, another person may be required to hold the child's head still while the swab is taken.
3. Gently remove the swab.
4. Using the same swab, repeat 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 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 biosecurity bag. 3. Close the cap or insert the tip of the tube 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: After testing is complete, place all components in the plastic biosafety bag and dispose of according to local regulations.
Reading the results
Positive: * two colored lines appear. One 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 the number of SARS-CoV-2 antigens present in the sample. Therefore the presence of any shade of color in the test region (T) should 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 prescribed by local regulations and contact your treating physician 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 line appears in the test line region (T). COVID-19 is unlikely. 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 COVID-19 even if the test gave a negative result.
Also, you can repeat the test with a new kit.
If suspected, repeat the test after 1-2 days, as the coronavirus cannot be determined at all stages of the infection. Even with a negative result, the rules of spacing and hygiene must continue to be observed.
Invalid: The control line does not appear.
Insufficient sample volume or incorrect procedure techniques are the most likely causes of missing 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-testing for in vitro self-diagnostic use only. Do not use after the expiration date.
Do not eat, drink or smoke in the area where specimens or kits are handled.
Do not drink the buffer liquid contained in the kit. Handle the swab with care and avoid 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 areas of excessive humidity. Please do not use if the foil package is damaged or has been opened.
This test kit is to be used as a preliminary test only and repeatedly abnormal results should be discussed with a physician or medical professional.
Strictly follow the indicated time.
Use the test only once. Do not disassemble and touch the test cassette window.
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 an adult.
Wash hands thoroughly before and after handling.
Please ensure that an adequate amount of samples are used for testing. Too much or too little sample can lead to deviation of the results.

Limitations

• Performance has been evaluated with nasal swab specimens only, using the procedures provided in this package insert.
• The Antigen Rapid 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 very early infection virus may not be detected, it is recommended to re-test with a new kit or test with a molecular diagnostic device to rule out 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 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 can impair test performance.
• False negative results can occur if a sample is improperly collected or handled.
• False negative results can occur if there are insufficient levels of virus in the sample.

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 use. Do not freeze. Do not use beyond the expiration date.
Validity intact packaging: 24 months.

Format

The package contains:

Test Cassette; leaflet; sterile swab; extraction buffer; biosecurity bag.