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1. INTENDED USE
One Step Test for SARS-CoV-2 Antigen (Colloidal Gold) is for the qualitative detection of SARS-CoV-2 antigen in human nasal swab specimens. This test is used in individuals with suspected COVID-19 within the first seven days of onset of symptoms such as headache, fever, cough, sore throat, loss of sense of smell or taste, shortness of breath, muscle pain. At the same time, the test is also applicable to people without symptoms. The results are used to identify the SARS-CoV-2 antigen. A positive result indicates the presence of SARS-CoV-2 antigen, but personal history and other diagnostic information are required to determine the status of infection. Negative results do not rule out SARS-CoV-2 infection. A negative result for individuals with symptoms similar to COVID-19 infection for more than 7 days may be considered negative. If necessary, this should be confirmed by molecular assay. One-step test for SARS-CoV-2 antigen (colloidal gold) should be used to diagnose SARS-CoV-2 infection. This test is for self-testing.
2. PACKING INFORMATION
3. SPECIMEN COLLECTION
4. TEST PROCEDURE
Step 1: Remove the cap from the extraction tube containing the sample extraction solution and place it in the packaging.
Step 2: Open the swab pack. Carefully insert the tip of the swab into one nostril. Do not insert the swab deeper than 1.5 cm into your nose.
Step 3: Rotatethe swab around the inner wall of your nostril at least four times. Repeat the same procedure with the same swab in the other nostril.
Step 4: After sampling, insert the swab into the extraction tube and rotate the swab 10 times in the solution.
Step 5: Press the swab tip 3 times along the inner wall of theextraction tube.
Step 6: Press the tip into the extraction tube, ensuring a tight fit. Gently press down on the extraction tube and dispense2 to 3 drops of solution into the sample well(s).
Step 7: Read the result visually in 10 to 15 minutes, do notread the results after20 minutes.
Step 8: Placetheentire contents of the test kit used in the Biohazard sample bag provided and dispose of it in the household waste. If necessary, dispose of all used tests according to local regulations. Wash hands thoroughly after disposal.
5. TEST RESULTS
Positive (+):
Two lines appear, one in the control region (C) and the other in the test region (T). The result indicates the presence of SARS-CoV-2 antigen.Any faint line in the test line area (T) should be considered positive.
Note:Positive results indicate very likely infected COVID-19. Contact your physician or local health department immediately.
Follow local guidelines for self-isolation andconfirmedbymolecular testing method.
Negative (-):
A single line appears in the control region (C) and no other lineappears in the test region (T). The result indicates that no SARS-CoV-2 antigen has been detected.
Note:Negative results indicate the unlikely infected COVID-19. Continue to follow all applicable rules and protective measures when contacting others. Even if the test is negative, infectionmay be present. If suspected, repeattest after 1 - 2 days orconfirmby molecular testing method.
Invalid:
Ifno line is displayed in the control area (C), the test result is invalid. Insufficient sample volume or incorrect operation are the likelyreasons for an invalid result. Readthe instructions again and test with a new test. If the same situation occurs again, please discontinue use of that lot of product and contact your physician or a COVID-19 testing center.
6. STORAGE AND STABILITY
Store the test kit at 4-30℃ with a validity period of 24 months. Use the test card within 1 hour after opening the foil pouch.
7. PRECAUTIONS
One Step Test for SARS-CoV-2 Antigen (Colloidal Gold) is for the qualitative detection of SARS-CoV-2 antigen in human nasal swab specimens. This test is used in individuals with suspected COVID-19 within the first seven days of onset of symptoms such as headache, fever, cough, sore throat, loss of sense of smell or taste, shortness of breath, muscle pain. At the same time, the test is also applicable to people without symptoms. The results are used to identify the SARS-CoV-2 antigen. A positive result indicates the presence of SARS-CoV-2 antigen, but personal history and other diagnostic information are required to determine the status of infection. Negative results do not rule out SARS-CoV-2 infection. A negative result for individuals with symptoms similar to COVID-19 infection for more than 7 days may be considered negative. If necessary, this should be confirmed by molecular assay. One-step test for SARS-CoV-2 antigen (colloidal gold) should be used to diagnose SARS-CoV-2 infection. This test is for self-testing.
2. PACKING INFORMATION
3. SPECIMEN COLLECTION
4. TEST PROCEDURE
Step 1: Remove the cap from the extraction tube containing the sample extraction solution and place it in the packaging.
Step 2: Open the swab pack. Carefully insert the tip of the swab into one nostril. Do not insert the swab deeper than 1.5 cm into your nose.
Step 3: Rotatethe swab around the inner wall of your nostril at least four times. Repeat the same procedure with the same swab in the other nostril.
Step 4: After sampling, insert the swab into the extraction tube and rotate the swab 10 times in the solution.
Step 5: Press the swab tip 3 times along the inner wall of theextraction tube.
Step 6: Press the tip into the extraction tube, ensuring a tight fit. Gently press down on the extraction tube and dispense2 to 3 drops of solution into the sample well(s).
Step 7: Read the result visually in 10 to 15 minutes, do notread the results after20 minutes.
Step 8: Placetheentire contents of the test kit used in the Biohazard sample bag provided and dispose of it in the household waste. If necessary, dispose of all used tests according to local regulations. Wash hands thoroughly after disposal.
5. TEST RESULTS
Positive (+):
Two lines appear, one in the control region (C) and the other in the test region (T). The result indicates the presence of SARS-CoV-2 antigen.Any faint line in the test line area (T) should be considered positive.
Note:Positive results indicate very likely infected COVID-19. Contact your physician or local health department immediately.
Follow local guidelines for self-isolation andconfirmedbymolecular testing method.
Negative (-):
A single line appears in the control region (C) and no other lineappears in the test region (T). The result indicates that no SARS-CoV-2 antigen has been detected.
Note:Negative results indicate the unlikely infected COVID-19. Continue to follow all applicable rules and protective measures when contacting others. Even if the test is negative, infectionmay be present. If suspected, repeattest after 1 - 2 days orconfirmby molecular testing method.
Invalid:
Ifno line is displayed in the control area (C), the test result is invalid. Insufficient sample volume or incorrect operation are the likelyreasons for an invalid result. Readthe instructions again and test with a new test. If the same situation occurs again, please discontinue use of that lot of product and contact your physician or a COVID-19 testing center.
6. STORAGE AND STABILITY
Store the test kit at 4-30℃ with a validity period of 24 months. Use the test card within 1 hour after opening the foil pouch.
7. PRECAUTIONS
- Always keep out of the reach of children. Small parts of the kit may pose a choking hazard.
- The sample extraction solution is a phosphate buffer containing a small concentration of sodium chloride, Tween, hexadecyltrimethylammoni- umbromide and sodium azide. If extraction solution splashes on your body or in your eyes, please wash with water.
8. CERTIFICATE
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