CLUNGENE 99802-25 is a rapid antigen test that detects the nucleocapsid protein of SARS-CoV-2 in nasal swabs from individuals 7 years or older with or without symptoms. It provides preliminary test results in 15 minutes to help you and your healthcare provider make informed decisions about your care. The test is intended for self-testing and can be used at home or in other non-laboratory settings. It is not intended to be used as the sole basis for diagnosis or to rule out COVID-19 infection.
CLUNGENE 99802-25 is a rapid antigen test that detects the nucleocapsid protein of SARS-CoV-2 in nasal swabs from individuals 7 years or older with or without symptoms. It provides preliminary test results in 15 minutes to help you and your healthcare provider make informed decisions about your care. The test is intended for self-testing and can be used at home or in other non-laboratory settings. It is not intended to be used as the sole basis for diagnosis or to rule out COVID-19 infection.
Frequently Asked Questions
CLUNGENE COVID-19 Antigen Rapid Test (For self-testing)
CLUNGENE COVID-19 Antigen Rapid Test (For self-testing)
Frequently asked questions (FAQ)
1. Intended use
2. When to use the test kit?
The COVID-19 Antigen Rapid Test is a lateral flow immunoassay intended for the qualitative
detection SARS-CoV-2 nucleocapsid antigens in nasal swab from individuals aged 7 years or
older.
Children aged 7-14 years should be tested by an adult (18+ years old). Individuals over 65
years of age should seek assistance in performing test.
The test provides only a preliminary screen test result. The result can help you and your
healthcare provider make informed recommendations about your care. The results of this test
may help limit the spread of COVID-19 to your family and others in your community.
Individuals who test negative and continue to experience COVID-like symptoms should seek
follow up care from your healthcare provider.
It is important you work with your healthcare provider to help you understand the next steps you
should take.
Use this test:
✓ If you have COVID-like symptoms including headache, fever, a cough, sore throat, loss of
sense of smell or taste, shortness of breath, etc.
✓ If you are concerned that you have been exposed to COVID-19.
Do not use this test:
X On anyone under 7 years of age;
X If you are prone to nosebleeds.
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CLUNGENE COVID-19 Antigen Rapid Test (For self-testing)
Frequently asked questions (FAQ)
3. What are the precautions when using the kit?
•For in vitro diagnostic use only.
•Do not use this test as the only guide to manage your illness. Please consult a healthcare
professional if your symptoms are persisting or worsening, or if you are concerned at any
time.
•Keep out of reach of children. Small kit parts may be a choking hazard.
•Do not use this product after the expiration date.
•Only use the test components provided. Do not replace the Extraction Reagent with any
other fluid.
•Do not perform the test in direct sunlight.
•Avoid contact with Extraction Reagent.
•This test involves taking a sample from deep inside your nose. When doing the test, pay
particular attention to the instructions on how to swab your nose. Incorrect swabbing may
lead to an inaccurate test result. This is particularly important if you do not have symptoms.
•The test cassette should remain in the sealed pouch until use.
•All specimens should be considered potentially hazardous and handled in the same manner
as an infectious agent
•The used test cassette should be discarded according to federal, state and local regulations.
Collect parts of the kit and swab specimens in a plastic bag and dispose of them with
household waste.
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CLUNGENE COVID-19 Antigen Rapid Test (For self-testing)
Frequently asked questions (FAQ)
4. What you need to do if you get a positive result?
5. What you need to do if you get a negative result?
6. What you need to do if you get a invalid result?
Consult your healthcare provider or local health department as soon as possible, and follow
local guidelines for self-isolation to avoid spreading the virus to others. A new test with other
test methods, such as molecular testing may be required.
If you have no symptoms, particularly if you live in an area with low numbers of COVID-19
infections and have had no exposure to anyone diagnosed with COVID-19, additional molecular
testing to confirm your result may be required. Please advise the healthcare professional you
have tested positive and have no symptoms. See FAQ 'Can I have a false positive test result?'.
Please consult your healthcare provider if you develop symptoms or symptoms are persisting,
or if you are concerned about your health. You must continue to comply with all applicable
rules regarding contact with others and protective measures.
It is possible for this test to give a negative result that is incorrect (false negative) in some
people with COVID-19. Please see FAQ 'Can I have a false negative test result?'.
You need to retest with a new test cassette or consult your healthcare provider.
7. What to do with used kits?
The used test cassette should be discarded according to federal, state and local regulations.
Collect parts of the kit and swab specimens in a plastic bag and dispose of them with
household waste.
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CLUNGENE COVID-19 Antigen Rapid Test (For self-testing)
Frequently asked questions (FAQ)
8. How does the CLUNGENE COVID-19 Antigen Rapid Test work?
The CLUNGENE COVID-19 Antigen Rapid Test is a type of test called an antigen test. When
you have COVID-19, the SARS-CoV-2 virus (the virus that causes COVID-19) can be present
in your nasal secretions. The CLUNGENE COVID-19 Antigen Rapid Test can detect small
parts of SARS-CoV-2 virus in your nasal secretions. These small parts of the SARS-CoV-2
virus are known as proteins or antigens.
9. Will this test hurt?
No, the nasal swab is not sharp and it should not hurt. Sometimes the swab can feel slightly
uncomfortable or tickly. If you feel pain, please stop the test and seek advice from a
healthcare provider.
10. What are the potential benefits and risks of this test?
Potential risks include:
Possible discomfort during sample collection.
Possible incorrect test results (see Results section).
Potential benefits include:
The results, along with other information, can help your healthcare provider make informed
recommendations about your treatment/care.
The results of this test may help limit the spread of COVID-19 to your family and others in
your community.
11. Is the test reusable?
No. The CLUNGENE COVID-19 Antigen Rapid Test is a single use test and cannot be reused.
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CLUNGENE COVID-19 Antigen Rapid Test (For self-testing)
Frequently asked questions (FAQ)
12. What is the difference between a COVID-19 antigen, molecular, and antibody test?
There are different kinds of tests for COVID-19. Molecular tests (also known as PCR tests)
detect genetic material from the virus. Antigen tests detect proteins from the virus. Antigen tests
are very specific for the virus, but are not as sensitive as molecular tests. This means that a
positive result is highly accurate, but a negative result does not rule out infection. If your test
result is negative, you should discuss with your healthcare provider whether an additional
molecular test would help with your care, and when you should discontinue home isolation.
Another type of test is an antibody test. A COVID-19 antibody test detects antibodies that have
been made by your immune system in response to a previous COVID-19 infection. Antibody
tests are not suitable to diagnose an active COVID-19 infection.
13. How to open the extraction reagent correctly?
14. Can I freeze the device for long-term storage?
Hold the tube at a distance from your face and gently twist the lid. If extraction reagent comes in
contact with your body, please pay attention to the following:
Skin Contact: Wash off with plenty of water, Seek medical attention if necessary.
Eye Contact: Wash with running water, saline or Eye washing liquid, Seek medical attention if
necessary.
Ingestion: Rinse mouth thoroughly with water. Let water be drunk in little sips (dilution effect).
Do NOT induce vomiting. In all cases of doubt, or when symptoms persist, seek medical advice.
Store as packaged in the sealed pouch between 4-30℃, and ensure all test components are at
room temperature(15-30 ℃) before performing the test.
15. Can I collect the specimen and test at a later time?
The specimen should be tested immediately after collection.
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CLUNGENE COVID-19 Antigen Rapid Test (For self-testing)
Frequently asked questions (FAQ)
16. Can I have a false negative test result?
17. Can I have a false positive test result?
It is possible for this test to give a negative result that is incorrect (a false negative result).
This means that you could possibly have COVID-19 even though the test is negative.
The amount of antigen in a sample may decrease as the duration of illness increases. As
days post-symptom onset increase, antigen test results may be more likely to be negative
compared to a molecular SARS-CoV-2 test. You may also test negative at the very beginning
of your infection before you develop symptoms.
Negative results, particularly in people without symptoms of COVID-19, are considered to be
presumptive which means that additional testing with a highly sensitive molecular assay may
be recommended to determine if you have COVID-19. If you develop symptoms, symptoms
persist or become more severe, if you are concerned about your health or if you develop any
of the emergency warning signs then you should seek medical attention immediately. If you
have any doubt about your test result, please discuss with your healthcare provider.
There is a chance that this test can give a positive result that is incorrect (a false positive
result).Anyone who receives a positive test result needs to consult a healthcare professional. If
you have any doubt about your test result, please discuss it with your healthcare provider. Your
healthcare provider will work with you to determine how best to care for you based on your test
result along with your medical history and symptoms.
If you do not have symptoms of COVID-19 and get a positive result, your test results should be
confirmed with a molecular SARS-COV-2 test. Positive results from the CLUNGENE COVID-
19 Antigen Rapid Test are presumptive in asymptomatic patients, particularly if you do not
have a known SARS-CoV-2 exposure and/or live in an area known to have low numbers of
SARS-CoV- 2 infections.
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CLUNGENE COVID-19 Antigen Rapid Test (For self-testing)
Frequently asked questions (FAQ)
18. Correct understanding of test cassette.
Control Region
Test Region
The figure shows the test result l i n e ：
◼“C” region shows control li line
◼“T” region shows test line
◼“S” region is sample well
i. Line C doesn’t appear in the specific time.
Possible reason
Solution
Sample added isn’t enough
Re-test and add sufficient sample size as
required by the instruction
It is possible that water or other liquid splashed
into the Result Window.
Be careful when you test, and keep water or
other liquid away from the sample well.
ii. Sample doesn’t flow or flow slowly.
Sample Well
Possible reason
Solution
Insufficient amount of sample is added
Re-test
Damaged package or invalid reagent
Re-test
Result Window
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CLUNGENE 99802-25 is a rapid antigen test that detects the nucleocapsid protein of SARS-CoV-2 in nasal swabs from individuals 7 years or older with or without symptoms. It provides preliminary test results in 15 minutes to help you and your healthcare provider make informed decisions about your care. The test is intended for self-testing and can be used at home or in other non-laboratory settings. It is not intended to be used as the sole basis for diagnosis or to rule out COVID-19 infection.
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