CLUNGENE 99802-25 COVID-19 Antigen Rapid Test User Guide

99802-25 COVID-19 Antigen Rapid Test
User Guide
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)

– Intended use

– 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 rovider 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.

– When to use the test kit?

– 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:
– On anyone under 7 years of age;
– If you are prone to nosebleeds.

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.

– What you need to do if you get a positive 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?’.

What you need to do if you get a negative 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?’.

– What you need to do if you get a invalid result?

– You need to retest with a new test cassette or consult your healthcare provider.

– 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.

– 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.

– 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.

– 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.

– Is the test reusable?

– No. The CLUNGENE COVID-19 Antigen Rapid Test is a single use test and cannot be reused.

– 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.

– How to open the extraction reagent correctly?

– 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.

– Can I freeze the device for long-term storage?

– 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.

– Can I collect the specimen and test at a later time?

– The specimen should be tested immediately after collection.

– Can I have a false negative 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.

– Can I have a false positive test result?

– 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 COVID19 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.

18. Correct understanding of test cassette.

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  splasheinto 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.

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