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Combo Antigen Testfor influenza A/B + COVID-19/RSVis an immunochromatographic test that allows you to detect the presence of SARS-CoV-2 virus antigens and influenza A and/or B antigens. The test is based on the use of specific monoclonal antibodies contained in the test cassette against antigens characteristic of the detected viruses.
Product characteristics
One of the test areas contains adsorbed monoclonal antibodies directed against SARS-CoV-2 virus nucleocapsid proteins.
After the sample is introduced into the test cassette well, it is migrated to the conjugate zone, which contains colloidal gold conjugated antibodies directed against SARS-CoV-2 antigens. If the test sample contains SARS-CoV-2 virus antigens, an antigen-antibody-conjugate complex is formed. The resulting complex migrates to the test line region of the cassette where it combines with specific antibodies to form a visible, colored line. The presence of a colored line in the area of the control line of the test indicates a properly conducted test.
The second test area contains adsorbed specific antibodies against influenza type A and B antigens. During the test, the sample with the test material undergoes an immunochemical reaction with specific antibodies, leading to the formation of an immunocomplex. The resulting complex migrates to the test line region of the cassette where it combines with specific antibodies to form a visible, colored line. The presence of a colored line in the area of the control line of the test indicates a properly conducted test.
Usage
This test is for home, over-the-counter, self-collected nasal swab samples from individuals 14 years of age and older with symptoms of influenza A/B and RSV/COVID-19 within the first 7 days of symptom onset. The test is also intended for use with nasal samples from individuals 2 years of age and older with symptoms of influenza A/B and RSV/COVID-19 within the first 7 days of symptom onset. This test is for over-the-counter home use, with self-collected nasal swab samples from individuals 14 years of age and older, or nasal samples from individuals 2 years of age and older with or without symptoms or for other epidemiological reasons, to suspect influenza A/B and RSV/COVID-19. People without COVID-19 symptoms and/or people who live in areas with low COVID-19 infection rates and no known exposure to COVID-19 may experience more false positives. Testing of asymptomatic individuals should be limited to contacts of confirmed or probable cases or other epidemiological reasons to suspect COVID-19 infection, followed by additional confirmatory testing by molecular testing.
Sample preparation
1. Preparation before the test
Wash or sanitize your hands, then dry them completely.
2. Sampling and processing
- ATTENTION:Collected swab samples should be processed and tested immediately.
- ATTENTION:Wear a face mask when taking swabs from other people. For children, it may not be necessary to insert the swab as deep into the nostril. For very young children, a second person may be needed to support the child's head while erasing.
- ATTENTION:Improper smearing may result in false-negative results.
- ATTENTION:Wash your hands before and after the test.
- ATTENTION:Do not touch the tip (sample site) of the swab.
- Remove the foil from the top of the sample collection tube.
- Place the tube in the tube rack or in the back of the box
- Remove the sampling swab from the bag.
- Using the sterile swab included in the kit, carefully insert the swab into one nostril.
- The swab tip should be inserted 2-4 cm until resistance is met. Rotate the swab 5 times in a circular motion around the inner wall to ensure that both mucus and cells are collected. Using the same swab, repeat this step in the other nostril to ensure that you have collected an adequate sample from both nasal cavities.
- Pull the swab out of the nasal cavity.
- The sample is now ready for preparation using the extraction buffer included in the test kit. Insert the swab into the sampling tube all the way to the bottom, turn and squeeze the swab 10 times, pressing the tip of the swab to the bottom and side of the tube.
- Leave the swab in the tube for 1 minute.
- Turn and squeeze the tube a few times with your fingers from the outside to dip the swab into it. Remove the swab.
- Place the tip of the dropper firmly on the test tube. Mix thoroughly by swirling or flicking the bottom of the tube.
Attention:
- A swab should be used to collect the sample.
- It is recommended to collect samples with protective gloves to avoid contamination.
- The sample should be collected as soon as possible after the onset of symptoms.
- It is recommended to treat the sample immediately after taking it.
test procedure
Please read the manual before testing. Allow the test in the pouch to come to room temperature before testing. Do not open the pouch until the test is started.
- Remove the test from the sealed pouch. Put it on a flat, clean and dry surface.
- Invert the sample collection tube and add 3 drops of test sample by squeezing out the collection tube into each opening of the test cassette.
- Read the results after 15 minutes.
Attention:
The test cassette should not be moved or lifted during the test to avoid inaccurate results. The test is designed to be read after 15 minutes. If the test is read before 10 minutes or after 30 minutes, the results may be inaccurate (false negative, false positive, or invalid) and the test should be repeated. Collect all used packaging components and place them in a waste bag: including swab, test cassette, and diluent bottle. Dispose of the waste bag according to local regulations.
Interpretation of results:
Influenza A/B antigen test
1. POSITIVE:
Influenza A positive:
The presence of two lines as a control line (C) and a T1 test line in the result window indicates a positive result for influenza A virus antigen.
Influenza B positive:
The presence of two lines as the control line (C) and the T2 test line in the result window indicates a positive result for influenza B virus antigen.
Influenza A+B positive:
The presence of three lines as control line (C), test line T1 and test line T2 in the result window indicates a positive result for influenza A and influenza B virus antigen.
2. NEGATIVE:
The presence of only the control band (C) in the result window indicates a negative result. If the control band (C) is not visible in the result window after the test is run, the result is considered invalid. Some reasons for invalid results are not following the instructions correctly or the quality of the test has deteriorated after the expiration date. It is recommended that the sample be retested with a new test.
For the COVID-19/RSV antigen test
1. POSITIVE:
RSV additional:
The presence of two lines as a control line (C) and a T1 test line in the result window indicates a positive result for RSV viral antigen.
COVID-19 Positive:
The presence of two lines as the control line (C) and the T2 test line in the result window indicates a positive result for the COVID-19 viral antigen. If a COVID-19 test is positive, users should not make any medically significant decisions without first consulting their physician.
COVID-19+RSV Additional:
The presence of three lines as the control line (C), the T1 test line and the T2 test line in the result window indicates a positive result for RSV and COVID-19 viral antigen.
2. NEGATIVE:
The presence of only the control band (C) in the result window indicates a negative result. If the control band (C) is not visible in the result window after the test is run, the result is considered invalid. Some reasons for invalid results are not following the instructions correctly or the quality of the test has deteriorated after the expiration date. It is recommended that the sample be retested with a new test.
Attention:
- Regardless of whether the test result is positive or negative, used test cassettes, swabs, and tubes should be placed in a waste bag and disposed of according to local regulations.
- If you test positive (regardless of which pathogen tested positive), you are likely infected with influenza A/B, RSV or COVID-19. In the event of a positive result, appropriate precautions should be taken and the assistance of a healthcare professional should be sought in time.
- If you test negative, it means you are not infected with influenza A/B, RSV or COVID-19. However, there is a possibility that the result is false negative. If your test is negative but you still have symptoms, or if you have been in contact with someone who is suspected of being infected, you must repeat the test after at least 24 hours and no more than 48 hours, use PCR reagents or go to the hospital to confirm if they are infected with flu A/influenza B, RSV or COVID-19.
Contents of the package:
- cassette
- user manual
- a sampling tube containing the solution
- sampling swab
- waste bag