Covid-19 Rapid Antigen Test Combo Self-Test Qualitative Determination of SARS-CoV-2 and Influenza A+B Antigens in Nasal Swabs by Immunochromatography Sofarmapiu' Sofarmapiu'

Description
Rapid test for the qualitative detection of SARS-CoV-2 nucleocapsid protein antigens and influenza A and influenza B nucleoproteins in nasal swab samples.
The test is intended for use in symptomatic/asymptomatic individuals with suspected COVID-19 and/or influenza A/B infection.
Results indicate the detection of SARS-CoV-2 nucleocapsid protein antigens and influenza A and B nucleoproteins. An antigen is generally detectable in upper respiratory tract samples during the acute phase of infection.
Positive results indicate the presence of viral antigens, but clinical correlation with patient history and other diagnostic information is necessary to determine infection status. Positive results are indicative of the presence of SARS-CoV-2 and/or influenza A/B. Individuals who test positive should self-isolate and contact their healthcare provider for additional assistance. A positive result does not rule out bacterial infection or co-infection with other viruses. A negative result does not rule out SARS-CoV-2 and/or influenza A/B infection.
Individuals who test negative and continue to experience COVID-19 or flu symptoms should contact their healthcare provider for additional assistance.
For in vitro self-testing.

Instructions for use
Sample collection
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 sterile swab from its packaging. Do not touch the soft tip of the swab. Insert the swab into the nostril until slight resistance is felt (approximately 2 cm deep into the nasal cavity). Slowly rotate the swab, rubbing it along the inside of the nostril 5-10 times. This may feel uncomfortable. If strong resistance or pain is felt, do not insert the swab deeper.
If the nasal mucosa is damaged or bleeding, nasal swab collection is not recommended.
If collecting from others, wear a mask.
For children, it may not be necessary to insert the swab as deeply into the nostril. For very young children, another person may be needed to hold the child's head during collection.
Gently remove the swab. Using the same swab, repeat the procedure in the other nostril.
Remove the swab.

Sample preparation
Remove the cap from the extraction buffer tube and place the tube in the tube holder in the box.
Place the swab into the extraction tube, ensuring it touches the bottom, and agitate the swab to mix thoroughly. Press the tip of the swab against the tube and rotate the swab for 10-15 seconds. Remove the swab by pressing the tip of the swab against the inner wall of the extraction tube.
Place the swab in a plastic bag. Close the extraction tube.

Performing the test
Remove the test cassette from the sealed foil pouch and use it within one hour. The most reliable results are obtained if the test is performed immediately after opening the pouch.
Place the test cassette on a flat, level surface. Invert the sample extraction tube and add 3 drops of extracted sample to each well (S) of the test cassette, then start the timer. Do not move the cassette during the test.
Read the result after 10 minutes. Do not interpret the result after 20 minutes.

Interpretation of results
Report test results to your healthcare provider and carefully follow local COVID-19 mitigation guidelines/requirements.

POSITIVE for SARS-CoV-2: A colored line must appear in the control area (C) and another in the test area (T). The intensity of the color in the test area (T) will vary depending on the amount of SARS-CoV-2 antigen present in the sample. Therefore, any shade of color in the test area (T) should be considered a positive result.
A positive result very likely indicates the presence of a COVID-19 infection, but this outcome must be confirmed by further testing. Immediately self-isolate in accordance with local guidelines and contact your general practitioner or local health service immediately, following the instructions provided by local authorities. The test result will be validated with a confirmatory PCR test and the next steps to follow will be explained.

POSITIVE for Influenza A: Two colored lines appear in the FLU A+B window. One colored line must appear in the control area (C) and the other in the influenza A area (A). The intensity of the color in the test area (A) will vary depending on the amount of influenza A antigen present in the sample. Therefore, any shade of color in the test area (A) should be considered a positive result.
A positive result very likely indicates the presence of an influenza A infection, but this outcome must be confirmed by further testing. Immediately self-isolate in accordance with local guidelines and contact your general practitioner or local health service immediately, following the instructions provided by local authorities. The test result will be validated with a confirmatory PCR test and the next steps to follow will be explained.

POSITIVE for Influenza B: Two colored lines appear in the FLU A+B window. One colored line must appear in the control area (C) and the other in the influenza B area (B). The intensity of the color in the test area (B) will vary depending on the amount of influenza B antigen present in the sample. Therefore, any shade of color in the test area (B) should be considered a positive result.
A positive result very likely indicates the presence of an influenza B infection, but this outcome must be confirmed by further testing. Immediately self-isolate in accordance with local guidelines and contact your general practitioner or local health service immediately, following the instructions provided by local authorities. The test result will be validated with a confirmatory PCR test and the next steps to follow will be explained.

POSITIVE for Influenza A and Influenza B: Three colored lines appear in the FLU A+B window. One colored line must appear in the control area (C) and the other two in the influenza A area (A) and influenza B area (B). The intensity of the color in the test area (A/B) will vary depending on the amount of influenza A/B antigen present in the sample. Therefore, any shade of color in the test area (A/B) should be considered a positive result.
A positive result very likely indicates the presence of an influenza A and influenza B infection, but this outcome must be confirmed by further testing. Immediately self-isolate in accordance with local guidelines and contact your general practitioner or local health service immediately, following the instructions provided by local authorities. The test result will be validated with a confirmatory PCR test and the next steps to follow will be explained.

NEGATIVE: A colored line appears in the control area (C). No visible colored line appears in the test area (T/B/A).
It is unlikely that you have a COVID-19 and/or influenza A/influenza B infection. However, this test may give an incorrect negative result (false negative) in some individuals with COVID-19 and/or influenza A/influenza B. This means that the individual may have a COVID-19 and/or influenza A/influenza B infection even with a negative test result. In addition, the test can be repeated with a new kit.
If infection is suspected, repeat the test after 1-2 days, as the coronavirus/influenza virus cannot be accurately detected at all stages of infection.
Even if the test result is negative, it is necessary to observe rules regarding distancing and hygiene, travel and movement, participation in events, and so on, according to local guidelines/requirements regarding COVID-19/influenza.

INVALID: The control line does not appear. The most likely causes of the control line not appearing are insufficient sample volume or incorrect procedural techniques.
Re-read the instructions and repeat the test using a new kit, or contact a COVID-19/flu swab center.

Warnings
For in vitro self-testing only. Do not use after the expiration date.
Before performing the test, read all information in the leaflet.
Do not eat, drink, or smoke in the area where samples or kits are handled.
Do not drink the extraction solution contained in the kit. Handle the extraction solution carefully and avoid contact with skin or eyes; in case of contact, rinse immediately with plenty of running water.
If the aluminum packaging is damaged or has been opened, do not use the product.
This test kit should only be used as a preliminary test, and repeatedly abnormal results should be analyzed with a doctor or healthcare professional.
Strictly adhere to the indicated times.
Use the test only once. Do not disassemble or touch the test cassette window.
The kit must not be frozen or used after the expiration date printed on the packaging.
For children, the test must be performed with the help of an adult.
Wash your hands thoroughly before and after handling.
Ensure that an appropriate amount of sample is used for the test. An excessive or insufficient amount of sample could cause results to deviate.
Performance has been evaluated only with nasal swab samples, using the procedures described in the leaflet.
The test only indicates the presence of SARS-CoV-2 and/or influenza A/influenza B antigens in the sample.
If the test result is negative or non-reactive and clinical symptoms persist, the virus may not be detected in the very early stages of infection. It is recommended to repeat the test with a new device or with a molecular diagnostic instrument 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. To rule out infection in these individuals, confirmatory molecular testing should be considered.
A negative result for influenza A or influenza B obtained from this kit must be confirmed by culture/RT-PCR.
Positive COVID-19 results may be due to infection with non-SARS-CoV-2 coronavirus strains or other interfering factors. A positive result for influenza A and/or B does not exclude co-infection with another pathogen, so the possibility of underlying bacterial infection should be considered.
Failure to observe testing procedures could alter test performance.
If a sample is collected or handled improperly, the test could give false negative results.
If virus levels in the sample are below the detection limit of the test, the test could return false negative results.

Storage
Store in the sealed package at room temperature or in the refrigerator (2–30 °C). Do not freeze.
The test is stable until the expiration date printed on the sealed pouch. The test must remain in the sealed pouch until use.
Shelf life in unopened packaging: 24 months.

Format
The kit contains:
- test cassette;
- sterile swab;
- instruction leaflet;
- extraction solution.

Code ISIN-525H