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

Description
Rapid test for the qualitative detection of SARS-CoV-2 nucleocapsid protein antigens and influenza A and influenza B nucleoproteins in nasal swab specimens.
The test is intended for use in symptomatic/asymptomatic subjects with suspected COVID-19 and/or influenza A/B infection.
The results indicate the detection of antigens of the SARS-CoV-2 nucleocapsid protein and influenza A and B nucleoproteins. One 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 needed 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 care. 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 have symptoms of COVID-19 or influenza should contact their healthcare provider for additional care.
For in vitro self-diagnostic use only.

How to use
Sample collection
Wash your hands with soap and water for at least 20 seconds before and after testing. If soap and water are not available, use a hand sanitizer with at least 60% alcohol.
Remove the sterile swab from the pouch. Do not touch the soft end of the swab. Insert the swab into your nostril until you feel slight resistance (about 2 cm deep into your nasal cavity). Slowly rotate the swab, rubbing it along the inside of your nostril 5-10 times. This may feel uncomfortable. If you feel strong resistance or pain, do not insert the swab deeper.
When the nasal mucosa is damaged or bleeding, nasal swab sampling is not recommended.
If you are taking blood from other people, wear a mask.
With children, you may not need to insert the swab as far into the nostril. For very young children, you may need another person to hold the child's head while sampling.
Gently remove the swab. Using the same swab, repeat the process in the other nostril.
Remove the swab.

Sample preparation
Remove the lid from the tube with the extraction buffer solution and place the tube in the tube rack in the box.
Place the swab into the extraction tube, making sure it touches the bottom, and swirl the swab to mix well. Press the tip of the swab against the tube and swirl the swab for 10-15 seconds. Remove the swab by pressing the tip of the swab against the inside wall of the extraction tube.
Place the swab in a plastic bag. Close the extraction tube.

Running 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, even 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 testing.
Read the result after 10 minutes. Do not interpret the result after 20 minutes.

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

POSITIVE for SARS-CoV-2: One colored line should be in the control area (C) and the other in the test area (T). The intensity of the color in the test area (T) will vary based 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 most likely indicates the presence of COVID-19 infection, but this result must be confirmed by further testing. Self-isolate immediately in accordance with local guidelines and contact your GP or local health service immediately following the instructions provided by local authorities. Your test result will be validated with a confirmatory PCR test and the next steps will be explained.

POSITIVE for Influenza A: Two colored lines appear in the FLU A+B window. One colored line should be 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 specimen. Therefore, any shade of color in the test area (A) should be considered a positive result.
A positive result most likely indicates an influenza A infection, but this result must be confirmed by further testing. Self-isolate immediately in accordance with local guidelines and contact your GP or local health service immediately following the instructions provided by your local authorities. Your test result will be validated with a confirmatory PCR test and the next steps will be explained.

POSITIVE for Influenza B: Two colored lines appear in the FLU A+B window. One colored line should be 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 specimen. Therefore, any shade of color in the test area (B) should be considered a positive result.
A positive result most likely indicates an influenza B infection, but this result must be confirmed by further testing. Self-isolate immediately in accordance with local guidelines and contact your GP or local health service immediately following the instructions provided by your local authorities. Your test result will be validated with a confirmatory PCR test and the next steps will be explained.

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

NEGATIVE: One colored line appears in the control region (C). No obvious colored line appears in the test region (T/B/A).
It is unlikely that you have COVID-19 and/or influenza A/influenza B infection. However, this test may give an incorrect negative result (false negative) in some people with COVID-19 and/or influenza A/influenza B. This means that you may have COVID-19 and/or influenza A/influenza B infection even if you have a negative test result. You may also be able to repeat the test with a new kit.
If you suspect an infection, repeat the test after 1-2 days, as it is not possible to accurately detect coronavirus/influenza virus at all stages of infection.
Even if your test result is negative, you must adhere to the rules regarding distancing and hygiene, travel, attendance at events, etc., as per local COVID-19/flu guidelines/requirements.

INVALID: Control line does not appear. The most likely causes for control line failure are insufficient sample volume or incorrect procedural techniques.
Please read the instructions again and repeat the test, using a new kit, or contact a COVID-19/flu testing center.

Warnings
For in vitro self-testing only. Do not use beyond expiration date.
Before performing the test, read all the information in the package leaflet.
Do not eat, drink, or smoke in the area where specimens or kits are handled.
Do not drink the extraction solution contained in the kit. Handle the extraction solution with care 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 be used only as a preliminary test and repeatedly abnormal results should be discussed with your doctor or healthcare provider.
Strictly adhere to the indicated times.
Use the test only once. Do not disassemble and touch the test cassette window.
The kit must not be frozen or used after the expiration date printed on the package.
In children, the test should be performed with the help of an adult.
Wash hands thoroughly before and after handling.
Make sure to use an appropriate amount of sample for testing. Too much or too little sample may cause deviation in results.
Performance was evaluated with nasal swab samples only, using the procedures described in the package insert.
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. Repeat testing with a new device or a molecular diagnostic tool is recommended to rule out infection in these individuals. Negative results do not rule out SARS-CoV-2 infection, especially in those who have been in contact with the virus. To rule out infection in these individuals, a confirmatory molecular test 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 rule out co-infection with another pathogen, so the possibility of an underlying bacterial infection should be considered.
Failure to follow test procedures may impair test performance.
If a sample is collected or handled improperly, the test may give false negative results.
If the sample contains levels of virus below the detection limit of the test, the test may return false negative results.

Conservation
Store in the sealed container 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.
Validity with intact packaging: 24 months.

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

Cod. ISIN-525H