Description
ALL TEST
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. For in vitro self-testing.
The SARS-CoV-2 and Influenza A/B Rapid Antigen Combo Test (Nasal Swab) is a single-use test kit intended to detect the SARS-CoV-2, influenza A, and influenza B viruses that cause COVID-19 and/or influenza in self-collected nasal swab specimens. The test is intended for use in symptomatic/asymptomatic individuals 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. An antigen is usually detectable in upper respiratory tract specimens 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 the 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 experience symptoms of COVID-19 or influenza should contact their healthcare provider for additional care.
How to use
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 lid from the tube with the extraction buffer solution and place the tube in the tube rack in the box.
Sample collection with nasal swab
1. Remove the sterile swab from the pouch. Do not touch the soft end of the swab.
2. Insert the swab into the nostril until you feel a slight resistance (about 2 cm into the nose). Slowly rotate the swab, rubbing it along the inside of the nostril 5-10 times against the nasal wall.
Note: This may be uncomfortable. If you feel strong resistance or pain, do not insert the swab any deeper.
When the nasal mucosa is damaged or bleeding, nasal swab sampling is not recommended.
If you are sampling someone else, 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.
3. Gently remove the swab.
4. Using the same swab, repeat in the other nostril.
5. Remove the swab.
Sample preparation
1. 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.
2. Remove the swab by pressing the tip of the swab against the inside wall of the extraction tube.
3. Place the swab in a plastic bag.
4. Close the cap or place the tube cap on the tube.
Running the test
1. 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.
2. 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.
3. Read the result after 10 minutes. Do not interpret the result after 20 minutes.
Note: After testing, place all components in a plastic bag, seal it well and dispose of it according to local regulations.
Reading the results
Please report your test results to your healthcare provider and carefully follow local COVID-19 guidelines/requirements.
POSITIVE for SARS-CoV-2:* Two colored lines appear in the COVID-19 window. One colored line should be in the control area (C) and the other in the test area (T).
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).
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).
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 area (C) and the other two should be in the influenza A (A) and influenza B (B) areas.
*NOTE: The intensity of the color in the test area (T/B/A) will vary based on the amount of SARS-CoV-2 and/or influenza A/B antigen present in the specimen. Therefore, any shade of color in the test area (T/B/A) should be considered a positive result.
A positive result most likely indicates the presence of COVID-19 and/or influenza A and/or 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.
The test result will be validated with a confirmatory PCR test and the next steps to follow 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.
Additionally, you can repeat the test with a new kit. If you suspect infection, repeat the test after 1-2 days, as coronavirus/influenza virus cannot be accurately detected 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 specimen volume or incorrect procedural techniques. Reread the instructions and repeat the test, using a new product, or contact a COVID-19/flu testing center.
Warnings
- For in vitro self-testing only. Do not use beyond expiration date.
- Do not eat, drink or smoke in the area where specimens or kits are handled.
- Do not drink the buffer solution contained in the kit.
Handle the buffer solution with care and avoid contact with skin or eyes; in case of contact, rinse immediately with plenty of running water.
- 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 respect 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 expiry date printed on the package.
- In children, the test must be used with the help of an adult.
- Wash your 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.
Limitations
1. Performance was evaluated with nasal swab specimens only, using the procedures described in this package insert.
2. The Combined Rapid Antigen Test for SARS-CoV-2 and Influenza A/B (nasal swab) indicates only the presence of SARS-CoV-2 and/or Influenza A/Influenza B antigens in the sample.
3. 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 tool to rule out infection in these subjects.
4. Negative results do not exclude SARS-CoV-2 infection, especially in those who have been in contact with the virus. To exclude infection in these subjects, a confirmatory molecular test should be considered.
5. A negative result for influenza A or influenza B obtained from this kit must be confirmed by culture/RT-PCR.
6. Positive results for COVID-19 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 underlying co-infection with another pathogen, therefore the possibility of an underlying bacterial infection should be considered.
7. Failure to follow these procedures may impair test performance.
8. If a sample is collected or handled improperly, the test may yield false negative results.
9. If inadequate levels of virus are present in the sample, the test may give false negative results.
Conservation
Store in the sealed pouch at room temperature or refrigerated (2 - 30 °C). The test is stable until the expiration date printed on the sealed pouch. The test must remain in the sealed pouch until use. Do not freeze. Do not use beyond the expiration date.
Format
Test cassette, package insert, sterile swab, extraction buffer solution, biohazard waste bag (optional).
Cod. ISIN-525H
Rapid test for the qualitative detection of SARS-CoV-2 nucleocapsid protein antigens and influenza A and influenza B nucleoproteins in nasal swab specimens. For in vitro self-testing.
The SARS-CoV-2 and Influenza A/B Rapid Antigen Combo Test (Nasal Swab) is a single-use test kit intended to detect the SARS-CoV-2, influenza A, and influenza B viruses that cause COVID-19 and/or influenza in self-collected nasal swab specimens. The test is intended for use in symptomatic/asymptomatic individuals 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. An antigen is usually detectable in upper respiratory tract specimens 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 the 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 experience symptoms of COVID-19 or influenza should contact their healthcare provider for additional care.
How to use
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 lid from the tube with the extraction buffer solution and place the tube in the tube rack in the box.
Sample collection with nasal swab
1. Remove the sterile swab from the pouch. Do not touch the soft end of the swab.
2. Insert the swab into the nostril until you feel a slight resistance (about 2 cm into the nose). Slowly rotate the swab, rubbing it along the inside of the nostril 5-10 times against the nasal wall.
Note: This may be uncomfortable. If you feel strong resistance or pain, do not insert the swab any deeper.
When the nasal mucosa is damaged or bleeding, nasal swab sampling is not recommended.
If you are sampling someone else, 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.
3. Gently remove the swab.
4. Using the same swab, repeat in the other nostril.
5. Remove the swab.
Sample preparation
1. 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.
2. Remove the swab by pressing the tip of the swab against the inside wall of the extraction tube.
3. Place the swab in a plastic bag.
4. Close the cap or place the tube cap on the tube.
Running the test
1. 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.
2. 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.
3. Read the result after 10 minutes. Do not interpret the result after 20 minutes.
Note: After testing, place all components in a plastic bag, seal it well and dispose of it according to local regulations.
Reading the results
Please report your test results to your healthcare provider and carefully follow local COVID-19 guidelines/requirements.
POSITIVE for SARS-CoV-2:* Two colored lines appear in the COVID-19 window. One colored line should be in the control area (C) and the other in the test area (T).
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).
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).
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 area (C) and the other two should be in the influenza A (A) and influenza B (B) areas.
*NOTE: The intensity of the color in the test area (T/B/A) will vary based on the amount of SARS-CoV-2 and/or influenza A/B antigen present in the specimen. Therefore, any shade of color in the test area (T/B/A) should be considered a positive result.
A positive result most likely indicates the presence of COVID-19 and/or influenza A and/or 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.
The test result will be validated with a confirmatory PCR test and the next steps to follow 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.
Additionally, you can repeat the test with a new kit. If you suspect infection, repeat the test after 1-2 days, as coronavirus/influenza virus cannot be accurately detected 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 specimen volume or incorrect procedural techniques. Reread the instructions and repeat the test, using a new product, or contact a COVID-19/flu testing center.
Warnings
- For in vitro self-testing only. Do not use beyond expiration date.
- Do not eat, drink or smoke in the area where specimens or kits are handled.
- Do not drink the buffer solution contained in the kit.
Handle the buffer solution with care and avoid contact with skin or eyes; in case of contact, rinse immediately with plenty of running water.
- 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 respect 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 expiry date printed on the package.
- In children, the test must be used with the help of an adult.
- Wash your 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.
Limitations
1. Performance was evaluated with nasal swab specimens only, using the procedures described in this package insert.
2. The Combined Rapid Antigen Test for SARS-CoV-2 and Influenza A/B (nasal swab) indicates only the presence of SARS-CoV-2 and/or Influenza A/Influenza B antigens in the sample.
3. 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 tool to rule out infection in these subjects.
4. Negative results do not exclude SARS-CoV-2 infection, especially in those who have been in contact with the virus. To exclude infection in these subjects, a confirmatory molecular test should be considered.
5. A negative result for influenza A or influenza B obtained from this kit must be confirmed by culture/RT-PCR.
6. Positive results for COVID-19 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 underlying co-infection with another pathogen, therefore the possibility of an underlying bacterial infection should be considered.
7. Failure to follow these procedures may impair test performance.
8. If a sample is collected or handled improperly, the test may yield false negative results.
9. If inadequate levels of virus are present in the sample, the test may give false negative results.
Conservation
Store in the sealed pouch at room temperature or refrigerated (2 - 30 °C). The test is stable until the expiration date printed on the sealed pouch. The test must remain in the sealed pouch until use. Do not freeze. Do not use beyond the expiration date.
Format
Test cassette, package insert, sterile swab, extraction buffer solution, biohazard waste bag (optional).
Cod. ISIN-525H
