Descrizione Clinica
Diagnostics - Sars-cov-2& influenza a+b self diagnostics
All
Combined quick antigenic test
for SARS-CoV-2 and A/B influence (nastical leg)
Description
Quick test for qualitative detection of SARS-CoV-2 nucleocapside protein antigens and nucleoproteins of influenza A and influenza B in nasal swab samples.
The test is intended for use in symptomatic/asymptomatic subjects with suspected COVID-19 infection and/or A/B influence.
The results indicate the detection of antigens of the nucleocapside protein of SARS-CoV-2 and nucleoproteins of influenza A and B. An antigen is generally detectable in the samples of the upper respiratory tract during the acute phase of the infection.
Positive results indicate the presence of viral antigens, but clinical correlation with patient history and other diagnostic information is required to determine the state of the infection. The positive results are indicative of the presence of SARS-CoV-2 and/or influenza A/B. Persons who are positive must self-isolate and contact their healthcare provider for additional assistance. A positive result does not exclude the presence of bacterial infection or co-infection from other viruses. A negative result does not exclude the presence of SARS-CoV-2 infection and/or A/B influence.
Those who are negative and continue to manifest the symptoms of COVID-19 or influenza must contact their healthcare provider for additional assistance.
For self-diagnostic use in vitro.
Mode of use
Sample withdrawal
Wash your hands with soap and water for at least 20 seconds before and after the test. If no soap and water are available, use a hand disinfectant with at least 60% alcohol.
Remove the sterile pad from the housing. Do not touch the soft end of the pad. Insert the swab into the nostril until a slight resistance occurs (about 2 cm deep in the nasal cavity). Slowly rotate the tampon, rubbing it along the inside of the nostril for 5-10 times. This could be annoying. If you feel a strong resistance or pain, do not insert the tampon deeper.
When the nasal mucosa is damaged or bleeding, the nasal swab withdrawal is not recommended.
If you withdraw to other people, wear the mask.
With children, it may not be necessary to insert the tampon so deep into the nostril. For very small children, another person may be required to keep the child's head during the withdrawal.
Gently remove the pad. Using the same swab, repeat the procedure in the other nostril.
Extract the tampon.
Sample preparation
Remove the test tube cover with the extraction buffer solution and place the test tube in the box.
Place the swab in the extraction tube, ensuring that it touches the bottom, and shake the pad to mix well. Press the swab tip against the tube and rotate the pad for 10-15 seconds. Remove the buffer by pressing the tip of the swab against the inner wall of the extraction tube.
Place the tampon in a plastic bag. Close the extraction test.
Test execution
Remove the test box from sealed aluminum envelope and use it within an hour. The most reliable results are obtained if the test is performed immediately after opening the envelope.
Place the test box on a flat and uniform surface. Turn the sample extraction test and add 3 drops of sample extracted in each test box (S) well, then start the timer. During the test, do not move the cassette.
Read the result after 10 minutes. Do not interpret the result after 20 minutes.
Interpretation of results
Communicate the test results to your healthcare provider and carefully follow the local guidelines/requirements in contrast to the spread of COVID-19.
POSITIVO to SARS-CoV-2: a colored line must be in the control area (C) and the other in the test area (T). The color intensity in the test area (T) will vary according to the amount of SARS-CoV-2 antigen present in the sample. Therefore, any color shade in the test area (T) must be considered as a positive result.
A positive result is likely to indicate the presence of a COVID-19 infection, but this result must be confirmed by further tests. Put yourself immediately in self-isolation in accordance with the local guidelines and immediately contact the basic doctor or local health service following the instructions provided by the local authorities. The test result will be validated with a confirmation PCR test and the next steps will be explained.
A: Two coloured lines are displayed in the FLU A+B window. A coloured line must be found in the control area (C) and the other in the influence area A (A). The color intensity in the test area (A) will vary according to the amount of antigen of flu A present in the sample. Therefore, any color shade in the test area (A) must be considered as a positive result.
A positive result most likely indicates the presence of an influenza A infection, but this outcome must be confirmed by further tests. Put yourself immediately in self-isolation in accordance with the local guidelines and immediately contact the basic doctor or local health service following the instructions provided by the local authorities. The test result will be validated with a confirmation PCR test and the next steps will be explained.
B: Two coloured lines are displayed in the FLU A+B window. A coloured line must be in the control area (C) and the other in the influence area B (B). The color intensity in the test area (B) will vary according to the amount of antigen of influenza B present in the sample. Therefore, any color shade in the test area (B) must be considered as a positive result.
A positive result most likely indicates the presence of an influenza B infection, but this outcome must be confirmed by further tests. Put yourself immediately in self-isolation in accordance with the local guidelines and immediately contact the basic doctor or local health service following the instructions provided by the local authorities. The test result will be validated with a confirmation PCR test and the next steps will be explained.
POSITIVE to influence A and influence B: three coloured lines are displayed in the FLU A+B window. A coloured line must be in the control area (C) and the other two in the flu A (A) and flu B (B). The color intensity in the test area (A/B) will vary according to the amount of antigen of the A/B influence present in the sample. Therefore, any color shade in the test area (A/B) must be considered as a positive result.
A positive result most likely indicates the presence of an influenza A infection and B influenza, but this outcome must be confirmed by further tests. Put yourself immediately in self-isolation in accordance with the local guidelines and immediately contact the basic doctor or local health service following the instructions provided by the local authorities. The test result will be validated with a confirmation PCR test and the next steps will be explained.
NEGATIVE: A coloured line appears in the control area (C). No obvious color line is displayed in the test area (T/B/A).
It is unlikely that there is a COVID-19 infection and/or influenza A/ influenza B. However, it is possible that this test provides an incorrect negative result (negative flux) in some subjects with COVID-19 and/or influence A/ influenza B. This means that the subject may have a COVID-19 infection and/or A/ flu infection B also in case of negative result of the test. In addition, you can repeat the test with a new kit.
In case of suspected infection, repeat the test after 1-2 days, since it is not possible to accurately detect the coronavirus/flu virus at all stages of the infection.
Although the result of the test is negative, it is necessary to comply with the rules regarding space and hygiene, travel and travel, participation in events and so on, according to the guidelines/local requirements relating to COVID-19/influence.
NOT VALIDO: the control line does not appear. The most likely causes of the failure of the control line are insufficient volume of the sample or incorrect procedural techniques.
Read the instructions again and repeat the test, using a new kit, or contact a COVID-19 swab center.
Warnings
Just for the autotest in vitro. Do not use it beyond the expiry date.
Before running the test, read all the information contained in the leaflet.
Do not eat, drink or smoke in the area where samples or kits are manipulated.
Do not drink the extraction solution contained in the kit. Carefully handle the extraction solution and prevent it from coming into contact with the skin or eyes; in case of contact, rinse immediately with abundant running water.
If the aluminum packaging is damaged or opened, do not use the product.
This test kit should only be used as a preliminary test and repeatedly abnormal results must be analyzed with your doctor or health care professional.
Strictly respect the times indicated.
Use the test once. Do not disassemble and touch the cassette window for testing.
The kit should not be frozen or used after the printed expiration date on the package.
In children, the test must be performed with the help of an adult.
Wash your hands thoroughly before and after manipulation.
Make sure to use an appropriate amount of sample for the test. An excessive or insufficient amount of sample could cause a deviation of results.
Performance has only been evaluated with nasal swab samples, using the procedures described in the leaflet.
The test indicates only the presence of antigens of SARS-CoV-2 and/or influenza A/ influenza B in the sample.
If the result of the test is negative or non-reactive and clinical symptoms persist, it is possible that the virus is not detected in the very early stages of the infection. It is recommended to repeat the test with a new device or with a molecular diagnostic tool to exclude the infection in these subjects. 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, you should consider running a molecular test of confirmation.
A negative result for influence A or influence B obtained from this kit must be confirmed by culture/RT-PCR.
The positive results of COVID-19 can be caused by infection of non-SARS-CoV-2 coronavirus strains or other interference factors. A positive result for influenza A and/or B does not exclude co-infection from other pathogen, therefore it should be considered the possibility of a soggiacent bacterial infection.
Failure to comply with test procedures could alter the test performance.
If a sample is taken or manipulated improperly, the test could give false negative results.
If in the sample there are levels of virus below the test detection limit, the test could return false negative results.
Conservation
Store in sealed packaging at room temperature or refrigerator (2–30 °C). Don't freeze.
The test is stable until the expiry date printed on the sealed envelope. The test must remain in the sealed envelope until use.
Validity of whole packaging: 24 months.
Format
The kit contains:
- test box;
- sterile swab;
- leaflet;
- extraction solution.
Cod. ISIN-525H
Quick test for qualitative detection of SARS-CoV-2 nucleocapside protein antigens and nucleoproteins of influenza A and influenza B in nasal swab samples.
The test is intended for use in symptomatic/asymptomatic subjects with suspected COVID-19 infection and/or A/B influence.
The results indicate the detection of antigens of the nucleocapside protein of SARS-CoV-2 and nucleoproteins of influenza A and B. An antigen is generally detectable in the samples of the upper respiratory tract during the acute phase of the infection.
Positive results indicate the presence of viral antigens, but clinical correlation with patient history and other diagnostic information is required to determine the state of the infection. The positive results are indicative of the presence of SARS-CoV-2 and/or influenza A/B. Persons who are positive must self-isolate and contact their healthcare provider for additional assistance. A positive result does not exclude the presence of bacterial infection or co-infection from other viruses. A negative result does not exclude the presence of SARS-CoV-2 infection and/or A/B influence.
Those who are negative and continue to manifest the symptoms of COVID-19 or influenza must contact their healthcare provider for additional assistance.
For self-diagnostic use in vitro.
Mode of use
Sample withdrawal
Wash your hands with soap and water for at least 20 seconds before and after the test. If no soap and water are available, use a hand disinfectant with at least 60% alcohol.
Remove the sterile pad from the housing. Do not touch the soft end of the pad. Insert the swab into the nostril until a slight resistance occurs (about 2 cm deep in the nasal cavity). Slowly rotate the tampon, rubbing it along the inside of the nostril for 5-10 times. This could be annoying. If you feel a strong resistance or pain, do not insert the tampon deeper.
When the nasal mucosa is damaged or bleeding, the nasal swab withdrawal is not recommended.
If you withdraw to other people, wear the mask.
With children, it may not be necessary to insert the tampon so deep into the nostril. For very small children, another person may be required to keep the child's head during the withdrawal.
Gently remove the pad. Using the same swab, repeat the procedure in the other nostril.
Extract the tampon.
Sample preparation
Remove the test tube cover with the extraction buffer solution and place the test tube in the box.
Place the swab in the extraction tube, ensuring that it touches the bottom, and shake the pad to mix well. Press the swab tip against the tube and rotate the pad for 10-15 seconds. Remove the buffer by pressing the tip of the swab against the inner wall of the extraction tube.
Place the tampon in a plastic bag. Close the extraction test.
Test execution
Remove the test box from sealed aluminum envelope and use it within an hour. The most reliable results are obtained if the test is performed immediately after opening the envelope.
Place the test box on a flat and uniform surface. Turn the sample extraction test and add 3 drops of sample extracted in each test box (S) well, then start the timer. During the test, do not move the cassette.
Read the result after 10 minutes. Do not interpret the result after 20 minutes.
Interpretation of results
Communicate the test results to your healthcare provider and carefully follow the local guidelines/requirements in contrast to the spread of COVID-19.
POSITIVO to SARS-CoV-2: a colored line must be in the control area (C) and the other in the test area (T). The color intensity in the test area (T) will vary according to the amount of SARS-CoV-2 antigen present in the sample. Therefore, any color shade in the test area (T) must be considered as a positive result.
A positive result is likely to indicate the presence of a COVID-19 infection, but this result must be confirmed by further tests. Put yourself immediately in self-isolation in accordance with the local guidelines and immediately contact the basic doctor or local health service following the instructions provided by the local authorities. The test result will be validated with a confirmation PCR test and the next steps will be explained.
A: Two coloured lines are displayed in the FLU A+B window. A coloured line must be found in the control area (C) and the other in the influence area A (A). The color intensity in the test area (A) will vary according to the amount of antigen of flu A present in the sample. Therefore, any color shade in the test area (A) must be considered as a positive result.
A positive result most likely indicates the presence of an influenza A infection, but this outcome must be confirmed by further tests. Put yourself immediately in self-isolation in accordance with the local guidelines and immediately contact the basic doctor or local health service following the instructions provided by the local authorities. The test result will be validated with a confirmation PCR test and the next steps will be explained.
B: Two coloured lines are displayed in the FLU A+B window. A coloured line must be in the control area (C) and the other in the influence area B (B). The color intensity in the test area (B) will vary according to the amount of antigen of influenza B present in the sample. Therefore, any color shade in the test area (B) must be considered as a positive result.
A positive result most likely indicates the presence of an influenza B infection, but this outcome must be confirmed by further tests. Put yourself immediately in self-isolation in accordance with the local guidelines and immediately contact the basic doctor or local health service following the instructions provided by the local authorities. The test result will be validated with a confirmation PCR test and the next steps will be explained.
POSITIVE to influence A and influence B: three coloured lines are displayed in the FLU A+B window. A coloured line must be in the control area (C) and the other two in the flu A (A) and flu B (B). The color intensity in the test area (A/B) will vary according to the amount of antigen of the A/B influence present in the sample. Therefore, any color shade in the test area (A/B) must be considered as a positive result.
A positive result most likely indicates the presence of an influenza A infection and B influenza, but this outcome must be confirmed by further tests. Put yourself immediately in self-isolation in accordance with the local guidelines and immediately contact the basic doctor or local health service following the instructions provided by the local authorities. The test result will be validated with a confirmation PCR test and the next steps will be explained.
NEGATIVE: A coloured line appears in the control area (C). No obvious color line is displayed in the test area (T/B/A).
It is unlikely that there is a COVID-19 infection and/or influenza A/ influenza B. However, it is possible that this test provides an incorrect negative result (negative flux) in some subjects with COVID-19 and/or influence A/ influenza B. This means that the subject may have a COVID-19 infection and/or A/ flu infection B also in case of negative result of the test. In addition, you can repeat the test with a new kit.
In case of suspected infection, repeat the test after 1-2 days, since it is not possible to accurately detect the coronavirus/flu virus at all stages of the infection.
Although the result of the test is negative, it is necessary to comply with the rules regarding space and hygiene, travel and travel, participation in events and so on, according to the guidelines/local requirements relating to COVID-19/influence.
NOT VALIDO: the control line does not appear. The most likely causes of the failure of the control line are insufficient volume of the sample or incorrect procedural techniques.
Read the instructions again and repeat the test, using a new kit, or contact a COVID-19 swab center.
Warnings
Just for the autotest in vitro. Do not use it beyond the expiry date.
Before running the test, read all the information contained in the leaflet.
Do not eat, drink or smoke in the area where samples or kits are manipulated.
Do not drink the extraction solution contained in the kit. Carefully handle the extraction solution and prevent it from coming into contact with the skin or eyes; in case of contact, rinse immediately with abundant running water.
If the aluminum packaging is damaged or opened, do not use the product.
This test kit should only be used as a preliminary test and repeatedly abnormal results must be analyzed with your doctor or health care professional.
Strictly respect the times indicated.
Use the test once. Do not disassemble and touch the cassette window for testing.
The kit should not be frozen or used after the printed expiration date on the package.
In children, the test must be performed with the help of an adult.
Wash your hands thoroughly before and after manipulation.
Make sure to use an appropriate amount of sample for the test. An excessive or insufficient amount of sample could cause a deviation of results.
Performance has only been evaluated with nasal swab samples, using the procedures described in the leaflet.
The test indicates only the presence of antigens of SARS-CoV-2 and/or influenza A/ influenza B in the sample.
If the result of the test is negative or non-reactive and clinical symptoms persist, it is possible that the virus is not detected in the very early stages of the infection. It is recommended to repeat the test with a new device or with a molecular diagnostic tool to exclude the infection in these subjects. 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, you should consider running a molecular test of confirmation.
A negative result for influence A or influence B obtained from this kit must be confirmed by culture/RT-PCR.
The positive results of COVID-19 can be caused by infection of non-SARS-CoV-2 coronavirus strains or other interference factors. A positive result for influenza A and/or B does not exclude co-infection from other pathogen, therefore it should be considered the possibility of a soggiacent bacterial infection.
Failure to comply with test procedures could alter the test performance.
If a sample is taken or manipulated improperly, the test could give false negative results.
If in the sample there are levels of virus below the test detection limit, the test could return false negative results.
Conservation
Store in sealed packaging at room temperature or refrigerator (2–30 °C). Don't freeze.
The test is stable until the expiry date printed on the sealed envelope. The test must remain in the sealed envelope until use.
Validity of whole packaging: 24 months.
Format
The kit contains:
- test box;
- sterile swab;
- leaflet;
- extraction solution.
Cod. ISIN-525H
