Descrizione Clinica
Diagnostics - diagnostics Screen tests covid-19 antigen
SCREEN CHECK TEST
SARS-CoV-2 Antigen Rapid Test
Description
Disposable test to detect SARS-CoV-2 that causes COVID-19 with nasal swab samples collected independently by symptomatic individuals who are suspected to be infected by COVID-19.
The results are for the detection of SARS-CoV-2 nucleocapside antigens. 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. Individuals who are positive to the test should self-isolate and seek further care from their healthcare provider. The positive results do not exclude bacterial infection or co-infection with other viruses.
negative results do not exclude SARS-CoV-2 infection. Individuals who are negative to the test and who continue to manifest symptoms similar to those of COVID should turn to their healthcare provider.
Mode of use
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 disinfectant with at least 60% alcohol. Remove the test tube cover with the extraction pad and put the test tube in the box.
Nasal swab sample collection:
Remove the sterile pad from the envelope. Insert the tampon into the nostril until you feel a slight resistance (about 2 cm on the nose). Slowly rotate the swab, rubbing it along the inside of the nostril for 5-10 times against the nasal wall.
Note: This can be annoying. Do not insert the tampon deeper if you feel a strong resistance or pain. When the nasal mucosa is damaged or bleeding, the nasal swab collection is not recommended. If you are collecting tampons from others, please wear a facial 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 hold the child’s head while picking the pad.
Gently remove the pad.
Using the same swab, repeat steps two in the other nostril.
Retract the sterile tampon.
Sample preparation:
Put the swab in the extraction test, make sure it touches the bottom and shake the tampon to mix it well. Press the swab head against the tube and rotate the pad for 10-15 seconds.
Remove the swab by pressing the head of the swab against the inside of the extraction test. Put the tampon in the biosafety bag.
Close the cap of the extraction test.
Test:
Remove the test box from the sealed aluminum envelope and use it within an hour. The best results are achieved if the test is performed immediately after opening the aluminum envelope.
Place the test box on a flat surface.
Open the small cap and reverse the sample extraction test and add 3 drops of the sample extracted to the test box sample (S) well and start the (timer).
Do not move the test box while developing the test.
Read the result at 15 minutes. Do not read the result after 20 minutes.
At the end of the test, put all the components in a plastic biosafety bag and dispose according to local regulations.
Reading results:
POSITIVE: two distinct colored lines appear. A coloured line should appear in the control area (C) and another coloured line should appear in the test region (T). The color intensity in the region of the test line (T) varies depending on the number of SARS-CoV-2 antigens present in the sample. Therefore the presence of any color shade in the test region (T) must be interpreted as a POSITIVE result. A positive result means that it is very likely that the person is infected by COVID-19, positive samples must be confirmed. Put yourself immediately in self-isolation as prescribed by local regulations and contact your doctor or health care district according to the instructions of local authorities. The test will be verified through a confirmation molecular test (PCR) and the instructions on the following steps will be provided.
NEGATIVE: a single coloured line appears in the control region (C). No coloured line appears in the region of the test line (T). It is unlikely that the person is infected by COVID-19. However, it is possible that this test gives an incorrect result (a false negative) in some people with COVID-19. This means that you could have contracted COVID-19 even if the test gave a negative result. In case of symptoms such as headaches, migraine, fever, loss of taste and smell, contact the nearest health care point according to the rules of the local authority. In addition, you can repeat the test with a new kit. In case of suspect, repeat the test after 1-2 days, since the coronavirus cannot be determined at all stages of the infection. Even with a negative result, the rules of space and hygiene must continue to be observed.
INVALIDO: the control line does not appear. An insufficient volume of sample or incorrect procedure techniques are the most likely causes of the lack of the control line. Review the procedure and repeat the test with a new kit or contact your doctor or a center for diagnosis of COVID-19.
Warnings
Please read all the information contained in the package leaflet before testing.
For autotest only for auto-diagnostic use in vitro. Do not use after the expiry date.
Do not eat, drink or smoke in the area where samples or kits are manipulated.
Do not drink the tampon liquid contained in the kit. Carefully handle the pad and prevent it from contacting the skin or eyes, rinse immediately with plenty of running water in case of contact.
Please do not use if the aluminum packaging is damaged or opened.
This test kit should only be used as a preliminary test and repeatedly abnormal results should be discussed with a doctor or medical professional.
Strictly follow the indicated time.
Use the test once. Do not disassemble and touch the test window of the test box.
The kit should not be frozen or used after the printed expiration date on the package.
Keep out of reach of children.
The test for children and teenagers should be carried out in the presence of an adult.
Do not use the test on children under 2 years of age.
Small children should carry out the tampon with the help of a second adult.
Wash your hands thoroughly before and after handling.
Please ensure that an adequate amount of test samples is used. Too little sample can lead to deviation of results.
Performance was only evaluated with nasal swab samples, using the procedures provided in the leaflet.
The test indicates only the presence of SARS-CoV-2 antigens in the sample.
If the test result is negative or non-reactive and clinical symptoms persist, it is because the very early infection virus may not be detected. It is recommended to test again with a new kit or test with a molecular diagnostic device to exclude infection in these individuals. Negative results do not exclude SARS-CoV-2 infection, especially in those who have been in contact with the virus. Control tests with a molecular diagnostic should be taken into account to exclude infection in these individuals.
The positive results from COVID-19 may be due to infection with non-SARS-CoV-2 coronavirus strains or other interference factors.
Failure to comply with test execution procedures may alter performance.
Fake negative results can occur if a sample is collected or handled improperly. Fake negative results can occur if there are insufficient levels of viruses in the sample.
Conservation
Store as packaged in the sealed envelope at room temperature or refrigerated (2-30° C), avoiding excessive humidity. 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.
Do not use it beyond the expiry date.
Validity of whole packaging: 12 months.
Format
The kit contains:
- Test box;
- Sterile drum;
- Illustrative sheet;
- Extraction drums;
- Biosafety bag.
Bibliography
1. Diagnosis and Treatment Protocol for Novel Coronavirus Pneumonia (Trial Version 7). National Health Commission & National Administration of Traditional Chinese Medicine.2020.
Disposable test to detect SARS-CoV-2 that causes COVID-19 with nasal swab samples collected independently by symptomatic individuals who are suspected to be infected by COVID-19.
The results are for the detection of SARS-CoV-2 nucleocapside antigens. 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. Individuals who are positive to the test should self-isolate and seek further care from their healthcare provider. The positive results do not exclude bacterial infection or co-infection with other viruses.
negative results do not exclude SARS-CoV-2 infection. Individuals who are negative to the test and who continue to manifest symptoms similar to those of COVID should turn to their healthcare provider.
Mode of use
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 disinfectant with at least 60% alcohol. Remove the test tube cover with the extraction pad and put the test tube in the box.
Nasal swab sample collection:
Remove the sterile pad from the envelope. Insert the tampon into the nostril until you feel a slight resistance (about 2 cm on the nose). Slowly rotate the swab, rubbing it along the inside of the nostril for 5-10 times against the nasal wall.
Note: This can be annoying. Do not insert the tampon deeper if you feel a strong resistance or pain. When the nasal mucosa is damaged or bleeding, the nasal swab collection is not recommended. If you are collecting tampons from others, please wear a facial 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 hold the child’s head while picking the pad.
Gently remove the pad.
Using the same swab, repeat steps two in the other nostril.
Retract the sterile tampon.
Sample preparation:
Put the swab in the extraction test, make sure it touches the bottom and shake the tampon to mix it well. Press the swab head against the tube and rotate the pad for 10-15 seconds.
Remove the swab by pressing the head of the swab against the inside of the extraction test. Put the tampon in the biosafety bag.
Close the cap of the extraction test.
Test:
Remove the test box from the sealed aluminum envelope and use it within an hour. The best results are achieved if the test is performed immediately after opening the aluminum envelope.
Place the test box on a flat surface.
Open the small cap and reverse the sample extraction test and add 3 drops of the sample extracted to the test box sample (S) well and start the (timer).
Do not move the test box while developing the test.
Read the result at 15 minutes. Do not read the result after 20 minutes.
At the end of the test, put all the components in a plastic biosafety bag and dispose according to local regulations.
Reading results:
POSITIVE: two distinct colored lines appear. A coloured line should appear in the control area (C) and another coloured line should appear in the test region (T). The color intensity in the region of the test line (T) varies depending on the number of SARS-CoV-2 antigens present in the sample. Therefore the presence of any color shade in the test region (T) must be interpreted as a POSITIVE result. A positive result means that it is very likely that the person is infected by COVID-19, positive samples must be confirmed. Put yourself immediately in self-isolation as prescribed by local regulations and contact your doctor or health care district according to the instructions of local authorities. The test will be verified through a confirmation molecular test (PCR) and the instructions on the following steps will be provided.
NEGATIVE: a single coloured line appears in the control region (C). No coloured line appears in the region of the test line (T). It is unlikely that the person is infected by COVID-19. However, it is possible that this test gives an incorrect result (a false negative) in some people with COVID-19. This means that you could have contracted COVID-19 even if the test gave a negative result. In case of symptoms such as headaches, migraine, fever, loss of taste and smell, contact the nearest health care point according to the rules of the local authority. In addition, you can repeat the test with a new kit. In case of suspect, repeat the test after 1-2 days, since the coronavirus cannot be determined at all stages of the infection. Even with a negative result, the rules of space and hygiene must continue to be observed.
INVALIDO: the control line does not appear. An insufficient volume of sample or incorrect procedure techniques are the most likely causes of the lack of the control line. Review the procedure and repeat the test with a new kit or contact your doctor or a center for diagnosis of COVID-19.
Warnings
Please read all the information contained in the package leaflet before testing.
For autotest only for auto-diagnostic use in vitro. Do not use after the expiry date.
Do not eat, drink or smoke in the area where samples or kits are manipulated.
Do not drink the tampon liquid contained in the kit. Carefully handle the pad and prevent it from contacting the skin or eyes, rinse immediately with plenty of running water in case of contact.
Please do not use if the aluminum packaging is damaged or opened.
This test kit should only be used as a preliminary test and repeatedly abnormal results should be discussed with a doctor or medical professional.
Strictly follow the indicated time.
Use the test once. Do not disassemble and touch the test window of the test box.
The kit should not be frozen or used after the printed expiration date on the package.
Keep out of reach of children.
The test for children and teenagers should be carried out in the presence of an adult.
Do not use the test on children under 2 years of age.
Small children should carry out the tampon with the help of a second adult.
Wash your hands thoroughly before and after handling.
Please ensure that an adequate amount of test samples is used. Too little sample can lead to deviation of results.
Performance was only evaluated with nasal swab samples, using the procedures provided in the leaflet.
The test indicates only the presence of SARS-CoV-2 antigens in the sample.
If the test result is negative or non-reactive and clinical symptoms persist, it is because the very early infection virus may not be detected. It is recommended to test again with a new kit or test with a molecular diagnostic device to exclude infection in these individuals. Negative results do not exclude SARS-CoV-2 infection, especially in those who have been in contact with the virus. Control tests with a molecular diagnostic should be taken into account to exclude infection in these individuals.
The positive results from COVID-19 may be due to infection with non-SARS-CoV-2 coronavirus strains or other interference factors.
Failure to comply with test execution procedures may alter performance.
Fake negative results can occur if a sample is collected or handled improperly. Fake negative results can occur if there are insufficient levels of viruses in the sample.
Conservation
Store as packaged in the sealed envelope at room temperature or refrigerated (2-30° C), avoiding excessive humidity. 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.
Do not use it beyond the expiry date.
Validity of whole packaging: 12 months.
Format
The kit contains:
- Test box;
- Sterile drum;
- Illustrative sheet;
- Extraction drums;
- Biosafety bag.
Bibliography
1. Diagnosis and Treatment Protocol for Novel Coronavirus Pneumonia (Trial Version 7). National Health Commission & National Administration of Traditional Chinese Medicine.2020.
