Descrizione Clinica
CLUNGEN
COVID-19 Antigen Rapid Test
Description
Lateral flow immunodose method for qualitative detection of SARS-CoV-2 nucleocapside antigen in the nasal buffer of subjects with symptoms or other epidemiological reasons that suspect COVID-19 infection.
The test is intended for use by non-professional subjects from 15 years and, depending on the case, by adults to test another subject under 15 years. Subjects over 65 years must require assistance in carrying out the test.
The test provides only a preliminary screening result for the SARS-CoV-2 virus. The positive results must be confirmed through a PCR test performed in the laboratory.
People with a negative test result that continue to manifest symptoms similar to those from COVID-19 must contact the doctor.
Mode of use
Test preparation
Make sure all test components are at room temperature (15-30 °C).
Keep a clock at your fingertips, timer or timer.
Make sure the package is integrated. Do not use the test if the packaging is damaged in a visible way.
Open the box for the test only when using. Use the test box within an hour of opening the package.
Wash your hands with soap and water and dry them thoroughly.
Test execution
Open the test tube containing the extraction reagent carefully removing the film. Insert the tube into the rack (hole present on the package).
Remove the pad from the envelope: open the box from the end of the stick. Don't touch the swab head. Remove the swab and gently insert the whole swab head into the nostril, at a depth of about 2.5 cm. Rotate the swab against the wall of the nostril for at least 5 times. Remove the pad, insert it into the other nostril and repeat the same operation. Carefully carry out this operation: negative false results may occur if the nasal buffer is not executed properly.
Insert the swab into the test tube containing the extraction reagent. Rotate the swab 5 times inside the reagent, pressing the swab head against the bottom and side of the test tube. leave the buffer in the reagent for 1 minute. Remove the swab by pressing the sides of the tube so that the liquid can be removed from the buffer. Close the test tube well.
Open the sealed envelope containing the test box and extract it. Put the test box on a flat surface.
Keep the test tube vertically above the sample well and add 3 drops in the well, gently pressing the sides of the test tube. A negative false result may occur if you add less than 3 drops of sample in the well. The result will not be affected if you add 1-2 extra sample drops, provided you can read the control line (C).
Start the clock/chronometer or timer. Read the test result after 15-20 minutes, do not read the result if more than 20 minutes have passed. Erroneous results may occur if the test results are read before 15 minutes or after 20 minutes.
Once the test runs, collect the parts of the used kit and the pad samples in a disposal bag and dispose of them with household waste. Wash your hands thoroughly after handling.
Interpretation of results
- POSITIVE: Two lines appear, the control line (C) and the test line (T). The color intensity of the test line (T) can be very weak, the result is however to be interpreted positive. A positive result of the test indicates that the COVID-19 disease is likely to occur. It is necessary to undergo a laboratory PCR test as soon as possible to confirm the diagnosis of COVID-19 and follow the local guidelines for isolation in order to avoid transmission of the virus to others.
- NEGATIVE: only a colored line appears, the control line (C). The test line (T) does not appear. A negative test result indicates that there is probably no COVID-19 disease. Even if you get a negative result, you have to follow all the guidelines to limit the spread of COVID-19. If symptoms develop or if symptoms persist, undergo a laboratory PCR test. If an infection is suspected, it is recommended to repeat the test after 1–2 days, since the virus cannot be accurately detected at all stages of the infection.
- NOT VALIDO: the control line (C) does not appear. The test result is not valid regardless of whether or not the test line (T). Repeat the test with a new cassette or contact your doctor.
Warnings
Only for in vitro diagnostics.
Do not use this test as the only basis for COVID-19 infection management. Please consult a health care professional at any time if symptoms persist or worsen, or if you fear for your health.
Negative results may occur if the test is not performed within the first 7 days of the symptoms manifestation.
The test on a subject under the age of 15 must be performed by an adult.
Keep out of reach of children to reduce the risk of accidentally drinking reagent or ingesting small parts.
Do not use after the expiry date.
The test is disposable and can only be used with the components provided.
Do not test in direct sunlight.
Avoid contact with the extraction reagent. In cases of inhalation, ingestion or exposure of the skin or eyes to the extraction reagent, immediately take first aid measures in accordance with the safety card (SDS).
The test requires a sample from the nasal cavity. When performing the test, pay special attention to the instructions on how to perform the buffer. The incorrect execution of sampling may result incorrectly. This is particularly important in case of no symptoms.
The test box must remain in the sealed envelope until use.
Wash your hands thoroughly before and after the test.
The test must be used only for the qualitative detection of SARS-CoV-2 antigens in samples taken with nasal swab.
The intensity of the test line is not necessarily related to the viral title of SARS-CoV-2 in the sample.
Failure to comply with "Instruments for Use" may adversely affect the performance of the test and/or invalidate the test result.
This is an exclusively presumed test. In case of positive result, it is necessary to immediately undergo a laboratory PCR test and a clinical follow-up.
Negative results may occur if the antigen level in a sample is lower than the test detection limit. It is recommended to repeat the test after 1-2 days if you suspect an ongoing infection, if you are in a high-risk environment or where there is a professional risk, or you have a well-known exposure to COVID-19.
Negative results do not exclude SARS-CoV-2 infection. If symptoms similar to those from COVID-19 occur, it is necessary to immediately undergo a further laboratory PCR test.
The positive results of the test do not exclude co-infections with other pathogenic agents.
A positive result cannot determine whether a person is contagious.
Conservation
Store in the sealed envelope at a temperature of 4-30 °C.
Validity of whole packaging: 24 months.
Format
The kit contains:
- 1 test box;
- 1 test tube containing extraction reagent;
- 1 buffer;
- 1 bag of disposal;
- 1 instructions for use.
Cod. ISCOVU002-B00
Lateral flow immunodose method for qualitative detection of SARS-CoV-2 nucleocapside antigen in the nasal buffer of subjects with symptoms or other epidemiological reasons that suspect COVID-19 infection.
The test is intended for use by non-professional subjects from 15 years and, depending on the case, by adults to test another subject under 15 years. Subjects over 65 years must require assistance in carrying out the test.
The test provides only a preliminary screening result for the SARS-CoV-2 virus. The positive results must be confirmed through a PCR test performed in the laboratory.
People with a negative test result that continue to manifest symptoms similar to those from COVID-19 must contact the doctor.
Mode of use
Test preparation
Make sure all test components are at room temperature (15-30 °C).
Keep a clock at your fingertips, timer or timer.
Make sure the package is integrated. Do not use the test if the packaging is damaged in a visible way.
Open the box for the test only when using. Use the test box within an hour of opening the package.
Wash your hands with soap and water and dry them thoroughly.
Test execution
Open the test tube containing the extraction reagent carefully removing the film. Insert the tube into the rack (hole present on the package).
Remove the pad from the envelope: open the box from the end of the stick. Don't touch the swab head. Remove the swab and gently insert the whole swab head into the nostril, at a depth of about 2.5 cm. Rotate the swab against the wall of the nostril for at least 5 times. Remove the pad, insert it into the other nostril and repeat the same operation. Carefully carry out this operation: negative false results may occur if the nasal buffer is not executed properly.
Insert the swab into the test tube containing the extraction reagent. Rotate the swab 5 times inside the reagent, pressing the swab head against the bottom and side of the test tube. leave the buffer in the reagent for 1 minute. Remove the swab by pressing the sides of the tube so that the liquid can be removed from the buffer. Close the test tube well.
Open the sealed envelope containing the test box and extract it. Put the test box on a flat surface.
Keep the test tube vertically above the sample well and add 3 drops in the well, gently pressing the sides of the test tube. A negative false result may occur if you add less than 3 drops of sample in the well. The result will not be affected if you add 1-2 extra sample drops, provided you can read the control line (C).
Start the clock/chronometer or timer. Read the test result after 15-20 minutes, do not read the result if more than 20 minutes have passed. Erroneous results may occur if the test results are read before 15 minutes or after 20 minutes.
Once the test runs, collect the parts of the used kit and the pad samples in a disposal bag and dispose of them with household waste. Wash your hands thoroughly after handling.
Interpretation of results
- POSITIVE: Two lines appear, the control line (C) and the test line (T). The color intensity of the test line (T) can be very weak, the result is however to be interpreted positive. A positive result of the test indicates that the COVID-19 disease is likely to occur. It is necessary to undergo a laboratory PCR test as soon as possible to confirm the diagnosis of COVID-19 and follow the local guidelines for isolation in order to avoid transmission of the virus to others.
- NEGATIVE: only a colored line appears, the control line (C). The test line (T) does not appear. A negative test result indicates that there is probably no COVID-19 disease. Even if you get a negative result, you have to follow all the guidelines to limit the spread of COVID-19. If symptoms develop or if symptoms persist, undergo a laboratory PCR test. If an infection is suspected, it is recommended to repeat the test after 1–2 days, since the virus cannot be accurately detected at all stages of the infection.
- NOT VALIDO: the control line (C) does not appear. The test result is not valid regardless of whether or not the test line (T). Repeat the test with a new cassette or contact your doctor.
Warnings
Only for in vitro diagnostics.
Do not use this test as the only basis for COVID-19 infection management. Please consult a health care professional at any time if symptoms persist or worsen, or if you fear for your health.
Negative results may occur if the test is not performed within the first 7 days of the symptoms manifestation.
The test on a subject under the age of 15 must be performed by an adult.
Keep out of reach of children to reduce the risk of accidentally drinking reagent or ingesting small parts.
Do not use after the expiry date.
The test is disposable and can only be used with the components provided.
Do not test in direct sunlight.
Avoid contact with the extraction reagent. In cases of inhalation, ingestion or exposure of the skin or eyes to the extraction reagent, immediately take first aid measures in accordance with the safety card (SDS).
The test requires a sample from the nasal cavity. When performing the test, pay special attention to the instructions on how to perform the buffer. The incorrect execution of sampling may result incorrectly. This is particularly important in case of no symptoms.
The test box must remain in the sealed envelope until use.
Wash your hands thoroughly before and after the test.
The test must be used only for the qualitative detection of SARS-CoV-2 antigens in samples taken with nasal swab.
The intensity of the test line is not necessarily related to the viral title of SARS-CoV-2 in the sample.
Failure to comply with "Instruments for Use" may adversely affect the performance of the test and/or invalidate the test result.
This is an exclusively presumed test. In case of positive result, it is necessary to immediately undergo a laboratory PCR test and a clinical follow-up.
Negative results may occur if the antigen level in a sample is lower than the test detection limit. It is recommended to repeat the test after 1-2 days if you suspect an ongoing infection, if you are in a high-risk environment or where there is a professional risk, or you have a well-known exposure to COVID-19.
Negative results do not exclude SARS-CoV-2 infection. If symptoms similar to those from COVID-19 occur, it is necessary to immediately undergo a further laboratory PCR test.
The positive results of the test do not exclude co-infections with other pathogenic agents.
A positive result cannot determine whether a person is contagious.
Conservation
Store in the sealed envelope at a temperature of 4-30 °C.
Validity of whole packaging: 24 months.
Format
The kit contains:
- 1 test box;
- 1 test tube containing extraction reagent;
- 1 buffer;
- 1 bag of disposal;
- 1 instructions for use.
Cod. ISCOVU002-B00
