Descrizione Clinica
Diagnostics - Flowflex sars-cov-2 autot tpp diagnostics
Flow
SARS-CoV-2 Antigen Rapid Test
(Self-Testing)
Description
Lateral flow test for the qualitative detection of the nucleocapside antigen from SARS-CoV-2 in front nasal swab samples directly from suspected COVID-19 individuals within the first seven days from the beginning of the symptoms.
The test can be used to analyze samples of asymptomatic subjects.
It does not distinguish between SARS-CoV and SARS-CoV-2.
The results relate to the identification of the SARS-CoV-2 antigen. This antigen is generally found in the samples taken from the upper respiratory tract during the acute phase of the infection.
The test results are visually read in the range of the next 15-30 minutes, depending on the presence or absence of colored lines.
Positive results indicate the presence of viral antigens, but to determine the state of the infection the anamnesi and other personal diagnostic data are necessary. The positive results do not exclude the presence of bacterial infections or simultaneous infection with other viruses. The pathogen detected may not be the exact cause of pathology.
The negative results obtained on subjects with symptoms that have appeared for over seven days should be treated as negative odds. If necessary, look for confirmation through a molecular analysis. Negative results do not exclude SARS-CoV-2 infection.
A coloured line, with a procedural control function, will always appear in the area of the control line, to indicate that a sufficient sample volume has been inserted and that the absorption of the membrane has occurred.
The test is intended for use as a support for the diagnosis of SARS-CoV-2 infection.
It was not determined the usability of autonomous tests carried out by subjects who were not 18 years old. It is recommended that children under 18 are tested by an adult.
Mode of use
1. Preparation:
Wash or disinfect your hands. Make sure they are dry before starting the test.
Before using the test kit, read the instructions carefully.
Check the printed expiration date on the film envelope. Open the envelope. Check the result window and sample cockpit on the cassette.
2. Sample withdrawal:
The autonomous withdrawal with nasal swab can be performed by those who are 18 years old. Children under 18 must be followed by a parent or legal guardian. Follow the local guidelines for sampling by children.
3. Analysis procedure:
Avoid the dropper cap from the test tube of the extraction solution without crushing it. Insert the pipe into the hole on the kit box (or place the tube in the pipe holder).
Open the box at the end of the stick. Do not touch the absorbent tip of the tampon with your hands.
Insert the whole tampon absorbent tip into a nostril. Using a slight rotation, push the pad less than 2.5 cm from the edge of the nostril. Rotate the swab 5 times touching slightly inside the nostril. Extract the tampon, insert it into the other nostril and repeat the procedure.
Extract the swab and insert it into the tube, making it carry out a circular motion for 30 seconds. Rotate the swab 5 times, compress the sides of the tube at the same time. Extract the tampon while compressing the tube.
Secure the dropper tip firmly on the extraction pad test containing the sample. Mix carefully by turning or touching the bottom of the tube. Unscrew the small cap from the end of the dropper. Gently compress the test tube and deliver 4 drops of solution in the sample well.
Read the result when the timer has reached 15-30 minutes. Don't read if it's been 30 minutes.
4. Interpretation of results:
NEGATIVE: Only the control line (C) and no test line (T) appears. It means that no SARS-CoV-2 antigen has been detected.
A negative result of the analysis indicates that it is unlikely that it is currently affected by COVID-19.
Continue to comply with all applicable rules and protection measures when contacting other persons. There may be an infection in place even if the test is negative. If you suspect it, repeat the test after 1 or 2 days, since the coronavirus cannot be accurately detected at all stages of the infection.
POSITIVE: both the control line (C) and the test line (T) appear. It means that the SARS-CoV-2 antigen has been detected (Note: any line, even very weak, present in the area of the test line must be considered positive).
The positive result of the test indicates a very high probability that the COVID-19 infection is in place. Please contact your doctor/basic doctor or local health care institution immediately. Follow the local self-isolation guidelines. A PCR test must be performed.
NOT VALIDO: the control line (C) does not appear. The most likely reasons for the invalid result are insufficient sample volume or incorrect procedure. Reread the instructions and repeat the test with a new cassette.
If the test results continue to be invalid, please contact your doctor or a center that tests for COVID-19.
Warnings
Before running the test, carefully read the leaflet. Non-compliance with indications can result in inaccurate test results.
Do not use the test after the expiration date shown on the envelope.
Do not eat, drink or smoke before and during the test.
Do not use the test if the envelope is damaged.
All tests used, samples and potentially contaminated material must be disposed of according to local regulations.
Humidity and temperature can adversely affect results.
The test line for a sample with high viral charge may appear within 15 minutes or even before, when the sample exceeds the test line area.
The test line for a sample with low viral charge may appear within 30 minutes.
Do not collect the nasal swab sample in case of bleeding from the nose.
Wash your hands thoroughly after use.
If the extraction pad accidentally comes in contact with the skin or eyes, rinse with large amounts of water and consult your doctor if necessary.
The test is only for auto-test: it should only be used for detecting the nucleocapsidic antigen from SARS-CoV-2 in front nasal swab samples.
The intensity of the test line is not necessarily related to the SARS-CoV-2 viral charge in the sample.
A negative false test could be obtained if the antigen concentration in a sample was lower than the test detection limit or if the sample was incorrectly collected.
The results of the analysis must be observed in the face of other clinical data available to the doctor.
The positive results do not exclude the presence of joint infections caused by other pathogens. The positive results do not exclude between SARS-CoV and SARS-CoV-2.
The negative results of the test do not exclude the presence of other viral or bacterial infections. A negative result obtained on a subject with symptoms appearing over 7 days should be treated as likely negative and, if necessary, check through molecular analysis.
Conservation
Store at a temperature between 2 °C and 30 °C. Don't freeze.
The test is stable until the expiry date printed on the sealed envelope. Do not use after the expiry date.
The test must remain in the sealed envelope until its use.
Validity of whole packaging: 24 months.
Format
The kit contains:
- 1 test cassette
- 1 test of the extraction pad
- 1 disposable tampon
- 1 waste bag
- leaflet
Bibliography
1. Shuo Su, Gary Wong, Weifeng Shi, et al. Epidemiology, Genetic recombination, and pathogenesis of coronaviruses. Trends in Microbiology, June 2016, vol. 24, No. 6:490-502
2. Susan R. Weiss, Julian L. Leibowitz, Coronavirus Pathogenesis, Advances in Virus Research, Volume 81: 85-164
Lateral flow test for the qualitative detection of the nucleocapside antigen from SARS-CoV-2 in front nasal swab samples directly from suspected COVID-19 individuals within the first seven days from the beginning of the symptoms.
The test can be used to analyze samples of asymptomatic subjects.
It does not distinguish between SARS-CoV and SARS-CoV-2.
The results relate to the identification of the SARS-CoV-2 antigen. This antigen is generally found in the samples taken from the upper respiratory tract during the acute phase of the infection.
The test results are visually read in the range of the next 15-30 minutes, depending on the presence or absence of colored lines.
Positive results indicate the presence of viral antigens, but to determine the state of the infection the anamnesi and other personal diagnostic data are necessary. The positive results do not exclude the presence of bacterial infections or simultaneous infection with other viruses. The pathogen detected may not be the exact cause of pathology.
The negative results obtained on subjects with symptoms that have appeared for over seven days should be treated as negative odds. If necessary, look for confirmation through a molecular analysis. Negative results do not exclude SARS-CoV-2 infection.
A coloured line, with a procedural control function, will always appear in the area of the control line, to indicate that a sufficient sample volume has been inserted and that the absorption of the membrane has occurred.
The test is intended for use as a support for the diagnosis of SARS-CoV-2 infection.
It was not determined the usability of autonomous tests carried out by subjects who were not 18 years old. It is recommended that children under 18 are tested by an adult.
Mode of use
1. Preparation:
Wash or disinfect your hands. Make sure they are dry before starting the test.
Before using the test kit, read the instructions carefully.
Check the printed expiration date on the film envelope. Open the envelope. Check the result window and sample cockpit on the cassette.
2. Sample withdrawal:
The autonomous withdrawal with nasal swab can be performed by those who are 18 years old. Children under 18 must be followed by a parent or legal guardian. Follow the local guidelines for sampling by children.
3. Analysis procedure:
Avoid the dropper cap from the test tube of the extraction solution without crushing it. Insert the pipe into the hole on the kit box (or place the tube in the pipe holder).
Open the box at the end of the stick. Do not touch the absorbent tip of the tampon with your hands.
Insert the whole tampon absorbent tip into a nostril. Using a slight rotation, push the pad less than 2.5 cm from the edge of the nostril. Rotate the swab 5 times touching slightly inside the nostril. Extract the tampon, insert it into the other nostril and repeat the procedure.
Extract the swab and insert it into the tube, making it carry out a circular motion for 30 seconds. Rotate the swab 5 times, compress the sides of the tube at the same time. Extract the tampon while compressing the tube.
Secure the dropper tip firmly on the extraction pad test containing the sample. Mix carefully by turning or touching the bottom of the tube. Unscrew the small cap from the end of the dropper. Gently compress the test tube and deliver 4 drops of solution in the sample well.
Read the result when the timer has reached 15-30 minutes. Don't read if it's been 30 minutes.
4. Interpretation of results:
NEGATIVE: Only the control line (C) and no test line (T) appears. It means that no SARS-CoV-2 antigen has been detected.
A negative result of the analysis indicates that it is unlikely that it is currently affected by COVID-19.
Continue to comply with all applicable rules and protection measures when contacting other persons. There may be an infection in place even if the test is negative. If you suspect it, repeat the test after 1 or 2 days, since the coronavirus cannot be accurately detected at all stages of the infection.
POSITIVE: both the control line (C) and the test line (T) appear. It means that the SARS-CoV-2 antigen has been detected (Note: any line, even very weak, present in the area of the test line must be considered positive).
The positive result of the test indicates a very high probability that the COVID-19 infection is in place. Please contact your doctor/basic doctor or local health care institution immediately. Follow the local self-isolation guidelines. A PCR test must be performed.
NOT VALIDO: the control line (C) does not appear. The most likely reasons for the invalid result are insufficient sample volume or incorrect procedure. Reread the instructions and repeat the test with a new cassette.
If the test results continue to be invalid, please contact your doctor or a center that tests for COVID-19.
Warnings
Before running the test, carefully read the leaflet. Non-compliance with indications can result in inaccurate test results.
Do not use the test after the expiration date shown on the envelope.
Do not eat, drink or smoke before and during the test.
Do not use the test if the envelope is damaged.
All tests used, samples and potentially contaminated material must be disposed of according to local regulations.
Humidity and temperature can adversely affect results.
The test line for a sample with high viral charge may appear within 15 minutes or even before, when the sample exceeds the test line area.
The test line for a sample with low viral charge may appear within 30 minutes.
Do not collect the nasal swab sample in case of bleeding from the nose.
Wash your hands thoroughly after use.
If the extraction pad accidentally comes in contact with the skin or eyes, rinse with large amounts of water and consult your doctor if necessary.
The test is only for auto-test: it should only be used for detecting the nucleocapsidic antigen from SARS-CoV-2 in front nasal swab samples.
The intensity of the test line is not necessarily related to the SARS-CoV-2 viral charge in the sample.
A negative false test could be obtained if the antigen concentration in a sample was lower than the test detection limit or if the sample was incorrectly collected.
The results of the analysis must be observed in the face of other clinical data available to the doctor.
The positive results do not exclude the presence of joint infections caused by other pathogens. The positive results do not exclude between SARS-CoV and SARS-CoV-2.
The negative results of the test do not exclude the presence of other viral or bacterial infections. A negative result obtained on a subject with symptoms appearing over 7 days should be treated as likely negative and, if necessary, check through molecular analysis.
Conservation
Store at a temperature between 2 °C and 30 °C. Don't freeze.
The test is stable until the expiry date printed on the sealed envelope. Do not use after the expiry date.
The test must remain in the sealed envelope until its use.
Validity of whole packaging: 24 months.
Format
The kit contains:
- 1 test cassette
- 1 test of the extraction pad
- 1 disposable tampon
- 1 waste bag
- leaflet
Bibliography
1. Shuo Su, Gary Wong, Weifeng Shi, et al. Epidemiology, Genetic recombination, and pathogenesis of coronaviruses. Trends in Microbiology, June 2016, vol. 24, No. 6:490-502
2. Susan R. Weiss, Julian L. Leibowitz, Coronavirus Pathogenesis, Advances in Virus Research, Volume 81: 85-164
