Descrizione Clinica
JusChek
Rapid Test for SARS-CoV-2 Antigen
Nasal Swab
Description
Single-use test intended to detect SARS-CoV-2 that causes COVID-19 with self-collected nasal swab specimens from symptomatic individuals suspected of being infected with 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. 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 can 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 during the swab withdrawal.
Gently remove the pad. Using the same swab, repeat the procedure in the other nostril.
Retract the sterile tampon.
Sample preparation
Place the swab in the extraction tube, make sure it touches the bottom and shake the swab to mix well.Press the head of the swab against the tube and rotate the swab for 10-15 seconds.Remove the swab by pressing the head of the swab against the inside of the extraction tube.Place the swab in the biosafety bag.Close the cap of the extraction tube.
Test procedure
Remove the test box from sealed aluminum envelope and use it within an hour. The best results are obtained if the test is performed immediately after the opening of the aluminum envelope.
Place the test box on a flat surface.
Open the small cap and turn the sample extraction test. Add 3 drops of sample extracted in the test box sample (S) well and start the timer.
Do not move the test box while developing the test.
Read the result after 15 minutes. Do not read the result after 20 minutes.
At the end of the test, put all the components in a bio-safety bag in plastic and dispose according to local regulations.
Reading results
Please share the test result with your healthcare provider and carefully follow the local guidelines/requirements for COVID cases.
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 contracted 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.
NEGATIVO: a single coloured line appears in the control area (C) and no coloured line appears in the test region (T). It is unlikely that the person has contracted COVID-19. However, it is possible that the 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 healthcare 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 line in the control area does not appear. An insufficient volume of sample or incorrect procedural 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
Read all the information contained in the package leaflet before testing.
Only for self-diagnostic use in vitro. Do not use after the expiry date.
Do not eat, drink or smoke in the area where you manipulate samples or kits.
Do not drink the buffer solution contained in the kit. Handle carefully and avoid contact with the skin or eyes. In case of contact, rinse immediately with plenty of running water.
Keep in a dry place, avoiding areas of excessive humidity. Do not use if the foil packaging is damaged or has been opened.
This 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 timing indicated.
Use the test once. Do not disassemble and touch the test window of the test box.
The kit should not be frozen.
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 pad with the help of a second adult.
Please ensure that an adequate amount of test samples is collected. Too much or too little sample, can lead to incorrect results.
The test indicates only the presence of SARS-CoV-2 antigens in the sample.
If the result is negative or non-reactive and clinical symptoms persist, it is because the virus may not be detectable at the early stage of the infection. Repeat the test with a new kit or perform a molecular diagnostic test 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. Molecular diagnostic control tests should be taken into consideration 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 follow test procedures may impair test performance.
Fake negative results can occur if the sample is collected improperly or if the level of antigens present in the sample is lower than the minimum limit of test detection.
Conservation
Store at room temperature or refrigerated (2-30°C). Do not freeze.
The test is stable until the expiration date printed on the sealed pouch.The test must remain in the sealed pouch until use.
Validity with intact packaging: 24 months.
Format
The kit contains:
- 1 test box;
- 1 sterile swab;
- 1 extraction pad;
- 1 leaflet;
- 1 bag of bio-security.
Bibliography
Diagnosis and Treatment Protocol for Novel Coronavirus Pneumonia (Trial Version 7). National Health Commission & National Administration of Traditional Chinese Medicine. 2020.
Cod. INCP-502H
Single-use test intended to detect SARS-CoV-2 that causes COVID-19 with self-collected nasal swab specimens from symptomatic individuals suspected of being infected with 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. 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 can 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 during the swab withdrawal.
Gently remove the pad. Using the same swab, repeat the procedure in the other nostril.
Retract the sterile tampon.
Sample preparation
Place the swab in the extraction tube, make sure it touches the bottom and shake the swab to mix well.Press the head of the swab against the tube and rotate the swab for 10-15 seconds.Remove the swab by pressing the head of the swab against the inside of the extraction tube.Place the swab in the biosafety bag.Close the cap of the extraction tube.
Test procedure
Remove the test box from sealed aluminum envelope and use it within an hour. The best results are obtained if the test is performed immediately after the opening of the aluminum envelope.
Place the test box on a flat surface.
Open the small cap and turn the sample extraction test. Add 3 drops of sample extracted in the test box sample (S) well and start the timer.
Do not move the test box while developing the test.
Read the result after 15 minutes. Do not read the result after 20 minutes.
At the end of the test, put all the components in a bio-safety bag in plastic and dispose according to local regulations.
Reading results
Please share the test result with your healthcare provider and carefully follow the local guidelines/requirements for COVID cases.
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 contracted 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.
NEGATIVO: a single coloured line appears in the control area (C) and no coloured line appears in the test region (T). It is unlikely that the person has contracted COVID-19. However, it is possible that the 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 healthcare 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 line in the control area does not appear. An insufficient volume of sample or incorrect procedural 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
Read all the information contained in the package leaflet before testing.
Only for self-diagnostic use in vitro. Do not use after the expiry date.
Do not eat, drink or smoke in the area where you manipulate samples or kits.
Do not drink the buffer solution contained in the kit. Handle carefully and avoid contact with the skin or eyes. In case of contact, rinse immediately with plenty of running water.
Keep in a dry place, avoiding areas of excessive humidity. Do not use if the foil packaging is damaged or has been opened.
This 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 timing indicated.
Use the test once. Do not disassemble and touch the test window of the test box.
The kit should not be frozen.
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 pad with the help of a second adult.
Please ensure that an adequate amount of test samples is collected. Too much or too little sample, can lead to incorrect results.
The test indicates only the presence of SARS-CoV-2 antigens in the sample.
If the result is negative or non-reactive and clinical symptoms persist, it is because the virus may not be detectable at the early stage of the infection. Repeat the test with a new kit or perform a molecular diagnostic test 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. Molecular diagnostic control tests should be taken into consideration 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 follow test procedures may impair test performance.
Fake negative results can occur if the sample is collected improperly or if the level of antigens present in the sample is lower than the minimum limit of test detection.
Conservation
Store at room temperature or refrigerated (2-30°C). Do not freeze.
The test is stable until the expiration date printed on the sealed pouch.The test must remain in the sealed pouch until use.
Validity with intact packaging: 24 months.
Format
The kit contains:
- 1 test box;
- 1 sterile swab;
- 1 extraction pad;
- 1 leaflet;
- 1 bag of bio-security.
Bibliography
Diagnosis and Treatment Protocol for Novel Coronavirus Pneumonia (Trial Version 7). National Health Commission & National Administration of Traditional Chinese Medicine. 2020.
Cod. INCP-502H
