Sars-cov-2 and influenza a/b - self-testing nasal swab

Product Description

Rapid antigen test for the qualitative detection of SARS-CoV-2 antigens and influenza A and B nucleoproteins in nasal swab specimens.

Characteristics

JusChek rapid test for the qualitative detection of SARS-CoV-2 nucleocapsid protein antigens and influenza A and B nucleoproteins in nasal swab specimens.

The test is intended for use in symptomatic/asymptomatic individuals with suspected COVID-19 and/or influenza A/B infection.

Results indicate the detection of SARS-CoV-2 nucleocapsid protein antigens and influenza A and B nucleoproteins. An antigen is generally detectable in upper respiratory tract specimens during the acute phase of infection.

Positive results indicate the presence of antigens viral, but clinical correlation with the patient's medical history and other diagnostic information is necessary to determine the infection status. Positive results are indicative of the presence of SARS-CoV-2 and/or influenza A/B. Individuals who test positive should self-isolate and contact their healthcare provider for additional care. A positive result does not rule out the presence of a bacterial infection or co-infection with other viruses.

A negative result does not rule out the presence of SARS-CoV-2 and/or influenza A/B infection. Individuals who test negative and continue to exhibit symptoms of COVID-19 or influenza should contact their healthcare provider for additional care.

For in vitro self-testing.

How to use

Sample collection
Wash your hands with soap and water for at least 20 seconds before and after testing. If soap and water are not available, use a hand sanitizer with at least 60% alcohol.
Remove the sterile swab from the pouch. Do not touch the soft end of the swab. Insert the swab into the nostril until you feel slight resistance (about 2 cm deep into the nasal cavity). Slowly rotate the swab, rubbing it along the inside of the nostril 5-10 times. This may be uncomfortable. If you feel severe resistance or pain, do not insert the swab any deeper.
If the nasal mucosa is damaged or bleeding, nasal swabbing is not recommended.
If you are swabbing someone else, wear a mask.
With children, it may not be necessary to insert the swab this far into the nostril. For very young children, another person may be needed to hold the child's head during the swab collection.
Gently remove the swab. Using the same swab, repeat the process in the other nostril.
Extract the swab.

Sample Preparation
Remove the lid from the extraction buffer tube and place the tube in the tube holder in the box.
Place the swab in the extraction tube, making sure it touches the bottom, and swirl the swab to mix well. Press the tip of the swab against the tube and rotate the swab for 10-15 seconds. Remove the swab by pressing the tip of the swab against the inside wall of the extraction tube.
Place the swab in a plastic bag. Close the extraction tube.

Testing
Remove the test cassette from the sealed foil pouch and use it within one hour. The most accurate results are obtained by pressing the tip of the swab against the inside wall of the extraction tube.
Place the swab in a plastic bag. Close the extraction tube.

Testing
Remove the test cassette from the sealed foil pouch and use it within one hour. The most accurate results are obtained by pressing the tip of the swab against the inside wall of the extraction tube. Reliable results are obtained if the test is performed immediately after opening the pouch.
Place the test cassette on a flat, even surface. Invert the specimen extraction tube and add 3 drops of extracted specimen to each well (S) of the test cassette, then start the timer. Do not move the cassette during the test.
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 local COVID-19 guidelines/requirements.

• POSITIVE for SARS-CoV-2: One colored line should be in the control region (C) and the other in the test region (T). The intensity of the color in the test region (T) will vary based on the amount of SARS-CoV-2 antigen present in the specimen. Therefore, any shade of color in the test area (T) should be considered a positive result.
  A positive result most likely indicates the presence of a COVID-19 infection, but this result must be confirmed by further testing. Immediately self-isolate in accordance with local guidelines and contact your primary care physician or local health department immediately following the instructions provided by local authorities. Your test result will be validated with a confirmatory PCR test and the next steps will be explained.
• POSITIVE for influenza A: Two colored lines appear in the FLU A+B window. One colored line should be in the control area (C) and the other in the influenza A area (A). The intensity of the color in the test area (A) will vary depending on the amount of influenza A antigen in the sample. Therefore, any shade of color in the test area (A) should be considered a positive result.
  A positive result most likely indicates the presence of an influenza A infection, but this result must be confirmed by further testing. Immediately self-isolate in accordance with local guidelines and contact your GP or local health service immediately following the instructions provided by local authorities. Your test result will be validated with a confirmatory PCR test and the next steps will be explained.
• POSITIVE for influenza B: Two colored lines appear in the FLU A+B window. One colored line should be in the control area (C) and the other in the influenza B area (B). The intensity of the color in the test area (B) will vary depending on the amount of influenza B antigen in the sample. Therefore, any shade of color in the test area (B) should be considered a positive result.
  A positive result most likely indicates the presence of an influenza B infection, but this result must be confirmed by further testing. Immediately self-isolate in accordance with local guidelines and contact your GP or local health service immediately following the instructions provided by local authorities. Your test result will be validated with a confirmatory PCR test and the next steps will be explained.
• POSITIVE for influenza A and influenza B: Three colored lines appear in the FLU A+B window. One colored line should be in the control area (C) and the other two should be in the influenza A (A) and influenza B (B) areas. The intensity of the color in the test area (A/B) will vary depending on the amount of influenza A/B antigen in the sample. Therefore, any shade of color in the test area (A/B) should be considered a positive result.
  A positive result most likely indicates the presence of an influenza A and influenza B infection, but this result must be confirmed by further testing. Immediately self-isolate in accordance with local guidelines and contact your GP or local health service immediately following the instructions provided by local authorities. The test result will be validated with a confirmatory PCR test and the next steps will be explained.
• NEGATIVE: A colored line appears in the control area (C). No obvious colored line appears in the test area (T/B/A).
  It is unlikely that COVID-19 and/or influenza A/influenza B infection is present. However, this test may give an incorrect negative result (false negative) in some people with COVID-19 and/or influenza A/influenza B. This is because the test results are not accurate. This means that the person may have a COVID-19 and/or influenza A/influenza B infection even if the test result is negative. Additionally, the test can be repeated with a new kit.
  If infection is suspected, repeat the test after 1-2 days, as it is not possible to accurately detect the coronavirus/influenza virus at all stages of infection.
  Even if the test result is negative, it is necessary to comply with the rules regarding distancing and hygiene, travel, attendance at events, and so on, according to local COVID-19/influenza guidelines/requirements.
• INVALID: The control line does not appear. The most common causes of infection are: Failure of the control line to appear is likely due to insufficient specimen volume or incorrect procedural techniques.
  Reread the instructions and repeat the test using a new kit, or contact a COVID-19/influenza testing center.

Warnings

For in vitro self-testing only. Do not use beyond the expiration date.
Read all information in the package insert before testing.
Do not eat, drink, or smoke in the area where specimens or kits are handled.
Do not drink the extraction solution contained in the kit. Handle the extraction solution with care and avoid contact with skin or eyes; In case of contact, rinse immediately with plenty of running water.
If the aluminum package is damaged or has been opened, do not use the product.
This test kit should only be used as a preliminary test and repeatedly abnormal results should be discussed with your doctor or healthcare professional.
Strictly adhere to the indicated times.
Use the test only once. Do not disassemble or touch the test cassette window.
The kit should not be frozen or used after the expiration date printed on the package.
In children, the test must be performed with the help of an adult.
Wash your hands thoroughly before and after handling.
Make sure to use an appropriate amount of sample for the test. Excessive or insufficient sample quantity may cause biased results.
Performance has been evaluated only with nasal swab samples, using the procedures described in the package insert.
The test indicates only the presence of SARS-CoV-2 and/or influenza A/influenza B antigens in the sample.
If the test result is negative or nonreactive and clinical symptoms persist, the virus may not be detected in the very early stages of infection. Repeating the test with a new device or a molecular diagnostic tool is recommended to rule out infection in these individuals. Negative results do not rule out SARS-CoV-2 infection, especially in those who have been in contact with the virus. To rule out infection in these individuals, a confirmatory molecular test should be considered.
A negative result for influenza A or influenza B obtained from this kit must be confirmed by culture/RT-PCR.
Positive COVID-19 results may be due to infection with non-SARS-CoV-2 coronavirus strains or other interfering factors. A positive result for influenza A and/or B does not rule out co-infection with another pathogen, therefore the possibility of an underlying bacterial infection should be considered.
Failure to follow test procedures may alter test performance.
If a specimen is collected or handled improperly, the test may yield false-negative results.
If the specimen contains virus levels below the test's detection limit, the test may yield false-negative results.

Storage

Store in the sealed pouch 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.
Shelf life with intact packaging: 24 months.

Format

The kit contains:

• test cassette;
• sterile swab;
• instruction leaflet;
• extraction solution.