Flowflex - 1 sars-cov-2 nasal swab rapid antigen test

Product Description

Nevia Biotech Rapid Antigen Test for SARS-CoV-2 is a rapid test for the detection of SARS-CoV-2 nucleocapsid antigens in anterior nasal swab specimens. For in vitro diagnostic use only. For self-testing.

Indications

The SARS-CoV-2 Rapid Antigen Test is a lateral flow test for the qualitative detection of SARS-CoV-2 nucleocapsid antigen in anterior nasal swab specimens directly from individuals suspected of having COVID-19 within the first seven days of symptom onset.
The test can be used to analyze specimens from asymptomatic subjects.
It does not distinguish between SARS-CoV and SARS-CoV-2.
The results are for the identification of SARS-CoV-2 antigen.
This antigen is generally found in specimens taken from the upper respiratory tract during the acute phase of infection.
Positive results indicate the presence of viral antigens, but a history and other personal diagnostic tests are required to determine the infection status.
Positive results do not exclude the presence of bacterial infections or simultaneous infection with other viruses.
The detected pathogen may not be the exact cause of the disease.
Negative results obtained in subjects with symptoms that have been present for more than seven days should be treated as probable negative.
If necessary, seek confirmation through molecular analysis.
Negative results do not exclude SARS-CoV-2 infection.
The SARS-CoV-2 rapid antigen test is intended for use as an aid in the diagnosis of SARS-CoV-2 infection. The usability of self-testing by subjects under 18 years of age has not been established.
It is recommended that children under 18 years of age be tested by an adult.
The SARS-CoV-2 Rapid Antigen Test is a test for the detection of SARS-CoV-2 nucleocapsid antigen in human anterior nasal swab specimens.
Test results are read visually over the next 15-30 minutes, based on the presence or absence of colored lines.
A colored procedural control line will always appear in the control line area, indicating that sufficient specimen volume has been added and membrane absorption has occurred.

Directions for Use and Dosage

Wash or disinfect your hands. Make sure they are dry before starting the test.
Before using the SARS-CoV-2 Rapid Antigen Test kit, read the instructions.
Check the expiration date printed on the foil pouch.

Specimen Collection

Self-Collection: Self-collection with a nasal swab can be performed by anyone 18 years of age or older. Children under 18 must be performed by a parent or legal guardian. Follow local guidelines for specimen collection from children.

Test Procedure

1. Remove the aluminum foil from the top of the extraction swab tube.
2. Insert the tube into the hole on the kit box.
   Or place the tube in the tube holder.
3. Open the swab package at the end of the swab.
   Do not touch the absorbent tip of the swab with your hands.
4. Insert the entire absorbent tip of the swab into one nostril.
   Using a gentle twist, push the swab within 2.5 cm of the edge of the nostril.
5. Rotate the swab 5 times while lightly touching the inside of the nostril.
   Withdraw the swab and insert it into the other nostril.
   Repeat step 4.
6. Withdraw the swab from the nostril.
7. Insert the swab into the tube, circling for 30 seconds.
8. Rotate the swab 5 times, while squeezing the side of the tube.
9. Withdraw the swab while squeezing the tube.
10. Firmly attach the dropper tip to the extraction buffer tube containing the specimen. Mix thoroughly by swirling or tapping the bottom of the tube.
11. Gently squeeze the tube and dispense 4 drops of solution into the sample well.
12. Read the result after the timer reaches 15-30 minutes.
    Do not read if 30 minutes have passed.

Interpretation of Results

• Positive: Both the control line (C) and the test line (T) appear.
  This means that SARS-CoV-2 antigen has been detected.
  Any line, even a very faint one, in the test line area (T) should be considered positive.
  A positive result indicates a very high probability that you have COVID-19.
  Contact your doctor/GP or local health authority immediately.
  Follow local guidelines regarding self-isolation.
  A confirmatory PCR test must be performed.
• Negative: Only the control line (C) appears and no test line (T).
  This means that no SARS-CoV-2 antigen has been detected.
  A negative test result indicates that it is unlikely that you currently have COVID-19. Continue to follow all applicable rules and protective measures when in contact with other people. You may still have an infection even if your test is negative.
  If you suspect this, repeat the test after 1 or 2 days, as the coronavirus cannot be accurately detected at all stages of infection.
• Invalid: The control line (C) does not appear.
  The most likely reasons for an invalid result are insufficient specimen volume or incorrect testing procedure.
  Reread the instructions and repeat the test with a new cassette.
  If the test results continue to be invalid, contact your healthcare provider or a COVID-19 testing center.

Warnings

Before testing, carefully read the package insert for the SARS-CoV-2 rapid antigen test.
Failure to follow these instructions may result in inaccurate test results.
Do not use the test after the expiration date printed on the pouch.
Do not eat, drink, or smoke before and during testing.
Do not use the test if the pouch is damaged.
All used tests, specimens, and potentially contaminated materials must be disposed of according to local regulations. Humidity and temperature may adversely affect results.
The test line for a sample with a high viral load may appear within 15 minutes or even sooner when the sample exceeds the test line area.
The test line for a sample with a low viral load may appear within 30 minutes.
Do not collect the nasal swab specimen if you have a nosebleed.
Wash your hands thoroughly after use.
If the extraction swab accidentally contacts your skin or eyes, rinse with large amounts of water and consult a doctor if necessary.
Do not freeze.
For self-testing only.
The test should only be used for the detection of SARS-CoV-2 nucleocapsid antigen in anterior nasal swab specimens.
The intensity of the test line does not necessarily correlate with the SARS-CoV-2 viral load in the specimen.
A false negative result may be obtained if the antigen concentration in a sample is below the test's detection limit or if the sample was collected incorrectly.
Test results must be considered in conjunction with other clinical data available to the physician.
Positive results do not exclude the presence of joint infections caused by other pathogens and do not distinguish between SARS-CoV and SARS-CoV-2.
Negative test results do not exclude the presence of other viral or bacterial infections.
A negative result obtained in a subject with symptoms appearing more than seven days previously should be considered probable negative and, if necessary, verified by molecular analysis.

Storage

Store in a cool, dry place, between 2°C and 30°C.
Keep away from light.

Format

The kit contains:

1 test cassette;
1 extraction swab tube;
1 disposable swab;
1 waste bag;
1 package insert.