SARS-COV-2 and influenza A+B rapid antigen test - self-test

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

For self-diagnostic use.

The SARS-CoV-2 and Influenza A/B Rapid Combined Antigen Test (Nasal Swab) is a single-use test kit intended to detect the SARS-CoV-2, influenza A, and influenza B viruses that cause COVID-19 and/or influenza in nasal swab specimens collected by self-sampling. The test is intended for use in symptomatic/asymptomatic individuals with suspected COVID-19 and/or influenza A/B infection.

The results indicate the detection of antigens of the nucleocapsid protein of SARS-CoV-2 and the nucleoproteins of influenza A and B. An antigen is generally detectable in upper respiratory specimens during the acute phase of infection. Positive results indicate the presence of viral antigens, but clinical correlation with patient history and other diagnostic information is needed to determine infection status.
Positive results are indicative of the presence of SARS-CoV-2 and/or influenza A/B. Individuals who test positive must self-isolate and contact their healthcare provider for additional assistance. A positive result does not rule out the presence of 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. People who test negative and continue to experience symptoms of COVID-19 or influenza should contact their healthcare provider for additional assistance.

How to 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 hand sanitizer with at least 60% alcohol.
Remove the tube cover with the extraction buffer solution and place the tube in the tube holder in the box.
Sample collection with nasal swab
1) Remove the sterile swab from the case. Do not touch the soft end of the pad.
2) Insert the swab into the nostril until you feel a slight resistance (about 2 cm in the nose). Slowly rotate the swab, rubbing it along the inside of the nostril 5-10 times against the nasal wall. Note: This may be annoying. If you feel severe resistance or pain, do not insert the pad deeper.
When the nasal mucosa is damaged or bleeding, nasal swab sampling is not recommended. If you take the sample from other people, wear a mask. With children, it may not be necessary to insert the swab as deeply into the nostril. For very young children, you may need another person to hold the child's head during the pickup.
3) Gently remove the swab.
4) Using the same swab, repeat in the other nostril.
5) Remove the swab.

Sample Preparation
1. Place the swab in the extraction tube, making sure it touches the bottom, and shake the swab to mix well. Press the swab tip against the tube and rotate the swab for 10-15 seconds.
2. Remove the swab by pressing the tip of the swab against the inside wall of the extraction tube.
3. Place the swab in a plastic bag.
4. Close the cap or place the tube closure on the tube.

Test Execution
1. Remove the test cassette from the sealed foil pouch and use it within one hour. The most reliable results are obtained if the test is performed immediately after opening the envelope.
Place the test cassette on a flat, even surface.
2. Turn the specimen extraction tube upside down and add 3 drops of extracted specimen to each well (S) of the test cassette, then start the timer. During the test, do not move the cassette.
3. Read the result after 10 minutes. Do not interpret the result after 20 minutes.
Note: After the test is complete, place all components in a plastic bag, seal it tightly, and dispose of it in accordance with local regulations.

Reading the results
Communicate your test results to your healthcare provider and carefully follow local COVID-19 guidelines/requirements.
SARS-CoV-2 POSITIVE:* Two colored lines appear in the COVID-19 window. One colored line should be in the control area (C) and the other in the test area (T).
POSITIVE for Influenza A:* Two colored lines are displayed in the FLU A+B window. One colored line should be in the control area (C) and the other in the area of influence A (A).
POSITIVE to Influence B:* Two colored lines are displayed in the FLU A+B window. One colored line must be in the control area (C) and the other in the area of influence B (B).

POSITIVE for Influenza A and Influenza B:* Three colored lines are displayed in the FLU A+B window. One colored line should be in the control area (C) and the other two in the area of influence A (A) and influence B (B).
*NOTE: The color intensity in the test area (T/B/A) will vary based on the amount of SARS-CoV-2 and/or influenza A/B antigen present in the specimen. Therefore, any color gradient in the test area (T/B/A) should be considered as a positive result.
A positive result is likely to indicate that you have a COVID-19 and/or influenza A and/or influenza B infection, but this result must be confirmed by further testing. Immediately self-isolate in accordance with local guidelines and contact your general practitioner or local health service immediately following the instructions provided by the local authorities. The test result will be validated with a confirmatory PCR test and the next steps to follow will be explained.

NEGATIVE: A colored line appears in the control area (C). No noticeable colored line appears in the test area (T/B/A).
COVID-19 and/or influenza A/influenza B infection is unlikely to be present. However, it is possible for this test to give an incorrect negative result (false negative) in some individuals with COVID-19 and/or influenza A/influenza B. This means that the person may have a COVID-19 and/or influenza A/influenza B infection even if the test result is negative.

In addition, you can repeat the test with a new kit. In case of suspected infection, 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, you must comply with the rules regarding distancing and hygiene, travel and travel, attending events, etc., according to local COVID-19/flu guidelines/requirements.

INVALID: The control line does not appear. The most likely causes of the failure to appear of the control line are insufficient sample volume or incorrect procedural techniques. Read the instructions again and retest, using a new product, or contact a COVID-19/flu testing center.

Warnings
- For in vitro self-test only. Do not use beyond the expiration date.
- Do not eat, drink, or smoke in the area where samples or kits are handled.
- Do not drink the buffer solution contained in the kit.
Handle the buffer solution with care and prevent it from coming into contact with the skin or eyes; In case of contact, rinse immediately with plenty of running water.
- This test kit should only be used as a preliminary test and repeatedly abnormal results should be analyzed with your doctor or a healthcare professional.
- Strictly respect the indicated times.
- Use the test only once. Do not disassemble and 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 should be used with the help of an adult.
- Wash your hands thoroughly before and after handling.
- Be sure to use an appropriate amount of specimen for the test. Too much or too little sample could cause a deviation in the results.

Limitations
1. Performance has been evaluated with nasal swab specimens only, using the procedures described in this package leaflet.
2. The SARS-CoV-2 and Influenza A/B Rapid Antigen Test (Nasal Swab) only indicates the presence of SARS-CoV-2 and/or influenza A/influenza B antigens in the specimen.
3. If the test result is negative or non-reactive and clinical symptoms persist, it is possible that the virus will not be detected in the very early stages of infection. It is recommended that the test be repeated with a new device or molecular diagnostic tool to rule out infection in these individuals.
4. Negative results do not rule out SARS-CoV-2 infection, particularly in those who have been in contact with the virus. To rule out infection in these individuals, a confirmatory molecular test should be considered.
5. A negative result for influenza A or influenza B obtained from this kit must be confirmed by culture/RT-PCR.
6. 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 underlying co-infection with another pathogen, therefore the possibility of an underlying bacterial infection should be considered.
7. Failure to follow these procedures could alter the performance of the test.
8. If a sample is improperly taken or handled, the test may return false negative results.
9. If there are inadequate levels of virus in the sample, the test may return false negative results.

Preservation
Store in the sealed package at room temperature or in the refrigerator (2–30 °C). The test is stable until the expiration date printed on the sealed pouch. The test should remain in the sealed pouch until use. Do not freeze. Do not use beyond the expiration date.

Format
Test cassette, package leaflet, sterile swab, extraction buffer solution, biohazard waste bag (optional).