SARS-CoV-2 and Influenza A+B Antigen Combo Rapid Test (Nasal Swab),Covid 19 Antigen Test
| Product: |
SARS-CoV-2 And Influenza A+B Antigen Combo Rapid Test (Nasal Swab),Covid 19 Antigen Test |
| Principle: |
Chromatographic Immunoassay |
| Certificate: |
CE1434 |
| Pack: |
1T,2T,5T,7T,10T,20T/25T |
| Shelf Life: |
2 Years |
| Specificity: |
99.41% |
| Format: |
Cassette |
| Specimen: |
Nasal Swab |
| Reading Time: |
10 Minutes |
| Storage Temperature: |
2-30°C |
| Sensitivity: |
94.12% |
| Accuracy: |
98.92% |
A rapid test for the qualitative detection of SARS-CoV-2 Nucleocapsid Protein, Influenza A and Influenza B nucleoproteins antigens present in nasal swab specimen.
For self-testing in vitro diagnostic use.
INTENDED USE
The SARS-CoV-2 and Influenza A+B Antigen Combo Rapid Test (Nasal Swab) is a single-use test kit intended to detect the SARS-CoV-2, Influenza A and Influenza B virus that causes COVID-19 and/or Influenza with self-collected nasal swab specimen. The test is intended for use in symptomatic / asymptomatic individuals who are suspected of being infected with COVID-19 and/or Influenza A+B.
Results are for the detection of SARS-CoV-2 Nucleocapsid protein, Influenza A and Influenza B nucleoproteins antigens. 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 necessary to determine 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 seek additional care from their healthcare provider. Positive results do not rule out bacterial infection or co-infection with other viruses.
Negative results do not preclude SARS-CoV-2 and/or Influenza A+B infection. Individuals who test negative and continue to experience COVID-like or flu-like symptoms should seek follow up care from their healthcare provider.
SUMMARY
The novel coronaviruses belong to the β genus. COVID-19 is an acute respiratory infectious disease. People are generally susceptible. Currently, the patients infected by the novel coronavirus are the main source of infection; asymptomatic
infected people can also be an infectious source. Based on the current epidemiological investigation, the incubation period is 1
to 14 days, mostly 3 to 7 days. The main manifestations include fever, fatigue and dry cough. Nasal congestion, runny nose,
sore throat, myalgia and diarrhea are found in a few cases. Influenza (commonly known as ‘flu’) is a highly contagious, acute viral infection of the respiratory tract. It is a communicable disease easily transmitted through the coughing and sneezing of aerosolized droplets containing live virus2 . Influenza outbreaks occur each year during the fall and winter months. Type A viruses are typically more prevalent than type B viruses
PROCEDURE
Wash your hands with soap and water for at least 20 seconds before and after test. If soap and water are not available, use hand sanitizer with at least 60% alcohol. Remove the cover of the tube with extraction buffer and place the tube in the tube holder in the box.
Nasal swab specimen Collection
1. Remove the sterile swab from the pouch. Do not touch the soft tip of the swab.
2. Insert the swab into your nostril until you feel slight resistance (Approx. 2cm up your nose). Slowly twist the swab, rubbing it along the insides of your nostril for 5-10 times against the nasal wall.
Note:
This may feel uncomfortable. Do not insert the swab any deeper if you feel strong resistance or pain.
When the nasal mucosa is damaged or bleeding, nasal swab collection is not recommended.
If you are swabbing others, please wear a face mask. With children, you may not need to insert the swab so far into the nostril. For very young children, you may need another person to steady the child’s head while swabbing.
3. Gently remove the swab.
4. Using the same swab, repeat step 2 in your other nostril.
5. Withdraw the swab.
Specimen Preparation
1. Place the swab into the extraction tube, ensure it is touching the bottom and stir the swab to mix well. Press the swab head against to the tube and rotate the swab for 10-15 seconds.
2. Remove the swab while squeezing the swab head against the inside of the extraction tube.
3. Place the swab in a plastic bag.
4. Close the cap or fit the tube tip onto the tube.
Testing
1. Remove the test cassette from the sealed foil pouch and use it within one hour. Best results will be obtained if the test is performed immediately after opening the foil pouch. Place the test cassette on a plat and level surface.
2. Invert the specimen extraction tube and add 3 drops of extracted specimen to each sample well(S) of the test cassette and start the timer. Do not move the test cassette during test developing.
3. Read the result at 10 minutes. Do not read the result after 20 minutes.
Note: After test is completed, place all the components into plastic bag and tightly sealed, then dispose according to local
regulation.
READING THE RESULTS
Please share your test result with your healthcare provider and carefully follow your local COVID guidelines/requirements.
POSITIVE SARS-CoV-2:* Two colored lines appear in the COVID-19 window. One colored line should be in the control region (C) and another colored line should be in the test region (T).
POSITIVE Influenza A:* Two colored lines appear in the FLU A+B window. One colored line should be in the control region (C) and another colored line should be in the Influenza A region (A).
POSITIVE Influenza B:* Two colored lines appear in the FLU A+B window. One colored line should be in the control region (C) and another colored line should be in the Influenza B region (B).
POSITIVE Influenza A and Influenza B:* Three colored lines appear in the FLU A+B window. One colored line should be in the control region (C) and two colored lines should be in the Influenza A region (A) and Influenza B region (B).
*NOTE: The intensity of the color in the test line region (T/B/A) will vary based on the amount of SARS-CoV-2 and/or Influenza A+B antigen present in the sample. So any shade of color in the test region (T/B/A) should be considered positive.
A positive results means it is very likely you have COVID-19 and/or Influenza A/Influenza B, but the positive samples should be confirmed to reflect this. Immediately go into self-isolation in accordance with the local guidelines and immediately contact your general practitioner/doctor or the local health department
in accordance with the instructions of your local authorities. Your test result will be checked by a PCR confirmation test and you will be explained the next steps.
NEGATIVE: One colored line appears in the control region (C). No apparent colored line appears in the test line region (T/B/A).
You are unlikely to have COVID-19 and/or Influenza A/Influenza B. However, it is possible for this test to give a negative result that is incorrect (a false negative) in some people with COVID-19 and/or Influenza A/Influenza B. This means you could possibly still have COVID-19 and/or Influenza A/Influenza B even though the test is negative.
In addition, you can repeat the test with a new test kit. In case of suspicion, repeat the test after 1-2 days, as the coronavirus/Influenza virus cannot be precisely detected in all phases of an infection.
Even with a negative test result, distance and hygiene rules must be observed, migration/traveling, attending events and etc. should follow your local COVID/Influenza guidelines/requirements.
INVALID: Control line fails to appear. Insufficient specimen volume or incorrect procedural techniques are the most likely reasons for control line failure. Review the procedure and repeat the test with a new test or contact with a COVID-19 and/or Influenza test center.
