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.
Order Information
| Cat. No. | Product | Specimen | Pack |
| COF-CT525H | SARS-CoV-2 and Influenza A+B Antigen Combo Rapid Test (Nasal Swab) | Nasal Swab | 1T,2T,5T,7T,10T,20T/25 |
