INTENDED USE
The COVID-19/RSV/Influenza A&B Antigen Test Kit is a lateral flow immunoassay for the qualitative detection of SARS-CoV-2, respiratory syncytial, influenza A and influenza B viral nucleoprotein antigens in nasal swabs from subjects. The symptoms of respiratory viral infection due to SARS-CoV-2, respiratory syncytial, influenza can be similar. The test is intended as an aid in diagnosis of symptomatic individual meeting respiratory infection for SARS-CoV-2 (within the first 7 days of the onset of symptoms) and influenza A/B or Respiratory syncytial virus (RSV) (within the first 4 days of the onset of symptoms). This kit is intended for layperson's home use in a non-laboratory environment. Test results of this kit are for clinical reference only. It is recommended that a comprehensive analysis of the disease be conducted based on clinical manifestations of patients and other laboratory tests.
PRINCIPLE
The COVID-19/RSV/Influenza A&B Antigen Test Kit is a lateral flow immunoassay based on the principle of the double antibody sandwich technique. A monoclonal SARS-CoV-2/RSV/Influenza A&B antibody conjugated with colored microparticles and sprayed onto the conjugation pad is used as a detector. During the test, the SARSCoV-2/RSV/Influenza A&B antigen in the sample interacts with the SARS-CoV-2/RSV/Influenza A&B antibody conjugated with colored microparticles, creating an antigen-antibody labeled complex. This complex migrates on the membrane by capillary action up to the Test line where it is captured by the pre-coated monoclonal SARS-CoV-2/RSV/Influenza A&B antibodies. A colored test line (T) would be visible in the each result window if SARS-CoV-2/RSV/Influenza A&B antigens are present in the sample. The absence of the T line indicates a negative result. The control line (C) is for procedural control and should appear whenever the test procedure is being performed properly.
PRECAUTIONS
1. For in vitro diagnostic use only. 2. Do not use after the expiration date. 3. Perform the test at room temperature 15 to 30°C. 4. The test cassette should remain in the sealed pouch until use. 5. Please read all information in this leaflet before performing the test. 6. Components from difference lots must not be mixed or used together. 7. Positive result cannot necessarily determine whether a person is infectious
STORAGE AND STABILITY
Store the test kit in the original packaging at 2°C - 30°C. Do not freeze. Test kit contents remain stable until the expiration date printed on the outer packaging. After opening the pouch, the test should be used within one hour. Prolonged contact with hot and humid environment will cause the product to deteriorate.
LIMITATION
Wearing a mask can help protect you and those around you if you are in an area with community transmission and physical distancing is not possible. Follow the directions of your local state or territory government health department to protect yourself. Test kit solutions should only be used as directed; do not ingest; do not dip the swab into provided solution or other liquid before inserting the swab into the nose; avoid contact with skin and eyes; keep out of the reach of children and pets before and after use. A negative result does not rule out infection with another type of respiratory virus. And a positive result cannot necessarily determine whether a person is infectious. The test can only be used once. Test can only be performed by person over 15 years age. Any persons or children under 15 years will require adult supervision or assistance. Not to be performed on children under 2 years of age. The performance of COVID-19/RSV/Influenza A&B Antigen Test Kit was established based on the evaluation of a limited number of clinical specimens. Clinical performance has not been established with all circulating variants but is anticipated to be reflective of the prevalent variants in circulation at the time and location of the clinical evaluation. Performance at the time of testing may vary depending on the variants circulating, including newly emerging strains of SARS-CoV-2 and their prevalence, which change over time. In particular, false negative results may occur if the testing is not performed within the first 7 days of the onset of COVID-19 or within the first 4 days of influenza A&B/RSV symptoms or if the antigen level in the sample is below the detection limit. The tests are less reliable in the later phase of infection and in asymptomatic individuals. Recommend repeat testing within 1-3 days if there is an ongoing suspicion of infection, being in a high risk setting or where there is an occupational risk or other requirement. Negative results may not mean that a person is not infectious and if symptoms are present the person must seek immediate further testing by PCR. STORAGE AND STABILITY LIMITATION 1
Performing the test
COVID-19 POSITIVE: Two colored lines appear on the membrane. One line appears in the control region (C) and the other line appears in the test region (T).
COVID-19 NEGATIVE: Only one colored line appears in the control region (C). No colored line appears in the test region (T).
COVID-19 INVALID: Control line fails to appear.
RSV POSITIVE: Two colored lines appear on the membrane. One line appears in the control region (C) and the other line appears in the test region (T).
RSV NEGATIVE: Only one colored line appears in the control region (C). No colored line appears in the test region (T). RSV INVALID: Control line fails to appear.
Influenza A POSITIVE: It is positive for Influenza A antigen if two Red lines appear. One red line should be in the control line region (C), and the other one appears in the A test line region.
Influenza B POSITIVE: It is positive for Influenza B antigen if two Red lines appear. One red line should be in the control line region (C), and the other one appears in the B test line region.
Influenza A and B POSITIVE: It is positive for both the antigens of Influenza A and Influenza B if three red lines appear. One Red line should be in the control line region (C), and another two should appear in A test line region and B test line region.
NEGATIVE: One Red line appears in the control region (C). No red line appears in the influenza A and B test region (T). INVALID: Control line fails to appear.
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