Table of Contents
Description of test combo antygen na grypę a/b+covid-19/rsv
Test combo antygen na grypę a/b+covid-19/rsv: The Influenza A/B + COVID-19/RSV Antigen Combo test is an immunochromatographic test that detects SARS-CoV-2 virus antigens and influenza A and B antigens. The test is based on specific antibodies in the test cassette—monoclonals directed against antigens characteristic of the detected viruses.
It is intended to aid in rapidly diagnosing influenza A, influenza B, respiratory syncytial virus RSV, and SARS-CoV-2 infections. This test is intended for over-the-counter home use with self-collected nasal swab samples from individuals 14 years and older with influenza A/B and RSV/COVID-19 symptoms within the first seven days of symptom onset.
The test is also intended for use with nasal specimens from individuals two years of age and older with symptoms of influenza A/B and RSV/COVID-19 within the first seven days of symptom onset.
Self-monitoring test – This test is intended for over-the-counter home use with self-collected nasal swab samples from individuals 14 years of age and older or with nasal samples collected from individuals two years of age and older with or without symptoms or with other epidemiological reasons to suspect influenza A/B and RSV/COVID-19.
People without symptoms of COVID-19 and those living in areas with low rates of COVID-19 infection and no known exposure to COVID-19 may experience more false positive results. Testing of asymptomatic people should be limited to contacts of confirmed or probable cases or for other epidemiological reasons to suspect COVID-19 infection, followed by additional confirmatory testing with a molecular test.
This test only provides a preliminary test result. Therefore, any reactive sample in the COMBO Influenza A/B COVID-19/RSV Antigen Test must be confirmed using alternative testing method(s) and clinical outcomes.
Product Characteristics Test Combo Antygen na Grypę A/B+Covid-19/rsv
One of the test areas contains adsorbed monoclonal antibodies directed against the nucleocapsid proteins of the SARS-CoV-2 virus.
After the test sample cassette is introduced into the well, it migrates to the conjugate zone, which contains antibodies conjugated with colloidal gold directed against SARS-CoV-2 antigens. If the tested model has antigens of the SARS-CoV-2 virus, an antigen-antibody-conjugate complex is formed.
The resulting complex migrates to the test line area of the cassette, where it combines with specific antibodies, creating a visible, colored line. A colored line in the size of the test control line indicates that the test was performed correctly.
The second test area contains adsorbed specific antibodies directed against influenza type A and B antigens. During the test, the sample with the test material is subjected to an immunochemical reaction with specific antibodies, forming an immunocomplex.
The resulting complex migrates to the test line area of the cassette, where it combines with particular antibodies, creating a visible, colored line. A colored line in the size of the test control line indicates that the test has been performed correctly.
Indications for Performing the Test
- fever
- headache
- weakness
- chills
- runny nose
- pharyngitis
- contact with an infected person
- suspected COVID-19 infection
Preparation before the test
Wash or sanitize your hands and then dry them thoroughly.
Contents of the package
- cassette
- instructions for use
- a sample collection tube containing the solution
- swab for sampling
- waste bag
TEST PROCEDURE
Please read the instructions before testing. Before testing, bring the test in the sachet to room temperature. Do not open the sachet until the trial begins.
- Remove the test from the sealed bag. Place it on a flat, clean, and dry surface.
- Invert the sample collection tube and add three drops of the test sample by squeezing the tube with the collected solution into each opening of the test cassette.
- Read the results after 15 minutes.
NOTE:
The test cassette should not be moved or lifted during the test to avoid inaccurate results. The test is designed to be read after 15 minutes. If the test is read before 10 minutes or after 30 minutes, the results may be inaccurate (false negative, false positive, or invalid), and the test should be repeated.
READING THE RESULTS
INFLUENZA A/B ANTIGEN TEST:
- POSITIVE:
Influenza A positive:
In the result window, two lines, the control line (C) and the test line T1 indicate a positive result for the influenza A virus antigen.
Influenza B positive:
In the result window, two lines, the control line (C) and the test line T2 indicate a positive result for influenza B virus antigen.
Influenza A+B positive:
Three lines as control line (C), test line T1 and test line T2 in the result window indicate a positive result for influenza A and influenza B virus antigen.
2. NEGATIVE:
The presence of only the control band (C) in the result window indicates a negative result.
The result is considered invalid if no control bar (C) is visible in the result window after running the test. Some reasons for weak results include not following instructions correctly or the test quality deteriorating after expiration.
It is recommended to retest the sample using a new test. If the problem persists, stop using the product and contact your testing distributor.
FOR COVID-19/RSV ANTIGEN TEST
1. POSITIVE:
RSV positive:
In the result window, the presence of two lines, control line (C) and test line T1, indicates a positive result for RSV viral antigen.
COVID-19 Positive:
The presence of two lines, the control line (C) and the T2 test line, in the result window indicates a positive result for the COVID-19 viral antigen.
If a COVID-19 test result is positive, users should not make any medically significant decisions without consulting a doctor.
COVID-19+RSV Positive:
The presence of three lines as control line (C), test line T1, and test line T2 in the result window indicates a positive result for RSV and
COVID-19 viral antigen.
2. NEGATIVE:
The presence of only the control band (C) in the result window indicates a negative result.
The result is considered invalid if no control bar (C) is visible in the result window after running the test. Some reasons for weak results include not following instructions correctly or the test quality deteriorating after expiration.
It is recommended to retest the sample using a new test. If the problem persists, stop using the product and contact your testing distributor.
Conclusion
The COMBO Influenza A/B +COVID-19/RSV Antigen test is an immunochromatographic test for the qualitative and differential detection of influenza A protein antigen (including H1N1 subtype), influenza B, respiratory virus RSV and SARS-CoV-2 in samples nasal swabs taken from people with or without symptoms. The test rapidly diagnoses influenza A, B, respiratory virus RSV, and SARS-CoV-2 infections. This test is intended for home use using self-collected nasal swab samples.
Also Read
