Humasis COVID-19 Ag Test uses monoclonal antibodies specific to COVID-19 antigens to detect COVID-19 specific antigens in human nasal swab and nasopharyngeal swab specimens.
The test results are more accurate because the test contains 2 antibodies - monoclonal antibody against SARS-CoV-2 nucleocapsid and monoclonal antibody specific to RBD against SARS-CoV-2 spike protein, most manufacturers use only one Ab.
A nitrocellulose membrane strip in the device contains one test line and one control line. The test line is pre-coated with anti-mouse monoclonal antibody to SARS-CoV-2 nucleocapsid and RBD for detection of SARS-CoV-2 antigens, and the control line is coated with goat anti-mouse IgG.
When the extracted swab specimen is added to the sample well, it will migrate to the conjugate pad, which contains conjugated antibodies conjugated with colloidal gold directed against the SARS-CoV-2 antigen. If the sample contains SARS-CoV-2 antigens, antigen-antibody-conjugate complex will be formed. The complex will continue to migrate across the membrane until it reaches the capture zone (test line) where the complex will bind to immobilized antibodies and form visible colored band in the test line. The sample will continue to move along the membrane until it reaches the control line where excess conjugate binds and produces a second visible line. This control line indicates that the sample has migrated across the membrane as intended and the test was performed properly.
Based on an exemption for antigen tests issued by the MoH pursuant to Section 4, Paragraph 8 of Government Decree No. 56/2015 Coll.*
NOTICE FOR CUSTOMERS:
As part of the testing, the customer is obliged to ensure that if a lay person has a positive antigen test the health service provider should be informed immediately to perform a confirmatory test.
If the customer is interested, the distributor will provide training for the designated person.
NOTICE TO THE LAY PUBLIC:
Read the package leaflet carefully. Follow the procedure: TEST PROCEDURE - Nasal swab, and then Test method: Nasopharyngeal / nasal swab for proper collection and testing. Evaluate the result according to the INTERPRETATION OF RESULTS.
If the antigen test performed is positive, inform the healthcare provider immediately to perform a confirmatory test.
Report any adverse event that occurs during the use of the product to the State Institute for Drug Control of any adverse event.
* Valid until 30th of April, 2021