Intended use and principle:
Spartacus-Biomed presents the COVID-19 ANTIGEN RAPID TEST for a rapid detection of the virus as a diagnostic aid for the COVID-19. This device is based on the rapid immunochromatography technique for the detection of the virus in nasal swab and nasal aspirate samples. This lateral flow device can reliably detect the new SARS-CoV-2 virus in 10 minutes. The test device is composed of a sample pad, a reagent pad and a reaction membrane. The assembled strip is fixed inside a plastic cassette. The reagent pad contains the colloidal-gold conjugated with the monoclonal antibodies against SARS-CoV-2; the reaction membrane contains the secondary antibodies for SARS-CoV-2 and the polyclonal antibodies against the mouse globulin, which are pre-immobilized on the membrane. In 2019, a new coronavirus disease COVID-19 was reported in Wuhan, China. This disease subsequently affected a majority of countries in the world causing significant lung damage and respiratory failure. The pathogen has been identified as a coronavirus similar to that of SARS and MERS. He was named severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). The COVID-19 Antigen Rapid Test is used for the in vitro qualitative detection of the virus in the throat swabs, sputum samples of suspected pneumonia infected patients or suspected clustering cases. When the sample is added into the sample well, conjugates (previously dried on the reagent pad) are dissolved and migrate along with the sample. If SARS-CoV-2 is present in the sample, a complex formed between the anti- SARS-CoV-2 conjugate and the virus will be caught by the specific anti- SARS-CoV-2 monoclonal coated on the T region. Results appear in 10 minutes in the form of a pink line.
It is applicable to the diagnosis of the COVID-19 virus using
nasal swabs or nasal aspirates samples. Use immediately freshly collected samples for optimal test performance. Inadequate sample collection or improper sample handling may yield a false-negative result.
Collect nasal aspirate fluids using the specific aspirator (not supplied).
Insert the supplied sterilized swab into the nasal basin and swab several times.
Put the extraction tube on the tube stand and add 10 drops (300 µL) of the buffer.
Nasal Aspirate Fluids:
Add 10 drops (300 µl) of the nasal aspirate fluids into the extraction tube which contains 300 µl of the buffer, screw the cap and shake the tube for 10 s. This extracted solution will be used as test sample.
Put the extraction tube on the tube stand and add 10 drops (300 µL) of the buffer. Remove the swab from its sterile packaging. Use the sterile swab to collect the sample. Insert the swab (with the sample) into the extraction tube which contains 10 drops (300 µl) of the buffer. Rotate the swab inside the tube using a circular motion to roll the side of the extraction tube (3 X) so that liquid is released and reabsorbed from the swab. Incubate 40s. This extracted solution will be used as test sample. Remove and discard the swab, screw the cap and