Can be performed on nasoharyngeal & oropharyngeal specimens
Test storage at room temperature
All test components -including sterile swabs contain
German production with ISO certification
The SARS-CoV-2 rapid antigen test is an immunochromatographic in vitro test for the direct and qualitative detection of viral SARS-CoV-2 antigens in nasopharyngeal and oropharyngeal secretions. This test is intended for professional use only and supports diagnosis in conjunction with clinical presentation and other diagnostic tests. The test results should not be used as the sole basis for diagnosis. The test provides preliminary test results. Negative results do not completely rule out a SARS-CoV-2 infection and should therefore not be used as the sole basis for decisions.
The SARS-CoV-2 rapid antigen test is an immunochromatographic assay. In this, the double antibody sandwich method was used to detect viral SARS-CoV-2 nucleocapsid antigen in the sample. If the sample contains antigen above the minimum detection limit, it forms a complex with the colloidal monoclonal gold antibodies and the monoclonal antibodies coated on the test line. As a result, a purple reddish test line appears, which speaks for a positive result. If the sample does not contain any antigen or if it is below the minimum detection limit, no purple reddish test line will form. Regardless of whether the analyte is present in the sample, a colored line forms in the control line area. The test is only valid when the control line appears.
Nasopharyngeal smear (NP smear)
Remove the swab from its packaging. When taking the sample, the person performing the test should hold the test person's head gently and slowly insert the swab into one of the nostrils to avoid traumatic bleeding. Insert the swab into the nostril parallel to the roof of your mouth. Rotate it against the nasal wall (to make sure the swab contains both cells and mucus) and carefully remove the swab.
Oropharyngeal smear (surgical smear)
The subject's head should be tilted slightly and the mouth wide open so that the tonsils are easily visible on either side of the throat. Wipe the swab over the root of the tongue and then wipe the tonsils on both sides at least three times with a little force. Finally, wipe the back of the throat wall up and down at least three times.
The package insert must be read and understood in its entirety before carrying out the procedure. Components, reagents and samples and / or measuring devices must be brought to room temperature (15 to 30 ° C) before use.
1. Add approx. 23 drops of sample buffer (approx. 550 μl) to the extraction tube.
2. Insert the swab into the extraction tube. Mix well and squeeze the swab 10 times. Rotate the swab head against the inside wall of the tube as you remove it. Try to get as much liquid out of the swab as possible. Dispose of the used swab according to your disposal protocol for biohazardous waste.
3. For each sample, open the foil pouch shortly before testing, remove the test cassette and place it on a clean, flat surface. Label the test cassette.
4. Close the lid of the extraction tube and, carefully squeezing the tube, add 2 drops (60-70μl) of the solution to the sample well.
5. Read the result after 15-20 minutes. The result is invalid after 20 minutes.