The SARS-CoV-2 Rapid Antigen Test is a reliable, rapid chromatographic immunoassay for the qualitative detection of specific antigens of SARS-CoV-2 present in the human nasopharynx.
This test is an aid in detecting antigen from the SARS-CoV-2 virus in individuals suspected of COVID-19. This product is strictly intended for professional use in laboratory and Point of Care environment.
The SARS-CoV-2 virus causes respiratory tract infection. It is transmitted mainly via respiratory droplets after close contact, and primary viral replication is presumed to occur in mucosal epithelium of the upper respiratory tract (nasal cavity and pharynx).1 At these locations viral load peaks within the first week after symptom onset, and then declines.2
A SARS-CoV-2 antigen test detects the presence of the SARS-CoV-2 virus from part of the upper respiratory tract swab specimens by identifying a nucleoprotein that is carried by the virus. The test identifies current infection during the acute phase of COVID-19, while the virus is still present in large quantities in the respiratory tract.
Besides laboratory PCR testing, antigen assays can also be offered as rapid testing in near-patient settings. The SARS-CoV-2 Rapid Antigen Test is a rapid chromatographic immunoassay intended for the qualitative detection of specific antigens of SARS-CoV-2 present in nasopharyngeal or combined nasopharyngeal/oropharyngeal samples. This test is intended to detect antigen from the SARS-CoV-2 virus in individuals suspected of COVID-19. This product is strictly intended for professional use in laboratory and Point of Care environments. Similar to laboratory instruments, it detects a SARS-CoV-2 antigen, the nucleoprotein. It can therefore be used to assess whether a person is infected with SARS-CoV-2 by providing a qualitative result showing coloured bands indicating the presence of SARS-CoV-2 antigens.
The SARS-CoV-2 Rapid Antigen Test enables fast decision making e.g. whether patients need to be put in quarantine, reducing the risk of further spreading. In addition to that it allows for screening of individuals after confirmed exposure to a SARS-CoV-2 infected person or individuals at risk of exposure such as healthcare workers.
The SARS-CoV-2 Rapid Antigen Test allows for decentralized testing at the point of care and helps to expand the range and quantity of direct virus testing into otherwise inaccessible locations. Rapid point of care testing can sometimes be the only viable option if lab testing is not sufficiently available. In addition to that, the SARS-CoV-2 Rapid Antigen Test is an instrument free test, allowing testing in rural/ low-infrastructure areas.
1. Collecting a sample (nasypharyngeal swab)*
Insert a sterile swab into the nostril of the patient and then rotate the swab 3-4 times against the nasopharyngeal surface. Withdraw the swab from the nasal cavity.
*When collecting a combined NP/OP sample be sure to follow the procedures described in the Instructions for Use.
2a. Preparing a sample
Insert the swab into an extraction buffer tube. While squeezing the buffer tube, stir the swab more than 5 times.
2b. Preparing a sample
Remove the swab while squeezing the sides of the tube to extract the liquid from the swab.
2c. Preparing a sample
Press the nozzle cap tightly onto the tube. Continue with 3a. Performing a test.
3a. Performing a test
Place the test device on a flat surface and apply 3 drops of extracted sample in a 90° angle to the specimen well of the test device.
3b. Performing a test
Read the test result at 15 to 30 min.
Warning: Risk of incorrect results. Do not read the test result after 30 min.
4. Interpreting results
A colored line appears in the top section of the result window to show that the test is working properly. This is the control line (C). Even if the control line is faint, the test should be considered to have been performed properly. If no control line is visible the test is invalid.
In case of a positive result, a colored line appears in the lower section of the result window. This is the test line (T). Even if the test line is very faint or not uniform, the test result should be interpreted as a positive result.