Antigen rapid test for the detection of an infection with SARS-CoV-2
NADAL® COVID-19 Ag Self-Test: Endorsed by multiple studies
Our NADAL® COVID-19 Ag Self-Test is in no way inferior in terms of quality to our tests for professional users. In fact, they are put together in almost exactly the same way. The version of the test for use by medical personnel has been evaluated and approved by the Paul-Ehrlich Institute, as well as by a team under the leadership of Prof. Drosten at the Berliner Charité. As a result, the NADAL® COVID-19 Test got the attention of the Federal Ministry of Health, who integrated it into their national testing strategy.
NADAL® COVID-19 Ag Self-Test: A product of almost 40 years of experience
We are not newcomers, nor have we jumped on the rapid test production bandwagon since the outbreak of the pandemic. We have 39 years of experience in the production and sale of in-vitro diagnostics. We are specialists in what we do. Our in-house laboratory is continually pushing innovation. Even in the midst of a pandemic, we are able to react quickly and were one of the first companies worldwide to bring COVID-19 antigen tests to the market. The NADAL® COVID-19 Ag self-test also stands out in this respect in terms of its quality and value.
Your benefits at a glance:
German manufacturer with EN ISO 13485 and ISO 9001 certification
For self-use; CE certified (CE0197)
Optimised test process
High specificity of > 99.9 %
High sensitivity of 94.1 % (Ct-range < 30)
Fast and reliable test results in just 15 minutes
Storage and test procedure at room temperature
All test components – including sterile swabs – are included
Reliable detection of mutated coronavirus strains, including those from Great Britain, South Africa and Brazil
Official partner of the Federal Ministry for Health. Our tests are part of the national testing strategy.
Video on specimen collection
Video on test procedure
The NADAL® antigen rapid test can detect the mutated coronavirus strains originating in Great Britain, South Africa and Brazil just as reliably as the original SARS-CoV-2 coronavirus variant.
Only the C-line is appears in the result area. No virus has been detected. There is no indication of an infection with SARS-CoV-2.
A negative test result does not rule out an infection. Continue to adhere to current regulations regarding contact with others, as well as protective measures (hygiene, social distancing etc). If you still suspect an infection, repeat the test after 1 – 2 days, as the virus is not easily detected in all stages of infection.
Invalid test results
No C-line appears. The result is invalid and indicates an error in the test procedure.
Please carry out a new test. In the event of further invalid results, contact your GP or COVID-19 test centre.
How does the NADAL® COVID-19 Ag Test detect the coronavirus?
The coronavirus is comprised of different proteins, one of which is the nucleocapsid protein. This surrounds the DNA – the genetic information – of the virus. The NADAL® COVID-19 Ag Test contains antibodies that detect the nucleocapsid proteins of the coronavirus. This detection follows the key-lock principle, as antibodies and nucleocapsid proteins fit together exactly.
How does the NADAL® COVID-19 Ag Test work?
If coronaviruses (SARS-CoV-2) are present in the sample obtained, the virus’ nucleocapsid proteins react with the coloured antibodies in the test, causing the formation of a T-line. If no C-line appears, the test has not functioned correctly and is invalid. If both the C-line and T-line appear, this indicates a potential infection with SARS-CoV-2. If only the C-line appears, no virus has been detected. In principle, the test works like a pregnancy test, but instead of the pregnancy hormone, this test detects the virus protein.
How can the antigen test be used?
The NADAL® COVID-19 Ag Test can be carried out, for example, if you are experiencing symptoms or suspect that you may have been infected. The test can help to identify people with a high viral load who are particularly contagious, even if they don’t feel ill themselves. The concentration of the coronavirus, and thus the concentration of the nucleocapsid proteins, can vary throughout the course of infection, meaning it is possible that the nucleocapsid protein is not detectable using a rapid test even though you are still contagious. For this reason, potential infectiousness cannot be ruled out on the basis of a negative test result.
What happens if I add fewer or more than 3 drops to the sample field?
In order that the test functions correctly, exactly 3 drops of the sample should be dispensed into the round sample well. If you have accidentally added more/fewer drops into the sample well, the test can no longer function reliably and a new test should be carried out.
If I read the results after more than 20 minutes, is the result still reliable?
No. The test should be read 15 minutes after adding the sample. The result is valid up to 20 minutes after adding the sample. You must strictly adhere to these reading times. If the test is read too late or too early, it can lead to incorrect results. Lines that appear after more than 20 minutes cannot be interpreted as a positive result.
How can I interpret the test if the intensity of the lines differs?
The intensity of the lines plays no role in the evaluation of results. Even a weak T-line should be interpreted as positive.
What does the line marked as 'C' mean?
'C' does NOT stand for COVID-19 or corona! The C-line is the control line, and signifies that the test has been carried out correctly. It indicates that a sufficient amount of sample has been added and that the liquid has been properly absorbed by the test. If the line doesn't appear, the test has not functioned properly. This means that the test result should not be interpreted (it is invalid).
What should I do if I get a positive result?
A positive result should always be confirmed using a PCR test. Contact your GP or local health centre. To reduce the chance of transmitting the infection, avoid contact with others.
What should I do if I get a negative result?
A negative result indicates that the coronavirus nucleocapsid protein has not been detected. However, it is not possible to rule out infection with the virus or its transmission to others. Continue to adhere to current hygiene regulations. If you continue to experience symptoms, please consult a GP.
Can the results be wrong?
In a clinical study, the test identified 96 out of 102 infected individuals with a positive result (diagnostic sensitivity). It identified 138 out of 139 non-infected individuals with a negative result (diagnostic specificity). These results were used to calculate the diagnostic sensitivity (94.1 %) and diagnostic specificity (>99.9 %). However, the test is dependent on a sufficient virus concentration. A very new or subsiding infection can lead to a negative result, even though the individual is still contagious. For this reason, compulsory hygiene regulations should continue to be adhered to.
Can the antigen test also detect other illnesses (such as influenza)?
The NADAL® COVID-19 Ag Test has been tested with various disease pathogens, including influenza viruses, a number of bacteria and seasonal coronaviruses (‘common cold viruses’). None of these disease pathogens were detected using our test. For further information, please see the section ‘Cross-reactivity studies’ in the package insert.
Can medications influence the results of the antigen test?
The effects of different medications and substances on our NADAL® COVID-19 Ag Test have already been tested and were found to have no influence on the test results. However, potential effects from medication cannot be ruled out. For further information, please see the section entitled 'Studies on interfering factors' in the package insert.
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