This is an in-vitro diagnostic rapid self-test for the qualitative detection of SARS-CoV-2 antigens. By taking a sample through a nasal swab, you can easily determine if you are infected with the virus that causes COVID-19.
The test is quick and reliable and gives you results in 15-30 minutes. Collect the test sample with a shallow swab in the nasal cavity with only minimal discomfort, regardless of whether you have symptoms or not, and wherever you are.
Each test kit consists of a nasal swab to take the sample, a test tube with buffer liquid to mix the sample with, a lid to seal it, and a test cartridge to reveal the results. The test also comes with detailed instructions in ten languages.
Test kits are available in three packaging sizes to suit different purposes, such as travel or quantitative testing. Read more about the products here: www.gibsonmedical.se/products
The test is performed by collecting a nasal swab sample which detects the presence of SARS-CoV-2, the virus that causes COVID-19, including its common mutations. The test has a high reliability, approximately 97% sensitivity (the probability of detecting infection in an infected patient) and over 99% specificity (the probability that a positive response is actually correct).
It is important to follow the instructions and to be aware that results may vary depending on the state of infection. You effectively monitor the risk of being contagious by applying a test on a regular basis, recommended every 2-3 days.
Follow the authorities' recommendations regarding infection tracing in case of a positive result. Contact a health care provider if in doubt. Even a very faint line is considered as positive. Additional testing, for example a PCR test, may be required to confirm viral infection or to initiate infection tracing.
A negative result means the sample does not contain a sufficient amount of the virus, but infection cannot be completely ruled out. Always follow local and governmental recommendations and regulations.
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In addition to sensitivity and specificity data that we answer in another question, there are a number of sources of error that can explain why PCR and antigen testing result in different outcomes.
We always recommend that you follow recommendations from authorities, which in Sweden currently means that you test yourself with Rt-PCR for symptoms and isolate yourself while waiting for an answer (per 2022-01-10). Antigen testing offers a fast, cost-effective complement to this testing and is currently the best tool for general screening.
Our most popular test from New Gene is on the EU's list of trusted tests and all the tests we provide have over 90% sensitivity, which has also been confirmed in independent studies in the EU. It shows that the test for independent validation at the Paul-Ehrlich-Institut in Germany has shown 92.5% sensitivity at high (≤30) Ct values (low virus levels) and 100% sensitivity at low (≤25) Ct values (high virus levels)
Current scientific evidence suggests that virus levels need to be high for you to be contagious and it usually takes 1-5 days until virus levels are sufficiently high that you are contagious (and get a positive test result). Therefore, sampling every 2-3 days is recommended.
There is, however, a risk that your viral load increases to a contagious level throughout the day and that the test taken in the morning is a false negative (see response regarding reliability above). There is no available rapid test that can exclude contagiousness to 100%, so be sure to always follow guidelines issued by the authorities.
Follow the authorities' recommendations regarding infection tracing in case of a positive result. Contact your local healthcare provider or call 1177 (in Sweden) if you have questions.
A negative result indicates that there is no virus in the sample, or that the virus load is below the detection limit for this product. The possibility of a virus infection cannot be completely ruled out though, and we recommend that you follow current guidelines from the authorities.
A travel certificate currently requires a healthcare provider to certify your test result. Different countries have different requirements for test methods. Many countries accept antigen tests, but some destinations require RT-PCR tests.
Conducted studies suggest the test performance is reliable when tested against most known mutations. Omicron has an increased number of mutations on the so-called spike protein (S-protein) compared to previous variants of the virus. However, not many mutations have been seen on the nucleocapsid protein (N-protein) which is decisive to discover an infection with the test. Our antigen tests are therefore expected to have maintained performance in detecting Omicron and other common variants.
It is not possible to give an exact figure, but the clinical data which is available suggest that if you have 100 infected people in the workforce, you will identify approximately 97 of these via correctly performed self-tests. Thus there is approximately a 3% risk of missing someone who is infected. However, testing should always be seen as a complement to other infection prevention measures and should not be regarded as a fool proof protection against infection.
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