Quality assured and validated tests

The corona pandemic has had severe implications on many aspects of the society. Even if the future of the pandemic is still uncertain, we know for a fact that the infection will remain in our communities for a long period of time. In order for the society to deal with the situation that we are currently in we need to have the right tools and knowledge. One important part of dealing with the pandemic is the availability and implementation of testing programmes, both on a large and small scale.

The testing landscape for COVID-19 is difficult to navigate as different tests fulfil different purposes. Noviral offers two types of tests: one identifying ongoing infection and the other detecting antibodies indicating a previous infection. Our medical advisors help your company identify which tests to perform, whom to test and when to test for maximizing the use and value of a testing programme. Please contact us for more information.

Noviral offers two tests, a rapid antigen test and a rapid IgG/IgM antibody test. These two tests are complementary and should be used for different purposes. Please see below for more information:

Antibody test

Studien fastställer att det snabbtest Noviral levererar uppfyller det högsta prestandakravet som Folkhälsomyndigheten kommunicerat och kan således användas på individnivå även för de lägsta prevalensnivåerna.

Antigen test

Antigen tests are used to identify ongoing Covid-19 infections. The rapid antigen test that Noviral distributes provides test results within 15 minutes and thereby facilitates patient treatment decisions quick and efficiently. Throughout the pandemic PCR testing been the most common screening method for ongoing infections. The antigen test fulfils the same purpose as PCR tests but does not require lab capacity nor specialised equipment and meanwhile has a much shorter turnaround time, making the test more beneficial in many aspects.

  • The test is CE certified
  • Initial studies reveal that the specificity is 100% compared to gold standard*
  • The antigen test is taken through a nasopharyngeal swab and is very easy to use

*Note that no antigen test is error-free, even if studies and validations show 100% accuracy, incorrect results may occur when tested on a larger population.

FAQ

It is a combined IgM / IgG antibody test for Covid-19 used to qualitatively detect the presence of coronavirus IgG and IgM antibodies in human serum, plasma or whole blood in vitro.

The test is performed in five simple steps. First, a stick is taken in the finger. The blood is drawn in with a disposable pipette and then added to the center box (S). The buffer solution is added to the round well at the bottom (B). The answer should be read within 15 minutes.

Unlike laboratory-based tests, test results can be read within 15 minutes.

The test shows whether a person has undergone a Covid-19 infection and thus developed antibodies. The test results are collected and compiled in DigiTrack, which provides a good basis for determining how employees should be organized and coordinated in the best way, in order to reduce the risk of new spread of infection.

According to current guidelines from the Public Health Authority, antibody tests for Covid-19 are not subject to reporting obligations for the disease according to the Infection Protection Act.

Yes, the test is CE marked. CE marking is a product marking in the EU and the European Economic Area (EEA). The letters CE are the abbreviation for Conformité Européenne (‘in accordance with EC directives’). A product with CE marking may be sold in the EEA area.
The rapid test has also, since May 2020, received EUA approval by the FDA (Food and Drug Administration), the US counterpart to the Swedish Medicines Agency.