Noviral comments on “Evaluation of production lots of a rapid point-of-care lateral flow serological test intended for identification of IgM and IgG against the N-terminal part of the spike protein (S1) of SARS-CoV-2 (Hoffman, T. et al.)”

A new study determines the Noviral point-of-care rapid test to meet the official anti body performance standards.
A new study determines the Noviral point-of-care rapid test to meet the official antibody performance standards set by the Swedish Health Authority.

Noviral comments on a current study from Uppsala University that determines the Noviral point-of-care rapid test to meet the official antibody performance standards. Scientists has validated the rapid test in accordance with the official Folkhälsomyndigheten (Swedish health authorities) guidelines. Noviral are proud to be able to deliver to our knowledge the only rapid test backed with extended research and that meets the highest official performance standards in a Swedish study.

“Noviral continuously has dialogues with authorities and scientist to make sure that the products we deliver maintain the highest standards and performances required. We welcomed the Swedish health authority’s publication regarding performances guidelines regarding antibody tests earlier this year. The publication set recommended standards as to the sensitivity and specificity antibody tests must perform as well as the number of samples used to calculate the numbers. The recommendations are only regarding the IgG-antibody. As to the IgM-antibody measured by many antibody tests there are no official performance recommendations, the authorities simply states that a positive IgM antibody test must not be used in order to diagnose COVID-19 or in order to asses whether a person is contagious. Hence, IgM is of less importance in the antibody rapid test result than IgG.

Since day one Noviral has had a close collaboration with researchers and gained a great deal of insights in the aspects of antibody tests. One important aspect is how the antibody test is constructed. Different antibody tests use different proteins to identify antibodies and research recently indicated that the possibility to identify antibodies over time depends on what proteins the test utilizes to provide a test result.

Most antibody tests on the market today are constructed based on either N- or S-protein. There are also tests utilizing the only receptor binding part of the S-protein, RDB. The Noviral point-of-care rapid test utilize a part of the S-protein, S1, while tests developed by i.e. Abbot and Roche uses the N-protein. Recent studies indicate that antibodies binding to the N-protein disappears quicker than those binding towards the S-protein, implicating that antibody tests using the S-protein are more suitable for testing over time on a larger population. Further research also indicates that the antibodies binding to the S-protein are neutralizing while the antibodies binding towards the S-protein are not. A neutralizing antibody could be able to prevent virus particles from infecting healthy sells, hence the neutralizing antibodies gives a person immunity. Of the vaccines in development many of them does include the S-protein and not the N-protein resulting in that in the case of screening before and after vaccination only antibody tests using the S-protein will be utilized.

The Noviral antibody test is globally one of the most evaluated and validated, a fact that was base for a Swedish municipal to come to the decision to implement the Noviral rapid antibody test in a large-scale test effort. The recent study concluded at Uppsala university is one of the most extensive studies done on this specific antibody test, performed in accordance with official authority guidelines regarding antibody tests. In order of further quality assurance, the researchers choose to validate not one but two batches of tests.

As the study concludes the Noviral point-of-care rapid test meets the highest official performance standards communicated by authorities and henceforward can be used individually even in case of the lowest levels of prevalence. Since the start Noviral has had the greatest confident in the test and we are positive to find that research yet again has established the high quality and performance of the test.

As the pandemic has been ongoing the challenges and base of knowledge has constantly shifted. Research confirms that the best rapid point-of-care tests holds a standard in level with the best laboratory tests and Noviral will continue to focus on the quality and advantages of the different tests available, in close collaboration with authorities and other vital stakeholders. This in order establish the quality and performance of the rapid tests and not generalize.

This will help us strengthen the knowledge base so that authorities, health care, business and organizations keep viewing the antibody test as an efficient and adequate way to gain oversight of the contagion and make sure that in regards to quality, cost, availability and construction that the best test is utilized. Further ahead the test could also be a vital tool in conjunction with vaccination and Noviral keeps tracking any development.”

Mikael Jämtberg
CEO Noviral

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Carlson, J. Vägledning för antikroppspåvisning, Folkhälsomyndigheten (2020)

Hoffman, T. et al.  Evaluation of production lots of a rapid point-of-care lateral flow serological test intended for identification of IgM and IgG against the N-terminal part of the spike protein (S1) of SARS-CoV-2, MedRxiv (2020)