Nekstgen: SARS-CoV-2-CoronaPass (the test for antibodies to COVID-19)

Main article: Antibodies to COVID-19 coronavirus

2020: Obtaining the registration certificate on "SARS-CoV-2-CoronaPass"

Nekstgen, subsidiary company of Human Stem Cells Institute and the resident of Skolkovo Foundation, received registration certificates on the new SARS-CoV-2-CoronaPass test systems for determination of total antibodies to COVID-19 coronavirus. The Skolkovo Foundation reported about it on September 2, 2020.

The test system developed by Nekstgen working by the principle sendvich-IFA (double specific binding), using biotin-streptavidinovoy of a system of detection. Such format is the most specific method for this reason it is accepted for screening of the majority of socially important infections (for example, when screening HIV). A test system allows to reveal total antibodies (IgG/IgM/IgA) on early terms of a disease, regardless of specific features of formation of the immune answer.

Development of a test system was conducted with assistance of Skolkovo Foundation in cooperation with Biopalitra company and one more Skolkovo resident – the Genetico Center. He one of the first used the receptor connecting the domain of S-antigen which provides higher specificity of researches in comparison with the nukleokapsidny antigen which is used in the test systems of other developers. According to the published data, antibodies to the domain RBD Spike-protein of a virus are neutralized therefore assessment of their existence has the big clinical importance.

In the subsequent, when performing vaccination, the test systems aimed at identification of neutralized antibodies will allow to draw conclusions, the carried-out vaccination was how effective.

The validation which is carried out on 263 samples of serum and plasmas of blood showed high characteristics of this SARS-CoV-2-CoronaPass test system: specificity - 100% and sensitivity - 98.7%. Also a system differs in simplicity, speed of the procedure of a research and lack of preliminary cultivation of a sample that, certainly, affects quality of results.

The test with specificity of 100% allows to avoid false positive results that is clinically very important. At the same time the combination in one test of the tests sensitive and to IgG, both IgA, and IgM, allows to expand the range of sensitivity of a method. It is also promoted by the fact that for use of the IFA this type it is not necessary to dissolve serum. Respectively the test is more convenient for laboratory - time for its carrying out less than the probability to mix samples decreases.

The test system developed and registered by the participant Skolkovo has the high accuracy and specificity at identification of total antibodies to COVID-19 (IgG/IgM/IgA) at early stages of a disease. At the same time the procedure of test simpler and quicker, than at the most widespread test systems, allows to save time and reduces risk of errors. Emergence of this test in an arsenal of domestic health care will help not only to reveal COVID-19 infection cases, but also to estimate efficiency of mass vaccination of Russians, controlling the immune answer.

Also the Nekstgen company received the registration certificate on the first series of rapid tests "Corona Pass". Their development was conducted together with the Federal research center "Fundamental Bases of Biotechnology" RAS and Genetico laboratory.

The rapid test allows to reveal separately antibodies of IgM and IgG to a coronavirus in 15 minutes, does not require the laboratory equipment and gives the chance with high degree of reliability to define the people who had a koronavirusny infection. The test can be used as independently, and in the medical centers or mobile laboratories. Set represents immunochromotographic test strips for determination of antibodies to SARS-CoV-2 in blood, plasma or serum of the person. In most cases existence of IgM testifies to an active phase of a disease, and IgG at the person without symptoms can demonstrate that he already had and is immune. The result is shown in the form of the colored lines.

Both test systems are available to laboratories and the medical centers since September 1, 2020.