Development of test kit for detection of specific IgM to SARS-CoV-2 by immune blotting in the «Line blot¼ format.

Test kit for detection of specific IgM to SARS-CoV-2 by immune blotting in the «Line blot¼ format has been developed. A preliminary study of diagnostic effectivity on clinical samples of blood serum from patients with COVID-19 and healthy donors showed its high sensitivity and specificity. The new test kit allows to detect IgM to all four structural antigens of SARS-CoV-2 and can be used as a confirmatory test to verify indeterminant screening results in laboratory etiological diagnosis of COVID-19.

Development of an enzyme-linked immunosorbent assay for the detection of IgG-antibodies to the causative agent of COVID-19 in human serum (plasma).

A new original Russian test kit for the detection of IgG-antibodies to the causative agent of COVID-19 - coronavirus SARS-CoV-2 by the method of enzyme-linked immunosorbent assay (ELISA) on a solid-phase «ELISA-SARS-CoV-2-AT-G¼ has been developed. In comparative tests with similar test systems «Vitrotest® SARS-CoV-2 IgG¼ (Vitrotest, Ukraine) and «Anti-SARS-Cov-2 ELISA (IgG)¼ (EUROIMMUN AG, Germany) high diagnostic efficiency of the new test system was shown.

Immune blotting as a method for diagnosis of toxoplasmosis.

Test kit for detection of IgG-antibodies to individual antigens of Toxoplasma gondii by immune blotting («Western blot¼ format) has been developed. Laboratory testing with first international WHO standard «Anti-toxoplasma serum (IgG), human, Lyophilized, 20 IU / ampoule¼ (NIBSC, Great Britain) demonstrated the analytical sensitivity of the new kit equal to 10 IU / ml. Study of the diagnostic efficiency of the new kit showed its high sensitivity, equal to 98.51 - 100%, and high specificity, equal to 99.5 - 100%. New test kit is intended for confirmatory testing in laboratory diagnostics of toxoplasmosis.

[Development of a set of reagents for detection of class G immunoglobulins to human herpes virus type 7 by the method of immune blotting in the format «Western blot¼.]

A new original domestic set of reagents has been developed for the determination of class G immunoglobulins to individual human herpes virus antigens of type 7 by the method of immune blotting in the "Western-blot" format. Preliminary clinical trials were conducted using 134 serums of healthy children aged 1-16 years who underwent diagnostic testing. Stud y of diagnostic efficiency ofthe new kit showed high sensitivity, comparable to the sensitivity of the reaction indirect immunofluorescence and high specificity, which is manifested in the absence of false positive results when testing samples containing immunoglobulin G to herpes virus 6 type.

[First results of application of an enzyme immunoassay in the serological diagnostics of infection caused by herpesvirus type 7.]

HHV-7 (Human Herpes virus type 7) is a relatively recently discovered, ubiquitous beta herpes virus. In Russia, the diagnosis of HHV-7 infection is carried out by PCR, which determines the DNA in serum or plasma, if there are clinical indications. Laboratory serological tests for HHV-7 are not performed. Currently, in the scientific literature, information on clinical studies of HHV-7 infection, its epidemiology, and its role in the etiopathogenesis of various diseases is insufficient. This article presents the results of the development of a test kit "ELISA-HHV-7-IgG", designed to detect specific IgG to HHV-7 by enzyme-linked immunosorbent assay (ELISA). Studies of the sensitivity and specificity of the developed test kit, including potential cross-reactive samples positive for other herpesvirus infections, were carried out. In the context of serological diagnostics, we studied samples of the sera of children (n = 167) and old people (n = 238) for the presence of IgG to HHV-7 with confirmation of the results in the indirect immunofluorescence reaction and the immune blotting reaction. The research results are evidence of the possibility of using the developed test kit for serological diagnosis of HHV-7 infection.

[Development of a test kit for the detection of IgG-antibodies to individual antigens of Rubella virus by immunoblotting (Western blot).]

A Russian test kit for detecting IgG-antibodies to individual antigens of Rubella virus by immunoblotting (Western Blot) was designed. The new test kit is intended for confirmation of positive screening results and for differentiation of stages of infection. It has sensitivity and specificity not conceding one of its analogues, the «Anti-Rubella virus (IgG) WESTERNBLOT¼ («EUROIMMUN AG¼, Germany).