SARS-CoV-2-RBD-ELISA-GAMALEYA, “Medgamal”, “NEARMEDIC PLUS” (Russia)

A test kit for the enzyme immunoassay of class G immunoglobulins to the receptor-binding domain of surface glycoprotein S (spike) of SARS-CoV-2 coronavirus.

To determine the herd immunity to coronavirus, antibodies are used to various antigens or to the antigen complex of the S1, S2 and N proteins of the SARS-CoV-2 virus.

risunok1.png Virus — antibodies that prevent the binding of the S (spike) glycoprotein of the SARS-CoV-2 virus to the human cell receptor ACE2 have a neutralizing activity. Direct binding to this receptor provides a special structural domain RBD (receptor — binding — domain). Thus, antibodies capable of binding to the RBD domain can block contact with the ACE2 receptor and, as a consequence, prevent the penetration of the virus into human cells and its subsequent multiplication.

The presence of anti-RBD antibodies in the patient’s blood plasma indicates that the patient was in contact with the coronavirus strain (SARS-CoV-2) and has  protective, virus — neutralizing antibodies.

SARS-CoV-2-RBD-ELISA-GAMALEYA — a test kit that detects the exact virus protective-neutralizing antibodies to SARS-CoV-2 and allows to determine if the patient has protective antibodies.

Application areas SARS-CoV-2-RBD-ELISA — GAMALEYA

K33gyw.png Verification of positive results for SARS-CoV-2 antibodies
The Russian Federation Interim Guidelines on diagnosis and treatment of COVID-19 (version 8 from 03.09.2020) mandate the use of anti-RBD antibody test kits.

t0fhxn.png Determination of protective antibodies against SARS-CoV-2 for those who have recovered
Infection risk assessment determining the need for vaccination.

WZvB7M.png Determination of protective antibodies in vaccinated individuals
Monitoring the formation of antibodies in the post-vaccination period.

QF6y7x.png Convalescent plasma donor selection
Selection of donors with the best levels of virus-neutralizing anti-RBD antibodies for the preparation of convalescent plasma for the treatment of  patients with a severe coronavirus infection.

Registration Certificate (Russia)

RZN 2020/10393 from 11/09/2020


Tests in one kit 48
Diagnostic sensitivity 96%
Diagnostic specificity 100%
Analytical sensitivity 100%
Analytical specificity 100%
Antibodies IgG, a qualitative test with the ability to quantify antibody titer
Biomaterial blood serum (plasma)