ABSTRACT
Confirming detected SARS-CoV-2-specific antibodies is necessary to reveal immune response in COVID-19 convalescent subjects as well as to conduct population studies by screening for specific antibodies to assess rate of COVID-19 prevalence. With this purpose St. Petersburg Pasteur Institute was the first in Russia to develop the ELISA kit for the quantitative determination of human IgG to the SARS-CoV-2 nucleocapsid (N-CoV-2-IgG PS). Arbitrary units (AU/ml) were used to assess the level of antibodies. The data shown in AU/ml were recalculated later to the international units (BAU/ml) in accordance with established the First WHO International Standard for anti-SARS-CoV-2 human Immunoglobulin. Comparing the data of the N-CoV-2-IgG PS calibration curve with those of the First WHO International Standard for anti-SARS- CoV-2 human Immunoglobulin revealed a complete inter-assay association (r = 0.999, R-2 = 0.997) allowing to find that 1BAU/ml = 5.97 AU/ml. The aim of the study was to characterize the "SARS-CoV-2 protein N Human IgG Quantitative ELISA Kit" (N-CoV-2-IgG PS), compare quantitative and qualitative data of ELISA kits, assess a correlation between the binding antibodies to SARS-CoV-2 N proteins and the neutralizing antibodies against SARS-CoV-2. The data of correlation analysis of the 83 COVID-19 convalescent blood plasma samples a significant relationship between the antibodies quantitative values and titers SARS-CoV-2-specific antibody (r = 0.8436, R-2 = 0.7802) as well as a moderate relationship between antibody concentration and positivity index (r = 0.6648, R-2 = 0.3307), assessed by Chaddock scale. Comparing concentration of N-protein binding antibodies with neutralizing antibody titers level uncovered data consistency obtained by quantitative and virus microneutralization assays (r = 0.7310, R-2 = 0.6527) used in parallel to analyze 80 blood plasma samples obtained from COVID-19 patients and convalescents. AUC under the ROC curve comprised 0.701 (P < 0.0001) evidencing about a satisfactory informative value for "N-CoV-2-IgG PS" compared with microneutralization assay. In addition, the efficacy of the "N-CoV-2-IgG PS" was 95%, while the positive and negative prognostic value was 97% and 87%, respectively. The data obtained confirmed a correlation between N-protein binding antibody level and neutralizing antibody titer. Checking inter-assay agreement evidenced about acceptance for informativeness and efficacy of using "N-CoV-2-IgG PS", thereby confirming an opportunity to apply the Kit to screen for SARS-CoV-2 N protein-specific IgG antibody level and assess seroprevalence in diverse population cohorts.
ABSTRACT
Objective: To study the seroprevalence of SARS-CoV-2 antibodies (AB) in children in the 2nd year of the COVID-19 pandemic in Russia. Materials and methods: Prospective cohort study. The seroprevalence research was conducted among 3670 children aged 1 to 17 y/o from 26 modelling regions of Russia (that have been participating earlier in the five stages of seromonitoring during 2020-2021). The serological testing was carried out in December, 2021. The work was carried out according to a unified methodology set by the Russian Federal Service for Supervision of Consumer Rights Protection and Human Well-Being with the Pasteur Institute of Epidemiology and Microbiology (Saint Petersburg, Russia). The plasma was obtained from 3 ml of venous blood, in which the level of AB to nucleocapsid (NC), and the SARS-CoV-2 receptor-binding domain (RBD) was determined by immunoferment method using reagents for qualitative and quantitative analysis. Results: The analysis of AB seroprevalence to NC and RBD showed the statistically significant increase in the share of seropositivity to RBD in children of all modelling regions (p<0.05). The most seropositive volunteers contained low levels of AB: 31.3-125.6 BAU/ml NC and 22.6-220 BAU/ml RBD. An increase in the level of AB to NC and RBD was accompanied by a decrease in the percentage of seropositive patients. Evaluating the contribution of children to the level of humoral immunity, convalescents (had been ill shortly before the examination), the «anamnesis» (had been ill at previous stages of seromonitoring) and asymptomatic (had been asymptomatically ill) groups were distinguished. The maximum contribution was made by children with asymptomatic cases of COVID-19 in anamnesis: In 82.3% (95% CI 81.1-83.6), of which 76.9% (95% CI 75.5-78.3) AB detected to RBD. The contribution of children of two other groups to the overall level of humoral immunity was 33 times less. Conclusion: Statistically significant predominance of AB to RBD above AB to NC and their main contribution to the level of humoral immunity to SARS-CоV-2 (p<0.001).
ABSTRACT
The Bioethics Committee of Belarus and the local ethics committee of the St. Petersburg Pasteur Institute approved the study. Selection of participants was carried out using a questionnaire method and online technology (internet, cloud server). Volunteers were randomized into seven age groups (years of age): 1–17;18–29;30–39;40–49;50–59;60–69;and 70+. Regional randomization ensured proportional representation of volunteers from each region, and no more than 30 people were included from one enterprise. In accordance with manufacturer instructions, blood plasma samples were analyzed for: IgG antibodies (Abs) to the SARS-CoV-2 nucleocapsid (Nc) using a quantitative ELISA test system;and IgG Abs to the receptor binding domain (RBD) of the SARS-CoV-2 S (spike) surface glycoprotein using a qualitative ELISA test system. Statistical processing was carried out using Excel 2010 and other software. Statistical differences were designated as significant when p < 0.05, unless otherwise indicated. Results. The level of seroprevalence, in terms of Abs to Nc among the Belarusian population, was 38.4% (95% CI 37.6–45.4). The highest Ab levels were found among individuals in older age groups (50-70+ years old). The lowest were found in children 1–17 years old and in young people 18–39 years old The distribution of seroprevalence across Belarusian regions was relatively homogeneous, with the exception of the Minsk Region, where a statistically significant decrease in the indicator was noted. In terms of profession, the largest share of seropositive individuals was found among transportation workers;the smallest was found in business. The moderate COVID-19 incidence has not led to a dramatic increase in the number of contacts. The base reproduction number (R0) was 1.3. In the Republic of Belarus, there was a moderate level of asymptomatic COVID-19 among seropositive individuals (45.3% [95% CI 44.0–46.7]). This form of infection was observed most often among children aged 1–17 years old (65.0% [95% CI 61.3–68.6]). In parallel with seroprevalence assessment, SARS-CoV-2 vaccination was carried out. We used two vaccines: Gam-COVID-Vac (also known as Sputnik V, developed by Gamaleya National Center for Epidemiology and Microbiology, Russia);and BBIBP-CorV (Sinopharm, PRC). Vaccination against SARS-CoV-2 was accompanied by an increase in the level of anti-RBD Abs (95% [95% CI 94.7–96.7]). Taking into account the vaccination of a subset of the population with BBIBP-CorV, the overall herd immunity, inferred from the analyzed indicators (presence of anti-Nc or anti-RBD Abs), was 47.1% (95% CI 46.3–48.0). Conclusion. COVID-19 in Belarus was characterized by a moderately pronounced course of the epidemic process. The threshold level of herd immunity to SARS-CoV-2 has not yet been reached, as a result of which the conditions for progression of the epidemic remain.
ABSTRACT
The first case of COVID-19 was diagnosed in St. Petersburg on March 2, 2020;the period of increase in the incidence lasted for 10 weeks, the maximum rates were recorded in mid-May, and subsequently there was a statistically significant decrease in the incidence. Objective: to determine the level and structure of community immunity to SARS-CoV-2 among the population of St. Petersburg during the period of intensive spread of COVID-19. Materials and methods. Selection of volunteers for the study was carried out through interviewing and randomization. The exclusion criterion was active COVID-19 infection at the time of the survey. 2713 people aged 1 to 70 years and above were examined for the presence of specific antibodies to SARS-CoV-2. Antibodies were detected by enzyme immunoassay. Results and discussion. Studies have shown that in St. Petersburg, in the active phase of COVID-19 epidemic, there was a moderate seroprevalence to SARS-CoV-2, which amounted to 26 %, against the background of a high frequency (84.5 %) of asymptomatic infection in seropositive individuals who did not have a history of COVID-19 disease, positive PCR result and ARI symptoms on the day of examination. The maximum indicators of herd immunity were established in children 1–6 years old (31.1 %), 7–13 years old (37.7 %) and people over 70 years old (30.4 %). Differences in the level of seroprevalence in the age groups of 18–49 years are statistically significant. The highest level of seroprevalence was found among the unemployed (29.7 %), healthcare workers (27.1 %), education sector (26.4 %) and business sector personnel (25 %). In convalescents, COVID-19 antibodies are produced in 75 % of cases. In individuals with positive result of PCR analysis carried out earlier, antibodies are detected in 70 % of the cases. The results of the study of herd immunity to SARS-CoV-2 are essential to forecast the development of the epidemiological situation, as well as to plan measures for specific and non-specific prevention of COVID-19. © 2020 Russian Research Anti-Plague Institute. All rights reserved.
ABSTRACT
The first case of COVID-19 was registered in the Leningrad Region on March 13, 2020. The period of increasing intensity of the epidemic process lasted 8 weeks. One month after reaching the maximum incidence rate, a study was organized to determine seroprevalence to COVID-19 among the population of the Region. Objective of the study was to determine the level and structure of community immunity to SARS-CoV-2 virus in the population of the Leningrad Region in the period of intensive COVID-19 transmission. Materials and methods. The work was carried out within the framework of the Rospotrebnadzor project on assessment of community immunity to the SARS-CoV-2 virus in the population of the Russian Federation. The content of antibodies to SARS-CoV-2 was determined applying ELISA using a kit for the analysis of human serum or blood plasma for the presence of specific IgG to the nucleocapsid of the SARS-CoV-2 virus, manufactured by the State Scientific Center of Applied Microbiology and Biotechnology (Obolensk) in accordance with the instructions for use. Results and discussion. The study has showed that the herd immunity of the population of the Leningrad Region was 20.7 %. The maximum level has been established in children 1–6 years old (42.3 %) and people over 70 years old (29.0 %). The highest level of seropositivity, except for children and older people, was found among the unemployed (25.1 %). The lowest level of seroprevalence was detected in civil servants (12.8 %) and military personnel (16.7 %). It has been shown that the risk of infection increases by 1.5 times in case of contacts with COVID-19 patients. After exposure to COVID-19 virus, antibodies are produced in 82.1 % of the cases. In individuals with a positive PCR test result obtained earlier, antibodies are detected in 82.8 % of cases. The share of asymptomatic forms among seropositive residents of the Leningrad Region was 86.9 %. The results of assessing the herd immunity to SARS-CoV-2 in the population of the Leningrad Region indicate that during the period of intensive COVID-19 transmission, an average level of seroprevalence was formed. A significant proportion of asymptomatic forms of infection characterizes the high intensity of the latently developing epidemic process. The results obtained should be taken into account when organizing preventive measures, including vaccination, and predicting morbidity rates. © 2020 Russian Research Anti-Plague Institute. All rights reserved.