ABSTRACT
Objective: To investigate the S protein cross-interference of the HB02 coronavirus strain, the Delta coronavirus strain and the Omicron coronavirus strain using the developed method of polyclonal enzyme-linked immunoassay (ELISA). Method(s): The monovalent vaccines of HB02 strain, Delta strain and Omicron strain were prepared in different ratios and combinations. The inactivated vaccines of HB02 strain, Delta strain and Omicon strain (Vero cell) S protein antigen ELISA method was used for detection, and the detection results were compared and the interference rate was calculated. At the same time, the interference rates between the monovalent antigen detection results of the three SARS-CoV-2 strains were analyzed. Result(s): The results of the two strains at different doses showed that the interference rate ranged from 4.21% to 29.53% when Delta strain was added to HB02 strain along with the increasing dose. When Omicron strain was increasingly added to HB02 strian, the interference rate ranged 4.40%~12.75%, and when HB02 strain was increasingly added to Delta strain, the interference rate ranged 56.17%~464.21%. The interference rate ranged from 6.29% to 25.91% when Omicron strain was added to Delta strain from a low to high dose. When HB02 strain was added to Omicron strain, the interference rate ranged from 32.05% to 337.22%. When Delta strain was added to Omicron strain, the interference rate ranged from 44.91% to 252.14%. The results of different doses of the three strains showed that the interference rate ranged from 2.79% to 22.86% when different doses of Delta strain+Omicron strain were added to HB02 strain. When different doses of HB02+Omicron strains were added to Delta strain, the interference rate was 67.16% to 267.95%. When different doses of HB02+Delta strains were added to Omicron strain, the interference rate was 100.66%~412.54%. In addition, the interference rates of monovalent Delta strain and Omicron strain detected by HB02 antigen detection kit were 70% and 90%, respectively. The interference rates of Delta strain antigen detection kit for monovalent HB02 strain and Omicron strain were 30% and 35%, respectively. The interference rates of Omicron strain antigen detection kit for monovalent HB02 strain and Delta strain were 5% and 10% respectively. Conclusion(s): Due to the high similarity of S protein in the HB02, Delta and Omicron COVID-19 vaccines, different strains were mixed at series ratios, and different components had different degrees of interference. When the components of the two strains were mixed at different doses, both Delta strain and Omicron strain showed positive interference to the HB02 strain, and the Delta strain showed a gradually increasing trend with the increasing Delta strain doses, while the interference rate did not change significantly with the variation of Omicron strain dose. HB02 strain showed strong positive interference to Delta strain, and the interference rate gradually increased with the increase of HB02 strain, while Omicron strain showed weak positive interference to Delta strain, and the interference rate did not change significantly with the increase of Omicron strain dose. Both HB02 strain and Delta strain showed strong positive interference to Omicron strain, and showed a stepwise increasing trend with the increase of the composition ratio of HB02 strain or Delta strain. When the three strains were mixed at different ratios, the Delta strain+Omicron strain showed positive interference to the HB02 strain, but the interference rate did not change significantly with the increase of the composition of Delta strain+Omicron strain. HB02 strain+Omicron strain showed strong positive interference to Delta strain. However, when the composition of HB02 strain and Delta strain was unchanged, the interference of Omicron strain to Delta strain did not change significantly no matter how Omicron strain changed. The results showed that HB02 strain had strong positive interference to Delta strain, but Omicron strain did not exert obvious interference to Delta strain. HB02+D lta strain showed strong positive interference to Omicron strain, and the ratio of HB02 and Delta strain increased stepwise. Different COVID-19 antigen detection kits were used to detect the monovalent COVID-19 samples of the three virus strains. Among them, HB02 antigen detection kit had the highest interference rate to Omicron strain samples, but Omicron strain antigen detection kit could effectively detect HB02 COVID-19 antigen. The Delta strain antigen detection kit could detect some COVID-19 antigens of HB02 strain and Omicron strain. Copyright © 2022, Chinese Journal of New Drugs Co. Ltd. All right reserved.