Development and Evaluation of a Rapid Neutralizing Antibody Assay for COVID-19 Vaccination

SARS-CoV-2 neutralizing antibodies have excellent application prospects in the prevention and treatment of COVID-19. This study established a competitive colloidal gold immunochromatography assay (GICA) to detect neutralizing antibodies against the receptor-binding domain (RBD) of SARS-CoV-2 in postvaccination serum. The sensitivity, stability, and specificity of GICA were evaluated using neutralizing antibody solution reference material and positive serum. The consistency and correlation between GICA, pseudovirus neutralization (PN) assay, and ELISA were compared. Consistency analysis of serum neutralizing antibody and specific IgG antibody titers was conducted, and changes in neutralizing antibodies and specific IgG antibodies in serum after inoculation with the homologous booster inactivated vaccine and recombinant vaccine were noted. The sensitivity of the reagent was 20.66 IU/L, and the specificity was 100%. There was a strong consistency and correlation between GICA and PN (κ = 0.886, n = 165; r = 0.918, P < 0.001). The correlation coefficient of serum anti-RBD antibody and specific IgG antibody titers was 0.5253 (P < 0.001). The specific IgG antibody titers in serum after (W4) inoculation with homologous booster inactivated vaccine were 10.80 (S/CO).The anti-RBD antibody titers were 28.33. The anti-RBD omicron variant (B.1.1.529) antibody titers were 11.67. After inoculation with the recombinant vaccine, the specific IgG antibody titers in the serum of W4 were 10.68. The serum anti-RBD antibody titers of W4 were 103.30. The serum anti-RBD omicron variant (B.1.1.529) antibody titers of W4 were 56.67. Therefore, vaccination of the third dose of the homologous booster inactivated vaccine and recombinant vaccine can enhance the level of neutralizing antibodies against the omicron variant (B.1.1.529). This study demonstrates that a GICA kit for neutralizing antibodies against the RBD of SARS-CoV-2 can be used for COVID-19 vaccine evaluation. Changes in titers enable long-term monitoring of a population's immunity and guide interventions when their immunity declines.