RESUMEN
This study aims to analyze the neutralization ability against Omicron parental variants in five clusters of individuals with different Coronavirus disease (COVID-19) immunity backgrounds, including individuals receiving a homologous or heterologous vaccine without prior infection, recovered patients with homologous or heterologous vaccination, and recovery patients without vaccination. Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) surrogate virus neutralization assay was performed on serum samples. Spearman correlation analysis showed that the percent inhibition against Omicron B.1.1.529 and BA.2 was significantly related to the period of serum collection (r = 0.730 and 0.787, p < 0.001, respectively). Very strong correlation between percent inhibition of neutralizing antibody against Omicron B.1.1.529 and BA.2 variants (rs = 0.973, p < 0.001) was also observed. The neutralizing activity of the sera from recovery patients receiving homologous and heterologous vaccine against the wild-type, B.1.1.529, and BA.2 Omicron variants was significantly higher (p < 0.001) than that of recovery patients without vaccination. This study robustly showed that the breakthrough SARS-CoV-2 Omicron variant in individuals who received homologous and heterologous vaccines had a high level of neutralizing activity against B.1.1.529 and BA.2 parental lineage of XBB subvariants. Therefore, the next-generation COVID-19 vaccine against emerging variants is needed to improve resilience against ongoing variants, particularly for persons who have never been infected.
RESUMEN
The antigen rapid diagnostic test (Ag-RDT) is a useful diagnostic tool for the detection and management of COVID-19 spread. Global SARS-CoV-2 variant outbreaks have highlighted the need for a test capable of detecting SARS-CoV-2 variants with high sensitivity and a low limit of detection. This study aimed to develop and evaluate, both analytically and clinically, an antigen rapid diagnostic test (the KestrelTM COVID-19 Ag Rapid Test) for professional use. A lateral flow immunoassay-based diagnostic test kit was developed, and various aspects of its analytical performance were evaluated. This test kit was clinically evaluated by two independent laboratories and showed closely related results of 96.49% and 98.33% of sensitivity, 100% and 100% of specificity, and 99.01% and 99.44% of accuracy, respectively. A limit of detection was observed at values as low as 0.156 ng/mL for recombinant SARS-CoV-2 nucleocapsid protein. Moreover, the test kit successfully detected the recombinant SARS-CoV-2 nucleocapsid protein (NP) of wild-type, Alpha-, Beta-, Gamma-, Delta-, Epsilon-, Kappa-, and Omicron-variants as positive results. Therefore, the KestrelTM COVID-19 Ag Rapid Test may have potential use for effective COVID-19 screening, surveillance, and infection control in a variety of global SARS-CoV-2 variant outbreaks.
