A method comparison of three immunoassays for detection of neutralizing antibodies against SARS-CoV-2 receptor-binding domain in individuals with adenovirus type-5-vectored COVID-19 vaccination.

OBJECTIVE: Detecting neutralizing antibodies targeting receptor-binding domain (RBD) is important for the assessment of humoral protection and vaccine efficacy after vaccination. We compared the performance of three surrogate immunoassays for detection of neutralizing antibodies targeting RBD. METHODS: We analyzed 115 serum samples obtained from individuals with Ad5-vectored COVID-19 vaccination using two competitive enzyme-linked immunosorbent assays (Wantai BioPharm and Synthgene Medical Technology) and one competitive chemiluminescence assay (YHLO Biotech). Performance evaluation and methodology comparison were performed according to the Clinical and Laboratory Standards Institute related guidelines. RESULTS: The precision met the manufacturers' statements. The linear range of the WANTAI was 0.0625-0.545 U/ml and the YHLO was 0.260-242.4 U/ml. The WANTAI's limit of blank (LoB) and limit of detection (LoD) were 0.03 and 0.06 U/ml, respectively. The YHLO's LoB and LoD were 0.048 and 0.211 U/ml, respectively. The correlations of semi-quantitative results of Synthgene with quantitative results of YHLO (ρ = 0.566) and WANTAI (ρ = 0.512) were medium. For YHLO and WANTAI, there was a good agreement (0.62) and a strong correlation (ρ = 0.931). Passing-Bablok analysis and Bland-Altman plot showed a positive bias (112.3%) of the YHLO compared to the WANTAI. The exclusion of samples >50 U/ml did not decrease bias. CONCLUSION: These findings contribute to a deeper understanding of surrogate viral neutralization assays and provide useful data for future comparison studies.

Atypical presentations of coronavirus disease 2019 (COVID-19) from onset to readmission.

BACKGROUND: To investigate the CT imaging and clinical features of three atypical presentations of coronavirus disease 2019 (COVID-19), namely (1) asymptomatic, (2) CT imaging-negative, and (3) re-detectable positive (RP), during all disease stages. METHODS: A consecutive cohort of 79 COVID-19 patients was retrospectively recruited from five independent institutions. For each presentation type, all patients were classified into atypical vs. typical groups (i.e., asymptomatic vs.symptomatic, CT imaging-negative vs. CT imaging-positive, and RP and non-RP,respectively). The chi-square test, Student's t test, and Kruskal-Wallis H test were performed to compare CT imaging and clinical features of atypical vs. typical patients for all three presentation categories. RESULTS: In our COVID-19 cohort, we found 12.7% asymptomatic patients, 13.9% CT imaging-negative patients, and 8.9% RP patients. The asymptomatic patients had fewer hospitalization days (P=0.043), lower total scores for bilateral lung involvement (P< 0.001), and fewer ground-glass opacities (GGOs) in the peripheral area (P< 0.001) than symptomatic patients. The CT imaging-negative patients were younger (P=0.002), had a higher lymphocyte count (P=0.038), had a higher lymphocyte rate (P=0.008), and had more asymptomatic infections (P=0.002) than the CT imaging-positive patients. The RP patients with moderate COVID-19 had lower total scores of for bilateral lung involvement (P=0.030) and a smaller portion of the left lung affected (P=0.024) than non-RP patients. Compared to their first hospitalization, RP patients had a shorter hospitalization period (P< 0.001) and fewer days from the onset of illness to last RNA negative conversion (P< 0.001) at readmission. CONCLUSIONS: Significant CT imaging and clinical feature differences were found between atypical and typical COVID-19 patients for all three atypical presentation categories investigated in this study, which may help provide complementary information for the effective management of COVID-19.