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The aim of this study was to evaluate the antibody reaction after administration of the BNT162b2 vaccine, and to reveal the factors that affect antibody production. This prospective study was carried out in the Association of EISEIKAI Medical and Healthcare Corporation Minamitama Hospital, in Tokyo, Japan, from April 15, 2021 to June 09, 2021. All our hospital's workers who were administered the BNT162b2 vaccine as part of a routine program were included in this study. We calculated the anti-SARS-CoV-2 spike-specific antibody titter (1) before vaccination, (2) 7 to 20 days after the first vaccination, and (3) A total of 7 to 20 days after the second vaccination. The low-antibody titer group (LABG) was defined as the group having less than 25 percentiles of antibody titer. Univariate and Multivariate logistic regression analysis were performed to ascertain the effects of factors on the likelihood of LABG. A total of 374 participants were eventually included in our study, and they were divided into 94 LABG and 280 non-LABG. All samples showed significant antibody elevation in the second antibody test, with a mean value of 3,476 U/mL. When comparing the LABG and non-LABG groups, the median age, blood sugar, and HbA1c were significantly higher in the LABG group. The rates of participants with low BMI (<18.5) and high BMI (>30) were significantly higher in the LABG group. The proportion of chronic lung disease, hypertension, diabetes, dyslipidemia, autoimmune disease, and cancer were significantly higher in the LABG group. Although there was no significant difference confirmed with respect to the exercise hours per day, the proportion of participants that did not perform outdoor exercises was significantly higher in the LABG group. The time interval between the second vaccination and the second antibody test, and between the first and the second vaccination was significantly longer in the non-LABG group. In the multivariate logistic regression analysis, older than 60 years, the past history of hypertension, HbA1c higher than 6.5%, and lack of outdoor exercises were significant suppressors of antibody responses, whereas the length of days from the first to the second vaccination longer than 25 days promoted a significant antibody response. Again, our single-center study demonstrates that older than 60 years, hypertension, HbA1c higher than 6.5%, and lack of outdoor exercises were significant suppressors of antibody responses, whereas the length of days from the first to the second vaccination longer than 25 days promoted a significant antibody response. Evidence from multi-center studies is needed to develop further vaccination strategies.
RESUMO
INTRODUCTION: The spread of coronavirus 2019 (COVID-19) is a serious problem all over the world. Several immunochromatography kits of the antibody for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) have been developed, but it is still unclear which kits have high diagnostic value. This study aims to evaluate the accuracy rate for antibody detection of each immunochromatography kit and reveal which kit has a high diagnostic value for antibody detection. METHODS: This study was carried out between 1 August 2020 and 14 October 2020 at the Association of EISEIKAI Medical and Healthcare Corporation Minamitama Hospital. Patients diagnosed with COVID-19 and approximately 30 days after symptom onset were included as the positive group. The serum SARS-CoV-2 antibodies were analysed using seven immunochromatography kits. RESULTS: Twenty samples (Positive group: 10 patients, Negative group: 10 healthy medical workers) were included in this study. The median age of the patients was 44 years, and the median duration from symptom onset was 30.5 days in the positive group. The accuracy rates for IgM/IgG detection were: 90.0%/100% in Kit A; 50.0%/95.0% in Kit B; 55.0%/65.0% in Kit C; 60.0%/55.0% in Kit D; 50.0%/80.0% in Kit E; 80.0%/90.0% in Kit F; and 90.0%/100% in Kit G. CONCLUSIONS: Our study showed that there is a variation of accuracy rates between immunochromatography kits for antibodies of SARS-CoV-2. COVID-19 IgG/IgM RAPID TEST CASSETTE (Hangzhou Biotest Biotech Co., Ltd., China) and Nadal COVID-19 IgG/IgM Rapid Test (BioServUK Ltd., UK: United Kingdom) have high accuracy rates for both IgM and IgG detection. Evidence from large population studies of immunochromatography kits is needed to clarify the details of diagnostic value for SARS-CoV-2.
