Shim Hyeon Woo, Shin Jae Hang, Shin Shang Cheol, Lee Hwa Jung, So Kyung Soon, Lee So Young, Jun Jae Woo, Seo Jeong Ku, Lee Hwa Seop, Lee Suk Young, Kim Seung Hyun, Kim Sun Jong, Kim Kyoung-Chol, Ryu Gyu Ha
BioFront, HanGang Xi Tower, 401 Yangcheon-ro, Gangseo-Gu, Seoul 07258, Korea.
EONE-DIAGNOMICS Genome Center Co., Ltd., #291, Harmony-ro, Yeonsu-Gu, Incheon 22014, Korea.
Diagnostics (Basel). 2022 Aug 9;12(8):1924. doi: 10.3390/diagnostics12081924.
(1) Objective: To investigate the factors that affect rates of neutralizing antibody production and duration after vaccination using the newly developed SARS-CoV-2 POCT. (2) Methods: The production of immunoglobulin and neutralizing antibody in clinical subjects who completed various vaccines was analyzed using the POCT, the semi-quantitative was interpreted by measurement application, and the quantified neutralizing antibody titers were using the ELISA. (3) Results: According to the clinical performance analysis of the POCT, the clinical sensitivity and the specificity were 96.8% (90/93) and 97.7% (167/171), respectively, for the S1 RBD IgG antibody. The clinical sensitivity was 92.22% (83/90), and the clinical specificity was 100.00% (174/174) for neutralizing antibodies. Factors influencing antibody production were analyzed using the whole blood of the five types of second-completed vaccinators (N = 736, 20−80 years old). General and neutralizing antibody and showed significant differences in age (p < 0.0001), vaccine type (p < 0.0001), inoculation interval (p < 0.0001), pain score (p < 0.0001), diabetes (p < 0.0001), and hypertension (p = 0.002). The gender (p = 0.021) and chronic fatigue (p = 0.02) did not show the significance. (4) Conclusions: An acquisition of immunoglobulin and neutralizing antibody varies according to vaccine type, age, days after vaccination, pain degree after vaccination, and underlying diseases. The POCT used in this study will be utilized for clinical recommendations such as deciding whether to receive additional vaccines through the immediate rapid determination of neutralizing antibody generation in the clinical site.
(1) 目的:使用新开发的新冠病毒即时检测(POCT)来研究影响接种疫苗后中和抗体产生率及持续时间的因素。(2) 方法:使用POCT分析完成各类疫苗接种的临床受试者体内免疫球蛋白和中和抗体的产生情况,通过测量应用进行半定量解读,使用酶联免疫吸附测定(ELISA)对中和抗体效价进行定量。(3) 结果:根据POCT的临床性能分析,S1受体结合域(RBD)IgG抗体的临床敏感性和特异性分别为96.8%(90/93)和97.7%(167/171)。中和抗体的临床敏感性为92.22%(83/90),临床特异性为100.00%(174/174)。使用五类完成第二剂接种者(N = 736,年龄20 - 80岁)的全血分析影响抗体产生的因素。一般抗体和中和抗体在年龄(p < 0.0001)、疫苗类型(p < 0.0001)、接种间隔(p < 0.0001)、疼痛评分(p < 0.0001)、糖尿病(p < 0.0001)和高血压(p = 0.002)方面显示出显著差异。性别(p = 0.021)和慢性疲劳(p = 0.02)未显示出显著性。(4) 结论:免疫球蛋白和中和抗体的获得因疫苗类型、年龄、接种疫苗后的天数、接种后疼痛程度及基础疾病而异。本研究中使用的POCT将用于临床建议,例如通过在临床现场即时快速测定中和抗体的产生情况来决定是否接种额外疫苗。