Department of Emergency Medicine, Children's Hospital of Orange County, Orange, California, USA; Department of Emergency Medicine, University of California, Irvine, California, USA.
Department of Hematology, Children's Hospital of Orange County, Orange, California, USA.
Int J Infect Dis. 2021 Dec;113:1-6. doi: 10.1016/j.ijid.2021.09.065. Epub 2021 Sep 30.
The durability of the immune response to severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) vaccination remains unknown. The objective of this study was to evaluate a rapid SARS-CoV-2 IgM/IgG antibody detection kit as a qualitative screen for the humoral response to vaccination.
Study participants (n = 125) included pediatric healthcare workers (HCWs) who had received two doses of BNT162b2 or mRNA-1273. Participants were tested on study entry (March 12, 2021 to April 9, 2021). The mean number of days post second dose was 22 (range 17-36). Participants were tested for IgM/IgG antibodies to the SARS-CoV-2 spike protein with the RightSign COVID-19 IgG/IgM Rapid Test Cassette. ELISA/competitive inhibition ELISA (CI-ELISA) were subsequently run to assess for the neutralization effect and SARS-CoV-2 anti-nucleocapsid IgM/IgG antibodies.
Overall, 98.4% of participants were IgG-positive and 0.8% were IgM-positive on rapid RightSign testing. Of those with IgG-positive results, 100% were anti-spike protein IgG-positive on CI-ELISA; none of those who tested IgG-negative via the rapid test were IgG-positive on CI-ELISA. All HCWs who tested RightSign positive demonstrated neutralizing capability on CI-ELISA. Overall, 1.6% demonstrated anti-nucleocapsid IgM antibodies and 5.6% demonstrated anti-nucleocapsid IgG antibodies.
The strong agreement between the rapid RightSign IgG results and confirmatory CI-ELISA testing suggests that this test may be used to assess for positive, and neutralizing, antibody responses to SARS-CoV-2 mRNA vaccination.
目前尚不清楚针对严重急性呼吸综合征冠状病毒 2(SARS-CoV-2)疫苗的免疫反应的持久性。本研究的目的是评估一种快速 SARS-CoV-2 IgM/IgG 抗体检测试剂盒,作为针对疫苗接种产生的体液反应的定性筛查。
研究参与者(n=125)包括接受了两剂 BNT162b2 或 mRNA-1273 的儿科医护人员(HCWs)。参与者于研究入组时(2021 年 3 月 12 日至 2021 年 4 月 9 日)进行了检测。接受第二剂疫苗的平均天数为 22 天(范围 17-36 天)。使用 RightSign COVID-19 IgG/IgM 快速检测试剂盒检测参与者针对 SARS-CoV-2 刺突蛋白的 IgM/IgG 抗体。随后进行 ELISA/竞争性抑制 ELISA(CI-ELISA)以评估中和效果和 SARS-CoV-2 抗核衣壳 IgM/IgG 抗体。
总体而言,快速 RightSign 检测中 98.4%的参与者 IgG 阳性,0.8%的参与者 IgM 阳性。在 IgG 阳性结果中,100%的参与者在 CI-ELISA 中为抗刺突蛋白 IgG 阳性;在快速检测中 IgG 阴性的参与者中,没有一人在 CI-ELISA 中 IgG 阳性。所有快速 RightSign 检测阳性的 HCWs 在 CI-ELISA 中均表现出中和能力。总体而言,1.6%的参与者检测出抗核衣壳 IgM 抗体,5.6%的参与者检测出抗核衣壳 IgG 抗体。
快速 RightSign IgG 结果与确证性 CI-ELISA 检测之间的高度一致性表明,该检测方法可用于评估针对 SARS-CoV-2 mRNA 疫苗接种的阳性和中和抗体反应。