PDF(Pubmed)
Abstract：
Patients with X-linked agammaglobulinemia (XLA) are characterized by humoral impairment and are routinely treated with intravenous immunoglobulin (IVIG). In this study, we aimed to investigate the presence of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) antibodies in IVIG preparations harvested globally and evaluate the transfer of SARS-CoV-2 antibodies to the XLA patient.
A single-center, prospective cohort study was conducted in the period of November 2020 to November 2022. Clinical and laboratory data, specifically, SARS-CoV-2 spike IgG levels from the serum of 115 IVIG preparations given to 5 XLA patient were collected. Concurrently, SARS-CoV-2 spike IgG levels from the serum of the 5 XLA was collected monthly.
Five XLA patients were evaluated within the study period. All were treated monthly with commercial IVIG preparations. A total of 115 IVIG treatments were given over the study period. The origin country and the date of IVIG harvesting was obtained for 111 (96%) of the treatments. Fifty-four IVIG preparations (49%) were harvested during the COVID-19 pandemic of which 76% were positive (>50AU/mL) for SARS-CoV-2 spike antibodies which were subsequently transmitted to the XLA patients in an approximate 10-fold reduction. SARS-CoV2 spike IgG was first detected in IVIG batches that completed their harvest date by September 2021. Positive products were harvested from origin countries with a documented prevalence over 2,000 per 100,000 population.
As the prevalence of COVID-19 infections rises, detection of SARS-CoV-2 spike IgG in commercial IVIG products increases and is then transmitted to the patient. Future studies are needed to investigate the neutralizing capabilities of SARS-CoV-2 IgG and whether titer levels in IVIG remain consistent as the incidence of infection and vaccination rates in the population changes.
A single-center, prospective cohort study was conducted in the period of November 2020 to November 2022. Clinical and laboratory data, specifically, SARS-CoV-2 spike IgG levels from the serum of 115 IVIG preparations given to 5 XLA patient were collected. Concurrently, SARS-CoV-2 spike IgG levels from the serum of the 5 XLA was collected monthly.
Five XLA patients were evaluated within the study period. All were treated monthly with commercial IVIG preparations. A total of 115 IVIG treatments were given over the study period. The origin country and the date of IVIG harvesting was obtained for 111 (96%) of the treatments. Fifty-four IVIG preparations (49%) were harvested during the COVID-19 pandemic of which 76% were positive (>50AU/mL) for SARS-CoV-2 spike antibodies which were subsequently transmitted to the XLA patients in an approximate 10-fold reduction. SARS-CoV2 spike IgG was first detected in IVIG batches that completed their harvest date by September 2021. Positive products were harvested from origin countries with a documented prevalence over 2,000 per 100,000 population.
As the prevalence of COVID-19 infections rises, detection of SARS-CoV-2 spike IgG in commercial IVIG products increases and is then transmitted to the patient. Future studies are needed to investigate the neutralizing capabilities of SARS-CoV-2 IgG and whether titer levels in IVIG remain consistent as the incidence of infection and vaccination rates in the population changes.
摘要：
■患有X连锁无丙种球蛋白血症(XLA)的患者的特征是体液损害,并且常规使用静脉注射免疫球蛋白(IVIG)治疗。在这项研究中,我们旨在调查全球收获的IVIG制剂中是否存在严重急性呼吸综合征冠状病毒2(SARS-CoV-2)抗体,并评估SARS-CoV-2抗体向XLA患者的转移.
■单中心，前瞻性队列研究于2020年11月至2022年11月期间进行。临床和实验室数据，具体来说,从给予5名XLA患者的115种IVIG制剂的血清中收集SARS-CoV-2峰值IgG水平。同时,每月收集来自5XLA血清的SARS-CoV-2峰值IgG水平。
■在研究期间对5名XLA患者进行了评估。每个月都用商业IVIG制剂治疗。在研究期间给予总共115个IVIG治疗。获得111种(96%)处理的来源国家和IVIG收获日期。在COVID-19大流行期间收获了54种IVIG制剂（49％），其中76％的SARS-CoV-2刺突抗体呈阳性（>50AU/mL），随后以大约10倍的速度传播给XLA患者。SARS-CoV2尖峰IgG首次在IVIG批次中检测到，这些批次在2021年9月之前完成了收获日期。阳性产品是从原籍国收获的，有记录的患病率超过每100,000人2,000。
■随着COVID-19感染率的上升，市售IVIG产品中SARS-CoV-2尖峰IgG的检测增加，然后传播给患者。需要进一步的研究来调查SARS-CoV-2IgG的中和能力，以及随着人群中感染率和疫苗接种率的变化，IVIG中的滴度水平是否保持一致。
■单中心，前瞻性队列研究于2020年11月至2022年11月期间进行。临床和实验室数据，具体来说,从给予5名XLA患者的115种IVIG制剂的血清中收集SARS-CoV-2峰值IgG水平。同时,每月收集来自5XLA血清的SARS-CoV-2峰值IgG水平。
■在研究期间对5名XLA患者进行了评估。每个月都用商业IVIG制剂治疗。在研究期间给予总共115个IVIG治疗。获得111种(96%)处理的来源国家和IVIG收获日期。在COVID-19大流行期间收获了54种IVIG制剂（49％），其中76％的SARS-CoV-2刺突抗体呈阳性（>50AU/mL），随后以大约10倍的速度传播给XLA患者。SARS-CoV2尖峰IgG首次在IVIG批次中检测到，这些批次在2021年9月之前完成了收获日期。阳性产品是从原籍国收获的，有记录的患病率超过每100,000人2,000。
■随着COVID-19感染率的上升，市售IVIG产品中SARS-CoV-2尖峰IgG的检测增加，然后传播给患者。需要进一步的研究来调查SARS-CoV-2IgG的中和能力，以及随着人群中感染率和疫苗接种率的变化，IVIG中的滴度水平是否保持一致。
