Department of Internal Medicine 3 - Rheumatology and Immunology Friedrich-Alexander University Erlangen-Nürnberg and Universitätsklinikum Erlangen, Erlangen, Germany.
Deutsches Zentrum für Immuntherapie, Friedrich-Alexander University Erlangen-Nürnberg and Universitätsklinikum Erlangen, Erlangen, Germany.
Front Public Health. 2022 Oct 14;10:994770. doi: 10.3389/fpubh.2022.994770. eCollection 2022.
Being able to independently determine vaccine induced antibody responses by minimal-invasive methods is of great interest to enable a flexible and effective vaccination strategy. This study aimed to evaluate (1) the accuracy, feasibility, usability and acceptability of capillary blood and saliva self-sampling to determine SARS-CoV-2 antibody responses in patients with immune-mediated inflammatory diseases (IMIDs) and health professionals (HP).
IMID patients and HP having received two doses of SARS-CoV-2 vaccines, self-collected capillary blood (Tasso+) and saliva samples. Capillary samples were considered interchangeable with venous blood if three criteria were met: Spearman's correlation coefficient (r) > 0.8, non-significant Wilcoxon signed-rank test (i.e., > 0.05), and a small bias or 95% of tests within 10% difference through Bland-Altman. Participants completed a survey to investigate self-sampling usability (system usability scale; SUS) and acceptability (net promoter score; NPS). Study personnel monitored correct self-sampling completion and recorded protocol deviations.
60 participants (30 IMID patients and 30 HP) were analyzed. We observed interchangeability for capillary samples with an accuracy of 98.3/100% for Anti-SARS-CoV-2 IgG/IgA antibodies, respectively. Fifty-eight capillary blood samples and all 60 saliva samples were successfully collected within the first attempt. Usability of both self-sampling procedures was rated as excellent, with significantly higher saliva ratings ( < 0.001). Capillary self-sampling was perceived as significantly ( < 0.001) less painful compared to traditional venous blood collection. Participants reported a NPS for capillary and saliva self-sampling of +68% and +63%, respectively. The majority of both groups (73%) preferred capillary self-sampling over professional venous blood collection.
Our results indicate that capillary self-sampling is accurate, feasible and preferred over conventional venous blood collection. Implementation could enable easy access, flexible vaccination monitoring, potentially leading to a better protection of vulnerable patient groups. Self-collection of saliva is feasible and safe however more work is needed to determine its application in clinical practice.
能够通过微创方法独立确定疫苗诱导的抗体反应,对于制定灵活有效的疫苗接种策略具有重要意义。本研究旨在评估(1)毛细血管血和唾液自我采样在确定免疫介导的炎症性疾病(IMID)患者和健康专业人员(HP)的 SARS-CoV-2 抗体反应方面的准确性、可行性、可用性和可接受性。
IMID 患者和接受过两剂 SARS-CoV-2 疫苗的 HP 自行采集毛细血管血(Tasso+)和唾液样本。如果满足以下三个标准,则认为毛细血管样本与静脉血可互换:Spearman 相关系数(r)>0.8、非显著 Wilcoxon 符号秩检验(即,>0.05)和通过 Bland-Altman 小偏差或 95%的测试在 10%差异内。参与者完成了一项调查,以调查自我采样的可用性(系统可用性量表;SUS)和可接受性(净推荐值;NPS)。研究人员监测正确的自我采样完成情况并记录方案偏差。
共分析了 60 名参与者(30 名 IMID 患者和 30 名 HP)。我们观察到毛细血管样本的互换性,抗 SARS-CoV-2 IgG/IgA 抗体的准确性分别为 98.3/100%。58 个毛细血管血样本和所有 60 个唾液样本均在首次尝试时成功采集。两种自我采样程序的可用性均被评为优秀,唾液评分明显更高(<0.001)。与传统的静脉血采集相比,毛细血管自我采样被认为明显(<0.001)更不痛。参与者报告的毛细血管和唾液自我采样的 NPS 分别为+68%和+63%。两组中大多数(73%)更喜欢毛细血管自我采样而不是专业的静脉血采集。
我们的结果表明,毛细血管自我采样准确、可行,并且优于传统的静脉血采集。实施毛细血管自我采样可以实现便捷的获取、灵活的疫苗监测,从而可能更好地保护弱势群体。唾液的自我采集是可行且安全的,但需要进一步研究以确定其在临床实践中的应用。