Kettlitz R, Ortmann J, Kerrinnes T, Ott J J, Castell S
Department for Epidemiology, Helmholtz Centre for Infection Research, Braunschweig, Lower Saxony, Germany.
PhD Programme "Epidemiology" Braunschweig-Hannover, Braunschweig, Germany.
Sci Rep. 2025 Jul 3;15(1):23693. doi: 10.1038/s41598-025-06674-7.
Health research in humans often requires biosamples, e.g. blood. However, collecting venous blood samples poses multiple logistic challenges and needs to be carried by practitioners at study centres. Using self-collected samples of dried blood spots is an attractive alternative, but its feasibility remains to be determined. We investigated the feasibility (including acceptance) of a self-sampling device called HemaSpot HF (HS) employing the use case of anti-Clostridium tetani toxin IgG detection among 154 volunteers. Of those, n = 49 underwent an additional venous blood puncture (VBP) by medical staff (gold standard) as and control for user errors, which were determined by adding serum on HS filter paper (HemaForm (HF)). Antibody concentrations were analysed via ELISA and the serological status was determined using different cut-off values (COV). Most participants (85%) found the self-sampling using the HS device (fully) acceptable. Sensitivity for HS ranged from 70% (95% CI 0.55; 0.83; COV: 1.0 lU/mL) to 100% (95% CI 0.93; 1.00; COV: 0.01 and 0.1 lU/mL), and for HF 85% (95% CI 0.72; 0.94; 1.0 lU/mL) to 100% (95% CI 0.93; 1.00; COV: 0.01 and 0.1 lU/mL). The correlation between HS and VBP was r = 0.73 (95% CI 0.56; 0.83), and between HF and VBP r = 0.81 (95% CI 0.69; 0.89). The average difference in antibody concentration between HS and VBP was 1.1 IU/mL (Bland-Altman plots) and increased with the IgG concentration. Therefore, despite high acceptability, self-sampling with HS needs further improvement to be a reliable alternative to VBP.
人体健康研究通常需要生物样本，例如血液。然而，采集静脉血样本面临诸多后勤方面的挑战，且需要研究中心的工作人员来操作。使用自我采集的干血斑样本是一种颇具吸引力的替代方法，但其可行性仍有待确定。我们以154名志愿者为例，研究了一种名为HemaSpot HF（HS）的自我采样设备在检测抗破伤风梭菌毒素IgG方面的可行性（包括接受度）。其中，n = 49名志愿者由医护人员进行了额外的静脉穿刺采血（VBP）（金标准），作为对用户错误的对照，用户错误是通过在HS滤纸（HemaForm（HF））上添加血清来确定的。通过酶联免疫吸附测定法（ELISA）分析抗体浓度，并使用不同的临界值（COV）确定血清学状态。大多数参与者（85%）认为使用HS设备进行自我采样（完全）可以接受。HS的灵敏度范围为70%（95%置信区间0.55；0.83；COV：1.0 lU/mL）至100%（95%置信区间0.93；1.00；COV：0.01和0.1 lU/mL），HF的灵敏度范围为85%（95%置信区间0.72；0.94；1.0 lU/mL）至100%（95%置信区间0.93；1.00；COV：0.01和0.1 lU/mL）。HS与VBP之间的相关性为r = 0.73（95%置信区间0.56；0.83），HF与VBP之间的相关性为r = 0.81（95%置信区间0.69；0.89）。HS与VBP之间抗体浓度的平均差异为1.1 IU/mL（布兰德-奥特曼图），且随IgG浓度增加。因此，尽管接受度较高，但HS自我采样要成为VBP的可靠替代方法仍需进一步改进。
