Article
How well does blood self-sampling perform in the laboratory? The use case of tetanus antibody detection
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Authors
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Robyn Kettlitz
- Department for Epidemiology, Helmholtz Centre for Infection Research, Braunschweig, Germany; PhD Programme “Epidemiology” Braunschweig-Hannover, Braunschweig, Germany
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Julia Ortmann
- Department for Epidemiology, Helmholtz Centre for Infection Research, Braunschweig, Germany
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Tobias Kerrinnes
- Department of RNA-Biology of Bacterial Infections, Helmholtz Institute for RNA-Based Infection Research, Würzburg, Germany
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Stefanie Castell
- Department for Epidemiology, Helmholtz Centre for Infection Research, Braunschweig, Germany
| Published: | September 6, 2024 |
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Outline
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Background: Serological data collection is an indispensable tool for monitoring public health, particularly during times of outbreaks or pandemics. The gold standard, venous blood sampling, continues to face multiple barriers. Dried blood self-sampling (DBS) is a possible solution using capillary blood. The HemaSpotTM-HF device for DBS solves some of the problems with traditional methods. Information on diagnostic accuracy is not complete. We aimed to investigate the diagnostic accuracy and reliability in detecting tetanus antibodies based on blood collection via HemaSpotTM-HF in adults.
Methods: In January 2017, 180 voluntary participants were enrolled in a study on self-sampling of blood from the campus of Helmholtz Centre for Infection Research, Germany. Participants performed the blood self-sampling at home (n=154, 58% females). Consenting participants underwent an additional venous blood puncture performed by medical staff (n=54). Application-attributable effects of self-sampling were minimized by inoculating the HemaForm-80 Plate Kit radial filter paper of HemaSpotTM-HF with serum. Antibodies against Clostridium tetani toxin were determined using NovaTec’s Clostridium tetani Toxin 5S IgG plus – ELISA (PTETG043, NovaTec, Germany). Sensitivity and inter-rater reliability were evaluated in complete observations (n=49, 59% females) with venous and capillary blood samplings.
Preliminary results: For tetanus antibody detection, sensitivity ranged from 67% (95% CI: 0.52, 0.80) to 70% (95% CI: 0.55, 0.83) for HemaSpotTM-HF, depending on the cut-off values used for antibody concentration. In comparison, the sensitivity of HemaFormTM was estimated to be 100% (95% CI: 0.93, 1.00) for antibodies against tetanus. In a specific scenario, inter-rater reliability (Krippendorff’s α) between HemaSpotTM-HF, HemaFormTM and venous blood puncture was 0.38 (95% CI: 0.15, 0.60).
Conclusion: We investigated sensitivity and reliability of the self-sampling HemaSpotTM-HF device in a real-world scenario. Since, we found differences in the sensitivities of HemaSpotTM-HF and HemaFormTM, effects of application by participants and logistical challenges seem to influence the quality of the laboratory measurements. Further improvements are required to provide a reliable alternative for venous blood puncture.
The authors declare that they have no competing interests.
The authors declare that a positive ethics committee vote has been obtained.
