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Evaluation of the performance and hematocrit independence of the HemaPEN as a volumetric dried blood spot collection device

(2019) ANALYTICAL CHEMISTRY. 91(22). p.14467-14475
Author
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Abstract
Dried blood spots (DBS) are often used as a less invasive alternative to venous blood sampling. Despite its numerous advantages, the use of conventional DBS suffers from the hematocrit (hct) effect when analyzing a subpunch. This effect could be avoided by using hct-independent sampling devices, of which the hemaPEN is a recent example. This device collects the blood via four integrated 2.74 mu L microcapillaries, each depositing the blood on a prepunched paper disc. In this study, we evaluated the technical performance of the hemaPEN devices, using an extensive bioanalytical validation and application on authentic patient samples. An LC-MS/MS method quantifying caffeine and its metabolite paraxanthine in dried whole blood (using the hemaPEN device) was fully validated, meeting all preset acceptance criteria. A comparative analysis of 91 authentic patient samples (hct range: 0.17-0.53) of hemaPEN, 3 mm DBS subpunches, and whole blood revealed a limited hct dependence (<= 7% concentration difference over a 0.20-0.50 hct range) for the hemaPEN devices, which we could not attribute to the analytical procedure. Using conventional partial-punch DBS (3 mm punches), concentration differences of >= 25% over this hct range were found. The hemaPEN showed to be robust to the effects of blood sample volume, device lot, analytical operator, and storage stability. The technical performance of the hemaPEN when dealing with patients having a high hct and in cases where a large blood drop is present should be further investigated. Based on the successful validation and application on patient samples, we conclude that the hemaPEN device shows good potential for the volumetric collection of DBS.
Keywords
VALIDATION, STANDARD, BIAS, TOOL

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MLA
Deprez, Sigrid, et al. “Evaluation of the Performance and Hematocrit Independence of the HemaPEN as a Volumetric Dried Blood Spot Collection Device.” ANALYTICAL CHEMISTRY, vol. 91, no. 22, 2019, pp. 14467–75.
APA
Deprez, S., Paniagua-Gonzalez, L., Velghe, S., & Stove, C. (2019). Evaluation of the performance and hematocrit independence of the HemaPEN as a volumetric dried blood spot collection device. ANALYTICAL CHEMISTRY, 91(22), 14467–14475.
Chicago author-date
Deprez, Sigrid, Lucia Paniagua-Gonzalez, Sofie Velghe, and Christophe Stove. 2019. “Evaluation of the Performance and Hematocrit Independence of the HemaPEN as a Volumetric Dried Blood Spot Collection Device.” ANALYTICAL CHEMISTRY 91 (22): 14467–75.
Chicago author-date (all authors)
Deprez, Sigrid, Lucia Paniagua-Gonzalez, Sofie Velghe, and Christophe Stove. 2019. “Evaluation of the Performance and Hematocrit Independence of the HemaPEN as a Volumetric Dried Blood Spot Collection Device.” ANALYTICAL CHEMISTRY 91 (22): 14467–14475.
Vancouver
1.
Deprez S, Paniagua-Gonzalez L, Velghe S, Stove C. Evaluation of the performance and hematocrit independence of the HemaPEN as a volumetric dried blood spot collection device. ANALYTICAL CHEMISTRY. 2019;91(22):14467–75.
IEEE
[1]
S. Deprez, L. Paniagua-Gonzalez, S. Velghe, and C. Stove, “Evaluation of the performance and hematocrit independence of the HemaPEN as a volumetric dried blood spot collection device,” ANALYTICAL CHEMISTRY, vol. 91, no. 22, pp. 14467–14475, 2019.
@article{8650068,
  abstract     = {Dried blood spots (DBS) are often used as a less invasive alternative to venous blood sampling. Despite its numerous advantages, the use of conventional DBS suffers from the hematocrit (hct) effect when analyzing a subpunch. This effect could be avoided by using hct-independent sampling devices, of which the hemaPEN is a recent example. This device collects the blood via four integrated 2.74 mu L microcapillaries, each depositing the blood on a prepunched paper disc. In this study, we evaluated the technical performance of the hemaPEN devices, using an extensive bioanalytical validation and application on authentic patient samples. An LC-MS/MS method quantifying caffeine and its metabolite paraxanthine in dried whole blood (using the hemaPEN device) was fully validated, meeting all preset acceptance criteria. A comparative analysis of 91 authentic patient samples (hct range: 0.17-0.53) of hemaPEN, 3 mm DBS subpunches, and whole blood revealed a limited hct dependence (<= 7% concentration difference over a 0.20-0.50 hct range) for the hemaPEN devices, which we could not attribute to the analytical procedure. Using conventional partial-punch DBS (3 mm punches), concentration differences of >= 25% over this hct range were found. The hemaPEN showed to be robust to the effects of blood sample volume, device lot, analytical operator, and storage stability. The technical performance of the hemaPEN when dealing with patients having a high hct and in cases where a large blood drop is present should be further investigated. Based on the successful validation and application on patient samples, we conclude that the hemaPEN device shows good potential for the volumetric collection of DBS.},
  author       = {Deprez, Sigrid and Paniagua-Gonzalez, Lucia and Velghe, Sofie and Stove, Christophe},
  issn         = {0003-2700},
  journal      = {ANALYTICAL CHEMISTRY},
  keywords     = {VALIDATION,STANDARD,BIAS,TOOL},
  language     = {eng},
  number       = {22},
  pages        = {14467--14475},
  title        = {Evaluation of the performance and hematocrit independence of the HemaPEN as a volumetric dried blood spot collection device},
  url          = {http://dx.doi.org/10.1021/acs.analchem.9b03179},
  volume       = {91},
  year         = {2019},
}

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