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Hematocrit effect on dried blood spots in adults: a computational study and theoretical considerations

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Authors
Daousani, C
Karalis, V
Malenović, Anđelija
Dotsikas, Yannis
Article (Published version)
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Abstract
Dried blood spots (DBS) are formed by deposition of a small amount of blood on specific adsorbent paper and its physical drying. DBS are employed as a sampling method in several fields of life sciences and drug research. A concern about DBS is the so-called ‘Hematocrit (Ht) effect’, as a different Ht leads, due to different viscosity, to different spot size, affecting assay bias. Solutions have been proposed, including the correction of quantified concentrations with a suitable correction factor. In order to quantitatively assess Ht impact on the DBS measurements, a computational approach was developed and implemented in R® language. First, the % relative error was modeled with respect to Ht. Then, Monte Carlo simulations were performed in virtual men/women populations with different Ht levels and the % relative error in relation to the Ht used for calibrators was quantified. An upper level for % relative error being a ‘tolerable contribution’ of Ht effect to % total analytical error w...as finally suggested, defining, for the first time, a potential Ht range for analysis of adults’ samples, where correction of concentrations of unknown samples may be omitted. Such tolerable level for % relative error may be defined in each laboratory, also based on experimental parameters (type of paper and blood volume). Using a Ht calibration value representing the study population is fully rationalized, leading to reduced probability for concentration corrections. Regulatory criteria for bioanalysis can thus be targeted, moving towards wider utilization of DBS in human pharmacokinetic and clinical trials.

Keywords:
correction factor / Dried blood spots / hematocrit effect / Monte Carlo simulations / relative error
Source:
Scandinavian Journal of Clinical and Laboratory Investigation, 2019
Publisher:
  • Taylor and Francis Ltd

DOI: 10.1080/00365513.2019.1622033

ISSN: 0036-5513

WoS: 000481824100009

Scopus: 2-s2.0-85066602286
[ Google Scholar ]
11
6
URI
https://farfar.pharmacy.bg.ac.rs/handle/123456789/3278
Collections
  • Radovi istraživača / Researchers’ publications
Institution/Community
Pharmacy
TY  - JOUR
AU  - Daousani, C
AU  - Karalis, V
AU  - Malenović, Anđelija
AU  - Dotsikas, Yannis
PY  - 2019
UR  - https://farfar.pharmacy.bg.ac.rs/handle/123456789/3278
AB  - Dried blood spots (DBS) are formed by deposition of a small amount of blood on specific adsorbent paper and its physical drying. DBS are employed as a sampling method in several fields of life sciences and drug research. A concern about DBS is the so-called ‘Hematocrit (Ht) effect’, as a different Ht leads, due to different viscosity, to different spot size, affecting assay bias. Solutions have been proposed, including the correction of quantified concentrations with a suitable correction factor. In order to quantitatively assess Ht impact on the DBS measurements, a computational approach was developed and implemented in R® language. First, the % relative error was modeled with respect to Ht. Then, Monte Carlo simulations were performed in virtual men/women populations with different Ht levels and the % relative error in relation to the Ht used for calibrators was quantified. An upper level for % relative error being a ‘tolerable contribution’ of Ht effect to % total analytical error was finally suggested, defining, for the first time, a potential Ht range for analysis of adults’ samples, where correction of concentrations of unknown samples may be omitted. Such tolerable level for % relative error may be defined in each laboratory, also based on experimental parameters (type of paper and blood volume). Using a Ht calibration value representing the study population is fully rationalized, leading to reduced probability for concentration corrections. Regulatory criteria for bioanalysis can thus be targeted, moving towards wider utilization of DBS in human pharmacokinetic and clinical trials.
PB  - Taylor and Francis Ltd
T2  - Scandinavian Journal of Clinical and Laboratory Investigation
T1  - Hematocrit effect on dried blood spots in adults: a computational study and theoretical considerations
DO  - 10.1080/00365513.2019.1622033
ER  - 
@article{
author = "Daousani, C and Karalis, V and Malenović, Anđelija and Dotsikas, Yannis",
year = "2019",
abstract = "Dried blood spots (DBS) are formed by deposition of a small amount of blood on specific adsorbent paper and its physical drying. DBS are employed as a sampling method in several fields of life sciences and drug research. A concern about DBS is the so-called ‘Hematocrit (Ht) effect’, as a different Ht leads, due to different viscosity, to different spot size, affecting assay bias. Solutions have been proposed, including the correction of quantified concentrations with a suitable correction factor. In order to quantitatively assess Ht impact on the DBS measurements, a computational approach was developed and implemented in R® language. First, the % relative error was modeled with respect to Ht. Then, Monte Carlo simulations were performed in virtual men/women populations with different Ht levels and the % relative error in relation to the Ht used for calibrators was quantified. An upper level for % relative error being a ‘tolerable contribution’ of Ht effect to % total analytical error was finally suggested, defining, for the first time, a potential Ht range for analysis of adults’ samples, where correction of concentrations of unknown samples may be omitted. Such tolerable level for % relative error may be defined in each laboratory, also based on experimental parameters (type of paper and blood volume). Using a Ht calibration value representing the study population is fully rationalized, leading to reduced probability for concentration corrections. Regulatory criteria for bioanalysis can thus be targeted, moving towards wider utilization of DBS in human pharmacokinetic and clinical trials.",
publisher = "Taylor and Francis Ltd",
journal = "Scandinavian Journal of Clinical and Laboratory Investigation",
title = "Hematocrit effect on dried blood spots in adults: a computational study and theoretical considerations",
doi = "10.1080/00365513.2019.1622033"
}
Daousani, C., Karalis, V., Malenović, A.,& Dotsikas, Y.. (2019). Hematocrit effect on dried blood spots in adults: a computational study and theoretical considerations. in Scandinavian Journal of Clinical and Laboratory Investigation
Taylor and Francis Ltd..
https://doi.org/10.1080/00365513.2019.1622033
Daousani C, Karalis V, Malenović A, Dotsikas Y. Hematocrit effect on dried blood spots in adults: a computational study and theoretical considerations. in Scandinavian Journal of Clinical and Laboratory Investigation. 2019;.
doi:10.1080/00365513.2019.1622033 .
Daousani, C, Karalis, V, Malenović, Anđelija, Dotsikas, Yannis, "Hematocrit effect on dried blood spots in adults: a computational study and theoretical considerations" in Scandinavian Journal of Clinical and Laboratory Investigation (2019),
https://doi.org/10.1080/00365513.2019.1622033 . .

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