Procedures and Practices for The Validation of Bioanalytical Methods Using Dried Blood Spots: A Review

Jager, Nynke G L; Rosing, Hilde; Schellens, Jan H.M.; Beijnen, Jos H.

doi:10.4155/bio.14.185

Cited by 82 publications

(65 citation statements)

References 89 publications

(118 reference statements)

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“…The influence of hematocrit, punch localization and spot volume were evaluated for the C-DBS method [27,28].…”

Section: Methods Validationmentioning

confidence: 99%

“…In this paper, we present the validation of UHPLC-ESI-MS/MS methods for the quantification of the 3 PEths (PEth 16:0/18:1, PEth 18:1/18:1 and PEth 16:0/16:0) in whole blood, V-DBS and C-DBS according to international guidelines [29] and published recommendations [27].…”

Section: Introductionmentioning

confidence: 99%

“…This partial-spot approach requires the assessment of the impact of variables such as hematocrit, punch localization and spot volume on the quantitative result [27,28].…”

Section: Introductionmentioning

confidence: 99%

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Quantification of phosphatidylethanol 16:0/18:1, 18:1/18:1, and 16:0/16:0 in venous blood and venous and capillary dried blood spots from patients in alcohol withdrawal and control volunteers

et al. 2015

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“…The influence of hematocrit, punch localization and spot volume were evaluated for the C-DBS method [27,28].…”

Section: Methods Validationmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

See 1 more Smart Citation

Quantification of phosphatidylethanol 16:0/18:1, 18:1/18:1, and 16:0/16:0 in venous blood and venous and capillary dried blood spots from patients in alcohol withdrawal and control volunteers

et al. 2015

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“…The validation was performed in accordance with the guidelines provided by the US FDA with pre-established acceptance criteria required to demonstrate the method is suitable for the intended purpose [30] and current scientific standards on microsampling [31][32][33]. The validation for extraction of fosfomycin from dried plasma spots was assessed for lower limit of quantification (LLOQ), linearity, inter-day precision and accuracy, sample spot volume, matrix effects, recovery, storage and transport stability.…”

Section: Methods Of Validationmentioning

confidence: 99%

A validated method for the quantification of fosfomycin on dried plasma spots by HPLC–MS/MS: Application to a pilot pharmacokinetic study in humans

Parker

Lipman

Dimοpoulos

et al. 2015

Journal of Pharmaceutical and Biomedical Analysis

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“…Unfortunately, official guidelines for validation of DBS are not available yet. However, in recent literature, several interesting issues related to analytical DBS research have been discussed [1,[6][7][8][9][10][11][12]. Ongoing research and improved understanding of the factors that influence DBS analysis results will ultimately result in well-founded guidelines for DBS analytical method validation.…”

mentioning

confidence: 99%

Dried blood spot analysis; facing new challenges

Koster¹,

Touw²,

Alffenaar³

2015

J Appl Bioanal

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IntroductionOver the last decade, DBS analysis has gained popularity for TDM because it's a patient friendly sampling procedure [1][2][3][4]. Additional advantages are prolonged sample stability, lower risk of infections and transportation at ambient temperature [1][2][3]5]. These advantages may facilitate implementation of TDM in different clinical settings including resource limited areas. Patients will benefit from DBS analysis but the analytical development and validation of DBS methods is more complex compared to plasma or serum analysis. Additional validation parameters, like the effect of the hematocrit (HT) and blood spot volume need to be evaluated. Drug substances may also interact with the blood matrix or with the DBS card, resulting in matrix related recovery effects. Unfortunately, official guidelines for validation of DBS are not available yet. However, in recent literature, several interesting issues related to analytical DBS research have been discussed [1,[6][7][8][9][10][11][12]. Ongoing research and improved understanding of the factors that influence DBS analysis results will ultimately result in well-founded guidelines for DBS analytical method validation. This would be very helpful for daily practice but would also benefit patient safety because uniformity in method validation prevents potential pitfalls during validation or method development and increase credibility of assay results. Our aim is to discuss some relevant topics related to DBS development prior to development of future guidelines on DBS development and validation. The influence of blood hematocrit value on analytical results.It is well known that the HT may affect analytical results. The blood HT affects the blood viscosity and that in turn influences the formation of a blood spot, which affects the analytical results. The preparation of the target HT values for standards and quality control samples is of great importance and a recent study has shown that the best result was obtained by centrifuging blood, followed by removal or addition of a calculated volume of plasma to adjust the HT [7]. However, it is advised to let the prepared HT be measured in order to confirm the correct preparation. In addition, extraction efficiency may also be influenced by the HT and concentration of the substance. It is important to investigate these influences before the analytical procedure can be implemented in routine patient care [13]. In daily practice, correction of analytical results for the HT value using a linear HT correction method is simple but may not always correct for all HT effects. In that case, a point-to-point relationship between recovery, HT and concentration may be more feasible. Recently, a DBS method for the determination of the HT by potassium measurement was published [14]. However, most likely a second spot is required for the potassium measurement using an immunoanalyzer. This implies a significant amount of work for the development and measurement of the HT value and subsequently for setting up the correction formu...

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Procedures and Practices for The Validation of Bioanalytical Methods Using Dried Blood Spots: A Review

Cited by 82 publications

References 89 publications

Quantification of phosphatidylethanol 16:0/18:1, 18:1/18:1, and 16:0/16:0 in venous blood and venous and capillary dried blood spots from patients in alcohol withdrawal and control volunteers

Quantification of phosphatidylethanol 16:0/18:1, 18:1/18:1, and 16:0/16:0 in venous blood and venous and capillary dried blood spots from patients in alcohol withdrawal and control volunteers

A validated method for the quantification of fosfomycin on dried plasma spots by HPLC–MS/MS: Application to a pilot pharmacokinetic study in humans

Dried blood spot analysis; facing new challenges

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