Dried Matrix on Paper Disks: The Next Generation Dbs Microsampling Technique For Managing The Hematocrit Effect in Dbs Analysis

Meesters, Roland J.W.; Zhang, Jamie; Huizen, Nick A. van; Hooff, Gero P.; Gruters, Rob A.; Luider, Theo M.

doi:10.4155/bio.12.175

Cited by 65 publications

(38 citation statements)

References 28 publications

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“…When no HT correction is applied, the method validation should include a range that covers substance concentration and a HT of the target population with the analytical re- , Jan-Willem C. Alffenaar 1* 1 sults within acceptable limits. The approach of whole spot analysis or pre-cut disks will show no effects of the HT on the spot formation [15][16][17][18]. However, if extraction efficiency is affected by HT and concentration of the substance, this effect cannot be compensated.…”

Section: The Influence Of Blood Hematocrit Value On Analytical Resultsmentioning

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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Section: The Influence Of Blood Hematocrit Value On Analytical Resultsmentioning

confidence: 99%

Dried blood spot analysis; facing new challenges

Koster¹,

Touw²,

Alffenaar³

2015

J Appl Bioanal

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“…Importantly, there have been a number of recent publications putting forwards potential approaches to overcome the hematocrit issue [13][14][15][16][17]. These include techniques for taking accu rate blood volumes, separating the plasma com ponent on the sample substrate and determining the hematocrit value in the test sample.…”

Section: The Way Forwardsmentioning

confidence: 98%

A Dried Blood Spot Update: Still an Important Bioanalytical Technique?

Spooner

2013

Bioanalysis

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“…The latter method has been also termed perforated dried blood spots (PDBS; [3]), dried matrix on paper disks (DMPD; [4]) or pre-cut dried blood spots (PCDBS; [5]). Spotting an accurate volume and analyzing the entire DBS avoids the haematocrit effect which refers to the spreading behaviour of blood on a filter paper in relation to its haematocrit value.…”

Section: Introductionmentioning

confidence: 99%