Validation and clinical application of an LC-MS/MS method for the quantification of everolimus using volumetric absorptive microsampling

Verheijen, Remy B.; Thijssen, Bram; Atrafi, Florence; Schellens, Jan H.M.; Rosing, Hilde; Vries, Niels de; Beijnen, Jos H.; Mathijssen, Ron H.J.; Steeghs, Neeltje; Huitema, Alwin D. R.

doi:10.1016/j.jchromb.2018.11.030

Cited by 35 publications

(34 citation statements)

References 19 publications

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“…Other studies report both lower and higher concentrations in VAMS compared to WB for various drugs [20,25]. The study by Kita et al reported an average of 14% higher AUC for tacrolimus in rat tail blood collected in VAMS compared to wet rat tail blood samples [43].…”

Section: Discussionmentioning

confidence: 97%

“…It is interesting to see Vethe et al describe the use of water as the first extraction solvent while other studies used organic extraction solvents (e.g. methanol or methanol/ water) [20,21,23,24,43]. The application of pure water as the first added extraction solvent might overcome the potential effects of anti-coagulants from the VAMS tips.…”

Section: Discussionmentioning

confidence: 99%

“…20 μL) into a porous substrate, independent of hematocrit, and potentially improve the ease of sampling for the patient [17][18][19]. Although the effects of the hematocrit on the sample volume can be overcome by VAMS, this does not necessarily apply for the effect of hematocrit on extraction recovery from VAMS tips [20][21][22][23].…”

Section: Introductionmentioning

confidence: 99%

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Volumetric absorptive microsampling and dried blood spot microsampling vs. conventional venous sampling for tacrolimus trough concentration monitoring

Veenhof

Koster

Junier

et al. 2020

Clinical Chemistry and Laboratory Medicine (CCLM)

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ObjectivesMonitoring tacrolimus blood concentrations is important for preventing allograft rejection in transplant patients. Our hospital offers dried blood spot (DBS) sampling, giving patients the opportunity to sample a drop of blood from a fingerprick at home, which can be sent to the laboratory by mail. In this study, both a volumetric absorptive microsampling (VAMS) device and DBS sampling were compared to venous whole blood (WB) sampling.MethodsA total of 130 matched fingerprick VAMS, fingerprick DBS and venous WB samples were obtained from 107 different kidney transplant patients by trained phlebotomists for method comparison using Passing-Bablok regression. Bias was assessed using Bland-Altman. A multidisciplinary team pre-defined an acceptance limit requiring >80% of all matched samples within 15% of the mean of both samples. Sampling quality was evaluated for both VAMS and DBS samples.Results32.3% of the VAMS samples and 6.2% of the DBS samples were of insufficient quality, leading to 88 matched samples fit for analysis. Passing-Bablok regression showed a significant difference between VAMS and WB, with a slope of 0.88 (95% CI 0.81–0.97) but not for DBS (slope 1.00; 95% CI 0.95–1.04). Both VAMS (after correction for the slope) and DBS showed no significant bias in Bland-Altman analysis. For VAMS and DBS, the acceptance limit was met for 83.0% and 96.6% of the samples, respectively.ConclusionsVAMS sampling can replace WB sampling for tacrolimus trough concentration monitoring, but VAMS sampling is currently inferior to DBS sampling, both regarding sample quality and agreement with WB tacrolimus concentrations.

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Section: Discussionmentioning

confidence: 97%

Section: Discussionmentioning

confidence: 99%

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Volumetric absorptive microsampling and dried blood spot microsampling vs. conventional venous sampling for tacrolimus trough concentration monitoring

Veenhof

Koster

Junier

et al. 2020

Clinical Chemistry and Laboratory Medicine (CCLM)

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“…The first step of the study was the testing of VAMS volume accuracy for plasma sampling, followed by the development of a suitable pretreatment procedure. Blood volume accuracy was taken for granted, according to the results of previous reports [38][39][40].…”

Section: Sampling and Pretreatment Procedures Developmentmentioning

confidence: 99%

Blood and Plasma Volumetric Absorptive Microsampling (VAMS) Coupled to LC-MS/MS for the Forensic Assessment of Cocaine Consumption

2020

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Reliable, feasible analytical methods are needed for forensic and anti-doping testing of cocaine and its most important metabolites, benzoylecgonine, ecgonine methyl ester, and cocaethylene (the active metabolite formed in the presence of ethanol). An innovative workflow is presented here, using minute amounts of dried blood or plasma obtained by volumetric absorptive microsampling (VAMS), followed by miniaturized pretreatment by dispersive pipette extraction (DPX) and LC-MS/MS analysis. After sampling 20 µL of blood or plasma with a VAMS device, the sample was dried, extracted, and loaded onto a DPX tip. The DPX pretreatment lasted less than one minute and after elution with methanol the sample was directly injected into the LC-MS/MS system. The chromatographic analysis was carried out on a C8 column, using a mobile phase containing aqueous formic acid and acetonitrile. Good extraction yield (> 85%), precision (relative standard deviation, RSD < 6.0%) and matrix effect (< 12%) values were obtained. Analyte stability was outstanding (recovery > 85% after 2 months at room temperature). The method was successfully applied to real blood and plasma VAMS, with results in very good agreement with those of fluid samples. The method seems suitable for the monitoring of concomitant cocaine and ethanol use by means of plasma or blood VAMS testing.

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“…Traditionally, venous blood samples are used for monitoring of immunosuppressive drug concentrations and patients have to travel to the hospital on a regular basis to have their blood drawn. To decrease the burden for patients, dried blood spot (DBS) home sampling has been developed among various micro sampling methods for several drugs, including immunosuppressants, to enable home sampling [5][6][7][8][9][10][11][12][13][14][15][16]. For this, a drop of blood from a fingerprick is applied to a sampling card and dried.…”

Section: Introductionmentioning

confidence: 99%

Clinical application of a dried blood spot assay for sirolimus and everolimus in transplant patients

Veenhof

Koster²,

Alffenaar

et al. 2019

Clinical Chemistry and Laboratory Medicine (CCLM)

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Background Monitoring of immunosuppressive drugs such as everolimus and sirolimus is important in allograft rejection prevention in transplant patients. Dried blood spots (DBS) sampling gives patients the opportunity to sample a drop of blood from a fingerprick at home, which can be sent to the laboratory by mail. Methods A total of 39 sirolimus and 44 everolimus paired fingerprick DBS and whole blood (WB) samples were obtained from 60 adult transplant patients for method comparison using Passing-Bablok regression. Bias was assessed using Bland-Altman. Two validation limits were pre-defined: limits of analytical acceptance were set at >67% of all paired samples within 20% of the mean of both samples and limits of clinical relevance were set in a multidisciplinary team at >80% of all paired samples within 15% of the mean of both samples. Results For both sirolimus and everolimus, Passing-Bablok regression showed no differences between WB and DBS with slopes of 0.86 (95% CI slope, 0.72–1.02) and 0.96 (95% CI 0.84–1.06), respectively. Only everolimus showed a significant constant bias of 4%. For both sirolimus and everolimus, limits of analytical acceptance were met (76.9% and 81.8%, respectively), but limits or clinical relevance were not met (77.3% and 61.5%, respectively). Conclusions Because pre-defined limits of clinical relevance were not met, this DBS sampling method for sirolimus and everolimus cannot replace WB sampling in our center at this time. However, if the clinical setting is compatible with less strict limits for clinical relevance, this DBS method is suitable for clinical application.

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Validation and clinical application of an LC-MS/MS method for the quantification of everolimus using volumetric absorptive microsampling

Cited by 35 publications

References 19 publications

Volumetric absorptive microsampling and dried blood spot microsampling vs. conventional venous sampling for tacrolimus trough concentration monitoring

Volumetric absorptive microsampling and dried blood spot microsampling vs. conventional venous sampling for tacrolimus trough concentration monitoring

Blood and Plasma Volumetric Absorptive Microsampling (VAMS) Coupled to LC-MS/MS for the Forensic Assessment of Cocaine Consumption

Clinical application of a dried blood spot assay for sirolimus and everolimus in transplant patients

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