Official International Association for Therapeutic Drug Monitoring and Clinical Toxicology Guideline: Development and Validation of Dried Blood Spot–Based Methods for Therapeutic Drug Monitoring

Capiau, Sara; Veenhof, Herman; Koster, Remco A.; Bergqvist, Yngve; Böettcher, Michael; Halmingh, Otto; Keevil, Brian; Koch, Birgit C. P.; Linden, Rafael; Pistos, Constantinos; Stolk, L. M. L.; Touw, Daan; Stove, Christophe; Alffenaar, Jan‐Willem C.

doi:10.1097/ftd.0000000000000643

Cited by 234 publications

(280 citation statements)

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“…Dilution integrity of the final extract was determined by spiking blank samples (n = 5) at 2.5 times higher than the highest calibrator. Extracts were diluted 1:5 with IS-spiked ACN or processed blank matrix containing IS [26]. Since prothipendyl shows a broad therapeutic range (ESM Table S4), two additional dilution factors were tested for this analyte.…”

Section: Methods Validationmentioning

confidence: 99%

“…Calibrator and QC samples were obtained by adding 10 μL of each working solution to 380 μL blank human whole EDTA blood. For the preparation of the different concentrations, the spiked solution did not exceed 5% of the total matrix volume in order not to influence the composition of the matrix [26]. The preparation of different target HT values was achieved by removing or adding plasma after centrifugation for 11 min at 9660×g [27,28].…”

Section: Chemicals and Other Materialsmentioning

confidence: 99%

“…Therefore, the aim of this study was to develop and evaluate a VAMS-based strategy for adherence monitoring of antipsychotics in FPB by using drug concentrations to complement qualitative urine analysis [24]. Analysis should be done by means of LC-HRMS/MS and the whole quantitative workflow should be validated in accordance with international guidelines [25,26]. Validation included the evaluation of an HT range from 20 to 60% and a quantitative comparison of VAMS to plasma samples gained from matched whole blood.…”

Section: Introductionmentioning

confidence: 99%

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Development, validation, and application of a quantitative volumetric absorptive microsampling–based method in finger prick blood by means of LC-HRMS/MS applicable for adherence monitoring of antipsychotics

2021

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Volumetric absorptive microsampling (VAMS), an emerging microsampling technique, is expected to overcome some disadvantages of dried blood spots such as volume inaccuracy and influence of hematocrit (HT). This study aimed to develop and evaluate a VAMS-based strategy for quantification of 13 frequently prescribed antipsychotics in finger prick blood within the scope of adherence monitoring to complement already-established qualitative urine analysis. The final workflow consisted of VAMS tip hydration and subsequent precipitation. Samples were analyzed by using reversed-phase ultra-high-performance liquid chromatography and Orbitrap mass spectrometry operated in parallel reaction monitoring mode. The analytical procedure was successfully validated based on international recommendations at three different HT values (20%, 40%, 60%) for most of the analytes. Selectivity and within/between-run accuracy and precision were in accordance with the recommendations in most cases. Internal standard–normalized matrix factor met recommended criteria for all analytes at HT 40%. For the HT values of 20% and 60%, only four substances did not meet the criteria. Dilution integrity was given for all substances, except for olanzapine, allowing a quantification over the whole therapeutic range of selected antipsychotics. Long-term stability in VAMS tips was tested and revealed degradation of five antipsychotic drugs after 1 week of storage at 24 °C. A proof of concept of the applicability of the method was obtained by quantification of a selection of the 13 antipsychotic drugs in VAMS tips and matched plasma samples. Results were coherent between matrices. Thus, VAMS was shown to be a promising alternative for adherence monitoring of at least the investigated antipsychotics.

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Section: Methods Validationmentioning

confidence: 99%

Section: Chemicals and Other Materialsmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

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Development, validation, and application of a quantitative volumetric absorptive microsampling–based method in finger prick blood by means of LC-HRMS/MS applicable for adherence monitoring of antipsychotics

2021

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“…The guidelines do not contain specific regulations for the validation of the DBS method. The procedure of sample preparation (including blood drop volume, drying time) was developed based on the suggestions of International Association for Therapeutic Drug Monitoring and Clinical Toxicology in the Guideline on development and validation of DBS methods [26]. In order to avoid the influence of (unknown levels of) hematocrit, the same type of blood and calculation strategy were used as in the work of Majda et al [15].…”

Section: Validation Parametersmentioning

confidence: 99%

“…All measurements were carried out using blood samples that were free of ketamine and internal standard. In future research, it will be necessary to perform a full method validation considering, apart from the basic validation parameters, also parameters specific to DBS methods such as volume effect and Volcano effect [26].…”

Section: Validation Parametersmentioning

confidence: 99%

The Double Face of Ketamine—The Possibility of Its Identification in Blood and Beverages

et al. 2021

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The purpose of this study was to develop and validate a high-sensitivity methodology for identifying one of the most used drugs—ketamine. Ketamine is used medicinally to treat depression, alcoholism, and heroin addiction. Moreover, ketamine is the main ingredient used in so-called “date-rape” pills (DRP). This study presents a novel methodology for the simultaneous determination of ketamine based on the Dried Blood Spot (DBS) method, in combination with capillary electrophoresis coupled with a mass spectrometer (CE-TOF-MS). Then, 6-mm circles were punched out from DBS collected on Whatman DMPK-C paper and extracted using microwave-assisted extraction (MAE). The assay was linear in the range of 25–300 ng/mL. Values of limits of detection (LOD = 6.0 ng/mL) and quantification (LOQ = 19.8 ng/mL) were determined based on the signal to noise ratio. Intra-day precision at each determined concentration level was in the range of 6.1–11.1%, and inter-day between 7.9–13.1%. The obtained precision was under 15.0% (for medium and high concentrations) and lower than 20.0% (for low concentrations), which are in accordance with acceptance criteria. Therefore, the DBS/MAE/CE-TOF-MS method was successfully checked for analysis of ketamine in matrices other than blood, i.e., rose wine and orange juice. Moreover, it is possible to identify ketamine in the presence of flunitrazepam, which is the other most popular ingredient used in DRP. Based on this information, the selectivity of the proposed methodology for identifying ketamine in the presence of other components of rape pills was checked.

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Therapeutic Drug Monitoring

2020

Fundamentals of Analytical Toxicology

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To study the appropriateness of phlebotomy for digoxin therapeutic drug monitoring (TDM) in outpatients, we conducted a retrospective chart review, a computer search of all previous TDM testing, and a questionnaire of all outpatients (n = 86) who had serum digoxin determinations between April 10 and April 28, 1992 (585 tests). In patients who took digoxin at the same time daily (40 patients, 300 tests), 52% of tests were performed on inappropriate samples drawn within 6 h of the last dose. No patient who took digoxin after 1700 had inappropriate tests. Phlebotomy for serum digoxin determinations before distribution of digoxin is complete is a common problem in outpatients, leading to clinically uninterpretable test results. Postdistribution sampling can be assured by nighttime dosing, and this recommendation has been implemented at our hospital. INDEXING TERMS: blood sampling #{149} pharmacokinetics Digoxin is one of the most widely prescribed drugs for both inpatients and outpatients /1], and digoxin serum concentration is the most commonly ordered therapeutic drug monitoring (TDM) test in the US. Digoxin serum concentrations have been shown to be useful in corroborating the clinical diagnosis of digoxin toxicity as well as correlating with therapeutic effects of digoxin [2, 3]. Digoxin pharmacokinetics are complex hut well characterized (for a review see [4]). For oral dosing of digoxin, rapid absorption occurs in the intestine /4/; reaching distributional equilibrium after a digoxin dose requires at least 8 h, the time at which the semilog plots of plasma and tissue concentrations vs time reach terminal linear and parallel slopes [4, 5]. Samples obtained within 8 h after a digoxin dose can be very misleading as an index of digoxin response /4/.

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Official International Association for Therapeutic Drug Monitoring and Clinical Toxicology Guideline: Development and Validation of Dried Blood Spot–Based Methods for Therapeutic Drug Monitoring

Cited by 234 publications

References 135 publications

Development, validation, and application of a quantitative volumetric absorptive microsampling–based method in finger prick blood by means of LC-HRMS/MS applicable for adherence monitoring of antipsychotics

Development, validation, and application of a quantitative volumetric absorptive microsampling–based method in finger prick blood by means of LC-HRMS/MS applicable for adherence monitoring of antipsychotics

The Double Face of Ketamine—The Possibility of Its Identification in Blood and Beverages

Therapeutic Drug Monitoring

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