The Use of Surrogate Matrix for Calibrators in the Analysis of Dried Blood Samples - A Feasibility Study
Lee et al.
The finding, in our words
This feasibility study demonstrated that a surrogate matrix solution enables accurate quantitation of a monoclonal antibody from dried blood samples collected via VAMS or Tasso-M20 devices. The method resolves challenges related to daily calibrator preparation and sample dilution for ligand binding assays used in pharmacokinetic studies.
A paraphrase to the Library’s standard, never the abstract. The source is one link away and is always the authority.
The authors developed and validated a workflow that couples Mitra volumetric absorptive microsampling with hybridisation LC-MS/MS to quantify the antisense oligonucleotide fomivirsen in human blood. Quantitative recovery was achieved irrespective of haematocrit level or sample age, and the method demonstrated sensitivity, linearity, precision, accuracy, and four-month stability, supporting its use for therapeutic drug monitoring of biologic candidates in decentralised trials.
The study found that daclizumab and trastuzumab showed encouraging recovery from VAMS after short term storage at room temperature and long term storage at -80 degrees Celsius, supporting the use of VAMS for therapeutic drug monitoring of biologics in decentralised settings.
VAMS coupled with LC-MS/MS showed good correlation with conventional serum sampling for monoclonal antibody pharmacokinetics in rhesus monkeys, but a subsequent clinical study revealed that EDTA anticoagulant in standard and quality control samples caused anomalous internal standard responses in patient fingerstick samples, compromising accuracy. The authors recommend specific best practices during method development and validation to detect such anticoagulant effects early before deploying VAMS in clinical studies.
The Mitra® microsampler demonstrated good recovery of seven therapeutic monoclonal antibodies from capillary blood after storage at room temperature for one month, with marginally better performance than conventional dried blood spot cards. This validates a practical protocol for decentralised therapeutic drug monitoring of biologic therapies.
Researchers successfully validated an analytical method for measuring creatinine across plasma and volumetric absorptive microsampling devices, demonstrating strong correlation between conventional plasma and dried microsamples. This provides a reliable, patient-centric approach for monitoring kidney function remotely during transplant follow-up.