CAMAG DBS-MS 500 Automated Dried Blood Spot Extraction System

Overview

The CAMAG DBS-MS 500 is a fully automated, walk-away dried blood spot (DBS) extraction platform engineered for high-integrity bioanalysis in regulated preclinical and clinical research environments. It implements a standardized, closed-loop workflow grounded in solvent-based elution kinetics and precision robotic handling—principles derived from CAMAG’s 50+ years of expertise in quantitative thin-layer chromatography (TLC) and controlled spray deposition. Unlike manual or semi-automated DBS workflows, the DBS-MS 500 executes end-to-end sample preparation—including card identification, internal standard addition, zone-specific extraction, and full-path decontamination—without human intervention between runs. Its architecture is purpose-built to interface directly with commercial LC-MS and standalone mass spectrometry systems, eliminating intermediate vial transfers and minimizing analyte loss, carryover, or degradation. The system supports both quantitative and qualitative applications where trace-level sensitivity, inter-run reproducibility, and regulatory traceability are non-negotiable.

Key Features

• High-capacity robotic deck accommodating up to 500 DBS cards per unattended run, with programmable batch sequencing and priority queueing.
• Integrated OCR (Optical Character Recognition) module featuring a calibrated digital camera and multi-spectral sensor array for real-time verification of card type, spot count, spot location, barcoded sample ID, and cassette integrity status.
• ISA (Internal Standard Addition) module delivering precise, volume-controlled deposition of isotopically labeled or structural analog internal standards directly onto defined DBS zones prior to extraction—ensuring stoichiometric consistency and correcting for matrix effects and recovery variability.
• Dedicated extraction module with programmable solvent delivery, temperature-regulated incubation, and adjustable dwell time; utilizes disposable or reusable extraction loops compatible with diverse LC-MS flow configurations (e.g., microflow, nano-LC, conventional HPLC).
• Full-path cleaning station employing multi-solvent flush protocols (including water, organic solvents, and surfactant solutions) to decontaminate all fluidic pathways, gripper tips, dispensing nozzles, and card-contact surfaces—validated per ICH M10 guidelines for carryover assessment.
• Modular software architecture based on CAMAG WinCATS Pro, supporting electronic lab notebook (ELN) integration, role-based user access control, and audit-trail-enabled operation logs compliant with FDA 21 CFR Part 11 requirements.

Sample Compatibility & Compliance

The DBS-MS 500 accepts standard 300 g/m² cellulose-based DBS cards (e.g., Whatman 903®, Ahlstrom Grade 226, Munktell TFN), as well as specialty substrates including functionalized polymers and silica-coated membranes. It accommodates single- or multi-spot configurations (1–8 spots/card) across common geometries (3.2 mm, 4.5 mm, 6.0 mm punch diameters). All operational parameters—including OCR threshold settings, ISA volume calibration, extraction solvent composition, and cleaning cycle duration—are configurable and stored as validated method templates. The system is designed to support analytical method validation per ICH Q2(R2), USP , and EMA/CHMP guideline on bioanalytical method validation. Routine performance qualification includes carryover testing (<0.05% peak area), intra- and inter-day precision (CV ≤8%), and accuracy (85–115% recovery) across clinically relevant concentration ranges.

Software & Data Management

Control and data acquisition are managed through CAMAG WinCATS Pro v2.5+, a GxP-ready platform offering method-driven workflow automation, real-time instrument status monitoring, and integrated reporting. Each run generates a timestamped, digitally signed metadata package containing raw OCR images, ISA delivery logs, extraction pressure/temperature profiles, cleaning cycle validation flags, and export-ready CSV/ASCII output for downstream statistical analysis. Audit trails record all user actions—including parameter modifications, method recalls, and error acknowledgments—with immutable timestamps and operator IDs. Optional extensions include LIMS connectivity via ASTM E1578-compliant API, automated QC flagging against predefined acceptance criteria, and PDF report generation with embedded chromatograms and calibration curves.

Applications

The DBS-MS 500 serves core applications in translational and clinical bioanalysis: therapeutic drug monitoring (TDM) of antiepileptics, immunosuppressants, and oncology agents; newborn screening for inborn errors of metabolism (IEM); virological quantification (e.g., HIV viral load, HBV DNA); pharmacokinetic profiling in first-in-human (FIH) trials; and biomarker discovery in critical care cohorts. Its ethical and logistical advantages—reduced blood volume requirements (≤20 µL per spot), ambient shipping stability, simplified biobanking, and minimized biosafety risk—make it particularly suited for decentralized sampling in multicenter studies and resource-limited settings. Method transfer studies confirm compatibility with widely adopted LC-MS/MS assays for >120 small-molecule therapeutics and endogenous metabolites.

FAQ

Does the DBS-MS 500 support custom DBS card formats?

Yes—users can define new card geometries, spot layouts, and barcode symbologies via the OCR configuration wizard; validation documentation is provided for each custom setup.
Can the system be integrated into an existing LIMS without custom coding?

It supports ASTM E1578-compliant data exchange and offers preconfigured connectors for major LIMS vendors (e.g., LabVantage, STARLIMS, Thermo SampleManager).
Is cleaning validation data included with the system?

A full IQ/OQ/PQ protocol suite—including cleaning efficiency test reports, carryover assessments, and blank run sequences—is delivered with installation qualification.
How is internal standard homogeneity verified post-deposition?

The ISA module includes optional UV-Vis reflectance imaging to quantify spatial uniformity of internal standard distribution across the DBS zone prior to extraction.
What regulatory documentation is supplied for audit readiness?

The system ships with a complete Design Qualification (DQ) dossier, 21 CFR Part 11 compliance statement, electronic signature validation report, and raw data integrity assessment per ALCOA+ principles.