Automated measurement of tacrolimus from hemaPENdried blood spots using CLAM-2030

User Benefits

- Micro-sampling technology such as hemaPEN allows more frequent and less invasive blood sampling - Fully automated sample preparation for LC/MS/MS system - The use of solid matrices with the CLAM-2030 beyond the current classic liquid samples

Introduction

The CLAM-2030 (Shimadzu) is a module that automates all analytical process steps and is directly connected to a liquid chromatography system to enable seamless analysis and management of samples. The module can today autonomously handle various types of wet samples such as whole blood (WB), urine, serum, or plasma. The CLAM-2030’s procedure results in an overall quicker analysis, while reducing the risk of human errors. Furthermore, the module allows technicians to optimize their time during routine analysis, by removing key manual preparation steps. However, such automation has not been employed yet to prepare solid samples, such as dried blood spot (DBS). Over the past few years, a growing interest in patient-centric micro-sampling has allowed DBS technology to position itself as an alternative substrate to wet samples. Innovative patient- centric sampling solutions have been developed to address unmet markets needs that cannot be served by standard phlebotomy. These tools enable the collection of low volumes of blood samples remotely at the convenience and comfort of the patient, while being less invasive than venipuncture, and to provide physicians the confident results to longitudinally monitor markers of health. The hemaPEN (Trajan Scientific and Medical) is one such patient-centric devices that allows rapid and quality remote- sampling. With its intuitive pen like-design, the hemaPEN collects four samples from any single source, rapidly and with minimal volume collection. Its capillary based technology ensures accurate and precise volume collection, while pre-punched DBS substrates store the samples inside a contained embodiment. The hemaPEN enables the precise quantification of analytes with high confidence, by simplifying the sample collection procedure and by maintaining sample integrity throughout the complete analytical workflow, from patient to analysis. The purpose of this study is to integrate hemaPEN DBS sample into a following workflow, demonstrating the possibility to use the CLAM-2030 with solid samples. Therefore, tacrolimus (TAC) was chosen as marker of interest due to its relatively complex and variable pharmacokinetics. Its narrow therapeutic index and usage in longitudinal monitoring of transplanted patients that require frequent and precise results to adjust their therapy makes TAC an ideal candidate for further clinical research implementation. In conclusion, TAC’s analysis on WB is already well-established, even with a CLAM-2030 preparation.

March 1, 2022 GMT