(W1330-02-11) One Drop of Blood, Multiple Sets of Data --- Establishing A Common Protocol for Serotype Specific IGG Concentration Testing Using Mitra® VAMS Dry Blood Samples to Support Vaccine Clinical Studies

Purpose: Micro Sampling technologies are a critical component in patient-centric clinical studies. Microsample collection is especially convenient for pediatric or critically ill patients and patients living in isolated areas with difficulty reaching clinical sites. Developing a simple and efficient micro-sample preparation strategy and integrating it into immunoassay development can help with patient enrollment and obtain more pediatric samples for vaccine clinical studies.

Methods: This study employed a multiplexed ECL assay platform to establish a finger-prick dry blood sample collection and analysis method in preparation for future vaccine clinical studies.

Results: We first compared the serotype-specific total IgG recovery rates of two commonly used microsampling technologies, Dried Blood Spot (DBS) and Mitra Volumetric Absorptive Micro-sampling (Mitra® VAMS) technology. Both technologies provided acceptable total IgG recovery from collected micro-samples. We then focused our evaluation on Mitra® VAMS because it can accurately measure the sample volume and is also automation-friendly. We first evaluated the optimal sample extraction buffer and time. Total IgG recovery reached a maximum plateau at approximately 90 minutes +/- 30 minutes in the D100 assay buffer. Secondly, we demonstrated the Mitra® VAMS dry blood sample stability at RT for up to three weeks when they were kept in a sealed desiccator. Thirdly, twenty paired venous serum samples and finger-prick capillary whole blood samples were compared. The IgG concentrations against the target antigens are comparable at the population level between the two types of samples. Furthermore, the paired samples were tested with the VaxArray platform using the Coronavirus assay kits. The data confirmed that this microsampling strategy is applicable to different types of platforms, including readers for point of care (POC) sample testing.

Conclusion: The study established a common strategy to integrate dry capillary whole blood microsample testing into our current immunoassay platforms. More platforms and analytes will be tested with this established method.

Mitra® VAMS Dried Whole Blood Sample Extraction Time Optimization: 90 mins +/- 30 mins


Mitra® VAMS Dried Whole Blood Samples Showed Up to Three Weeks of Stability at RT in a Sealed Desiccator


Comparison of Anti-Serotype Specific IgG Concentrations in Paired Venous Serum Samples and Finger Prick Whole Blood Samples Using Customized ECL Assay and VaxArray Serology Assay