Volumetric Absorptive Microsampling as a Sampling Alternative in Clinical Trials and Therapeutic Drug Monitoring During the COVID-19 Pandemic: A Review

Abstract

An infectious disease, COVID-19, caused by a new type of coronavirus, has been discovered recently. This disease can cause respiratory distress, fever, and fatigue. It still has no drug and vaccine for treatment and prevention. Therefore, WHO recommends that people should stay at home to reduce disease transmission. Due to the quarantine, FDA stated that this could hamper drug development clinical trial protocols. Hence, an alternative sampling method that can be applied at home is needed. Currently, volumetric absorptive microsampling (VAMS) has become attention in its use in clinical and bioanalytical fields. This paper discusses the advantages and challenges that might be found in the use of VAMS as an alternative sampling tool in clinical trials and therapeutic drug monitoring (TDM) during the COVID-19 pandemic. VAMS allows easy sampling, can be done at home, storage and delivery at room temperature, and the volume taken is small and minimally invasive. VAMS is also able to absorb a fixed volume that can increase the accuracy and precision of analytical methods, and reduce the hematocrit effects (HCT). The use of VAMS is expected to be implemented immediately in clinical trials and TDM during this pandemic considering the benefits it has.

Lessons Learned from the COVID-19 Pandemic and its Impact on Bioanalysis and Drug Development

“…The pandemic necessitated access to testing that can be conducted safely, in other words, avoiding the need for travel to a hospital or clinic, resulting in drive through and at home testing options. Although most at home testing has been noninvasive (self-sampling using a nasal swab), several COVID-19 clinical trials have included in-home collection of blood samples for serology testing, using volumetric absorptive microsampling (VAMs) and Tasso blood sampling devices [12][13][14][15]. This demonstrates the utility of in-home or patient centric blood sampling devices.…”

Volumetric Absorptive Microsampling: Its Use in Covid-19 Research and Testing

“…Prior to the COVID-19 pandemic, remote sampling using Mitra devices was beginning to gain good traction, with a number of clinical trials reported in the literature. Sixteen of these trials were listed in a recent review by Y Harahap and colleagues [ 47 ]. Additionally, a paper has recently been published by AstraZeneca, discussing the benefits of patient-centric sampling using Mitra devices (and other remote solutions) to allow for a mixed approach to sample collection for clinical trials.…”

Developing a Nationwide Infrastructure for Therapeutic Drug Monitoring of Targeted Oral Anticancer Drugs: The ON-TARGET Study Protocol

“…As a minimally invasive approach, volumetric absorptive microsampling (VAMS), an enhanced development of dried blood spot sampling, allows collecting a small defined volume (10–30 μL) of capillary blood from the patient’s fingertip [ 18 ] which is subsequently air-dried and sent to the analytical laboratory using normal post. In contrast to venous blood, using dried capillary blood as matrix for TDM has several advantages: (i) the samples can be collected in a home-based setting [ 19 ], (ii) the collected blood samples do not have to be cooled or further processed [ 19 , 20 ], and therefore (iii) the samples can be shipped to the laboratory via normal post [ 19 , 20 ]. The main advantages of VAMS over dried blood spots sampling are the collection of defined blood volumes (10–30 μL), its independence of hematocrit values [ 18 ], and its easy handling.…”