Opportunities and obstacles for microsampling techniques in bioanalysis: Special focus on DBS and VAMS

Londhe, Vaishali; Rajadhyaksha, Madhura

doi:10.1016/j.jpba.2020.113102

Cited by 77 publications

(77 citation statements)

References 92 publications

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“…21 Using a sampling amount compatible with microsampling, we validated a method achieving a higher sensitivity and broader dynamic range (LLOQ of 0.250 µg/mL vs 1 µg/mL and range of 0.250-250 µg/mL vs 1-100 µg/mL for trastuzumab). 27 The use of a small sample volume generally results in reduced background interference, contributing to a higher signal/ noise (S/N) ratio even at the lowest analyte concentrations. Theoretically, the sensitivity of the assay could have been enhanced further with prolonged incubation with protein A and with the introduction of a solid phase extraction at peptide level prior to electrospray ionization.…”

Section: Discussionmentioning

confidence: 99%

Development and validation of an LC-MS/MS method for simultaneous quantification of co-administered trastuzumab and pertuzumab

Schokker

Bonardi

Molenaar

et al. 2020

mAbs

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Given the increasing use of combination therapy with multiple monoclonal antibodies (mAbs), there is a clinical need for multiplexing assays. For the frequently co-administered anti-human epidermal growth factor receptor 2 (HER2) mAbs trastuzumab and pertuzumab, we developed a high-throughput and robust hybrid ligand-binding liquid chromatography-mass spectrometry (LC-MS)/MS quantitative assay. Nanomolar concentrations of trastuzumab and pertuzumab were determined in 10 µL serum samples after extraction by affinity purification through protein A beads, followed by on-bead reduction, alkylation, and trypsin digestion. After electrospray ionization, quantification was obtained by multiple reaction monitoring LC-MS/MS using SILuMab as an internal standard. The method was validated according to the current guidelines from the US Food and Drug Administration and the European Medicines Agency. Assay linearity was established in the ranges 0.250-250 μg/mL for trastuzumab and 0.500-500 μg/mL for pertuzumab. The method was accurate and selective for the simultaneous determination of trastuzumab and pertuzumab in clinical samples, thereby overcoming the limitation of ligand binding assays that cannot quantify mAbs targeting the same receptor. Furthermore, this method requires a small blood volume, which reduces blood collection time and stress for patients. The assay robustness was verified in a clinical trial where trastuzumab and pertuzumab concentrations were determined in 670 serum samples. As we used commercially available reagents and standards, the described generic bioanalytical strategy can easily be adapted to multiplex quantifications of other mAb combinations in non-clinical and clinical samples.

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Section: Discussionmentioning

confidence: 99%

Development and validation of an LC-MS/MS method for simultaneous quantification of co-administered trastuzumab and pertuzumab

Schokker

Bonardi

Molenaar

et al. 2020

mAbs

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“…Right from the first use of dried blood spots (DBS) in neonatal screening by Guthrie and Susi, the technique is getting evolved 32 . The various dried blood microsampling techniques along with their benefits and hurdles are discussed in our previous publication 33 . Despite known obstacles and challenges, dried blood microsampling techniques are being explored in various expanses of bioanalysis.…”

Section: Microsamplingmentioning

confidence: 99%

Microsampling: A role to play in Covid‐19 diagnosis, surveillance, treatment and clinical trials

Rajadhyaksha

Londhe

2021

Drug Testing and Analysis

Self Cite

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The outbreak of the new coronavirus disease changed the world upside down. Every day, millions of people were subjected to diagnostic testing for Covid‐19, all over the world. Molecular tests helped in the diagnosis of current infection by detecting the presence of viral genome whereas serological tests helped in detecting the presence of antibody in blood as well as contributed to vaccine development. This testing helped in understanding the immunogenicity, community prevalence, geographical spread and conditions post‐infection. However, with the contagious nature of the virus, biological specimen sampling involved the risk of transmission and spread of infection. Clinic or pathology visit was the most concerning part. Trained personnel and resources was another barrier. In this scenario, microsampling played an important role due to its most important advantage of remote, contactless, small volume and self‐sampling. Minimum requirements for sample storage and ease of shipment added value in this situation. The highly sensitive instruments and validated assay formats assured the accuracy of results and stability of samples. Microsampling techniques are contributing effectively to the Covid‐19 pandemic by reducing the demand for clinical staff in population‐level testing. The validated and established applications supported the use of microsampling in diagnosis, therapeutic drug monitoring, development of treatment or vaccines and clinical trials for Covid‐19.

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“…Since the withdrawal can be made in the absence of qualified personnel, it allows for sample collection at home. Today, VAMS ® may represent a very promising microsampling technique (reviewed in [ 14 , 15 , 16 ]) (a complete list of published papers involving VAMS ® use can be found in [ 17 ]). As discussed in ref [ 12 ] and [ 13 ] VAMS ® are reliable tools for pharmacokinetic and toxicokinetic studies.…”

Section: Introductionmentioning

confidence: 99%

Therapeutic Drug Monitoring of Antiseizure Medications Using Volumetric Absorptive Microsampling: Where Are We?

et al. 2021

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Therapeutic drug monitoring (TDM) of antiseizure medications (ASMs) represents a valuable tool to establish an appropriate patient therapy, to collect important information about drugs’ interactions and to evaluate patient’s metabolic capabilities. In recent years, a new volumetric absorptive microsampling technique using VAMS® technology and Mitra® devices, consisting of a sampling technique for the collection of fixed-volume capillary blood, was developed. These new devices provide a new home-sampling technique for whole blood that has been spread out to simplify sample collection from finger-pricks. This review is aimed to compare published articles concerning the application of VAMS® in epilepsy and to identify the strengths and improvement points for the TDM of antiseizure medications. VAMS® allowed a minimally invasive blood sampling even in the absence of trained personnel. Good stability data have indicated that storage and delivery can be facilitated only for specific ASMs. Trueness and precision parameters have been evaluated, and the hematocrit (HCT) effect was minimized.

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Opportunities and obstacles for microsampling techniques in bioanalysis: Special focus on DBS and VAMS

Cited by 77 publications

References 92 publications

Development and validation of an LC-MS/MS method for simultaneous quantification of co-administered trastuzumab and pertuzumab

Development and validation of an LC-MS/MS method for simultaneous quantification of co-administered trastuzumab and pertuzumab

Microsampling: A role to play in Covid‐19 diagnosis, surveillance, treatment and clinical trials

Therapeutic Drug Monitoring of Antiseizure Medications Using Volumetric Absorptive Microsampling: Where Are We?

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