Analytical and Clinical Validation of Assays for Volumetric Absorptive Microsampling (VAMS) of Drugs in Different Blood Matrices: A Literature Review
Volumetric absorptive microsampling (VAMS) is the newest and most promising sample-collection technique for quantitatively analyzing drugs, especially for routine therapeutic drug monitoring (TDM) and pharmacokinetic studies. This technique uses an absorbent white tip to absorb a fixed volume of a s...
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MDPI AG
2023-08-01
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| Series: | Molecules |
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| author | Rhea Veda Nugraha Vycke Yunivita Prayudi Santoso Aliya Nur Hasanah Rob E. Aarnoutse Rovina Ruslami |
| author_facet | Rhea Veda Nugraha Vycke Yunivita Prayudi Santoso Aliya Nur Hasanah Rob E. Aarnoutse Rovina Ruslami |
| author_sort | Rhea Veda Nugraha |
| collection | DOAJ |
| description | Volumetric absorptive microsampling (VAMS) is the newest and most promising sample-collection technique for quantitatively analyzing drugs, especially for routine therapeutic drug monitoring (TDM) and pharmacokinetic studies. This technique uses an absorbent white tip to absorb a fixed volume of a sample (10–50 µL) within a few seconds (2–4 s), is more flexible, practical, and more straightforward to be applied in the field, and is probably more cost-effective than conventional venous sampling (CVS). After optimization and validation of an analytical method of a drug taken by VAMS, a clinical validation study is needed to show that the results by VAMS can substitute what is gained from CVS and to justify implementation in routine practice. This narrative review aimed to assess and present studies about optimization and analytical validation of assays for drugs taken by VAMS, considering their physicochemical drug properties, extraction conditions, validation results, and studies on clinical validation of VAMS compared to CVS. The review revealed that the bio-analysis of many drugs taken with the VAMS technique was optimized and validated. However, only a few clinical validation studies have been performed so far. All drugs that underwent a clinical validation study demonstrated good agreement between the two techniques (VAMS and CVS), but only by Bland–Altman analysis. Only for tacrolimus and mycophenolic acid were three measurements of agreement evaluated. Therefore, VAMS can be considered an alternative to CVS in routine practice, especially for tacrolimus and mycophenolic acid. Still, more extensive clinical validation studies need to be performed for other drugs. |
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| institution | Directory Open Access Journal |
| issn | 1420-3049 |
| language | English |
| last_indexed | 2024-03-10T23:41:43Z |
| publishDate | 2023-08-01 |
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| record_format | Article |
| series | Molecules |
| spelling | doaj.art-ab9e2ac18047457e9847479b9c98ecdb2023-11-19T02:23:56ZengMDPI AGMolecules1420-30492023-08-012816604610.3390/molecules28166046Analytical and Clinical Validation of Assays for Volumetric Absorptive Microsampling (VAMS) of Drugs in Different Blood Matrices: A Literature ReviewRhea Veda Nugraha0Vycke Yunivita1Prayudi Santoso2Aliya Nur Hasanah3Rob E. Aarnoutse4Rovina Ruslami5Doctoral Study Program, Faculty of Medicine, Universitas Padjadjaran, Bandung 40161, IndonesiaDivision of Pharmacology and Therapy, Department of Biomedical Sciences, Faculty of Medicine, Universitas Padjadjaran, Bandung 40161, IndonesiaDivision of Respirology and Critical Care, Department of Internal Medicine, Faculty of Medicine, Universitas Padjadjaran—Hasan Sadikin Hospital, Bandung 40161, IndonesiaDepartment of Pharmaceutical Analysis and Medicinal Chemistry, Faculty of Pharmacy, Universitas Padjadjaran, Bandung 45363, IndonesiaDepartment of Pharmacy, Radboud University Medical Center, Research Institute for Medical Innovation, 6255 HB Nijmegen, The NetherlandsDivision of Pharmacology and Therapy, Department of Biomedical Sciences, Faculty of Medicine, Universitas Padjadjaran, Bandung 40161, IndonesiaVolumetric absorptive microsampling (VAMS) is the newest and most promising sample-collection technique for quantitatively analyzing drugs, especially for routine therapeutic drug monitoring (TDM) and pharmacokinetic studies. This technique uses an absorbent white tip to absorb a fixed volume of a sample (10–50 µL) within a few seconds (2–4 s), is more flexible, practical, and more straightforward to be applied in the field, and is probably more cost-effective than conventional venous sampling (CVS). After optimization and validation of an analytical method of a drug taken by VAMS, a clinical validation study is needed to show that the results by VAMS can substitute what is gained from CVS and to justify implementation in routine practice. This narrative review aimed to assess and present studies about optimization and analytical validation of assays for drugs taken by VAMS, considering their physicochemical drug properties, extraction conditions, validation results, and studies on clinical validation of VAMS compared to CVS. The review revealed that the bio-analysis of many drugs taken with the VAMS technique was optimized and validated. However, only a few clinical validation studies have been performed so far. All drugs that underwent a clinical validation study demonstrated good agreement between the two techniques (VAMS and CVS), but only by Bland–Altman analysis. Only for tacrolimus and mycophenolic acid were three measurements of agreement evaluated. Therefore, VAMS can be considered an alternative to CVS in routine practice, especially for tacrolimus and mycophenolic acid. Still, more extensive clinical validation studies need to be performed for other drugs.https://www.mdpi.com/1420-3049/28/16/6046optimizationanalytical validationclinical validationvolumetric absorptive microsampling (VAMS)conventional venous sampling (CVS) |
| spellingShingle | Rhea Veda Nugraha Vycke Yunivita Prayudi Santoso Aliya Nur Hasanah Rob E. Aarnoutse Rovina Ruslami Analytical and Clinical Validation of Assays for Volumetric Absorptive Microsampling (VAMS) of Drugs in Different Blood Matrices: A Literature Review Molecules optimization analytical validation clinical validation volumetric absorptive microsampling (VAMS) conventional venous sampling (CVS) |
| title | Analytical and Clinical Validation of Assays for Volumetric Absorptive Microsampling (VAMS) of Drugs in Different Blood Matrices: A Literature Review |
| title_full | Analytical and Clinical Validation of Assays for Volumetric Absorptive Microsampling (VAMS) of Drugs in Different Blood Matrices: A Literature Review |
| title_fullStr | Analytical and Clinical Validation of Assays for Volumetric Absorptive Microsampling (VAMS) of Drugs in Different Blood Matrices: A Literature Review |
| title_full_unstemmed | Analytical and Clinical Validation of Assays for Volumetric Absorptive Microsampling (VAMS) of Drugs in Different Blood Matrices: A Literature Review |
| title_short | Analytical and Clinical Validation of Assays for Volumetric Absorptive Microsampling (VAMS) of Drugs in Different Blood Matrices: A Literature Review |
| title_sort | analytical and clinical validation of assays for volumetric absorptive microsampling vams of drugs in different blood matrices a literature review |
| topic | optimization analytical validation clinical validation volumetric absorptive microsampling (VAMS) conventional venous sampling (CVS) |
| url | https://www.mdpi.com/1420-3049/28/16/6046 |
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