Development of a new ultra‐high‐performance liquid chromatography–tandem mass spectrometry method for the determination of digoxin and digitoxin in plasma: Comparison with a clinical immunoassay

Ballotari, Marco; Taus, Francesco; Tolle, Giulia; Danese, Elisa; Dorizzi, Romolo M.; Tagliaro, Franco; Gottardo, Rossella

doi:10.1002/elps.202100290

Cited by 10 publications

(9 citation statements)

References 31 publications

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“…Nevertheless, digoxin immunoassays still overestimate digoxin concentrations compared with LC-MS/MS. Recently, Bollotari reported an average of 0.18 ng/mL positive bias with immunoassay compared with LC-MS/ MS. 52 In contrast, an older study indicated significant discordance between values obtained by an immunoassay and a more specific chromatography-based method in more than 20% of all specimens analyzed by authors. 53 Therefore, newer immunoassays are significant, more specific, and superior compared with older immunoassays.…”

Section: Gap Analysismentioning

confidence: 93%

Significant Improvement in Digoxin Immunoassays Over Four Decades: Newer Assays are Less Affected by Interferences

Dasgupta

2023

Therapeutic Drug Monitoring

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Background:Digitalis glycosides derived from foxglove plants have been used for medicinal purposes since the 16th century. Currently, digoxin derived from foxgloves is used clinically. Owing to the narrow therapeutic range, therapeutic drug monitoring is essential; however, digoxin immunoassays suffer from interference.Methods:The issue of interference was reviewed for both older polyclonal antibody–based digoxin assays and newer monoclonal antibody–based digoxin assays. A literature search was conducted using PubMed, ScienceDirect, Scopus, Web of Science, and ResearchGate for studies on digoxin immunoassays published in the English language from 1969 to the present.Results:Radioimmunoassays for digoxin in the 1970s and, later, first-generation nonradioimmunoassay methods were liable to several interferences, including digoxin-like immunoreactive substances, spironolactone, potassium canrenoate, and various digoxin metabolites. However, for the last 10–15 years, next next-generation digoxin immunoassays have been virtually free from such interferences. Nevertheless, certain herbal supplements, as well as both Digibind and DigiFab, interfere with serum digoxin measurement, even with the more recently developed digoxin assays.Conclusions:More recently introduced monoclonal antibody–based digoxin assays are superior to the older polyclonal antibody–based digoxin assays.

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Section: Gap Analysismentioning

confidence: 93%

Significant Improvement in Digoxin Immunoassays Over Four Decades: Newer Assays are Less Affected by Interferences

Dasgupta

2023

Therapeutic Drug Monitoring

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“…Methods for detecting digoxin concentration in blood mainly include HPLC, 20 capillary electrophoresis, LC-MS, and immunoassays including radioimmunoassay, enzyme immunoassay, fluorescence immunoassay, and chemiluminescence immunoassay. 21 Some of them are summarized as Table 2 .…”

Section: Resultsmentioning

confidence: 99%

“…ATTO520-C2-maleimide was obtained from ATTO-TEC (Siegen, Germany) and TAMRA-C5-maleimide was obtained from Biotium (Hayward, CA, USA). Other reagents, if not specified, were purchased from Sigma-Aldrich, Shanghai Sango Biotechnology, and Beijing Solarbio Biotechnology Co. Ltd. fluorescence polarization technology and competitive binding of antigen/antibody 2 ng/mL convenient, fast but limited to the small molecules, low sensitivity, and specific antibodies required DNA-based digoxin detection 27 changes in the equilibrium of the DNA strand displacement competition response 7.8 μg/ mL convenient but low concentrations of digoxin need to be detected over longer time lateral flow immunoassay with multicolor gold nanorod etching 28 the sample acts through a capillary tube and is visually detected with a colorimetric index bound to the antibody not reported convenient, fast but samples require additional processing steps and can only be semiquantitative HPLC-tandem mass spectrometry 20 ionizing components of the substance, the mass-to-charge ratio of the ions generated by different components, and qualitatively analyzed 0.5 ng/ mL highly sensitive but the equipment and reagent are expensive; highly skilled operator is needed Q-body technology (this study) detection based on the photoinduced electron transfer between fluorescent dye and tryptophan of antibody 0.023 ng/ mL convenient, fast and highly sensitive; preparation of recombinant antibody and labeling are needed…”

Section: Materials E Coli Competent Dh5α Cells For Gene Cloning and P...mentioning

confidence: 99%

Immunosensor for Rapid and Sensitive Detection of Digoxin

et al. 2023

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Digoxin is a cardiac glycosylated steroid-like drug with a positive inotropic effect and has been widely used in treating congestive heart failure, atrial fibrillation, atrial flutter, and other heart diseases. Digoxin is also a dangerous drug, which can cause drug poisoning at a low blood drug concentration (2.73–3.9 nmol/L, i.e., 2.14–3.05 ng/mL). Therefore, the timely detection of a patient’s blood drug concentration plays a significant role in controlling blood drug concentration, reducing the occurrence of drug poisoning events, and maximizing the role of drug therapy. In this study, a DNA vector for the expression of the antidigoxin antibody Fab fragment was constructed. With the vector, Fab was expressed in E. coli and purified, and 1.2 mg of antibodies was obtained from 100 mL of culture. An immunofluorescent sensor based on the mechanism of photoinduced electron transfer was constructed by labeling additional cysteines in the heavy chain variable region and light chain variable region of the antibody Fab fragment with fluorescent dyes. The assay for digoxin with the immunosensor could be finished within 5 min with a limit of detection of 0.023 ng/mL, a detectable range of 0.023 ng/mL to 100 μg/mL, and an EC50 of 0.256 ng/mL. A new approach for the rapid detection of digoxin was developed and will contribulte to therapeutic drug monitoring.

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“…The results indicated that over 50% of hospitals performed TDM for valproate sodium, digoxin, carbamazepine, vancomycin and cyclosporine. Of note, most of these drugs have narrow therapeutic ranges and high intra-and inter-individual variability (Patsalos et al, 2018;He et al, 2020;Deprez and Stove, 2021;Ballotari et al, 2022). In these scenarios, TDM is useful to adjust medication dosages of treatments to maximize clinical effectiveness and decrease their toxicity.…”

Section: Analysis For Implementing Projects Of Tdm and Pgx Testingmentioning

confidence: 99%

A national survey of individualized pharmaceutical care practice in Chinese hospitals in 2019

Cai

Zhang²,

Gao³

et al. 2023

Front. Pharmacol.

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Background: Individualized pharmaceutical care, which consists of therapeutic drug monitoring (TDM), pharmacogenetic (PGx) testing and pharmacist-managed clinic (PMC), is one of the most important trends in clinical pharmacy development in the future. While relevant studies in China were primarily single-center or regional. This study aims to explore the current status of individualized pharmaceutical care in China, find out the existing problems and provide references for its further development.Methods: An electronic questionnaire was used and national hospitals’ pharmaceutical administration data from January to December 2019 were collected. The data were sorted into Excel for further statistical analysis. All analyses were descriptive.Results: The proportions of hospitals that performed TDM and PGx testing were 12.83% and 9.48%, respectively. The major responsible departments were the clinical laboratory and pharmacy department. External quality control was carried out in around 70% of hospitals for both TDM and PGx testing. More than half of hospitals provided TDM services for valproate sodium, digoxin, carbamazepine, vancomycin and cyclosporine. And an average of 6.84 drugs were performed TDM in 540 hospitals. Clopidogrel and warfarin were the top two drugs that performed PGx testing. As for the PMC, 10.03% of hospitals opened PMC, of which 60.00% had independent PMC. Approximately 80% of PMC services were free of charge.Conclusion: The development of individualized pharmaceutical care in China is still in the early stage. Different sectors have to coalesce to promote its implementation, including the appropriate education, coverage, reimbursement policies, high-quality evidence, data systems, health system processes and health policies, etc.

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Development of a new ultra‐high‐performance liquid chromatography–tandem mass spectrometry method for the determination of digoxin and digitoxin in plasma: Comparison with a clinical immunoassay

Cited by 10 publications

References 31 publications

Significant Improvement in Digoxin Immunoassays Over Four Decades: Newer Assays are Less Affected by Interferences

Significant Improvement in Digoxin Immunoassays Over Four Decades: Newer Assays are Less Affected by Interferences

Immunosensor for Rapid and Sensitive Detection of Digoxin

A national survey of individualized pharmaceutical care practice in Chinese hospitals in 2019

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