A Rapid Nanoparticle Immunoassay to Quantitate Busulfan In Plasma

Salamone, S J; Benfield, Caitlyn; Courtney, Jodi B.; Harney, Rebecca L.; Kozo, Daniel; Li, Y.; Lundell, G. D.; Shaw, L. M.; Gardiner, JoAnn

doi:10.1016/j.bbmt.2008.12.480

Cited by 3 publications

(3 citation statements)

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Section: Methodsmentioning

confidence: 99%

“…The structures of busulfan and the stabilized busulfan analog are shown in Figure 1; the substitution of nitrogen for oxygen atoms in the labile methane sulfonate groups creates a stabilized standard. 11,13 The difference in antibody binding to busulfan and the stabilized busulfan analog was used to assign apparent busulfan concentrations to the calibrators and controls. The crossreactivity of the busulfan analog in the immunoassay was determined by calibrating the immunoassay with plasma spiked with United States Pharmacopeia-certified busulfan, concentrations of which were independently verified by mass spectrometry and measuring the stabilized busulfan analog calibrators.…”

Section: Calibration and Standardizationmentioning

confidence: 99%

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Evaluation of a Nanoparticle-Based Busulfan Immunoassay for Rapid Analysis on Routine Clinical Analyzers

Hilaire

Gill

Courtney

et al. 2021

Therapeutic Drug Monitoring

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Background: Busulfan is an alkylating agent used in allogeneic hematopoietic stem cell transplantation for various malignant and nonmalignant disorders. Therapeutic drug monitoring of busulfan is common because busulfan exposure has been linked to venoocclusive disease, disease relapse, and failed engraftment. The authors developed an automated immunoassay, along with stable calibrators and controls, and quantified busulfan in sodium heparin plasma. Methods:The authors evaluated a homogenous nanoparticle immunoassay, the MyCare Oncology Busulfan Assay Kit (Saladax Biomedical, Inc), for precision, sensitivity, accuracy, and linearity on an open channel clinical chemistry analyzer; they compared the method with 2 mass spectrometry methods (liquid chromatographytandem mass spectrometry and gas chromatography/mass spectrometry), using anonymized, remnant patient samples. Results:The coefficients of variation for repeatability and withinlaboratory precision were #9.0%. The linear range was 150-2000 ng/mL; samples up to 6000 ng/mL can be measured with sample dilution. Measured values deviated by #14% from assigned values. Comparison between validated mass spectrometry methods resulted in a correlation coefficient R $ 0.995. Conclusions:The MyCare Busulfan Assay Kit shows the precision, accuracy, linearity, and test range for performing busulfan concentration measurements in sodium heparin plasma on routine clinical chemistry analyzers.

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Section: Methodsmentioning

confidence: 99%

Section: Calibration and Standardizationmentioning

confidence: 99%

Evaluation of a Nanoparticle-Based Busulfan Immunoassay for Rapid Analysis on Routine Clinical Analyzers

Hilaire

Gill

Courtney

et al. 2021

Therapeutic Drug Monitoring

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“…Busulfan concentrations can be monitored in serum, plasma and cerebrospinal fluid by chromatography with and without MS or by immunoassay methods [63,80]. ELISA formats have also recently been adapted to detect busulfan [81].…”

Section: Disadvantagesmentioning

confidence: 99%

Therapeutic Drug Monitoring in Cancer Chemotherapy

Bach

Straseski

Clarke³

2010

Bioanalysis

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For a select number of drugs, proper management of patients includes monitoring serum or plasma concentrations of the drugs and adjusting the doses accordingly - this practice is referred to as therapeutic drug monitoring (TDM). The need for TDM arises when pharmacokinetic variability of drugs is not easily accounted for by common clinical parameters. Many chemotherapeutic drugs have large interindividual variability, yet TDM is not commonplace in chemotherapy management. This review will discuss pharmacokinetics in the context of chemotherapeutic drugs, examine the few instances where TDM is currently used in the field of oncology and propose other drugs where TDM might be useful for dose adjustments in the management of chemotherapy.

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