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

ABSTRACT:

Background

Busulfan is an alkylating agent used in allogeneic hematopoietic stem cell transplantation for various malignant and non-malignant disorders. Therapeutic drug monitoring of busulfan is common, as busulfan exposure has been linked to veno-occlusive 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 MyCaretm 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 two mass spectrometry methods (LC-MS/MS and GC/MS), using anonymized, remnant patient samples.

Results

The coefficients of variation for repeatability and within-laboratory precision were ≤9.0%. The linear range was 150-2,000 ng/mL, samples up to 6,000 ng/mL can be measured with sample dilution. Measured values deviated by ≤14% from assigned values. Comparison between validated mass spectrometry methods resulted in 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.

SUBMITTER: Hilaire MR

PROVIDER: S-EPMC8594508 | biostudies-literature |

REPOSITORIES: biostudies-literature

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