Saladax Biomedical, Inc., Bethlehem.
Department of Pathology and Laboratory Medicine, Perelman School of Medicine, University of Pennsylvania, Philadelphia, Pennsylvania; and.
Ther Drug Monit. 2021 Dec 1;43(6):766-771. doi: 10.1097/FTD.0000000000000883.
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 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.
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 chromatography-tandem mass spectrometry and gas chromatography/mass spectrometry), using anonymized, remnant patient samples.
The coefficients of variation for repeatability and within-laboratory 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.
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.
白消安是一种烷化剂，用于治疗各种恶性和非恶性疾病的异基因造血干细胞移植。由于白消安的暴露与静脉阻塞性疾病、疾病复发和植入失败有关，因此对白消安进行治疗药物监测很常见。作者开发了一种自动化免疫分析法，同时还开发了稳定的校准品和对照品，并对肝素钠血浆中的白消安进行定量。
作者评估了一种均质纳米颗粒免疫分析法，即 MyCare Oncology Busulfan 检测试剂盒（Saladax Biomedical，Inc.），用于在开放通道临床化学分析仪上评估其精密度、灵敏度、准确性和线性度；他们使用匿名的剩余患者样本，将该方法与 2 种质谱方法（液相色谱-串联质谱法和气相色谱/质谱法）进行了比较。
重复性和实验室内精密度的变异系数均≤9.0%。线性范围为 150-2000ng/mL；可以通过样品稀释测量高达 6000ng/mL 的样品。测量值与赋值值的偏差≤14%。验证后的质谱方法之间的比较得出相关系数 R≥0.995。
MyCare Busulfan 检测试剂盒在常规临床化学分析仪上用于测量肝素钠血浆中的白消安浓度时，显示出精密度、准确性、线性度和测试范围。
