OBJECTIVE:The aim of this study was the evaluation of the first commercially available in-vitro diagnostic (IVD)- mass spectrometric immunosuppressant assay from Chromsystems (MassTox Immunosuppressants ONEMINUTE Test) and the comparison to a routinely used online solid phase extraction liquid chromatography-tandem mass spectrometric assay method for the measurement of cyclosporine A, everolimus, sirolimus, and tacrolimus in patient whole blood samples.
METHODS:An API 4000 [tandem mass spectrometer (AB SCIEX)] combined with a CTC Pal autosampler (CTC Analytics AG) and a Shimadzu ultra-fast liquid chromatography (UFLC) system were applied for the direct liquid chromatography-tandem mass spectrometric assay analysis using electrospray ionization in positive ion mode. Isotope-labeled internal standards were used for the commercial assay. Within- and between-day variation, accuracy, and limits of quantification were determined. Samples from external international proficiency testing schemes were measured to assess the accuracy of the commercial assay. About 100 patient samples were reanalyzed with the commercial test kit, and the results were compared with our in-house results.
RESULTS:The limit of quantification for the commercial assay was 0.5 ng/mL for everolimus, sirolimus, and tacrolimus and 5 ng/mL for cyclosporine A. The coefficient of variation for all immunosuppressants was lower than 7% (within day) and 12% (between days) for all 5 concentration levels. Accuracy ranged between 82% and 111% for quality control samples and between 89% and 112% for samples from the external quality assurance program. Both methods showed a very good agreement (r > 0.91) in patient samples over the whole concentration range for all immunosuppressants.
CONCLUSION:The commercial immunosuppressant assay from Chromsystems represents a standardized IVD-certified alternative to our in-house developed assay.
-
【Evaluation of a novel commercial assay for the determination of cyclosporine A, tacrolimus, sirolimus, and everolimus by liquid chromatography-tandem mass spectrometric assay.].
【液相色谱-串联质谱测定法用于测定环孢菌素A，他克莫司，西罗莫司和依维莫司的新型商业测定方法的评估。】
复制标题
收藏
DOI：10.1097/FTD.0b013e318274827d文章类型：杂志文章
复制DOI
译文
目的：本研究的目的是评估Chromsystems的第一个可商购的体外诊断（IVD）-质谱免疫抑制试验（MassTox免疫抑制剂ONEMINUTE测试），并将其与常规使用的在线固相萃取液相色谱串联进行比较质谱法测定患者全血样品中的环孢素A，依维莫司，西罗莫司和他克莫司。
方法：将API 4000 [串联质谱仪（AB SCIEX）]结合CTC Pal自动进样器（CTC Analytics AG）和Shimadzu超快速液相色谱（UFLC）系统用于直接液相色谱-串联质谱分析在正离子模式下使用电喷雾电离。同位素标记的内标用于商业检测。确定日内和日间变化，准确性和定量限。对来自外部国际能力验证计划的样本进行了测量，以评估商业化验的准确性。使用商业测试套件对大约100个患者样品进行了重新分析，并将结果与我们的内部结果进行了比较。
结果：商业化验的定量限为依维莫司，西罗莫司和他克莫司为0.5 ng / mL，环孢霉素A为5 ng / mL。所有免疫抑制剂的变异系数均低于7％（日内）和12％ （介于两天之间）所有5种浓度水平。对于质量控制样品，其准确性介于82％至111％之间，对于来自外部质量保证计划的样品，其准确性介于89％至112％之间。两种方法在所有免疫抑制剂的整个浓度范围内的患者样品中均显示出很好的一致性（r> 0.91）。
结论：Chromsystems的商业免疫抑制剂测定法是我们内部开发测定法的标准化IVD认证替代品。
方法：将API 4000 [串联质谱仪（AB SCIEX）]结合CTC Pal自动进样器（CTC Analytics AG）和Shimadzu超快速液相色谱（UFLC）系统用于直接液相色谱-串联质谱分析在正离子模式下使用电喷雾电离。同位素标记的内标用于商业检测。确定日内和日间变化，准确性和定量限。对来自外部国际能力验证计划的样本进行了测量，以评估商业化验的准确性。使用商业测试套件对大约100个患者样品进行了重新分析，并将结果与我们的内部结果进行了比较。
结果：商业化验的定量限为依维莫司，西罗莫司和他克莫司为0.5 ng / mL，环孢霉素A为5 ng / mL。所有免疫抑制剂的变异系数均低于7％（日内）和12％ （介于两天之间）所有5种浓度水平。对于质量控制样品，其准确性介于82％至111％之间，对于来自外部质量保证计划的样品，其准确性介于89％至112％之间。两种方法在所有免疫抑制剂的整个浓度范围内的患者样品中均显示出很好的一致性（r> 0.91）。
结论：Chromsystems的商业免疫抑制剂测定法是我们内部开发测定法的标准化IVD认证替代品。
