Abstract：
OBJECTIVE: Ciclosporin (CSA) is an immunosuppressive agent that requires therapeutic drug monitoring (TDM). High partitioning in erythrocytes indicates that whole blood (WB) is a suitable matrix for CSA determination. Alternative sampling strategies, such as volumetric absorptive microsampling (VAMS), are novel possibilities for blood collection during TDM for various analytes, including immunosuppressants. This technique is attractive for vulnerable pediatric patients, including home-based self-sampling, remote therapy, and adherence control.
METHODS: This study aimed to develop and validate a new method for CSA determination based on liquid chromatography-tandem mass spectrometry (LC-MS/MS) of WB and VAMS samples. Additionally, these methods were applied for CSA determination in clinical samples from pediatric transplant recipients. A strong point of this study is the assessment of an external proficiency testing scheme.
RESULTS: Both methods were successfully validated within the 1-2000 ng/mL calibration range, with LOD 0.5 and 1 ng/mL for WB and VAMS methods, respectively. All the validation parameters fulfilled the international acceptance criteria for bioanalytical methods. Cross-validation confirmed the interchangeability of the LC-MS/MS method developed in this study.
CONCLUSIONS: This study developed and validated novel methods for CSA determination in whole blood and VAMS using LC-MS/MS. Clinical validation and proficiency testing confirmed their utility in routine clinical practice.
METHODS: This study aimed to develop and validate a new method for CSA determination based on liquid chromatography-tandem mass spectrometry (LC-MS/MS) of WB and VAMS samples. Additionally, these methods were applied for CSA determination in clinical samples from pediatric transplant recipients. A strong point of this study is the assessment of an external proficiency testing scheme.
RESULTS: Both methods were successfully validated within the 1-2000 ng/mL calibration range, with LOD 0.5 and 1 ng/mL for WB and VAMS methods, respectively. All the validation parameters fulfilled the international acceptance criteria for bioanalytical methods. Cross-validation confirmed the interchangeability of the LC-MS/MS method developed in this study.
CONCLUSIONS: This study developed and validated novel methods for CSA determination in whole blood and VAMS using LC-MS/MS. Clinical validation and proficiency testing confirmed their utility in routine clinical practice.
摘要：
目的：环孢素（CSA）是一种免疫抑制剂，需要进行治疗药物监测（TDM）。红细胞中的高分配表明全血(WB)是用于CSA测定的合适基质。替代抽样策略，例如体积吸收微量采样(VAMS)，是各种分析物的TDM期间血液收集的新可能性，包括免疫抑制剂.这项技术对脆弱的儿科患者很有吸引力，包括家庭自采样，远程治疗,和依从性控制。
方法：本研究旨在开发和验证一种基于WB和VAMS样品的液相色谱-串联质谱（LC-MS/MS）测定CSA的新方法。此外,这些方法用于测定儿科移植受者临床样本中的CSA.这项研究的重点是评估外部能力测试计划。
结果：两种方法均在1-2000ng/mL校准范围内成功验证，WB和VAMS方法的LOD为0.5和1ng/mL，分别。所有验证参数均符合生物分析方法的国际验收标准。交叉验证证实了本研究中开发的LC-MS/MS方法的互换性。
结论：本研究开发并验证了使用LC-MS/MS测定全血和VAMS中CSA的新方法。临床验证和能力测试证实了它们在常规临床实践中的实用性。
方法：本研究旨在开发和验证一种基于WB和VAMS样品的液相色谱-串联质谱（LC-MS/MS）测定CSA的新方法。此外,这些方法用于测定儿科移植受者临床样本中的CSA.这项研究的重点是评估外部能力测试计划。
结果：两种方法均在1-2000ng/mL校准范围内成功验证，WB和VAMS方法的LOD为0.5和1ng/mL，分别。所有验证参数均符合生物分析方法的国际验收标准。交叉验证证实了本研究中开发的LC-MS/MS方法的互换性。
结论：本研究开发并验证了使用LC-MS/MS测定全血和VAMS中CSA的新方法。临床验证和能力测试证实了它们在常规临床实践中的实用性。
