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.
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。