Paper spray ionization (PSI) is a direct, fast, and low‐cost ambient ionization technique which may have clinical utility for qualitative and quantitative analysis of therapeutic drugs and metabolites from patient specimens. We developed and validated a PSI‐mass spectrometry (PSI‐MS/MS) method according to the US‐FDA guidelines for bioanalytical studies to measure the prostate cancer drug abiraterone directly from patient plasma. The established linearity range was 3.1–156.8 ng/mL with a precision (%CV) and an accuracy (%) range of 0.5–10.7 and 93.5–103.2, respectively. The mean internal standard normalized matrix factor for abiraterone was just below 1 with highest %CV of 10.2 at the low‐level quality control. In benchmarking the performance of this assay against a published LC‐MS/MS assay, we showed they were mostly equivalent, with the exception of accuracy with clinical samples. We found the quantitative values observed for abiraterone measured directly from patient plasma using PSI‐MS/MS showed positive bias. Upon investigation, we concluded the increased values were due to summed quantitation of isomeric abiraterone conjugates and metabolites which are separable by LC‐MS/MS, but not with the current PSI‐MS/MS configuration. Despite demonstrating the utility of PSI‐MS/MS for rapid bioanalysis, this study also highlighted a limitation encountered with the direct analysis of abiraterone in clinical samples.

中文翻译：

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评估纸浆喷雾电离用于患者血浆中阿比特龙药物定量的生物分析能力。

纸喷雾电离（PSI）是一种直接，快速且低成本的环境电离技术，对于从患者标本中对治疗药物和代谢产物进行定性和定量分析可能具有临床实用性。根据美国食品药物管理局（FDA）的生物分析研究指南，我们开发并验证了一种PSI-质谱（PSI-MS / MS）方法，可直接从患者血浆中测量前列腺癌药物阿比特龙。建立的线性范围为3.1–156.8 ng / mL，精确度（％CV）和准确度（％）范围分别为0.5-10.7和93.5-103.2。在低水平的质量控制下，阿比特龙的平均内标归一化矩阵因子略低于1，最高％CV为10.2。在对照已发布的LC-MS / MS分析对该方法的性能进行基准测试时，我们显示它们几乎是等效的，除了临床样本的准确性外。我们发现使用PSI-MS / MS直接从患者血浆中测得的阿比特龙的定量值显示出正偏差。经调查，我们得出结论，增加的值是由于对总和定量的异构阿比特龙酯结合物和代谢物进行了定量分析，这些分离物可通过LC-MS / MS分离，但不适用于当前的PSI-MS / MS配置。尽管证明了PSI-MS / MS可用于快速生物分析，但本研究还强调了临床样品中阿比特龙直接分析所遇到的局限性。我们得出的结论是，增加的值是由于对总和定量的异构阿比特龙酯结合物和代谢物进行了定量分析，而LC-MS / MS可以分离这些异构体，而当前的PSI-MS / MS配置却无法分离。尽管证明了PSI-MS / MS可用于快速生物分析，但本研究还强调了临床样品中阿比特龙直接分析所遇到的局限性。我们得出的结论是，增加的值是由于对总和定量的异构阿比特龙酯结合物和代谢物进行了定量分析，而LC-MS / MS可以分离这些异构体，而当前的PSI-MS / MS配置却无法分离。尽管证明了PSI-MS / MS可用于快速生物分析，但本研究还强调了临床样品中阿比特龙直接分析所遇到的局限性。