Skaggs Christine L, Ren Greta J, Elgierari El Taher M, Sturmer Lillian R, Shi Run Z, Manicke Nicholas E, Kirkpatrick Lindsey M
Department of Chemistry and Chemical Biology, Indiana University-Purdue University Indianapolis, Indianapolis, IN, USA.
Stanford Health Care, Palo Alto, CA, USA.
Clin Chem Lab Med. 2020 Apr 28;58(5):836-846. doi: 10.1515/cclm-2019-0895.
Background Invasive fungal disease is a life-threatening condition that can be challenging to treat due to pathogen resistance, drug toxicity, and therapeutic failure secondary to suboptimal drug concentrations. Frequent therapeutic drug monitoring (TDM) is required for some anti-fungal agents to overcome these issues. Unfortunately, TDM at the institutional level is difficult, and samples are often sent to a commercial reference laboratory for analysis. To address this gap, the first paper spray-mass spectrometry assay for the simultaneous quantitation of five triazoles was developed. Methods Calibration curves for fluconazole, posaconazole, itraconazole, hydroxyitraconazole, and voriconazole were created utilizing plasma-based calibrants and four stable isotopic internal standards. No sample preparation was needed. Plasma samples were spotted on a paper substrate in pre-manufactured plastic cartridges, and the dried plasma spots were analyzed directly utilizing paper spray-mass spectrometry (paper spray MS/MS). All experiments were performed on a Thermo Scientific TSQ Vantage triple quadrupole mass spectrometer. Results The calibration curves for the five anti-fungal agents showed good linearity (R2 = 0.98-1.00). The measured assay ranges (lower limit of quantification [LLOQ]-upper limit of quantitation [ULOQ]) for fluconazole, posaconazole, itraconazole, hydroxyitraconazole, and voriconazole were 0.5-50 μg/mL, 0.1-10 μg/mL, 0.1-10 μg/mL, 0.1-10 μg/mL, and 0.1-10 μg/mL, respectively. The inter- and intra-day accuracy and precision were less than 25% over the respective ranges. Conclusions We developed the first rapid paper spray-MS/MS assay for simultaneous quantitation of five triazole anti-fungal agents in plasma. The method may be a powerful tool for near-point-of-care TDM aimed at improving patient care by reducing the turnaround time and for use in clinical research.
背景 侵袭性真菌病是一种危及生命的疾病,由于病原体耐药性、药物毒性以及药物浓度未达最佳水平导致治疗失败,其治疗具有挑战性。一些抗真菌药物需要频繁进行治疗药物监测(TDM)以克服这些问题。不幸的是,机构层面的TDM存在困难,样本通常被送到商业参考实验室进行分析。为了填补这一空白,开发了首个用于同时定量五种三唑类药物的纸喷雾质谱分析法。方法 使用基于血浆的校准物和四种稳定同位素内标物创建氟康唑、泊沙康唑、伊曲康唑、羟基伊曲康唑和伏立康唑的校准曲线。无需样品制备。将血浆样本点在预制塑料盒中的纸质基质上,干燥后的血浆斑点直接采用纸喷雾质谱法(纸喷雾MS/MS)进行分析。所有实验均在赛默飞世尔科技的TSQ Vantage三重四极杆质谱仪上进行。结果 五种抗真菌药物的校准曲线显示出良好的线性(R2 = 0.98 - 1.00)。氟康唑、泊沙康唑、伊曲康唑、羟基伊曲康唑和伏立康唑的测定范围(定量下限[LLOQ] - 定量上限[ULOQ])分别为0.5 - 50μg/mL、0.1 - 10μg/mL、0.1 - 10μg/mL、0.1 - 10μg/mL和0.1 - 10μg/mL。在各自范围内,日内和日间准确度和精密度均小于25%。结论 我们开发了首个用于同时定量血浆中五种三唑类抗真菌药物的快速纸喷雾 - MS/MS分析法。该方法可能是一种强大的工具,用于床边即时TDM,旨在通过缩短周转时间改善患者护理,并用于临床研究。