Clinical Diagnostics, SCIEX, Framingham, MA, USA.
Rapid Commun Mass Spectrom. 2020 Apr 15;34(7):e8632. doi: 10.1002/rcm.8632.
Mass spectrometry (MS) generally delivers more accurate results than immunoassay (IA) for certain clinically relevant analytes, but IA is still the more prevalent methodology used by clinical laboratories because of barriers to MS adoption, such as lower throughput. Therefore, it is increasingly important to develop new strategies to increase LC/MS/MS throughput so that more accurate results can be delivered to patients and clinicians.
Throughput can be increased by reducing assay calibration time using a single-tube calibrator, a mix of isotopologues of the target analyte at different concentrations in a biological matrix, rather than a set of traditional, multiple-tube calibrators. One injection from a single-tube calibrator can generate a full calibration curve such that each calibration point is from the multiple reaction monitoring (MRM) signal corresponding to a specific isotopologue.
In this study, a single-tube calibrator (five levels in one vial) and a set of multiple-tube calibrators (seven levels in seven vials) were used to measure the concentration of testosterone in 42 serum samples originally value assigned by the Centers for Disease Control and Prevention (CDC) reference method. The bias between the CDC reference method and the single-tube calibrator measurements and the multiple-tube calibrators measurements was +1.1% and - 5.5%, respectively. These results were within the CDC Hormone Standardization (HoSt) program bias acceptance criteria of ±6.4%.
The results show that LC/MS/MS throughput can be increased using a single-tube calibrator because it reduces assay calibration time while delivering equivalent results to those generated using traditional, multiple-tube calibrators. The single-tube calibrator may also save cost to laboratories through reductions in consumable consumption, technician labor time, and inventory management, as well as to manufacturers because fewer vials would need to be manufactured, tested, stored, and shipped.
与免疫测定（IA）相比，质谱（MS）通常能为某些临床相关分析物提供更准确的结果，但由于采用 MS 的障碍，如通量较低，IA 仍然是临床实验室更常用的方法。因此，开发新策略来提高 LC/MS/MS 的通量以向患者和临床医生提供更准确的结果变得越来越重要。
通过使用单管校准器，即生物基质中不同浓度的目标分析物的同位素混合物，而不是一组传统的多管校准器来减少分析校准时间，可以提高通量。单管校准器的一次进样即可生成完整的校准曲线，使得每个校准点均来自对应于特定同位素的多重反应监测（MRM）信号。
在这项研究中，使用单管校准器（一个小瓶中五个浓度水平）和一组多管校准器（七个小瓶中七个浓度水平）来测量最初由疾病控制与预防中心（CDC）参考方法赋值的 42 个血清样本中的睾酮浓度。CDC 参考方法与单管校准器测量值和多管校准器测量值之间的偏差分别为+1.1%和-5.5%。这些结果在 CDC 激素标准化（HoSt）计划偏差接受标准内，即±6.4%。
结果表明，使用单管校准器可以提高 LC/MS/MS 的通量，因为它减少了分析校准时间，同时提供与使用传统的多管校准器生成的等效结果。单管校准器还可以通过减少消耗品消耗、技术人员劳动时间和库存管理以及由于需要制造、测试、存储和运输的小瓶数量减少，从而为实验室和制造商节省成本。
