Pfizer, Inc., La Jolla, California, USA.
Pfizer, Inc., Andover, Massachusetts, USA.
AAPS J. 2017 Dec 1;20(1):10. doi: 10.1208/s12248-017-0156-7.
An in-depth evaluation of the Quanterix© Simoa™ platform was undertaken by scientists from the AAPS Emerging Technologies Focus Group to determine the overall performance of the technology as well as provide guidance to future users. In order to test the platform in a non-GLP bioanalytical setting, a cross-site evaluation of the Quanterix IL-6 biomarker kit was performed. Parameters tested during this evaluation included sensitivity, accuracy and precision, and parallelism in human serum from normal individuals. The results demonstrated improved sensitivity compared to the claimed sensitivity of other commercially available IL-6 kits and showed excellent site-to-site reproducibility. Observed issues included difficulties with system reliability and a lack of parallelism and specificity in a subset of samples. Overall, these results demonstrate that while there are challenges to the Simoa platform this technology offers automation capabilities and excellent sensitivity that enhance bioanalysis especially of low-abundance analytes.
AAPS 新兴技术焦点小组的科学家对 Quanterix© Simoa™ 平台进行了深入评估，以确定该技术的整体性能，并为未来的用户提供指导。为了在非 GLP 生物分析环境中测试该平台，对 Quanterix IL-6 生物标志物试剂盒进行了跨站点评估。在该评估中测试的参数包括灵敏度、准确性和精密度，以及正常人血清中的平行性。结果表明，与其他市售 IL-6 试剂盒声称的灵敏度相比，该平台具有更高的灵敏度，并且表现出出色的站点间重现性。观察到的问题包括系统可靠性方面的困难，以及一部分样本中缺乏平行性和特异性。总体而言，这些结果表明，尽管 Simoa 平台存在挑战，但该技术提供了自动化功能和出色的灵敏度，特别增强了低丰度分析物的生物分析。
