A Multi-site In-depth Evaluation of the Quanterix Simoa from a User’s Perspective

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,...

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Bibliographic Details
Published in:The AAPS journal 2018-01, Vol.20 (1), p.10-10, Article 10
Main Authors: Chunyk, Allison Given, Joyce, Alison, Fischer, Saloumeh K., Dysinger, Mark, Mikulskis, Alvydas, Jeromin, Andreas, Lawrence-Henderson, Rosemary, Baker, Dana, Yeung, David
Format: Article
Language:English
Subjects:
Biochemistry
Biomedical and Life Sciences
Biomedicine
Biotechnology
Pharmacology/Toxicology
Pharmacy
Research Article
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Summary: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.
ISSN:1550-7416
1550-7416
DOI:10.1208/s12248-017-0156-7