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The AAPS Journal

, 20:10 | Cite as

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

  • Allison Given Chunyk
  • Alison Joyce
  • Saloumeh K. Fischer
  • Mark Dysinger
  • Alvydas Mikulskis
  • Andreas Jeromin
  • Rosemary Lawrence-Henderson
  • Dana Baker
  • David Yeung
Research Article

Abstract

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.

KEY WORDS

automation IL-6 ligand binding assay Simoa ultrasensitive technology 

Notes

Acknowledgments

The authors would like to thank David Duffy and David Wilson for the technical support and review of content and Joe Palandra for LC-MS/MS testing of IL-6 samples.

Compliance with Ethical Standards

This manuscript has undergone documented review and approval from a formally constituted review board for all studies involving people, medical records, and human tissues, per the uniform guidelines from the World Medical Association (http://www.wma/net/en/30publications/10policies/HB-E-2011.pdf).

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Copyright information

© American Association of Pharmaceutical Scientists 2017

Authors and Affiliations

  • Allison Given Chunyk
    • 1
  • Alison Joyce
    • 2
  • Saloumeh K. Fischer
    • 3
  • Mark Dysinger
    • 4
  • Alvydas Mikulskis
    • 5
  • Andreas Jeromin
    • 6
  • Rosemary Lawrence-Henderson
    • 2
  • Dana Baker
    • 3
  • David Yeung
    • 2
  1. 1.Pfizer, Inc.La JollaUSA
  2. 2.Pfizer, Inc.AndoverUSA
  3. 3.GenentechSouth San FranciscoUSA
  4. 4.Alexion PharmaceuticalsNew HavenUSA
  5. 5.BiogenCambridgeUSA
  6. 6.QuanterixLexingtonUSA

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