Validation of novel multiplex technologies

Authors

  • Levent Akyüz Institute for Medical Immunology BCRT Immunological Studies Laboratory - Biomarkers
  • Andreas Wilhelm
  • Florian Butke
  • Park Su-Jin
  • Anja Kuckuck
  • Hans-Dieter Volk
  • Gerald Grütz

DOI:

https://doi.org/10.18063/apm.v2i1.200

Keywords:

biomarker, multiplex, validation

Abstract

The parallel analysis of multiple factors, such as cytokines, from small sample size is an interesting approach for assessment of in vivo activation signatures and functionality after ex vivo stimulation. One interesting application is for therapy monitoring, such as safety data, pharmacodynamics, evidences for mode-of-action and side effects, particularly useful for accompanying early phase clinical trials. There are different platforms for Multiplex analysis of ligands available. We compared in this study the performance of three different platforms (Luminex Bio-Plex® 200, MesoScale Discovery®, Ella®) which use different ways of achieving parallel measurements of biomarkers from small liquid sample size. We show examples of in house assessment of intra- and inter-assay variations, determination of range and recovery for classical immunological serum markers and discuss advantages and disadvantages for these three platforms in relation to the question addressed.

References

Aziz N, Nishanian P, Fahey J L, 1998, Levels of cytokines and immune activation markers in plasma in human immunodeficiency virus infection: Quality control procedures. Clinical and Diagnostic Laboratory Immunology, vol.5(6): 755–761.

Carson R T, Vignali D A, 1999, Simultaneous quantitation of 15 cytokines using a multiplexed flow cytometric assay. Journal of Immunological Methods, vol.227(1–2): 41–52. https://dx.doi.org/10.1016/S0022-1759(99)00069-1.

Bloniecki V, Aarsland D, Cummings J, et al., 2014, Agitation in dementia: Relation to core cerebrospinal fluid biomarker levels. Dementia and Geriatric Cognitive Disorders Extra, vol.4(2): 335–343. https://dx.doi.org/10.1159/000363500.

Reiken S R, Van Wie B J, Sutisna H, et al., 1994, Efficient optimization of ELISAs. Journal of Immunological Methods, vol.177(1–2): 199–206. https://dx.doi.org/10.1016/0022-1759(94)90157-0.

Ellington A A, Kullo I J, Bailey K R, et al., 2010, Antibody-based protein multiplex platforms: Technical and operational challenges. Clinical Chemistry, vol.56(2): 186–193. https://dx.doi.org/10.1373/clinchem.2009.127514.

Hubert P, Nguyen-Huu J J, Boulanger B, et al., 2004, Harmonization of strategies for the validation of quantitative analytical procedures. A SFSTP proposal—Part I. Journal of Pharmaceutical and Biomedical Analysis, vol.36(3): 579–586. https://dx.doi.org/10.1016/j.jpba.2004.07.027.

Leng S X, McElhaney J E, Walston J D, et al., 2008, ELISA and multiplex technologies for cytokine measurement in inflammation and aging research. The Journals of Gerontology. Series A, Biological Sciences and Medical Sciences, vol.63(8): 879–84. https://dx.doi.org/10.1093/gerona/63.8.879.

Chowdhury F, Williams A, Johnson P, 2009, Validation and comparison of two multiplex technologies, Luminex® and Mesoscale Discovery, for human cytokine profiling. Journal of Immunological Methods, vol.340(1): 55–64. https://dx.doi.org/10.1016/j.jim.2008.10.002.

Aldo P, Marusov G, Svancara D, et al., 2016, Simple Plex™: A novel multi-analyte, automated microfluidic immunoassay platform for the detection of human and mouse cytokines and chemokines. American Journal of Reproductive Immunology, vol.75(6): 678–693. https://dx.doi.org/10.1111/aji.12512.

dupont N C, Wang K, Wadhwa P D, et al., 2005, Validation and comparison of luminex multiplex cytokine analysis kits with ELISA: Determinations of a panel of nine cytokines in clinical sample culture supernatants. Journal of Reproductive Immunology, vol.66(2): 175–191. https://dx.doi.org/10.1016/j.jri.2005.03.005.

Diaz-Toscano M L, Olivas-Flores E M, Zavaleta-Muniz S A, et al., 2014, Comparison of two assays to determine anti-citrullinated peptide antibodies in rheumatoid arthritis in relation to other chronic inflammatory rheumatic diseases: Assaying anti-modified citrullinated vimentin antibodies adds value to second-generation anti-citrullinated cyclic peptides testing. BioMed Research International, vol.2014: 198198. https://dx.doi.org/10.1155/2014/198198.

Wittmann M, Helliwell P S, 2013, Phosphodiesterase 4 inhibition in the treatment of psoriasis, psoriatic arthritis and other chronic inflammatory diseases. Dermatology and Therapy, vol.3(1): 1–15. https://dx.doi.org/10.1007/s13555-013-0023-0.

Saldova R, 2016, Cause of cancer and chronic inflammatory diseases and the implications for treatment. Discovery Medicine, vol.22(120): 105–119.

Volk H D, Stevens M M, Mooney D J, et al., 2015, Key elements for nourishing the translational research environment. Science Translational Medicine, vol.7(282): 282CM2. https://dx.doi.org/10.1126/scitranslmed.aaa2049.

Docke W D, Asadullah K, Belbe G, et al., 2009, Comprehensive biomarker monitoring in cytokine therapy: Heterogeneous, time-dependent, and persisting immune effects of interleukin-10 application in psoriasis. Journal of Leukocyte Biology, vol.85(3): 582–593. https://dx.doi.org/10.1189/jlb.0408249.

Downloads

Published

2017-07-20

Issue

Section

Original Articles