Recent Advances in Multiplex Immunoassays

Marquette, Christophe A.; Corgier, Benjamin P.; Blum, Loı̈c J.

doi:10.4155/bio.12.56

Cited by 46 publications

(27 citation statements)

References 36 publications

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“…The intended use should be the driving force on selecting the appropriate multiplex assay. In addition, several recent publications comprehensively review the latest multiplexing technologies (5)(6)(7)(8).…”

Section: Overview Of Multiplexing Technologiesmentioning

confidence: 99%

Recommendations for Use and Fit-for-Purpose Validation of Biomarker Multiplex Ligand Binding Assays in Drug Development

Jani

Allinson²,

Berisha

et al. 2015

AAPS J

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Abstract. Multiplex ligand binding assays (LBAs) are increasingly being used to support many stages of drug development. The complexity of multiplex assays creates many unique challenges in comparison to single-plexed assays leading to various adjustments for validation and potentially during sample analysis to accommodate all of the analytes being measured. This often requires a compromise in decision making with respect to choosing final assay conditions and acceptance criteria of some key assay parameters, depending on the intended use of the assay. The critical parameters that are impacted due to the added challenges associated with multiplexing include the minimum required dilution (MRD), quality control samples that span the range of all analytes being measured, quantitative ranges which can be compromised for certain targets, achieving parallelism for all analytes of interest, cross-talk across assays, freeze-thaw stability across analytes, among many others. Thus, these challenges also increase the complexity of validating the performance of the assay for its intended use. This paper describes the challenges encountered with multiplex LBAs, discusses the underlying causes, and provides solutions to help overcome these challenges. Finally, we provide recommendations on how to perform a fit-forpurpose-based validation, emphasizing issues that are unique to multiplex kit assays.

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Section: Overview Of Multiplexing Technologiesmentioning

confidence: 99%

Recommendations for Use and Fit-for-Purpose Validation of Biomarker Multiplex Ligand Binding Assays in Drug Development

Jani

Allinson²,

Berisha

et al. 2015

AAPS J

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“…Some are related to the need for miniaturization and trends for multiplexing [110][111][112], which means that the parallel measurements of different analytes are performed in one set and with the same fluidic system. These two specific requirements must be addressed along with the basic requirement for minimum user manipulation to ensure high precision and accuracy [113] of the immunosensor.…”

Section: Microfluidic Systemsmentioning

confidence: 99%

Immunodiagnostics and Immunosensor Design

Gubala¹,

Klein²,

Templeton³

et al. 2016

IUPAC Standards Online

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This work compiles information on the principles of diagnostic immunochemical methods and the recent advances in this field. It presents an overview of modern techniques for the production of diagnostic antibodies, their modification with the aim of improving their diagnostic potency, the different types of immunochemical detection systems, and the increasing diagnostic applications for human health that include specific disease markers, individualized diagnosis of cancer subtypes, therapeutic and addictive drugs, food residues, and environmental contaminants. A special focus lies in novel developments of immunosensor techniques, promising approaches to miniaturized detection units and the associated microfluidic systems. The trends towards high-throughput systems, multiplexed analysis, and miniaturization of the diagnostic tools are discussed. It is also made evident that progress in the last few years has largely relied on novel chemical approaches.

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“…The ideal assay should be specific, sensitive, easy to perform, reliable and reproducible, inexpensive, rapid and suitable for automation, able to make a high-throughput screening [76], and with the possibility to quantify multiple analytes in a single assay (multiplexed capabilities) [77,78]. The biorecognition element consists in a biomolecule such as an enzyme, a nuclear or membrane receptor, or an antibody that recognizes selectively the analyte of interest.…”

Section: Biochemical Assaysmentioning

confidence: 99%