Validation and Quality Control of Protein Microarray-based Analytical Methods

Kricka, Larry J.; Master, Stephen R.

doi:10.1007/s12033-007-0066-5

Cited by 34 publications

(14 citation statements)

References 104 publications

(136 reference statements)

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“…Proposed analytical performance criteria include range of linearity, analytical specificity, recovery, limits of detection and quantification, reasonable imprecision, and comparison to a quality reference method (36). …”

Section: Analytical Validationmentioning

confidence: 99%

“…Although reproducibility and reliability are critical for diagnostic assays, QC algorithms are not well developed for multiplexed protein immunoassays (36). Single-analyte QC protocols have been implemented in most clinical laboratories (46).…”

Section: Operational Controlmentioning

confidence: 99%

“…Observed results are compared with the control reference ranges, and observed results falling outside of the reference ranges signify unacceptable assay performance and rejection of data. QC considerations are compounded as the number of individual reactions on an array increases, and generation of control materials with appropriate concentrations of each constituent protein is a major challenge to clinical use of protein multiplexes (36). Control materials must be manufactured in large quantities to provide a sustained source of protein in a matrix similar to the testing specimen, with minimal variability in concentration from aliquot to aliquot or from lot to lot.…”

Section: Operational Controlmentioning

confidence: 99%

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Antibody-Based Protein Multiplex Platforms: Technical and Operational Challenges

Ellington

Kullo²,

Bailey³

et al. 2010

Clinical Chemistry

279

241

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BACKGROUND:The measurement of multiple protein biomarkers may refine risk stratification in clinical settings. This concept has stimulated development of multiplexed immunoassay platforms that provide multiple, parallel protein measurements on the same specimen. CONTENT:We provide an overview of antibody-based multiplexed immunoassay platforms and discuss technical and operational challenges. Multiplexed immunoassays use traditional immunoassay principles in which high-affinity capture ligands are immobilized in parallel arrays in either planar format or on microspheres in suspension. Development of multiplexed immunoassays requires rigorous validation of assay configuration and analytical performance to minimize assay imprecision and inaccuracy. Challenges associated with multiplex configuration include selection and immobilization of capture ligands, calibration, interference between antibodies and proteins and assay diluents, and compatibility of assay limits of quantification. We discuss potential solutions to these challenges. Criteria for assessing analytical multiplex assay performance include the range of linearity, analytical specificity, recovery, and comparison to a quality reference method. Quality control materials are not well developed for multiplexed protein immunoassays, and algorithms for interpreting multiplex quality control data are needed.

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Section: Analytical Validationmentioning

confidence: 99%

Section: Operational Controlmentioning

confidence: 99%

Section: Operational Controlmentioning

confidence: 99%

See 1 more Smart Citation

Antibody-Based Protein Multiplex Platforms: Technical and Operational Challenges

Ellington

Kullo²,

Bailey³

et al. 2010

Clinical Chemistry

279

241

View full text Add to dashboard Cite

show abstract

“…Protein microarrays are a useful screening method for whole cell lysates, fractionated proteomes, intact glycoproteins, and antigen-antibody reactions (Kricka & Master, 2008; Tao, Chen, & Zhu, 2007). Unlike oligonucleotides, proteins are broadly heterogeneous in size, shape, and chemistry.…”

Section: Microarray Platforms For Glycoprotein Analysismentioning

confidence: 99%

Glycoprotein analysis using protein microarrays and mass spectrometry

Patwa

Simeone

et al. 2010

Mass Spectrometry Reviews

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Protein glycosylation plays an important role in a multitude of biological processes such as cellcell recognition, growth, differentiation, and cell death. It has been shown that specific glycosylation changes are key in disease progression, and can have diagnostic value for a variety of disease types such as cancer and inflammation. The complexity of carbohydrate structures and their derivatives makes their study a real challenge. Improving the isolation, separation, and characterization of carbohydrates and their glycoproteins is a subject of increasing scientific interest. With development of new stationary phases and molecules that have affinity properties for glycoproteins, the isolation and separation of these compounds have advanced significantly. In addition to detection with mass spectrometry, the microarray platform has become an essential tool to characterize glycan structure and to study glycosylation-related biological interactions, by using probes as a means to interrogate the spotted or captured glycosylated molecules on the arrays. Furthermore, the high-throughput and reproducible nature of microarray platforms have been highlighted by its extensive applications in the field of biomarker validation, where a large number of samples must be analyzed multiple times. This review covers a brief survey of the other experimental methodologies that are currently being developed and used to study glycosylation, and emphasizes methodologies that involve the use of microarray platforms. This review describes recent advances in several options of microarray platforms used in glycoprotein analysis, including glycoprotein arrays, glycan arrays, lectin arrays, and antibody/lectin arrays. The translational use of these arrays in applications related to characterization of cells and biomarker discovery is also included.

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“…Consequently, researchgrade biomarker kits typically pose a considerable challenge for analytical validation, especially when the intended goal is to conduct a 'GLP similar' validation to support regulatorycom pliant bioanalysis. For this editorial, we have used the term GLPsimilar validation to denote an analytical method validation process that is analogous to the one employed commonly for assays used to support PK assessments of drugs, as opposed to the one typically employed for validation of clinical diagnostics that is rec ommended by the Clinical and Laboratory Standards Institute and used to support diag nosis and treatment of disease as outlined in CLIA regulations [11,12,102,103].…”

mentioning

confidence: 99%