Clinical Chemistry
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Clinical Chemistry 55: 1053-1055, 2009. First published April 24, 2009; 10.1373/clinchem.2009.126557
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(Clinical Chemistry. 2009;55:1053-1055.)
© 2009 American Association for Clinical Chemistry, Inc.

Editorials

Quality Control and Protein Microarrays

Larry J. Kricka1,a and Stephen R. Master1,a

1 Department of Pathology and Laboratory Medicine, Founders Pavilion, University of Pennsylvania Medical Center, 3400 Spruce St., Philadelphia, PA.

aAddress correspondence to the authors at: E-mail kricka@mail.med.upenn.edu or srmaster@mail.med.upenn.edu.

The first 300 words of the full text of this article appear below.

The scale of testing required in clinical analysis has of necessity driven analytical methods to a variety of multiplexed formats. A single assay in a test tube has evolved to automated multiple testing in cuvettes in multicuvette carousels, or wells of a microplate with up to 9600 wells (1). Other formats for multiplex testing include 2-dimensional microarrays of spots of reagents on a planar surface and microbeads either in suspension [so-called liquid or 3-dimensional (3D)1 arrays] or held in wells on the end of a fiber optic bundle (2)(3). The microarray testing format has grown in popularity for both protein and nucleic acid analysis, and is now the dominant method for applications such as gene expression and single nucleotide polymorphism analysis.

Multiplex testing presents specific analytical and quality control challenges. One factor that complicated early array-based tests in a microplate format was the regional differences in results due to different thermal properties of the outer vs the inner wells of the plate—the so-called edge effect. It was observed that the thermal properties of a well in the interior of a microplate differed significantly from wells at the edge of the array. The consequent temperature differences affected the results of immunoassays performed in microplates, a problem resolved by better control of incubations (4). In most modern-day microarray-based tests, a variety of performance controls are included to monitor analytical performance and safeguard the quality of the analytical data. Such controls include blank areas, positive controls, negative controls, normalization controls, controls for nonspecific binding and to confirm sample addition, cross-reactivity controls, and controls to assess the activity of assay reagents such as the detection conjugate (5).

The report in this issue by Klee and colleagues (6) highlights an underlying concern in . . . [Full Text of this Article]






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