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Activity Number:
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287
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Type:
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Contributed
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Date/Time:
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Tuesday, August 8, 2006 : 10:30 AM to 12:20 PM
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Sponsor:
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Biometrics Section
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| Abstract - #306683 |
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Title:
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Evaluation Parallelism Testing Methods in Immunoassay
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Author(s):
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Lanju Zhang*+ and Harry Yang and Iksung Cho
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Companies:
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MedImmune, Inc. and MedImmune, Inc. and MedImmune, Inc.
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Address:
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One MedImmune Way, Gaitherburg, MD, 20878,
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Keywords:
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bioassay ; dilution ; parallelism
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Abstract:
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The potency of a biological product is often measured through immunoassays such as ELISA (enzyme-linked immunosorbent assay). Due to large amount of variability inherent to bioassays, the potency is normally determined relative to a known standard. It measures how much the test preparation is "diluted" or "concentrated" relative to the standard. A fundamental assumption in this type of assays for determining relative potency is that the test preparation behaves as a dilution of the standard preparation. In clinical testing literature, this is referred to as parallelism. While several model-based parallelism testing methods were available, there is little work done in evaluating the appropriateness of using these methods. In this paper, both through theoretical derivation and simulation, we establish results that can be used to guide the selection of parallelism testing methods.
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- Authors who are presenting talks have a * after their name.
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