JSM Preliminary Online Program
This is the preliminary program for the 2009 Joint Statistical Meetings in Washington, DC.

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Activity Number: 572
Type: Contributed
Date/Time: Thursday, August 6, 2009 : 8:30 AM to 10:20 AM
Sponsor: Biopharmaceutical Section
Abstract - #304338
Title: A Cluster Binomial Model for Resistance-Mutations Detectable in Clonal Sequencing Analysis
Author(s): Jianliang Zhang*+
Companies: MedImmune, LLC
Address: One Medimmune Way, Gaithersburg, MD, 20878,
Keywords: Clonal sequencing ; Two-stage binomial model ; resistance-mutation rate
Abstract:

Clonal sequencing (CS), a highly sensitive assay, is commonly used to detect resistance-mutations in viruses. The original viral RNAs extracted from a specimen are not simply chosen or sampled for the CS analysis, but are also replicated in the process. After a viral RNA sample has been extracted and reverse transcribed into cDNA, the cDNA sample is then amplified by PCR. Given the replication in this process, the entire sampling process in a CS procedure is not simply random sampling. However, binomial models are currently used to determine the minimal sensitivity and the confidence intervals. The assay procedure on statistical models is described in the paper; Simulation results of the CS procedure do not agree with the analytical results based on the binomial model. A more appropriate two-stage binomial model is derived for the number of resistance-mutations detected in a CS assay.


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