JSM Preliminary Online Program
This is the preliminary program for the 2007 Joint Statistical Meetings in Salt Lake City, Utah.

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Activity Number: 154
Type: Contributed
Date/Time: Monday, July 30, 2007 : 10:30 AM to 12:20 PM
Sponsor: Biometrics Section
Abstract - #309200
Title: Effect of Sample Aliquot Size on the Sensitivity and Reproducibility of Clinical Assays
Author(s): Guorong Chen*+ and Irina Nazarenko
Companies: Digene Corp and Digene Corp
Address: 1201 Clopper Rd, Gaithersburg, MD, 20878,
Keywords: clinical assay ; probability model ; sample preparation
Abstract:

Many available nucleic acid amplification technologies contribute to highly sensitive diagnostic assays. However, the ability to amplify fewer than 10 target copies of DNA or RNA puts new requirements for the preparation of clinical specimens. One important question is how large an aliquot is needed from a clinical specimen to reproducibly capture a certain number of target particles (for example, bacteria cells). A probability model has been developed to estimate the required aliquot size and concentration of "particles" in a clinical sample for optimal assay performance. This method can be used to calculate the probability for getting no particles in an aliquot of a given size and to determine the concentration of particles in a clinical sample to generate a reproducible sample aliquot. This model can also be applied to predict the level of variability contributed by sampling error.


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Revised September, 2007