Qualitative and Quantitative HIV RNA Detection in Saliva Using the Oragene RNA Kit
The purpose of this study is to determine if the Oragene.RNA kit is able to detect HIV RNA in saliva.
|Study Design:||Observational Model: Cohort
Time Perspective: Prospective
|Official Title:||Qualitative and Quantitative HIV RNA Detection in Saliva Using the Oragene RNA Kit|
|Study Start Date:||October 2007|
|Study Completion Date:||December 2010|
|Primary Completion Date:||May 2008 (Final data collection date for primary outcome measure)|
There is an important need for a rapid, non-invasive, sensitive and specific method for detection of HIV RNA, particularly in clinical settings in which patients at risk for HIV exposure are assessed and screened. A rapid and non-invasive method for quantitative testing of HIV RNA would be also valuable to monitor suppression of HIV RNA as a primary surrogate marker of combination antiretroviral therapy efficacy. An Ottawa-based biotech company (DNA Genotek Inc) has developed and sells to research and clinical labs world-wide a kit (Oragene� DNA Self-collection kit) that permits the collection, stabilization at room temperature, and purification of DNA present in saliva. They have recently developed a kit (Oragene��RNA) that is purported to stabilize RNA in saliva, a non-invasive source of a biological fluid.