Qualitative and Quantitative HIV RNA Detection in Saliva Using the Oragene RNA Kit

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.

Inclusion criteria

• Four groups of 10 patients each will be recruited:

• Controls (HIV and HCV seronegative by previous testing)
• HIV seropositive with HIV RNA >1000 copies/mL and not on combination antiretroviral therapy. No concurrent HCV infection.
• HIV seropositive with HIV RNA <50 copies/mL as a consequence of combination antiretroviral therapy use. No concurrent HCV infection.
• HIV seropositive with HIV RNA >1000 copies/mL and not on combination antiretroviral therapy. HCV RNA positive and not on antiviral therapy.

Exclusion criteria

• Not fitting one of the 4 groups