We propose to develop a highly sensitive, specific, reproducible and rapid point-of-care nucleic acid test based on IQuum's lab-in-a-tube (Liat(tm)) platform for the detection of and quantification of HIV-1 Group M virus in infected patients. The Liat HIV Assay will utilize the Liat Analyzer to enable minimally trained personnel the ability to perform the HIV-1 Quantitative test at a hospital, clinic, rural health center, physician's office or in the field. By enabling effective and sensitive HIV-1 quantitative testing, we expect that the Liat assay will: (i) allow clinicians to identify HIV-1 infected volunteers for clinical trials (both vaccine and treatment trials), (ii) allow clinicians monitoring clinical trials a rapid testing methodology for the determination of vaccine treatment benefit in infected patients, (iii) health personnel to detect and quantitate HIV-1 virus in acutely infected patients, (iv) allow point-of-care real time testing of infect patients on highly active antiretroviral therapy (HAART) allowing treating physicians the ability to make treatment decisions and (v) testing of pediatric patients where testing is complex due to maternal antibodies and sample volumes. The Liat HIV Assay overcomes the limitations of current HIV-1 tests, whose long turnaround time and technical complexity requires testing to be performed in centralized laboratories, resulting in missed opportunities for disease prevention due to significant patient loss to follow-up and lack of penetration into resource-poor regions in the US and abroad. In Phase I of this project, we intend to prove the feasibility and initial verification of a rapid-self contained sample-to-result Liat HIV-1 Quantitative Assay. This will be done by the porting and optimize the existing commercialized HIV-1 assay chemistry to the Liat system. We further intend to characterize and verify that the Liat HIV Assay has the capability of quantifying representative samples from all subtypes within Group M. At the conclusion of this project, we will be prepared to carry the Liat HIV assay to the next level of validation and analytical characterization. The assay will be among the first point-of-care nucleic acid tests, and will provide significant benefit to public health. The Liat HIV Assay will utilize the Liat Analyzer to enable minimally trained personnel the ability to perform the HIV-1 Quantitative test at a hospital, clinic, rural health center, physician's office or in the field. By enabling effective and sensitive HIV-1 quantitative testing, we expect that the Liat assay will: (i) allow clinicians to identify HIV-1 infected volunteers for clinical trials (both vaccine and treatment trials), (ii) allow clinicians monitoring clinical trials a rapid testing methodology for the determination of vaccine treatment benefit in infected patients, (iii) health personnel to detect and quantitate HIV-1 virus in acutely infected patients, (iv) allow point-of-care real time testing of infect patients on highly active antiretroviral therapy (HAART) allowing treating physicians the ability to make treatment decisions and (v) testing of pediatric patients where testing is complex due to maternal antibodies and sample volumes. The Liat HIV Assay overcomes the limitations of current HIV-1 tests, whose long turnaround time and technical complexity requires testing to be performed in centralized laboratories, resulting in missed opportunities for disease prevention due to significant patient loss to follow-up and lack of penetration into resource-poor regions in the US and abroad. ? ? ?
