Validation of a Simple and Cost-Effective Nucleic Acid Test for HIV Detection



Status:Completed
Conditions:HIV / AIDS
Therapuetic Areas:Immunology / Infectious Diseases
Healthy:No
Age Range:18 - Any
Updated:6/17/2016
Start Date:March 2009
End Date:April 2016

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Validate a simple and cost-effective Nucleic Acid Test for HIV Detection in order to develop
a rapid, highly sensitive and specific, one-stage test for the diagnosis of HIV infection.
Blood samples collected will be assayed using the BioHelix Corporation helicase-dependent
amplification or the Cepheid Xpert HIV-1 Quant Assay. A false negative or false positive
rate of >1.0% would make this test unacceptable as a screening test for HIV viremia.


Inclusion Criteria:

- Current patient in the Medical Faculty Associates Infectious Diseases (ID) clinic
with known HIV infection

- Suspected to be viremic at the time of their clinic visit based on history and/or
current symptoms

- Able to provide informed consent

- 18 Years or older

Exclusion Criteria:

- Patient unable to provide informed consent.

- Pregnancy
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