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

George Washington University (GW)

Status: Completed

Conditions: HIV; HIV Infections

Study type: Observational

Funder types: Other

Identifiers

NCT01084954

040907

Details and patient eligibility

About

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.

Enrollment: 153 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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