An Investigation to Evaluate the Performance of the Cepheid Xpert® HIV-1 VL XC Test
Not Applicable
- Conditions
- HIV/AIDS
- Registration Number
- PACTR201908919241847
- Lead Sponsor
- Cepheid
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- All
- Target Recruitment
- 800
Inclusion Criteria
•18 years of age or older
•Able and willing to provide the required amount of blood without compromising their well being
•Able to understand the study and sign the informed consent
•Adults at risk for HIV infection as defined by WHO guidelines 5 and/or the individual is from a region with known high incidence of HIV infection
•Adults who have not been previously screened for HIV or that have been previously screened for HIV and were negative for HIV infection.
Exclusion Criteria
•Study participant previously tested positive for HIV infection
•Previously enrolled in this study.
•The Investigator does not feel the study participant is suitable to participate in this study.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Performance of the Xpert® HIV-1 Viral Load XC test for detection and quantitation of HIV-1 RNA in human plasma
- Secondary Outcome Measures
Name Time Method Performance of the Expert HIV-1 Viral Load XC Test for the detection of and quantification of HIV-1 RNA in human plasma