Clinical Evaluation of the Xpert® HIV-1 VL
Overview
Compare the clinical performance of the Xpert® HIV-1 VL to another FDA approved HIV-1 RNA quantitative assay using frozen and fresh specimens from known HIV-1 positive individuals.
Full Title of Study: “Clinical Evaluation of the Xpert® HIV-1 VL: A Method Comparison Study”
Study Type
- Study Type: Observational
- Study Design
- Time Perspective: Cross-Sectional
- Study Primary Completion Date: February 24, 2017
Interventions
- Device: Xpert HIV-1 VL Assay
- in vitro diagnostic test to quantify HIV-1 RNA
Arms, Groups and Cohorts
- HIV-1 infected
- this is a study comparing Xpert HIV-1 VL assay quantitation to an already FDA approved HIV-1 quantitative HIV-1 RNA assay in known HIV-1 infected individuals
Clinical Trial Outcome Measures
Primary Measures
- Quantification of HIV-1 RNA in copies/mL in known HIV-1 positive subjects
- Time Frame: 1 day (A single time point)
- This study is a comparative analysis of HIV-1 RNA quantitation between Xpert HIV-1 VL to another FDA approved test. A single time point (cross-sectional) from each of at least 300 subjects with HIV-1 RNA quantitation within the dynamic range of both assays will be used in regression models to assess performance of the Xpert HIV-1 VL in comparison to the other FDA approved test.
Participating in This Clinical Trial
Inclusion Criteria
- HIV-1 seropositive adults using an FDA approved method – At least 18 years of age or older – Informed consent, if applicable Exclusion Criteria:
- Subject is less than 18 years of age – Previously enrolled in this study – Samples not collected according to the procedure
Gender Eligibility: All
Minimum Age: 18 Years
Maximum Age: N/A
Are Healthy Volunteers Accepted: No
Investigator Details
- Lead Sponsor
- Cepheid
- Provider of Information About this Clinical Study
- Sponsor
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