An observational study in Human Immunodeficiency Virus, sponsored by Cepheid. Completed. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2018-02-06.
Sponsored by Cepheid · Observational
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.
2,040 studies on the registry are indexed under Acquired Immunodeficiency Syndrome; 272 are open to participants now.
This study's enrollment of 966 is above the median of 236 across 355 observational studies indexed under Acquired Immunodeficiency Syndrome.
Browse Acquired Immunodeficiency Syndrome studies →Cepheid is the lead sponsor of 10 studies on the registry; 1 is open to participants now.
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Males and females >18 yours who are known HIV-1 infected and may be on treatment or untreated with ARV therapy
Exclusion Criteria:
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
Device: Xpert HIV-1 VL Assay
in vitro diagnostic test to quantify HIV-1 RNA
Quantification of HIV-1 RNA in copies/mL in known HIV-1 positive subjects
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.
Time frame: 1 day (A single time point)
No study locations are listed for this record.
This study is completed, as verified in Feb 2018. You cannot join it, but the record below documents what was studied.
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Acquired Immunodeficiency Syndrome→
Cepheid