Clinical Evaluation of the Xpert® HIV-1 VL

Cepheid966 enrolled

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.

Study Type

OBSERVATIONAL

Enrollment

966

Conditions

Human Immunodeficiency Virus

Interventions

Xpert HIV-1 VL AssayDEVICE

in vitro diagnostic test to quantify HIV-1 RNA

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

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)

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.