Clinical Evaluation of the Xpert® HIV-1 VL

Clinical Evaluation of the Xpert® HIV-1 VL: A Method Comparison Study

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02461576

Enrollment

966

Registered

2015-06-03

Start date

2015-07-31

Completion date

2017-02-24

Last updated

2018-02-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Human Immunodeficiency Virus

Keywords

HIV-1

Brief summary

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.

Interventions

DEVICEXpert HIV-1 VL Assay

in vitro diagnostic test to quantify HIV-1 RNA

Study design

Observational model

OTHER

Time perspective

CROSS_SECTIONAL

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Quantification of HIV-1 RNA in copies/mL in known HIV-1 positive subjects	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.

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026