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Performance Evaluation of the Bio-Rad Geenius HIV1/2 Supplemental Assay

NCT02401555 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 419

Last updated 2017-03-28

Study results available
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Summary

The purpose of this study was to evaluate the performance of the Bio-Rad Geenius HIV 1/2 Supplemental Assay, a single-use immunochromatographic assay for the confirmation and differentiation of individual antibodies to Human Immunodeficiency Virus Types 1 and 2 (HIV-1 and HIV-2) in fingerstick whole blood, venous whole blood, serum, or plasma samples (EDTA, heparin, and sodium citrate).

Conditions

Interventions

DEVICE

Geenius HIV1/2 Supplemental Assay

The purpose of this study is to evaluate the performance of the Bio-Rad Geenius HIV1/2 Supplemental Assay test in finger stick whole blood, venous whole blood, serum or plasma (EDTA, heparin, sodium citrate).

Sponsors & Collaborators

  • Bio-Rad Laboratories

    lead INDUSTRY

Principal Investigators

  • Scott Dennis, BS · Bio-Rad Laboratories

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2013-04-30
Primary Completion
2013-12-31
Completion
2013-12-31

Countries

  • United States

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02401555 on ClinicalTrials.gov