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NOWDx Test for the Diagnosis of Herpes Simplex Virus Type 2

NCT04294030 · Status: WITHDRAWN · Type: OBSERVATIONAL

Last updated 2024-02-29

No results posted yet for this study

Summary

This study is designed to compare the performance of the NOWDx HSV-2 Test to a currently marketed device. The intent is to show the rapid test device is comparable to the currently marketed device. The NOWDx HSV-2 Test is intended for qualitatively detecting the presence or absence of human Immunoglobulin G (IgG) class antibodies to HSV-2 in human whole blood to aid in the diagnosis of infection caused by herpes simplex virus type 2 (HSV-2).

Conditions

  • HSV-2 Infection
  • Herpes Simplex Virus Infection

Interventions

DEVICE

Diagnostic Test: NOWDx HSV-2 Test

For this observational trial, the intervention of interest is the NOWDx HSV-2 Test.

Sponsors & Collaborators

  • NOWDiagnostics, Inc.

    lead INDUSTRY

Principal Investigators

  • Beth Cobb · NOW Diagnostics, Inc.

Eligibility

Min Age
18 Years
Max Age
64 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-03-01
Primary Completion
2023-10-31
Completion
2023-10-31
FDA Device
Yes

Countries

  • United States

Study Locations

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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 NCT04294030 on ClinicalTrials.gov