NCT04294030

NOWDx Test for the Diagnosis of Herpes Simplex Virus Type 2

• Status: Withdrawn
• Phase: —
• Study type: Observational
• Enrollment: 0 (actual)
• Sponsor: NOWDiagnostics, Inc. · Industry
• Sex: All
• Age: 18 Years – 64 Years
• Healthy volunteers: —

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).

Detailed description

The objective of this study is to establish the performance characteristics of the NOWDx HSV-2 Test based on comparison to the HerpeSelect 1 and 2 Immunoblot IgG and HerpeSelect 2 ELISA IgG assays. The external clinical study along with in-house analytical studies will demonstrate the efficacy of the NOWDx HSV-2 Test as an aid in the diagnosis of HSV-2 infection for at home testing and point of care testing sites. Participants will self test and be tested by Clinical Laboratory Improvement Amendments (CLIA) Waived operators with the NOWDx HSV-2 Test at independent sites in Florida, Kentucky, and Arizona. Two sample types will be tested with the NOWDx HSV-2 Test for each participant: capillary whole blood and venous whole blood. Sera from each participant will be tested at an independent reference laboratory. The NOWDx HSV-2 Test will be evaluated in diverse populations of sexually active persons who self-select for genital herpes testing, expectant mothers, and persons claiming to lack sexual experience.

Conditions

• HSV-2 Infection
• Herpes Simplex Virus Infection

Interventions

Type	Name	Description
DEVICE	Diagnostic Test: NOWDx HSV-2 Test	For this observational trial, the intervention of interest is the NOWDx HSV-2 Test.

Timeline

• Start date: 2023-03-01
• Primary completion: 2023-10-31
• Completion: 2023-10-31
• First posted: 2020-03-03
• Last updated: 2024-02-29

Locations

3 sites across 1 country: United States

Regulatory

• FDA-regulated device study