NOWDx Test for the Diagnosis of Herpes Simplex Virus Type 2

Withdrawn

• Conditions: HSV-2 Infection; Herpes Simplex Virus Infection

• Registration Number: NCT04294030
• Lead Sponsor: NOWDiagnostics, Inc.

Brief 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.

Study Timeline

• Study First Submitted: 2020-03-01
• Study First Submitted QC: 2020-03-02
• Study First Posted: 2020-03-03
• Study Start: 2023-03-01
• Primary Completion: 2023-10-31
• Study Completion: 2023-10-31
• Status Verified: 2024-02
• Last Update Submitted: 2024-02-28
• Last Update Posted: 2024-02-29

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Compare NOWDx HSV-2 Test result to comparator method lab result to assess sensitivity and specificity of investigational device.	through study completion, an average of 6 months	The results should be presented as sensitivity and specificity as compared to the comparator method and should have a point estimate of 95% with a lower bound of the two-sided 95% confidence interval of 90%.

Secondary Outcome Measures

Name	Time	Method
Compare results of NOWDx HSV-2 Tests conducted by lay users with expected results to evaluate test reproducibility by lay users.	through study completion, an average of 6 months	Test lay user reproducibility using prepared samples for % agreement with expected results.

Trial Locations

Locations (3)

Clinical Research Consortium; 🇺🇸 Tempe, Arizona, United States

Alliance for Multispecialty Research Lexington; 🇺🇸 Lexington, Kentucky, United States

Clinical Research of South Florida; 🇺🇸 Coral Gables, Florida, United States