NOWDx Test for the Diagnosis of Herpes Simplex Virus Type 2

Herpes Simplex Virus Infection Clinical Trial

Official title:

NOWDx Test for the Diagnosis of Herpes Simplex Virus Type 2

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT04294030
• Other study ID #: NOWDx HSV-2 Study
• Status: Withdrawn
• Start date: March 1, 2023
• Est. completion date: October 31, 2023

Study information

• Verified date: February 2024
• Source: NOWDiagnostics, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: October 31, 2023
• Est. primary completion date: October 31, 2023
• Gender: All
• Age group: 18 Years to 64 Years

Eligibility

• Sexually active persons who self-select for syphilis testing n=750 participants; ~250 per study site Inclusion criteria: sexually active persons 18-64 years old Exclusion criteria: persons <18 years old; persons >64 years old; persons with limited or no reading skills; persons who previously participated in a NOWDx study
• Expectant mothers n=90 participants; ~30 per study site Inclusion criteria: expectant mothers =18 years old Exclusion criteria: persons <18 years old; persons with limited or no reading skills; persons who previously participated in a NOWDx study
• Low prevalence population n=201 participants; ~67 per study site Inclusion criteria:

persons aged 18-64 years old claiming to lack sexual experience Exclusion criteria:

persons <18 years old; persons >64 years old; persons with limited or no reading skills; persons who previously participated in a NOWDx study

• Lay users n=48 participants; ~16 per study site Inclusion criteria: persons 18-64 years old; ½ high risk sexual behavior; ½ low risk sexual behavior Exclusion criteria: persons <18 years old; persons >64 years old; persons with limited or no reading skills; persons who previously participated in a NOWDx study

Related Conditions & MeSH terms

• Communicable Diseases
• Herpes Simplex
• Herpes Simplex Virus Infection
• HSV-2 Infection
• Infections

Intervention

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

Locations

Country	Name	City	State
United States	Clinical Research of South Florida	Coral Gables	Florida
United States	Alliance for Multispecialty Research Lexington	Lexington	Kentucky
United States	Clinical Research Consortium	Tempe	Arizona

Sponsors (1)

Lead Sponsor	Collaborator
NOWDiagnostics, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Compare NOWDx HSV-2 Test result to comparator method lab result to assess sensitivity and specificity of investigational device.	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%.	through study completion, an average of 6 months
Secondary	Compare results of NOWDx HSV-2 Tests conducted by lay users with expected results to evaluate test reproducibility by lay users.	Test lay user reproducibility using prepared samples for % agreement with expected results.	through study completion, an average of 6 months