NOWDx Test for the Diagnosis of Herpes Simplex Virus Type 2

NOWDiagnostics

Status: Withdrawn

Conditions: HSV-2 Infection; Herpes Simplex Virus Infection

Treatments: Device: Diagnostic Test: NOWDx HSV-2 Test

Study type: Observational

Funder types: Industry

Identifiers

NCT04294030

NOWDx HSV-2 Study

Details and patient eligibility

About

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).

Full 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.

Sex: All

Ages: 18 to 64 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

• 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

Trial design

0 participants in 4 patient groups

Sexually active persons who self-select for HSV-2 testing

Description:

Participants must be a mixture of English and Spanish speaking, geographically diverse, gender diverse, ethnically and racially diverse, economically diverse, and with different levels of education; 18-64 years

Treatment:

Device: Diagnostic Test: NOWDx HSV-2 Test

Expectant mothers

Description:

Participants must be a mixture of English and Spanish speaking, geographically diverse, gender diverse, ethnically and racially diverse, economically diverse, and with different levels of education; 18-64 years

Treatment:

Device: Diagnostic Test: NOWDx HSV-2 Test

Low prevalence population

Description:

Participants must be a mixture of English and Spanish speaking, geographically diverse, gender diverse, ethnically and racially diverse, economically diverse, and with different levels of education; 18-64 years

Treatment:

Device: Diagnostic Test: NOWDx HSV-2 Test

Lay users

Description:

Participants must be a mixture of English and Spanish speaking, geographically diverse, gender diverse, ethnically and racially diverse, economically diverse, and with different levels of education; 18-64 years; 1/2 high risk sexual behavior; 1/2 low risk sexual behavior

Treatment:

Device: Diagnostic Test: NOWDx HSV-2 Test