NOWDx Test for the Diagnosis of Herpes Simplex Virus Type 2

Study Overview
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Brief Summary
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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
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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.

Official Title
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NOWDx Test for the Diagnosis of Herpes Simplex Virus Type 2

Conditions
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HSV-2 Infection, Herpes Simplex Virus Infection

Intervention / Treatment
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* Device: Diagnostic Test: NOWDx HSV-2 Test


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 64 Years

Sexes Eligible for Study
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All

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Sexually active persons who self-select for HSV-2 testing<br>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 | Device: Diagnostic Test: NOWDx HSV-2 Test<br>* For this observational trial, the intervention of interest is the NOWDx HSV-2 Test.<br>|
| Expectant mothers<br>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 | Device: Diagnostic Test: NOWDx HSV-2 Test<br>* For this observational trial, the intervention of interest is the NOWDx HSV-2 Test.<br>|
| Low prevalence population<br>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 | Device: Diagnostic Test: NOWDx HSV-2 Test<br>* For this observational trial, the intervention of interest is the NOWDx HSV-2 Test.<br>|
| Lay users<br>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 | Device: Diagnostic Test: NOWDx HSV-2 Test<br>* For this observational trial, the intervention of interest is the NOWDx HSV-2 Test.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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HSV-2, Genital Herpes