NOWDx Test for the Diagnosis of Herpes Simplex Virus Type 2

February 28, 2024 updated by: NOWDiagnostics, Inc.
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).

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

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 Type

Observational

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Arizona
      • Tempe, Arizona, United States, 85283
        • Clinical Research Consortium
    • Florida
      • Coral Gables, Florida, United States, 33134
        • Clinical Research of South Florida
    • Kentucky
      • Lexington, Kentucky, United States, 40509
        • Alliance for Multispecialty Research Lexington

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 62 years (Adult)

Accepts Healthy Volunteers

N/A

Sampling Method

Probability Sample

Study Population

Residents of the U.S. who elect to participate in the study

Description

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Sexually active persons who self-select for HSV-2 testing
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
For this observational trial, the intervention of interest is the NOWDx HSV-2 Test.
Expectant mothers
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
For this observational trial, the intervention of interest is the NOWDx HSV-2 Test.
Low prevalence population
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
For this observational trial, the intervention of interest is the NOWDx HSV-2 Test.
Lay users
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
For this observational trial, the intervention of interest is the NOWDx HSV-2 Test.

What is the study measuring?

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.
Time Frame: 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%.
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.
Time Frame: through study completion, an average of 6 months
Test lay user reproducibility using prepared samples for % agreement with expected results.
through study completion, an average of 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

NOWDiagnostics, Inc.

Investigators

  • Principal Investigator: Beth Cobb, NOW Diagnostics, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

March 1, 2023

Primary Completion (Estimated)

October 31, 2023

Study Completion (Estimated)

October 31, 2023

Study Registration Dates

First Submitted

March 1, 2020

First Submitted That Met QC Criteria

March 2, 2020

First Posted (Actual)

March 3, 2020

Study Record Updates

Last Update Posted (Estimated)

February 29, 2024

Last Update Submitted That Met QC Criteria

February 28, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NOWDx HSV-2 Study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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