Clinical trial NCT04294030: NOWDx Test for the Diagnosis of Herpes Simplex Virus Type 2
Official title: NOWDx Test for the Diagnosis of Herpes Simplex Virus Type 2
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: HSV-2 Infection
Herpes Simplex Virus Infection
Keywords: HSV-2
Genital Herpes
Lead sponsor: NOWDiagnostics, Inc.
Sponsor class: INDUSTRY
First posted: 2020-03-03
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 64
Standard ages: ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Residents of the U.S. who elect to participate in the study

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.

Eligibility 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

Primary outcomes:
measure: Compare NOWDx HSV-2 Test result to comparator method lab result to assess sensitivity and specificity of investigational device.
timeFrame: through study completion, an average of 6 months
Secondary outcomes:
measure: Compare results of NOWDx HSV-2 Tests conducted by lay users with expected results to evaluate test reproducibility by lay users.
timeFrame: through study completion, an average of 6 months
Other outcomes:
Locations:
city: Tempe
country: United States
facility: Clinical Research Consortium
state: Arizona
city: Coral Gables
country: United States
facility: Clinical Research of South Florida
state: Florida
city: Lexington
country: United States
facility: Alliance for Multispecialty Research Lexington
state: Kentucky
Study officials:
affiliation: NOW Diagnostics, Inc.
name: Beth Cobb
role: PRINCIPAL_INVESTIGATOR
References: