Herpes Simplex Virus Infection, HSV-2 Infection
Conditions
Keywords
HSV-2, Genital Herpes
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.
Interventions
DEVICEDiagnostic Test: NOWDx HSV-2 Test
For this observational trial, the intervention of interest is the NOWDx HSV-2 Test.
Sponsors
NOWDiagnostics, Inc.
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 64 Years
Inclusion 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Compare NOWDx HSV-2 Test result to comparator method lab result to assess sensitivity and specificity of investigational device. | 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%. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Compare results of NOWDx HSV-2 Tests conducted by lay users with expected results to evaluate test reproducibility by lay users. | through study completion, an average of 6 months | Test lay user reproducibility using prepared samples for % agreement with expected results. |
Countries
United States
Outcome results
None listed