WithdrawnNot Applicable

NOWDx Test for the Diagnosis of Herpes Simplex Virus Type 2

Stopped: Deprioritized by Sponsor

United States0Started 2023-03-01

Plain-language 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).

Who can participate

Age range18 Years – 64 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

* 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

What they're measuring

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

Trial details

NCT IDNCT04294030

SponsorNOWDiagnostics, Inc.

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2023-10-31