NCT05063344

NOWDx Test for the Diagnosis of Syphilis

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 1,535 (actual)
• Sponsor: NOWDiagnostics, Inc. · Industry
• Sex: All
• Age: 18 Years – 64 Years
• Healthy volunteers: —

Summary

This study is designed to compare the performance of the NOWDx Syphilis Test to a currently marketed device. The intent is to show the rapid test device is comparable to the currently marketed device. The NOWDx Syphilis Test is intended for qualitatively detecting the presence or absence of human antibodies to syphilis in human whole blood to aid in the diagnosis of infection caused by Treponema pallidum.

Detailed description

The objective of this study is to establish the performance characteristics of the NOWDx Syphilis Test based on comparison to the BioRad Bioplex 2200 series Syphilis Total (IgG/IgM), Wampole Impact RPR Test Kit, and to the Serodia Treponema pallidum particle agglutination assay (TP-PA). The external clinical study along with in-house analytical studies will demonstrate the efficacy of the NOWDx Syphilis Test as an aid in the diagnosis of syphilis 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 Syphilis Test at independent sites in WA, AZ, and NV. Two sample types will be tested with the NOWDx Syphilis Test for each participant: fingerstick whole blood and venous whole blood. Sera from each participant will be tested at an independent reference laboratory. The NOWDx Syphilis Test will be evaluated in diverse populations of sexually active persons who self-select for syphilis testing and expectant mothers.

Conditions

• Syphilis Infection
• Treponema Pallidum Infection

Interventions

Type	Name	Description
DEVICE	Diagnostic Test: NOWDx Syphilis Test	For this observational trial, the Intervention of interest is the NOWDx Syphilis Test.

Timeline

• Start date: 2021-10-04
• Primary completion: 2023-10-17
• Completion: 2023-12-11
• First posted: 2021-10-01
• Last updated: 2024-02-29

Locations

6 sites across 1 country: United States

Regulatory

• FDA-regulated device study