NOWDx Test for the Diagnosis of Syphilis

Status Completed

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT05063344
Study type	Observational
Source	NOWDiagnostics, Inc.
Contact
Status	Completed
Phase
Start date	October 4, 2021
Completion date	December 11, 2023

View Details

See also
Status	Clinical Trial	Phase
Not yet recruiting	`NCT02262390` - Syphilis Treatment of Partners Trial	N/A
Active, not recruiting	`NCT06367621` - Retrospective Study of iStatis Syphilis Ab Test (POC)
Not yet recruiting	`NCT06244966` - GUM Remote Testing v4.0	N/A
Recruiting	`NCT05831098` - Evaluation of the Sensitivity, Specificity, and Utility of the Reveal® TP (Syphilis) Antibody POCT	N/A
Completed	`NCT03156751` - Feasibility of Introducing an Onsite Test for Syphilis in the Package of Antenatal Care in Burkina Faso	N/A
Not yet recruiting	`NCT05727033` - Extraordinarily Fun Training Project in Compulsory Secondary Education - Sexually Transmitted Infections	N/A
Recruiting	`NCT06365606` - Study to Evaluate Diagnostic Sensitivity and Specificity of iStatis Syphilis Ab Test at the Point- Of-Care Sites	N/A
Not yet recruiting	`NCT06391125` - LIMIT Trial - Lidocaine With Intramuscular Injection of Benzathine Penicillin G for Treponema Pallidum Treatment	Phase 3
Not yet recruiting	`NCT06463314` - Multiplex Near Patient Non-HCP Study	N/A
Completed	`NCT04455425` - Acquired Syphlis by Non Sexual Contact
Active, not recruiting	`NCT04050540` - Doxycycline PEP for Prevention of Sexually Transmitted Infections Among Kenyan Women Using HIV PrEP	Phase 4
Recruiting	`NCT05534633` - APPROACH 2.0: HIV, HCV and Syphilis Testing Through Pharmacies	N/A
Not yet recruiting	`NCT05692505` - Multicenter Performance Study of QuadQuik Invitro Diagnostic Device