NOWDx Test for the Diagnosis of Syphilis

Completed

• Conditions: Syphilis Infection; Treponema Pallidum Infection

• Registration Number: NCT05063344
• Lead Sponsor: NOWDiagnostics, Inc.

Brief 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.

Study Timeline

• Study First Submitted: 2020-03-01
• Study First Submitted QC: 2021-09-20
• Study First Posted: 2021-10-01
• Study Start: 2021-10-04
• Primary Completion: 2023-10-17
• Study Completion: 2023-12-11
• Status Verified: 2024-02
• Last Update Submitted: 2024-02-28
• Last Update Posted: 2024-02-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1535

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Compare serological status to comparator method	through study completion, an average of 6 months	The comparator method used in this study is an algorithm comprised of results from three different commercially available syphilis assays: an FDA-cleared treponemal immunoassay, an FDA-cleared non-treponemal assay (RPR assay) and a second treponemal assay (TP-PA).
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.

Trial Locations

Locations (6)

AMR Tempe; 🇺🇸 Tempe, Arizona, United States

Matrix Clinical Research; 🇺🇸 Los Angeles, California, United States

AMR Las Vegas; 🇺🇸 Las Vegas, Nevada, United States

People Care Institute; 🇺🇸 West Orange, New Jersey, United States

Multicare Rockwood; 🇺🇸 Cheney, Washington, United States

Segal Trials; 🇺🇸 North Miami, Florida, United States