NOWDx Test for the Diagnosis of Syphilis

Syphilis Infection Clinical Trial

Official title:

NOWDx Test for the Diagnosis of Syphilis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05063344
• Other study ID #: NOWDx Syphilis Study
• Status: Completed
• Start date: October 4, 2021
• Est. completion date: December 11, 2023

Study information

• Verified date: February 2024
• Source: NOWDiagnostics, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1535
• Est. completion date: December 11, 2023
• Est. primary completion date: October 17, 2023
• Gender: All
• Age group: 18 Years to 64 Years

Eligibility

• Sexually active persons who self-select for syphilis testing
• n=840 participants; ~280 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=222 participants; ~74 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
• 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

Related Conditions & MeSH terms

• Communicable Diseases
• Infections
• Syphilis
• Syphilis Infection

Intervention

Device:
• Diagnostic Test: NOWDx Syphilis Test
For this observational trial, the Intervention of interest is the NOWDx Syphilis Test.

Locations

Country	Name	City	State
United States	Multicare Rockwood	Cheney	Washington
United States	AMR Las Vegas	Las Vegas	Nevada
United States	Matrix Clinical Research	Los Angeles	California
United States	Segal Trials	North Miami	Florida
United States	AMR Tempe	Tempe	Arizona
United States	People Care Institute	West Orange	New Jersey

Sponsors (1)

Lead Sponsor	Collaborator
NOWDiagnostics, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Compare serological status to comparator method	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).	through study completion, an average of 6 months
Primary	Evaluate test reproducibility by lay users	Test lay user reproducibility using prepared samples for % agreement with expected results.	through study completion, an average of 6 months