NOWDx Test for the Diagnosis of Syphilis

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.

Study Overview

• Status: Completed
• Conditions: Syphilis Infection; Treponema Pallidum Infection
• Intervention / Treatment: Device: Diagnostic Test: NOWDx Syphilis Test

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 Type: Observational
• Enrollment (Actual): 1535

Contacts and Locations

Study Locations

• United States
  • Arizona
    • Tempe, Arizona, United States, 85281
      • AMR Tempe
  • California
    • Los Angeles, California, United States, 90057
      • Matrix Clinical Research
  • Florida
    • North Miami, Florida, United States, 33161
      • Segal Trials
  • Nevada
    • Las Vegas, Nevada, United States, 89119
      • AMR Las Vegas
  • New Jersey
    • West Orange, New Jersey, United States, 07052
      • People Care Institute
  • Washington
    • Cheney, Washington, United States, 99004
      • Multicare Rockwood

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 64 years (Adult)
• Accepts Healthy Volunteers: N/A

• Sampling Method: Probability Sample

Study Population

Residents of the U.S. who elect to participate in the study

Description

• 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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Expectant mothers; Participants must be a mixture of English and Spanish speaking, geographically diverse, gender diverse, ethnically and racially diverse, economically diverse, and with different levels of education; 18-64 years	Device: Diagnostic Test: NOWDx Syphilis Test; For this observational trial, the Intervention of interest is the NOWDx Syphilis Test.
Sexually active persons who self-select for syphilis testing; Participants must be a mixture of English and Spanish speaking, geographically diverse, gender diverse, ethnically and racially diverse, economically diverse, and with different levels of education; 18-64 years	Device: Diagnostic Test: NOWDx Syphilis Test; For this observational trial, the Intervention of interest is the NOWDx Syphilis Test.
Lay users; Participants must be a mixture of English and Spanish speaking, geographically diverse, gender diverse, ethnically and racially diverse, economically diverse, and with different levels of education; 18-64 years; 1/2 high risk sexual behavior and 1/2 low risk sexual behavior	Device: Diagnostic Test: NOWDx Syphilis Test; For this observational trial, the Intervention of interest is the NOWDx Syphilis Test.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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

Collaborators and Investigators

• Sponsor: NOWDiagnostics, Inc.
• Investigators: Study Director: Sharon Rabine, MS, NOW Diagnostics, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): October 4, 2021
• Primary Completion (Actual): October 17, 2023
• Study Completion (Actual): December 11, 2023

Study Registration Dates

• First Submitted: March 1, 2020
• First Submitted That Met QC Criteria: September 20, 2021
• First Posted (Actual): October 1, 2021

Study Record Updates

• Last Update Posted (Estimated): February 29, 2024
• Last Update Submitted That Met QC Criteria: February 28, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Keywords: Syphilis; Treponema Pallidum
• Additional Relevant MeSH Terms: Pathologic Processes; Sexually Transmitted Diseases; Disease Attributes; Gram-Negative Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Sexually Transmitted Diseases, Bacterial; Spirochaetales Infections; Urogenital Diseases; Genital Diseases; Infections; Communicable Diseases; Syphilis; Treponemal Infections
• Other Study ID Numbers: NOWDx Syphilis Study

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No