NOWDx Test for the Diagnosis of Syphilis

Last updated: February 28, 2024
Sponsor: NOWDiagnostics, Inc.
Overall Status: Completed

Phase

N/A

Condition

Hiv

Rash

Sexually Transmitted Diseases (Stds)

Treatment

Diagnostic Test: NOWDx Syphilis Test

Clinical Study ID

NCT05063344
NOWDx Syphilis Study
  • Ages 18-64
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

  • 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

  • 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 Design

Total Participants: 1535
Treatment Group(s): 1
Primary Treatment: Diagnostic Test: NOWDx Syphilis Test
Phase:
Study Start date:
October 04, 2021
Estimated Completion Date:
December 11, 2023

Study 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.

Connect with a study center

  • AMR Tempe

    Tempe, Arizona 85281
    United States

    Site Not Available

  • Matrix Clinical Research

    Los Angeles, California 90057
    United States

    Site Not Available

  • Segal Trials

    North Miami, Florida 33161
    United States

    Site Not Available

  • AMR Las Vegas

    Las Vegas, Nevada 89119
    United States

    Site Not Available

  • People Care Institute

    West Orange, New Jersey 07052
    United States

    Site Not Available

  • Multicare Rockwood

    Cheney, Washington 99004
    United States

    Site Not Available

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.