NOWDx Test for the Diagnosis of Syphilis

NOWDiagnostics

Status: Completed

Conditions: Syphilis Infection; Treponema Pallidum Infection

Treatments: Device: Diagnostic Test: NOWDx Syphilis Test

Study type: Observational

Funder types: Industry

Identifiers

NCT05063344

NOWDx Syphilis Study

Details and patient eligibility

About

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.

Full 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.

Enrollment: 1,535 patients

Sex: All

Ages: 18 to 64 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

• 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

Trial design

1,535 participants in 3 patient groups

Sexually active persons who self-select for syphilis testing

Description:

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

Treatment:

Device: Diagnostic Test: NOWDx Syphilis Test

Expectant mothers

Description:

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

Treatment:

Device: Diagnostic Test: NOWDx Syphilis Test

Lay users

Description:

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

Treatment:

Device: Diagnostic Test: NOWDx Syphilis Test