Clinical trial NCT05063344: NOWDx Test for the Diagnosis of Syphilis
Official title: NOWDx Test for the Diagnosis of Syphilis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Syphilis Infection
Treponema Pallidum Infection
Keywords: Syphilis
Treponema Pallidum
Lead sponsor: NOWDiagnostics, Inc.
Sponsor class: INDUSTRY
First posted: 2021-10-01
Enrollment: 1535
Sex: ALL
Minimum age (years): 18
Maximum age (years): 64
Standard ages: ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Residents of the U.S. who elect to participate in the study

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.

Eligibility 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

Primary outcomes:
measure: Compare serological status to comparator method
timeFrame: through study completion, an average of 6 months
measure: Evaluate test reproducibility by lay users
timeFrame: through study completion, an average of 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Tempe
country: United States
facility: AMR Tempe
state: Arizona
city: Los Angeles
country: United States
facility: Matrix Clinical Research
state: California
city: North Miami
country: United States
facility: Segal Trials
state: Florida
city: Las Vegas
country: United States
facility: AMR Las Vegas
state: Nevada
city: West Orange
country: United States
facility: People Care Institute
state: New Jersey
city: Cheney
country: United States
facility: Multicare Rockwood
state: Washington
Study officials:
affiliation: NOW Diagnostics, Inc.
name: Sharon Rabine, MS
role: STUDY_DIRECTOR
References: