Syphilis Infection, Treponema Pallidum Infection
Conditions
Keywords
Syphilis, Treponema Pallidum
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.
Interventions
DEVICEDiagnostic Test: NOWDx Syphilis Test
For this observational trial, the Intervention of interest is the NOWDx Syphilis Test.
Sponsors
NOWDiagnostics, Inc.
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 64 Years
Inclusion 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 *
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Compare serological status to comparator method | through study completion, an average of 6 months | 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). |
| Evaluate test reproducibility by lay users | through study completion, an average of 6 months | Test lay user reproducibility using prepared samples for % agreement with expected results. |
Countries
United States
Outcome results
None listed