NOWDx Test for the Diagnosis of Syphilis

Study Overview
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Brief Summary
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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
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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.

Official Title
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NOWDx Test for the Diagnosis of Syphilis

Conditions
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Syphilis Infection, Treponema Pallidum Infection

Intervention / Treatment
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* Device: Diagnostic Test: NOWDx Syphilis Test


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 64 Years

Sexes Eligible for Study
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All

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Sexually active persons who self-select for syphilis testing<br>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<br>* For this observational trial, the Intervention of interest is the NOWDx Syphilis Test.<br>|
| Expectant mothers<br>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<br>* For this observational trial, the Intervention of interest is the NOWDx Syphilis Test.<br>|
| Lay users<br>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<br>* For this observational trial, the Intervention of interest is the NOWDx Syphilis Test.<br>|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Syphilis, Treponema Pallidum