NOWDx Test for the Diagnosis of Syphilis

NOWDiagnostics, Inc.1,535 enrolled

Overview

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.

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.

Study Type

OBSERVATIONAL

Enrollment

1,535

Conditions

Syphilis Infection Treponema Pallidum Infection

Interventions

Diagnostic Test: NOWDx Syphilis TestDEVICE

For this observational trial, the Intervention of interest is the NOWDx Syphilis Test.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 64 Years

Medical Language ↔ Plain English

* 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

Locations (6)

AMR Tempe

Tempe, Arizona, United States

Matrix Clinical Research

Los Angeles, California, United States

Segal Trials

North Miami, Florida, United States

AMR Las Vegas

Las Vegas, Nevada, United States

Outcomes

Primary Outcomes

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).

Time frame: 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.

Time frame: through study completion, an average of 6 months

Data from ClinicalTrials.gov

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