NOWDx Test for the Diagnosis of Syphilis

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.

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Key information

Conditions

Syphilis Infection Bacterial Infections Bacterial Infections and Mycoses Communicable Diseases Genital Diseases Gram-Negative Bacterial Infections Infections Sexually Transmitted Diseases Sexually Transmitted Diseases, Bacterial Spirochaetales Infections Syphilis Treponema Pallidum Infection Treponemal Infections Urogenital Diseases

Age range

18 year–64 year

Sex eligibility

All sexes

Study type

Observational

Primary location

AMR Tempe, Tempe, Arizona, United States

About this study

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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Diagnostic Test: NOWDx Syphilis Test

Device

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

Primary outcomes

Compare serological status to comparator method

Time frame: 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

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

Test lay user reproducibility using prepared samples for % agreement with expected results.

Sponsors and collaborators

Lead sponsor

NOWDiagnostics, Inc.

Industry

Registry information

Important dates

Study start: 2021
Primary completion: 2023
Study completion: 2023
First posted: Oct 1, 2021
Registry last updated: Feb 29, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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