Studybox Research Dual Submission Studies

Trichomonas vaginalis Point-of-Care Test

One integrated study supporting both 510(k) clearance and CLIA waiver.

Studybox

Dual Submission Studies

Trichomoniasis is the most common non-viral sexually transmitted infection, and because wet mount microscopy misses a large share of infections, point-of-care antigen and molecular tests have a clear clinical rationale. The clinical study is straightforward in structure, a vaginal swab tested on the device with a paired swab sent to a laboratory NAAT reference, but the reference has shifted: studies that once used wet mount and culture now use NAAT and must explain how culture, if included, contributes to the reference.

Prevalence varies widely by population, from a few percent in general clinics to much higher in some sexual health and emergency department populations, and this variation drives site selection. A male urine claim adds a specimen type and population with lower parasite load and distinct enrollment challenges.

Analyte: Trichomonas vaginalis antigen (lateral flow) or nucleic acid (point-of-care molecular), depending on the device
Therapeutic area: STD/STI Detection
Specimens: Vaginal Swab, Urine
Intended-use settings: urgent care, physician office, emergency department
Operators: Non-laboratory clinic staff in waived settings; laboratory staff for moderate-complexity claims.
Comparator: Typically an FDA-cleared T. vaginalis nucleic acid amplification test, sometimes combined with culture; wet mount microscopy is the historical point-of-care comparator and is no longer an adequate reference because of its low sensitivity.

Dual Submission specifics

What Changes for This Assay on This Pathway.

A single prospective study at waived sites supports both components, with the NAAT reference run centrally and operator status documented at every site.
The dual program typically centers on the vaginal swab claim and treats a male urine claim as a separable component.
Enrollment may need supplementation from higher-prevalence sites that are not strictly waived settings; how those data are used in each half of the submission should be set in advance.

Endpoints the study must support

Sensitivity and specificity against the NAAT-based reference, with 95% confidence intervals, in women by vaginal swab and, where claimed, in men by urine
Performance in symptomatic and asymptomatic subjects separately
Invalid rate and inter-operator agreement for visually read devices

Enrollment realities

Driven by NAAT-positive women, with prevalence varying several-fold by site type; symptomatic and asymptomatic strata are typically both required and the asymptomatic positives accrue slowly.

How Studybox runs it

Pre-Qualified Sites, Embedded Coordinators.

Waiver evidence depends on genuine intended-use operators in genuine waived settings. Our network of 100+ pre-qualified urgent care, physician office, and point-of-care sites already runs IVD protocols, so operator recruitment and site activation don't start from zero. How we run dual submission studies →

Same assay, other pathways

Relevant FDA guidance

FAQ

Trichomonas vaginalis Point-of-Care Test Study Questions.

01 Who operates the trichomonas vaginalis point-of-care test in a dual submission study?

Non-laboratory clinic staff in waived settings; laboratory staff for moderate-complexity claims.

02 What is the comparator for a trichomonas vaginalis point-of-care test study?

Typically an FDA-cleared T. vaginalis nucleic acid amplification test, sometimes combined with culture; wet mount microscopy is the historical point-of-care comparator and is no longer an adequate reference because of its low sensitivity.

03 What drives enrollment for a trichomonas vaginalis point-of-care test study?

Driven by NAAT-positive women, with prevalence varying several-fold by site type; symptomatic and asymptomatic strata are typically both required and the asymptomatic positives accrue slowly.

Let's talk IVD research

Planning a trichomonas vaginalis point-of-care test study?

Tell us the intended use and setting. We'll come back with a site plan, operator strategy, and a realistic activation timeline for the dual submission pathway.