Studybox Research 510(k) Clinical Studies

Trichomonas vaginalis Point-of-Care Test

Clinical and analytical performance to support substantial equivalence.

Studybox

510(k) Clinical 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.

510(k) Studies specifics

What Changes for This Assay on This Pathway.

The reference should be NAAT-based; a device compared only to wet mount or culture will appear to have inflated sensitivity and the labeling will be questioned.
Vaginal swab and male urine are separate claims with separate performance tables and separate enrollment plans.
Antigen devices are typically compared to NAAT with the expectation that sensitivity will be lower than molecular alternatives; labeling must reflect this and the study should be powered to characterize it precisely.

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.

Our 100+ pre-qualified U.S. sites are matched to the intended-use population and setting, with Studybox coordinators embedded on site for recruitment, consent, specimen handling, and data capture. Typical activation is about four weeks. How we run 510(k) clinical 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 510(k) studies 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 510(k) studies pathway.