Studybox Research Dual Submission Studies
RSV Rapid Antigen Test
One integrated study supporting both 510(k) clearance and CLIA waiver.
Studybox
Dual Submission Studies
RSV antigen tests perform well in infants and young children, who shed virus at high titer, and poorly in adults, who do not. This single fact shapes the clinical study: most RSV antigen tests carry a pediatric-only intended use, and a sponsor who wants an adult claim must be prepared to show sensitivity in a population where antigen detection has historically fallen well short of molecular methods.
Enrollment is therefore pediatric, which brings parental permission, assent where appropriate, pediatric collection technique and sites with high infant and toddler volume during RSV season. Seasons have been less predictable since 2020, and the introduction of maternal vaccination and long-acting monoclonal antibody prophylaxis for infants may lower the proportion of symptomatic infants who present with high viral loads.
- Analyte
- Respiratory syncytial virus antigen (fusion or nucleoprotein target, depending on the device)
- Therapeutic area
- Infectious Disease
- Specimens
- Nasopharyngeal (NP) Swab, Anterior Nares (Nasal) Swab
- Intended-use settings
- urgent care, physician office, hospital POC, emergency department
- Operators
- Pediatric and family practice clinic staff and urgent care staff in waived settings; laboratory staff for moderate-complexity claims.
- Comparator
- Typically an FDA-cleared RSV RT-PCR assay on a paired specimen; viral culture and direct fluorescent antibody staining were historical comparators and are rarely used now.
Dual Submission specifics
What Changes for This Assay on This Pathway.
- One prospective pediatric study at waived sites supports both the 510(k) comparison and the waiver demonstration when the device specimen is one untrained operators can collect and run.
- If an adult claim is pursued, the integrated protocol should pre-specify that the adult analysis is separable and can be dropped from the waiver without affecting the pediatric claim.
- Season shifts since 2020 argue for a two-season enrollment plan written into the dual protocol from the start.
Endpoints the study must support
- Positive and negative percent agreement against the molecular comparator in the claimed age range, with 95% confidence intervals
- Performance by age stratum (infants, young children and, if claimed, adults) and by specimen type
- Invalid rate and inter-reader agreement for visually read devices
Enrollment realities
Positives in the claimed age range drive sample size; infant and toddler enrollment is limited by season length, parental consent rates and the availability of pediatric sites. Adult positives are rare and typically require a disproportionate number of adult enrollments. RSV season has historically run from fall through winter in most of the United States, with regional variation; timing has been irregular since 2020 and should be tracked with surveillance data.
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
RSV Rapid Antigen Test Study Questions.
01 Who operates the rsv rapid antigen test in a dual submission study?
Pediatric and family practice clinic staff and urgent care staff in waived settings; laboratory staff for moderate-complexity claims.
02 What is the comparator for a rsv rapid antigen test study?
Typically an FDA-cleared RSV RT-PCR assay on a paired specimen; viral culture and direct fluorescent antibody staining were historical comparators and are rarely used now.
03 What drives enrollment for a rsv rapid antigen test study?
Positives in the claimed age range drive sample size; infant and toddler enrollment is limited by season length, parental consent rates and the availability of pediatric sites. Adult positives are rare and typically require a disproportionate number of adult enrollments. RSV season has historically run from fall through winter in most of the United States, with regional variation; timing has been irregular since 2020 and should be tracked with surveillance data.
Let's talk IVD research
Planning a rsv rapid antigen 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.