Studybox Research Dual Submission Studies

Group A Streptococcus Rapid Antigen Test

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

Studybox

Dual Submission Studies

Rapid strep A antigen tests are among the most-run waived tests in the country, and their clinical studies follow a well-worn design: patients with sore throat are enrolled, two throat swabs are collected simultaneously using a dual-swab technique, one is tested on the device by the site and the other goes to culture or a molecular comparator. The choice of comparator matters more than it used to, because molecular tests detect more positives than culture, and a device compared to culture will show different performance than the same device compared to NAAT.

Pediatric enrollment dominates because pharyngitis in school-age children is where group A streptococcus is most common, and the period from late fall through spring supplies most of the positives. Carriage without disease is a known confounder: a positive culture in a carrier still counts as a positive for study purposes, which is one reason these studies enroll symptomatic patients only.

Analyte: Group A streptococcal (Streptococcus pyogenes) cell wall carbohydrate antigen
Therapeutic area: Infectious Disease
Specimens: Oropharyngeal (Throat) Swab
Intended-use settings: urgent care, physician office, pharmacy, emergency department
Operators: Medical assistants, nurses and other non-laboratory staff in physician offices, urgent care centers and pharmacies with waived certificates.
Comparator: Typically bacterial culture on blood agar with confirmatory identification of beta-hemolytic group A streptococcus; an FDA-cleared group A streptococcus nucleic acid test is increasingly used as the comparator or for discordant resolution.

Dual Submission specifics

What Changes for This Assay on This Pathway.

A single prospective study at pediatric and urgent care waived sites with untrained operators supports both components, with the laboratory comparator run centrally or at a qualified local laboratory.
Because most existing strep A tests are already waived, the predicate in the 510(k) half is typically a waived device and the waiver half must show the new device is at least as robust in untrained hands.
Seasonal enrollment is reliable enough that a single season often suffices, but the protocol should allow extension if positives lag.

Endpoints the study must support

Sensitivity and specificity (or positive and negative percent agreement) against the culture or molecular comparator, with 95% confidence intervals
Performance in children and adults separately, and by clinical presentation where a clinical score is collected
Invalid rate and inter-operator agreement in waived settings

Enrollment realities

Driven by the number of culture- or NAAT-positive symptomatic patients, which depends on pediatric volume during strep season; adult positives are less frequent and accrue more slowly. Dual-swab collection failures and inadequate swabs are a predictable loss. Group A streptococcal pharyngitis peaks in late fall through spring in temperate U.S. regions, with low summer incidence.

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

Our track record here

Studies Our Team Has Run for This Test Type.

Dual 510(k) + CLIA waiver · Infectious disease

Dual 510(k) and CLIA Waiver Study for a Point-of-Care Molecular Strep A Test

A semi-automated PCR test with a visual lateral-flow readout was cleared to aid in the rapid diagnosis of Group A Streptococcus infection from throat swabs of patients with signs and symptoms of pharyngitis, for use in clinical laboratories and CLIA-waived sites. A prospective study at 8–10 point-of-care sites, with same-day testing by non-laboratory health professionals, compared results with blood agar culture and an FDA-cleared molecular assay and supported a combined 510(k) and CLIA waiver review.

FAQ

Group A Streptococcus Rapid Antigen Test Study Questions.

01 Who operates the group a streptococcus rapid antigen test in a dual submission study?

Medical assistants, nurses and other non-laboratory staff in physician offices, urgent care centers and pharmacies with waived certificates.

02 What is the comparator for a group a streptococcus rapid antigen test study?

Typically bacterial culture on blood agar with confirmatory identification of beta-hemolytic group A streptococcus; an FDA-cleared group A streptococcus nucleic acid test is increasingly used as the comparator or for discordant resolution.

03 What drives enrollment for a group a streptococcus rapid antigen test study?

Let's talk IVD research

Planning a group a streptococcus 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.