Studybox Research CLIA Waiver Studies

COVID-19 and Influenza A/B Combination Rapid Antigen Test

Accuracy in the hands of untrained intended-use operators at waived sites.

Studybox

CLIA Waiver Studies

Combination tests report three results from one swab, and the clinical study must support each independently. In practice this is three studies sharing a population: the influenza A and B analyses are held to the special controls for antigen-based influenza tests, while the SARS-CoV-2 analysis follows the expectations established for standalone SARS-CoV-2 antigen tests. A season that produces plenty of SARS-CoV-2 and influenza A but little influenza B leaves the submission incomplete.

The multi-line result window introduces a readability question that single-analyte tests do not have. Operators and lay users must correctly assign a faint line to the right analyte, and flex and human factors work typically probes this directly. Because the three viruses do not circulate on the same schedule, combination studies are routinely planned across two or more respiratory seasons.

Analyte: SARS-CoV-2 nucleocapsid antigen and influenza A and B nucleoprotein antigens, reported separately from one specimen
Therapeutic area: Infectious Disease
Specimens: Anterior Nares (Nasal) Swab, Nasopharyngeal (NP) Swab
Intended-use settings: urgent care, physician office, pharmacy, home use, hospital POC, emergency department
Operators: Non-laboratory clinic staff in waived settings; lay users for over-the-counter versions.
Comparator: Typically FDA-cleared or authorized molecular assays for SARS-CoV-2 and for influenza A/B, run on a paired swab, with cycle threshold values recorded.

CLIA Waiver Studies specifics

What Changes for This Assay on This Pathway.

The flex study should include misread scenarios specific to a multi-line window: a faint line in one position, two lines of different intensity, and reads at early and late time points.
Untrained operators at waived sites need enough positives of each analyte in their own hands; low influenza B counts at waived sites are the common gap.
Waived sites that serve both adults and children broaden the age distribution for all three analytes in one enrollment stream.

Endpoints the study must support

Positive and negative percent agreement for each of the three analytes (SARS-CoV-2, influenza A, influenza B) separately, each with 95% confidence intervals
Agreement when the comparator is positive for more than one target (co-infection), reported descriptively
Invalid rate and, for home use, lay user interpretation of a multi-line result window

Enrollment realities

Driven by influenza B positives in most seasons, and by SARS-CoV-2 positives when a wave is absent; realistic plans assume two seasons and a large site footprint. Co-infections are too infrequent to power on and are reported descriptively. Influenza components depend on the fall-to-spring season; SARS-CoV-2 circulates year-round with winter and variant-driven peaks, so enrollment windows differ by analyte within the same study.

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 clia waiver studies →

Same assay, other pathways

Relevant FDA guidance

FAQ

COVID-19 and Influenza A/B Combination Rapid Antigen Test Study Questions.

01 Who operates the covid-19 and influenza a/b combination rapid antigen test in a clia waiver studies study?

Non-laboratory clinic staff in waived settings; lay users for over-the-counter versions.

02 What is the comparator for a covid-19 and influenza a/b combination rapid antigen test study?

Typically FDA-cleared or authorized molecular assays for SARS-CoV-2 and for influenza A/B, run on a paired swab, with cycle threshold values recorded.

03 What drives enrollment for a covid-19 and influenza a/b combination rapid antigen test study?

Let's talk IVD research

Planning a covid-19 and influenza a/b combination 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 clia waiver studies pathway.