Description
Status COVID-19/Flu A&B is a rapid immunoassay for the simultaneous direct detection and differential diagnosis of SARS-CoV-2, influenza A and influenza B antigens from anterior nasal and nasopharyngeal swab specimens. LifeSign lists it as FDA 510(k) cleared and CLIA waived, with visually read results in 15 minutes.
- Three Results, One Swab – COVID-19, flu A and flu B differentiate in a single run, ending the two-test respiratory workup.
- 510(k) Cleared, CLIA Waived – LifeSign lists FDA 510(k) clearance with CLIA waived status for anterior nasal and nasopharyngeal swabs.
- 28-Month Shelf Life – The long dating from manufacture eases stocking for seasonal respiratory surges.
One Swab for COVID-19 and Flu Differentiation
Respiratory season sends the same symptoms down three different treatment paths, and this assay separates them in one procedure. It detects SARS-CoV-2, influenza A and influenza B antigens simultaneously and differentiates the result, from anterior nasal or nasopharyngeal swab specimens. The manufacturer's published performance for anterior nasal swabs reports COVID-19 PPA of 97.4 percent with NPA of 100 percent, and the instructions carry the full per-analyte, per-specimen data. Results are visually read in 15 minutes. Each box holds 25 tests, and the 28-month shelf life from manufacture supports seasonal stocking. Clinics retire the separate flu test for symptomatic patients when this combo is on the shelf.
Features and Benefits
Published Performance
- COVID-19 Agreement – The manufacturer reports anterior nasal PPA of 97.4 percent and NPA of 100 percent for SARS-CoV-2, with nasopharyngeal figures in the instructions.
- Flu A and B Data – Per-analyte agreement data for influenza A and B is published for both specimen types in the manufacturer's materials.
Workflow Fit
- Two Specimen Options – Anterior nasal swabs suit front-line collection, with nasopharyngeal swabs also cleared for use.
- Visual 15-Minute Read – No instrument is required, and the quarter-hour read fits visit-length decision making.
Product Specifications
Test Details
- Analytes: SARS-CoV-2, influenza A and influenza B antigens
- Specimen: Anterior nasal or nasopharyngeal swab
- Result Time: 15 minutes, visually read
- Regulatory: FDA 510(k) cleared, CLIA waived (per manufacturer)
- Shelf Life: 28 months from date of manufacture
Packaging
- Tests per Box: 25
- Packaging: Sold by the box, each
Browse the full Infectious Disease range, or shop everything from LifeSign.
Why Choose the Status COVID-19/Flu A&B Test
Separate COVID and flu tests double the swabs, the documentation and the wait during the busiest weeks of the year. This combo answers all three analytes from one collection in 15 minutes, with published agreement data behind each result. For respiratory-season throughput, that consolidation is the difference.
- Differential in One Run – The result separates COVID-19, flu A and flu B, pointing treatment and isolation decisions immediately.
- Cleared for Two Swab Types – Anterior nasal and nasopharyngeal collection are both covered, matching clinic preference.
- Season-Ready Dating – A 28-month shelf life lets practices stock ahead of respiratory season without waste pressure.
Frequently Asked Questions
What does this test detect?
It detects and differentiates SARS-CoV-2, influenza A and influenza B antigens from one swab specimen. Results are visually read in 15 minutes.
Is it FDA cleared?
Yes, LifeSign lists the test as FDA 510(k) cleared and CLIA waived for anterior nasal and nasopharyngeal swab specimens. The distributor file's older EUA wording is superseded by the manufacturer's clearance.
What performance does the manufacturer publish?
For anterior nasal swabs it reports COVID-19 PPA of 97.4 percent and NPA of 100 percent. Full per-analyte data for both specimen types is in the instructions for use.
Which swabs can be used?
Anterior nasal and nasopharyngeal swab specimens are both listed. Collection follows the instructions for the chosen specimen type.
How many tests come in a box?
Each box holds 25 tests with a 28-month shelf life from manufacture. Boxes are sold individually.
