Data on FDA-Cleared Influenza A/B + SARS-CoV-2 POC Diagnostic Tests
(As of April 16, 2026)
RT-PCR Tests
| Platform | Technology | Respiratory Panel | Published Time to Result | Website Source | IFU Source |
|---|---|---|---|---|---|
| QuidelOrtho™ NULEXA™ System | RT-PCR | Influenza A & B + SARS-CoV-2 | 6-10 minutes | NULEXA System | NULEXA Respiratory Test IFU |
| Biomerieux BIOFIRE® SPOTFIRE® | RT-PCR | SPOTFIRE R/ST Panel Mini: Influenza A & B + SARS-CoV-2 + RSV + Human rhinovirus (one cartridge) | 15 minutes | BIOFIRE SPOTFIRE System | SPOTFIRE R/ST Panel Mini IFU |
| Baebies FINDER® Platform | RT-PCR | Influenza A & B + SARS- CoV-2 (one cartridge) | ~20 minutes | FINDER Flu A&B/SARS-CoV-2 Test | FINDER Flu A&B/SARS-CoV-2 Test IFU |
| Cepheid GeneXpert® Systems | RT-PCR | Xpert® Xpress: Influenza A & B + SARS-CoV-2 + RSV (one cartridge) | 25-36 minutes | Respiratory Xpert Tests | Xpert Xpress CoV-2/Flu/RSV plus IFU |
| Diasorin LIAISON NES® | RT-PCR | Influenza A & B + SARS-CoV-2 + RSV (one cartridge) | 15 minutes | LIAISON NES Flu, RSV & COVID-19 Assay | LIAISON NES Flu A/B, RSV & COVID-19 Test IFU |
| Roche cobas® liat | RT-PCR | Influenza A & B + SARS-CoV-2 (one cartridge) | 20 minutes | cobas SARS-CoV-2 & Influenza A/B | cobas SARS-CoV-2 & Influenza A/B IFU |
Data on FDA-Cleared Influenza A/B + SARS-CoV-2 POC Diagnostic Tests
(As of April 16, 2026)
Molecular, but non-RT-PCR Tests
| Platform | Technology | Respiratory Panel | Published Time to Result | Website Source | IFU Source |
|---|---|---|---|---|---|
| Nuclein DASH® Rapid PCR System | Isothermal NAAT | Influenza A & B + SARS-CoV-2 (one cartridge) | 15 minutes | DASH SARS-CoV-2 & Flu A/B Test | DASH SARS-CoV-2 & Flu A/B Test IFU |
| Abbott ID NOW™ | Isothermal NAAT | Influenza A & B SARS-CoV-2 (2 separate cartridges) | ~22 minutes |
QuidelOrtho and NULEXA are trademarks of QuidelOrtho Corporation or its affiliates. All rights reserved. Other product or brand names may be claimed as the property of others.
Patents: quidelortho.com/us/en/patents
