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NULEXA™ System Comparison

Data on FDA-Cleared Influenza A/B + SARS-CoV-2 POC Diagnostic Tests

(As of June 16, 2026)

RT-PCR Tests

Platform Technology Respiratory Panel Published Time to Result FDA Clearance DateWebsite Source IFU and Published Sources 
QuidelOrtho™ NULEXA™ SystemRT-PCR

Influenza A & B + SARS-CoV-2
(one cartridge)

6-10 minutesFebruary 13, 2026NULEXA SystemNULEXA Respiratory Test IFU
AMDI™ Fast PCRRT-PCRMini Respiratory Panel: RSV, Influenza A, Influenza B + SARS-CoV-2<10 minutesJune 12, 2026AMDI™ Fast PCRAMDI™ Fast PCR
Biomerieux BIOFIRE® SPOTFIRE®RT-PCRSPOTFIRE R/ST Panel Mini: Influenza A & B + SARS-CoV-2 + RSV + Human rhinovirus
(one cartridge)		15 minutesJune 26, 2024BIOFIRE SPOTFIRE SystemSPOTFIRE R/ST Panel Mini IFU
Baebies FINDER® PlatformRT-PCRInfluenza A & B + SARS- CoV-2
(one cartridge)		~20 minutesMarch 30, 2026FINDER Flu A&B/SARS-CoV-2 TestFINDER Flu A&B/SARS-CoV-2 Test IFU
Cepheid GeneXpert® Systems RT-PCRXpert® Xpress: Influenza A & B + SARS-CoV-2 + RSV
(one cartridge)		25-36 minutesAugust 17, 2023Respiratory Xpert TestsXpert Xpress CoV-2/Flu/RSV plus IFU
Diasorin LIAISON NES®RT-PCRInfluenza A & B + SARS-CoV-2 + RSV
(one cartridge)		15 minutesDecember 23, 2025LIAISON NES Flu, RSV & COVID-19 AssayLIAISON NES Flu A/B, RSV & COVID-19 Test IFU
Roche cobas® liatRT-PCRInfluenza A & B + SARS-COoV-2 + RSV
(one tube)		20 minutesApril 25, 2025cobas SARS-CoV-2, Influenza A/B & RSV Testcobas SARS-CoV-2, Influenza A/B & RSV Test IFU

Data on FDA-Cleared Influenza A/B + SARS-CoV-2 POC Diagnostic Tests

(As of June 16, 2026)

Molecular, but non-RT-PCR Tests

Platform Technology Respiratory Panel Published Time to Result FDA Clearance Date Website Source IFU and Published Source 
Nuclein DASH® Rapid PCR SystemIsothermal NAATInfluenza A & B + SARS-CoV-2
(one cartridge)		15 minutesDecember 20, 2024DASH SARS-CoV-2 & Flu A/B TestDASH SARS-CoV-2 & Flu A/B Test IFU
Abbott ID NOW™Isothermal NAATInfluenza A & B SARS-CoV-2
(2 separate cartridges)		~22 minutes

ID NOW Influenza A& B 2: June 24, 2022

ID NOW SARS-CoV-2: August 10, 2023

ID NOW Flu A&B 2 Test

ID NOW COVID-19 2.0 Test

ID NOW Flu A B 2 Test IFU

ID NOW COVID-19 2.0 IFU

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Patents: quidelortho.com/us/en/patents