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QuidelOrtho (Nasdaq: QDEL) launched the QUICKVUE Influenza + SARS Test, a CLIA‑waived, 510(k)‑cleared rapid immunoassay for professional use that detects and differentiates influenza A, influenza B and SARS‑CoV‑2 antigens from a single nasal swab.

The visually read combo test delivers results in as fast as 10 minutes, is designed for physician office labs, urgent care, emergency departments, pharmacies and decentralized hospital labs, and complements QuidelOrtho's instrumented SOFIA 2 Flu + SARS product as a cost‑effective point‑of‑care option. The test is available in the United States through existing distribution channels and is not intended for in‑home use.

Positive

• 510(k) clearance secured for commercial use
• CLIA‑waived for point‑of‑care professional settings
• Results available in as fast as 10 minutes
• Adds a visual, cost‑effective option to respiratory portfolio

Negative

• Product is not intended for in‑home use, limiting consumer reach

SAN DIEGO, Sept. 22, 2025 /PRNewswire/ -- Building on its leadership in point-of-care diagnostic testing, QuidelOrtho Corporation (Nasdaq: QDEL) ("QuidelOrtho"), a leading global provider of innovative in vitro diagnostic technologies, is expanding its QUICKVUE portfolio with the QUICKVUE Influenza + SARS Test, a CLIA-waived, 510(k)–cleared rapid, easy-to-use immunoassay designed for professional use in physician office laboratories, urgent care centers, emergency departments, pharmacies and decentralized hospital labs.

The QUICKVUE Influenza + SARS Test is designed to deliver rapid, simultaneous detection and differentiation of influenza A, influenza B and SARS-CoV-2 antigens from a single patient sample, providing results in as fast as 10 minutes. This capability can help clinicians distinguish between COVID-19 and seasonal flu infections, which present similar symptoms, enabling timely treatment decisions and improved patient outcomes.

Key Features and Benefits:

• Triple Detection Capability: Differentiates influenza A/B and COVID-19 in one test.
• Fast Results: Clear results available in as fast as 10 minutes at the point of care.
• Professional Use: Designed for CLIA-waived and moderate/high-complexity lab settings.
• Efficient Workflow: Easy-to-collect nasal swab, streamlined processing and clear result window.
• Affordable Access: Cost-effective visual combo test.

"Physician office labs and urgent care centers are on the front lines of respiratory illness diagnosis. With the QUICKVUE Influenza + SARS Test, we're equipping healthcare providers with a reliable, affordable and efficient tool to differentiate between COVID-19 and influenza in minutes," said Tammi Ranalli, PhD, Senior Vice President, Molecular Diagnostics and Point of Care Business Units, QuidelOrtho. "This innovation reflects QuidelOrtho's commitment to supporting healthcare professionals with cost-effective solutions that streamline clinical decisions and help manage seasonal surges in respiratory infections."

The launch of the QUICKVUE Influenza + SARS Test expands QuidelOrtho's portfolio of respiratory solutions, including the SOFIA^™ 2 Flu + SARS Antigen FIA, by offering a visually read option alongside QuidelOrtho's instrumented version and reinforces QuidelOrtho's market leadership in point-of-care respiratory testing. The QUICKVUE Influenza + SARS Test is available in the United States through QuidelOrtho's existing distribution channels and is not intended for in-home use.

About QuidelOrtho Corporation
With expertise spanning clinical chemistry, immunoassay, immunohematology and molecular testing, QuidelOrtho Corporation (Nasdaq: QDEL) is a leading global provider of diagnostic solutions, delivering fast, accurate and reliable results that help improve patient outcomes – from the point of care to hospital, lab to clinic. Building on a legacy of innovation, QuidelOrtho works with healthcare providers to advance diagnostics that connect insights with solutions, defining a clearer path for informed decisions and better care.

For more information, visit www.quidelortho.com and follow QuidelOrtho on LinkedIn, Facebook and X.

Investor Contact:
Juliet Cunningham
Vice President, Investor Relations
IR@QuidelOrtho.com

Media Contact:
D. Nikki Wheeler
Senior Director, Corporate Communications
media@QuidelOrtho.com

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SOURCE QuidelOrtho Corporation

FAQ

What is the QUICKVUE Influenza + SARS Test launched by QuidelOrtho (QDEL)?

A CLIA‑waived, 510(k)‑cleared rapid immunoassay that simultaneously detects influenza A, influenza B and SARS‑CoV‑2 from one nasal swab with results in as fast as 10 minutes.

Is the QuidelOrtho QUICKVUE Influenza + SARS Test available for home use?

No. The test is designed for professional use in physician office labs, urgent care, emergency departments, pharmacies and decentralized hospital labs and is not intended for in‑home use.

How does the QUICKVUE Influenza + SARS Test differ from QuidelOrtho's SOFIA 2 Flu + SARS test?

QUICKVUE is a visually read, cost‑effective combo test for point‑of‑care use, while SOFIA 2 is an instrumented antigen FIA option.

When will QuidelOrtho's QUICKVUE Influenza + SARS Test deliver results?

The test is designed to provide clear results in as fast as 10 minutes from a single nasal swab.

Where can healthcare providers obtain the QUICKVUE Influenza + SARS Test in the U.S.?

The test is available in the United States through QuidelOrtho's existing distribution channels.