QuidelOrtho Announces Availability of QUICKVUE™ Influenza + SARS Test for Professional Use
QuidelOrtho (NASDAQ: QDEL) has launched the QUICKVUE Influenza + SARS Test, a professional-use diagnostic tool that simultaneously detects and differentiates between influenza A, influenza B, and SARS-CoV-2 antigens from a single patient sample. The CLIA-waived, 510(k)-cleared test delivers results in as fast as 10 minutes.
The test is designed for use in physician office laboratories, urgent care centers, emergency departments, pharmacies, and decentralized hospital labs. Key features include triple detection capability, fast results, professional use designation, efficient workflow with easy-to-collect nasal swabs, and cost-effective visual combo testing. The product is available in the United States through QuidelOrtho's existing distribution channels but is not intended for in-home use.
QuidelOrtho ( NASDAQ: QDEL ) ha lanciato il QUICKVUE Influenza + SARS Test, uno strumento diagnostico per uso professionale che rileva e differenzia contemporaneamente antigeni di influenza A, influenza B e SARS-CoV-2 da un singolo campione di paziente. Il test CLIA-waived, 510(k) -cleared, fornisce risultati in soli 10 minuti.
Il test è progettato per l'uso in laboratori di studi medici, centri di assistenza urgente, dipartimenti di emergenza, farmacie e laboratori ospedalieri decentrati. Le principali caratteristiche includono capacità di rilevazione tripla, risultati rapidi, design per uso professionale, flusso di lavoro efficiente con tamponi nasali facili da raccogliere e test visuali di combinazione economici. Il prodotto è disponibile negli Stati Uniti tramite i canali di distribuzione esistenti di QuidelOrtho, ma non è destinato all'uso domestico.
QuidelOrtho (NASDAQ: QDEL) ha lanzado el QUICKVUE Influenza + SARS Test, una herramienta diagnóstica de uso profesional que detecta y diferencia simultáneamente los antígenos de influenza A, influenza B y SARS-CoV-2 a partir de una sola muestra del paciente. La prueba, exenta de CLIA y aprobada 510(k), ofrece resultados en tan rápido como 10 minutos.
La prueba está diseñada para su uso en laboratorios de consultorios médicos, centros de atención urgente, departamentos de emergencia, farmacias y laboratorios hospitalarios descentralizados. Entre sus características se incluyen la capacidad de detección triple, resultados rápidos, designación de uso profesional, flujo de trabajo eficiente con hisopos nasales fáciles de recoger y pruebas de visualización de combinación rentables. El producto está disponible en Estados Unidos a través de los canales de distribución existentes de QuidelOrtho, pero no está destinado para uso en el hogar.
QuidelOrtho (NASDAQ: QDEL)은 QUICKVUE Influenza + SARS Test를 출시했으며, 단일 환자 샘플에서 인플루엔자 A, 인플루엔자 B, 그리고 SARS-CoV-2 항원을 동시에 검출하고 구별하는 전문용 진단 도구입니다. CLIA 면제, 510(k) 승인 테스트로 결과는 최소 10분 내에 제공됩니다.
이 검사는 의사 진료실 실험실, 신속 진료 센터, 응급실, 약국, 분산형 병원 실험실에서 사용하도록 설계되었습니다. 주요 특징으로는 삼중 검출 능력, 빠른 결과, 전문용 사용 지칭, 쉽게 채취할 수 있는 비강 면봉으로의 효율적인 워크플로우, 비용 효율적인 시각적 콤보 테스트가 있습니다. 이 제품은 미국에서 QuidelOrtho의 기존 유통 채널을 통해 구입 가능하지만 가정용으로는 의도되지 않았습니다.
QuidelOrtho (NASDAQ: QDEL) a lancé le QUICKVUE Influenza + SARS Test, un outil diagnostique à usage professionnel qui détecte et différencie simultanément les antigènes de la grippe A, de la grippe B et du SARS-CoV-2 à partir d’un seul échantillon du patient. Le test, exempt de CLIA et approuvé 510(k), fournit des résultats en en aussi peu que 10 minutes.
Le test est conçu pour une utilisation dans les laboratoires des cabinets médicaux, les centres de soins urgents, les services d’urgence, les pharmacies et les laboratoires hospitaliers décentralisés. Ses caractéristiques clés incluent une détection triple, des résultats rapides, une désignation d’utilisation professionnelle, un flux de travail efficace avec des écouvillons nasaux faciles à collecter et des tests visuels en combinaison économiques. Le produit est disponible aux États-Unis par les canaux de distribution existants de QuidelOrtho mais n’est pas destiné à un usage à domicile.
QuidelOrtho (NASDAQ: QDEL) hat den QUICKVUE Influenza + SARS Test eingeführt, ein diagnostisches Werkzeug für den professionellen Einsatz, das gleichzeitig Influenza A-, Influenza B- und SARS-CoV-2-Antigene aus einer einzigen Probe nachweist und differenziert. Der CLIA-verwaltete, 510(k)-freigegebene Test liefert Ergebnisse in so schnell wie 10 Minuten.
Der Test ist konzipiert für die Nutzung in Arztpraxen, Notfallzentren, Notaufnahmen, Apotheken und dezentralen Krankenhauslabors. Zu den Hauptmerkmalen gehören Dreifach-Erkennung, schnelle Ergebnisse, Professional-Use-Bezeichnung, effizienter Arbeitsablauf mit einfach zu entnehmenden Nasenabstrichen und kostengünstige visuelle Kombinations-Tests. Das Produkt ist in den USA über die bestehenden Vertriebswege von QuidelOrtho erhältlich, ist jedoch nicht für den Heimgebrauch bestimmt.
QuidelOrtho (NASDAQ: QDEL) أطلقت اختبار QUICKVUE Influenza + SARS، أداة تشخيصية للاستخدام المهني تكشف وتفرق بين مستضدات الإنفلونزا A والإنفلونزا B وSARS-CoV-2 من عينة مريضة واحدة في الوقت نفسه. الاختبار المعفي من CLIA والمعتمد بموجب 510(k)، يوفر النتائج في بسرعة تصل إلى 10 دقائق.
يُصمَّم الاختبار للاستخدام في مختبرات مكاتب الأطباء ومراكز الرعاية العاجلة وأقسام الطوارئ والصيدليات ومختبرات المستشفيات الموزَّعة. تشمل الميزات الرئيسية القدرة على الكشف الثلاثي، نتائج سريعة، تصنيف الاستخدام المهني، سير عمل فعال مع مسحات أنفية سهلة الجمع، واختبار بصري اقتصادي مدمج. المنتج متاح في الولايات المتحدة من خلال قنوات التوزيع الحالية لـ QuidelOrtho، ولكنه ليس مخصصاً للاستخدام المنزلي.
QuidelOrtho (NASDAQ: QDEL) 已推出 QUICKVUE Influenza + SARS Test，这是一个面向专业使用的诊断工具，可从单一样本中同时检测并区分流感A、流感B和SARS-CoV-2抗原。该测试为CLIA豁免、510(k) 认证，结果在最快10分钟内出具。
该测试设计用于医生办公室实验室、急诊中心、急诊科、药房以及分散的医院实验室。主要特征包括三重检测能力、快速结果、专业使用 designation、与易于采集的鼻拭子配合的高效工作流程，以及具有成本效益的可视化组合测试。该产品可通过 QuidelOrtho 现有分销渠道在美国购买，但不适用于居家使用。
- New test enables rapid differentiation between COVID-19 and flu in 10 minutes
- CLIA-waived and 510(k)-cleared status allows broad professional use across healthcare settings
- Expands QuidelOrtho's respiratory testing portfolio and reinforces market leadership
- Cost-effective solution for healthcare providers during seasonal respiratory surges
- None.
Insights
QuidelOrtho's new triple-detection test strengthens their diagnostic portfolio and market position in the competitive respiratory testing space.
QuidelOrtho's launch of the QUICKVUE Influenza + SARS Test represents a strategic enhancement to their point-of-care diagnostic portfolio. This professional-use immunoassay delivers simultaneous detection of influenza A, influenza B, and SARS-CoV-2 from a single sample in as little as 10 minutes, addressing a critical clinical need to distinguish between these infections that present with similar symptoms.
The test's CLIA-waived status enables widespread deployment across multiple healthcare settings including physician offices, urgent care centers, emergency departments, pharmacies, and decentralized hospital labs. This accessibility is particularly valuable during respiratory illness seasons when rapid differentiation can guide appropriate treatment decisions.
From a technical perspective, this product complements QuidelOrtho's existing SOFIA 2 Flu + SARS Antigen FIA by offering a visual read option that doesn't require an instrument. This dual-approach strategy allows the company to serve different market segments - those requiring instrument-based documentation and those preferring simpler visual interpretation.
The nasal swab collection method balances patient comfort with diagnostic accuracy, while the streamlined workflow addresses healthcare provider needs for efficiency during high-volume testing periods. By focusing on professional settings rather than home use, QuidelOrtho maintains quality control while targeting the healthcare facilities most likely to encounter mixed respiratory infections.
This product launch reinforces QuidelOrtho's position in the competitive respiratory diagnostics market, where multiplexed testing capabilities (detecting multiple pathogens simultaneously) are increasingly valued for their efficiency and cost-effectiveness in clinical decision-making.
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
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
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