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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.
QuidelOrtho (Nasdaq: QDEL) ha lanciato il QUICKVUE Influenza + SARS Test, un test immunologico rapido conforme CLIA con esenzione CLIA (CLIA‑waived), autorizzato tramite 510(k) per uso professionale, che rileva e differenzia antigeni di influenza A, influenza B e SARS‑CoV‑2 da un singolo tampone nasale.
Il test combinato ad interpretazione visiva fornisce risultati in 10 minuti, è progettato per laboratori di studi medici, cure urgent, reparti di emergenza, farmacie e laboratori ospedalieri decentrati, e completa l'offerta del prodotto SOFIA 2 Flu + SARS strumentato di QuidelOrtho come opzione conveniente di point‑of‑care. Il test è disponibile negli Stati Uniti attraverso i canali di distribuzione esistenti ed non è destinato all'uso domestico.
QuidelOrtho (Nasdaq: QDEL) lanzó el QUICKVUE Influenza + SARS Test, un inmunoensayo rápido para uso profesional con exención CLIA y aprobado por 510(k), que detecta y diferencia antígenos de influenza A, influenza B y SARS‑CoV‑2 a partir de un único hisopo nasal.
La prueba combinada de lectura visual ofrece resultados en tan solo 10 minutos, está diseñada para laboratorios de consultas médicas, atención urgente, departamentos de emergencias, farmacias y laboratorios hospitalarios descentralizados, y complementa el producto SOFIA 2 Flu + SARS con instrumentación de QuidelOrtho como una opción rentable de punto de atención. La prueba está disponible en Estados Unidos a través de los canales de distribución existentes y no está destinada para uso en el hogar.
퀴덜오르소(나스닥: QDEL)는 QUICKVUE Influenza + SARS Test를 출시했습니다. 이는 직업적 사용을 위한 CLIA 면제, 510(k) 승인된 신속 면역분석 검사로 단일 비강 면봉에서 인플루엔자 A, 인플루엔자 B 및 SARS‑CoV‑2 항원을 검출하고 구분합니다.
시각적으로 읽는 이 조합 검사는 최소 10분 이내에 결과를 제공하며 의사 진료실 실험실, 바쁜 진료소, 응급실, 약국 및 분산된 병원 실험실을 위해 설계되었고, 비용 효율적인 포인트 애코어 옵션으로 QuidelOrtho의 계측기 SOFIA 2 Flu + SARS 제품을 보완합니다. 이 검사는 미국 내 기존 유통 채널을 통해 이용 가능하며 가정 사용용으로는 의도되지 않음입니다.
QuidelOrtho (Nasdaq : QDEL) a lancé le QUICKVUE Influenza + SARS Test, un immunodosage rapide professionnel, exempt CLIA et autorisé par 510(k), qui détecte et différencie les antigènes de influenza A, influenza B et SARS‑CoV‑2 à partir d’un seul écouvillon nasal.
Le test combiné à lecture visuelle donne des résultats en aussi peu que 10 minutes, est conçu pour les laboratoires de cabinets médicaux, les soins urgents, les services d’urgence, les pharmacies et les laboratoires hospitaliers décentralisés, et complète le produit SOFIA 2 Flu + SARS équipé de QuidelOrtho en tant qu’option économique de point‑of‑care. Le test est disponible aux États‑Unis via les canaux de distribution existants et n’est pas destiné à un usage à domicile.
QuidelOrtho (Nasdaq: QDEL) hat den QUICKVUE Influenza + SARS Test eingeführt, einen CLIA‑gehobenen, 510(k)-geprüften Schnell-Immunoassay für den professionellen Gebrauch, der Influenza A-, Influenza B- und SARS‑CoV‑2‑Antigene aus einem einzigen Nasenabstrich erkennt und differenziert.
Der visuell ablesbare Kombi-Test liefert Ergebnisse in bis zu 10 Minuten, ist konzipiert für Arztpraxen, Notfalldienste, Notaufnahmen, Apotheken und dezentralisierte Krankenhauslabore und ergänzt QuidelOrtho's instrumentierten SOFIA 2 Flu + SARS‑Produkt als kosteneffiziente Point‑of‑Care‑Option. Der Test ist in den USA über bestehende Vertriebskanäle erhältlich und ist NICHT für die häusliche Verwendung bestimmt.
QuidelOrtho (بورصة ناسداك: QDEL) أطلقت QUICKVUE Influenza + SARS Test، وهو اختبار مناعي سريع معفي من CLIA وموثق بـ 510(k) للاستخدام المهني يكتشف ويميز مستضدات الإنفلونزا A وB و SARS‑CoV‑2 من مسحة أنفية واحدة.
يقدم الاختبار ذو القراءة البصرية نتائج في أسرع وقت يصل إلى 10 دقائق، ويُصمم لمختبرات عيادات الأطباء، الرعاية العاجلة، أقسام الطوارئ، الصيدليات ومختبرات المستشفيات الموزعة، ويكمل منتج SOFIA 2 Flu + SARS المجهز بالأجهزة من QuidelOrtho كخيار روتيني فعّال من حيث التكلفة. الاختبار متاح في الولايات المتحدة من خلال قنوات التوزيع الحالية وهو ليس مخصصاً للاستخدام المنزلي.
- 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
- Product is not intended for in‑home use, limiting consumer reach
Insights
QuidelOrtho launched a CLIA‑waived, 510(k)‑cleared rapid triple‑detection antigen test for flu A/B and SARS‑CoV‑2, available in the U.S.
As described, QuidelOrtho expanded its QUICKVUE line with the QUICKVUE Influenza + SARS Test, a visually read, CLIA‑waived, 510(k)‑cleared immunoassay that detects and differentiates influenza A, influenza B and SARS‑CoV‑2 from one nasal swab with results in as fast as 10 minutes. This product adds a non‑instrument, point‑of‑care option alongside the company’s instrumented SOFIA™ 2 offering and targets physician office labs, urgent care, emergency departments, pharmacies and decentralized hospital labs.
The business mechanism is straightforward: a regulatory‑cleared, rapid visual combo test lowers the procedural barrier in decentralized settings by avoiding instrumentation while offering simultaneous triple detection. Dependencies and risks disclosed include reliance on existing distribution channels and appropriate clinical use settings; the release specifically notes availability in the United States and that it is not intended for in‑home use, which limits end markets to professional settings. Watch for uptake signals and channel rollout details over the next quarters, plus any formal adoption metrics or changes to labeled use; the clearance date noted is
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
What is the QUICKVUE Influenza + SARS Test launched by QuidelOrtho (QDEL)?
Is the QuidelOrtho QUICKVUE Influenza + SARS Test available for home use?
How does the QUICKVUE Influenza + SARS Test differ from QuidelOrtho's SOFIA 2 Flu + SARS test?
When will QuidelOrtho's QUICKVUE Influenza + SARS Test deliver results?
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