Binax Announces FDA 510(k) Clearance of NOW Influenza A & B Rapid Test for Identification and Differentiation between Flu A and Flu B on One Simple Test
PORTLAND, Maine -- Binax, Inc., a developer of rapid diagnostic tests, announced today that the U.S. Food and Drug Administration (FDA) has granted 510(k) clearance for the NOW(R) Influenza A & B test. This latest test from Binax replaces two individual tests, NOW Flu A and NOW Flu B, and complements the company's portfolio of diagnostic tests for respiratory tract infections.
Influenza infects an estimated 10-20 percent of the U.S. population annually, resulting in 114,000 hospitalizations and 36,000 deaths. The flu is caused by a virus that affects people of all ages -- not just children, the elderly or immunocompromised individuals. In fact, influenza infection can predispose one to a more serious co-infection with Streptococcus pneumoniae or Staphylococcus aureus.
Traditional methods to identify the flu provide results in two to 10 days, whereas rapid tests require only 15 minutes. NOW Influenza A & B is an easy, one-step test that is as simple to read as a pregnancy test. Performance is comparable to NOW Flu A and NOW Flu B tests currently on the market. The advantage of the new test is the ability to identify both flu A and flu B and differentiate between the two using one simple device. "Rapid diagnosis of influenza is critical for patient management during the winter months," says Michael Musgnug, product manager. "A positive result identifies those patients who do not require antibiotics and who should be monitored more closely for secondary infection."
Source: Binax, Inc.
Newsletter
Stay prepared and protected with Infection Control Today's newsletter, delivering essential updates, best practices, and expert insights for infection preventionists.
Reducing Hidden Risks: Why Sharps Injuries Still Go Unreported
July 18th 2025Despite being a well-known occupational hazard, sharps injuries continue to occur in health care facilities and are often underreported, underestimated, and inadequately addressed. A recent interview with sharps safety advocate Amanda Heitman, BSN, RN, CNOR, a perioperative educational consultant, reveals why change is overdue and what new tools and guidance can help.
New Study Explores Oral Vancomycin to Prevent C difficile Recurrence, But Questions Remain
July 17th 2025A new clinical trial explores the use of low-dose oral vancomycin to prevent Clostridioides difficile recurrence in high-risk patients taking antibiotics. While the data suggest a possible benefit, the findings stop short of statistical significance and raise red flags about vancomycin-resistant Enterococcus (VRE), underscoring the delicate balance between prevention and antimicrobial stewardship.
What Lies Beneath: Why Borescopes Are Essential for Verifying Surgical Instrument Cleanliness
July 16th 2025Despite their smooth, polished exteriors, surgical instruments often harbor dangerous contaminants deep inside their lumens. At the HSPA25 and APIC25 conferences, Cori L. Ofstead, MSPH, and her colleagues revealed why borescopes are an indispensable tool for sterile processing teams, offering the only reliable way to verify internal cleanliness and improve sterile processing effectiveness to prevent patient harm.
The Next Frontier in Infection Control: AI-Driven Operating Rooms
Published: July 15th 2025 | Updated: July 15th 2025Discover how AI-powered sensors, smart surveillance, and advanced analytics are revolutionizing infection prevention in the OR. Herman DeBoard, PhD, discusses how these technologies safeguard sterile fields, reduce SSIs, and help hospitals balance operational efficiency with patient safety.
Targeting Uncertainty: Why Pregnancy May Be the Best Time to Build Vaccine Confidence
July 15th 2025New national survey data reveal high uncertainty among pregnant individuals—especially first-time parents—about vaccinating their future children, underscoring the value of proactive engagement to strengthen infection prevention.
