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(HealthNewsDigest.com) – ABBOTT PARK, Ill., (February 27, 2019) Abbott (NYSE: ABT) today announced the availability 1
of its latest rapid influenza diagnostic test (RIDT), BinaxNOW ® Influenza A & B Card 2. The
reformulated test has been granted waived status under the Clinical Laboratory Improvements
Amendments (CLIA) by the U.S. Food and Drug Administration (FDA) for use with Abbott's
DIGIVAL TM diagnostic reader (formerly Alere Reader) for the rapid detection of influenza virus.
The DIGIVAL reader accurately reads and interprets BinaxNOW Influenza A & B Card 2 tests in
seconds, delivering automated, objective results in a broad range of healthcare settings. The
combined platform is available for use in hospital laboratories, emergency rooms, physician
offices, walk-in clinics and urgent care centers throughout the U.S.
This flu season, healthcare providers need objective tests that can provide fast, accurate results
to determine the best course of care for patients," said Sharon Bracken, senior vice president,
Rapid Diagnostics, Abbott. "The BinaxNOW Influenza A & B Card 2 adds to our strong portfolio of rapid flu tests by providing rapid and easy diagnosis, while DIGIVAL enhances healthcare
providers confidence in results by reducing user subjectivity.
The BinaxNOW Influenza A & B Card 2 and DIGIVAL platform take the guesswork out of
interpreting visually-read tests, empowering our staff to give an accurate influenza diagnosis and
put patients on the path to recovery," said Marissa Ciminera, Strategic Sourcing and
Procurement Manager, ProHealth. "We've installed DIGIVAL across our practices as it offers significant improvement over the subjective, visually-read tests we have historically used.
ABOUT BINAXNOW INFLUENZA A & B CARD 2 AND DIGIVAL (FORMERLY ALERE READER)
The BinaxNOW Influenza A & B Card 2 test provides an advancement in lateral-flow testing
technology. The card can be easily used by healthcare staff in physician offices and hospitals. The
card is placed in the camera-based DIGIVAL diagnostic reader for result interpretation, which
removes subjectivity and provides consistency in reading. In addition, the instrument helps with
quality control management and can be connected to the hospital information system. As a Class
II assay, the BinaxNOW Influenza A & B Card 2 complies with the FDAs new reclassification
requirements for RIDTs. Abbott will offer assays for use with both existing Alere Reader
instruments and new DIGIVAL instruments.
In addition to the BinaxNOW Influenza A & B Card 2, Abbott's rapid influenza test portfolio
includes ID NOW, the first CLIA-waived point-of-care molecular platform used for the
qualitative detection of influenza A & B, Strep A and respiratory syncytial virus (RSV).
ABOUT INFLUENZA
Each year, a combination of influenza A and B virus strains circulate within the United States.
The burden of influenza in the United States is currently estimated to be 9 to 36 million cases per
year. The disease and its complications cause as many as 140,000-710,000 hospitalizations and
12,000-56,000 deaths annually. Influenza also poses a significant economic burden including
medical care expenses and loss of productivity. 2 Rapid influenza diagnosis can help guide
appropriate treatment decisions so that antivirals can be prescribed, and antibiotics withheld, as
needed.
ABOUT ABBOTT
Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our
portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses
and products in diagnostics, medical devices, nutritionals and branded generic medicines. Our
103,000 colleagues serve people in more than 160 countries.