Abbott Laboratories said its latest rapid influenza diagnostic test has been granted waived status under CLIA by FDA.
The Abbott Park, IL-based company’s BiaxNow Influenza A&B Card 2 is for use with the Digival diagnostic reader (formerly Alere Reader). Recall, Abbott acquired Alere for $5.3 billion in 2017.
The prevalence of influenza in the U.S. is both high in incident and costly. The burden of influenza is estimated to be 9 million to 36 million cases per year. Influenza and its complications cause as many as 140,000-710,000 hospitalizations and 12,000-56,000 deaths annually. The disease also poses a significant economic burden including medical care expenses and loss of productivity.
Rapid influenza diagnosis can help guide appropriate treatment decisions so that antivirals can be prescribed, and antibiotics withheld, as needed.
Abbott said 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 FDA's new reclassification requirements for RIDTs.