FDA CLIA-waives BinaxNOW influenza rapid test

Abbott’s reformulated lateral flow influenza assay has been waived by the FDA under the Clinical Laboratory Improvement Amendments, or CLIA, for use with the company’s camera-based Digival diagnostic test reader, according to a press release.

The assay is intended for use in multiple health care settings, including hospital labs, EDs, physician offices, walk-in clinics and urgent care clinics. When used with the Digival reader — formerly offered by Abbott as the Alere Reader — the rapid influenza test delivers results in seconds, the company said.

Additionally, the Digival reader can be connected to hospital information systems to assist with quality control.

“This flu season, health care providers need objective tests that can provide fast, accurate results to determine the best course of care for patients,” Sharon Bracken, senior vice president of rapid diagnostics at Abbott, said in the release. “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 health care providers' confidence in results by reducing user subjectivity.”

According to the CDC, the proportion of outpatient visits for influenza-like illness in the United States increased to 5.1% — above the national baseline of 2.2% — as of the week ending Feb. 16. The agency also reported 7,922 laboratory-confirmed influenza-related hospitalizations so far this season. During the last week of reporting, seven children died as a result of influenza infection. – by Katherine Bortz

References:

CDC. FluView - Influenza positive tests reported to CDC by U.S. clinical laboratories, 2018-2019 season. https://www.cdc.gov/flu/weekly/weeklyarchives2018-2019/data/whoAllregt_cl07.html. Accessed February 28, 2019.

CDC. FluView: 2018-2019 Influenza season Week 7 ending February 16, 2019. https://www.cdc.gov/flu/weekly/index.htm#S3. Accessed February 28, 2019.

Disclosure: Bracken is an employee of Abbott.