Alere Reader lateral flow assay receives FDA marketing clearance for rapid influenza testing.
Last week, the FDA granted marketing clearance to point-of-care diagnostic manufacturer Alere’s Alere Reader, a diagnostic analyzer that can be used for influenza detection at the point-of-care and in the laboratory setting. The Reader will initially be available for use with the BinaxNOW Influenza A & B Card 2. The Alere Reader is a platform that detects, identifies, and analyzes lateral flow assays to provide a speedy diagnosis. The tests and platform will be available for clinical use in time for next year’s influenza season.
In an interview with The American Journal of Pharmacy Benefits, Jeff Nixon, marketing director, Alere Reader, North America Infectious Disease, said that rapid diagnostics will drastically improve care received for influenza.
AJPB: What is the Alere Reader?
Nixon: The Alere Reader is small bench top analyzer that automatically reads and interprets Alere lateral flow assays, delivering fast and objective results near patient and in laboratory settings. It improves testing workflow and accuracy by automating data transfer and by eliminating operator subjectivity and potential errors.
AJPB: What is the BinaxNOW Influenza A &B Card 2?
Nixon: The Alere BinaxNOW Influenza A & B Card 2 is an in vitro immunochromatographic assay for the qualitative detection of influenza A and B nucleoprotein antigens in nasopharyngeal (NP) swab and nasal swab specimens. It is intended to aid in the rapid differential diagnosis of influenza A and B viral infections. Alere BinaxNOW Influenza A & B Card 2 must be read by the Alere Reader.
AJPB: How do rapid diagnostic systems improve patient care and their outcomes?
Nixon: Rapid diagnostics provide immediate and actionable information, which contributes to clinical, operational, and economical health care outcomes. [It also] helps clinicians make treatment decisions while the patient is still in the office.
AJPB: How can rapid diagnostic tests surpass the current methods used to diagnose influenza?
Nixon: Current rapid diagnostic methods include visual interpretation lateral flow influenza testing, but with the introduction of advanced technology, such as the Alere Reader and the Alere i molecular platform, stronger assay performance can lead to better patient outcomes.
AJPB: What are some consequences of traditional methods?
Nixon: [It can cause] delays in patient treatment, inappropriate use of antibiotics, and inefficiencies in health care setting workflow.
AJPB: How does the Alere Reader platform use technology to enhance care?
Nixon: [It provides] objective assay results, removing subjectivity of visual interpretation; intuitive workflow, supporting ease of use; barcode capabilities, supporting efficient workflow and reduces transcription errors; connectivity capable, supporting efficient workflow and reduces transcription errors; and quality control management and lockout features, leading to risk reduction.
AJPB: Could the rapid diagnostic system (the Reader platform) be used to potentially diagnose other conditions?
Nixon: The Alere Reader will be initially available for use with the BinaxNOW Influenza A & B Card 2, with other lateral flow applications and assays to follow.
AJPB: What should health care providers and patients know about Alere’s rapid diagnostic system?
Nixon: The Alere Reader accurately reads and interprets select Alere lateral flow assays, delivering objective results in any health care setting. The BinaxNOW Influenza A & B Card 2 is the first rapid antigen influenza test to achieve 510(k) clearance as a Class II assay under the new FDA reclassification requirements. When our products provide immediate, actionable information, both clinical and economic health care outcomes can be improved.