Meeting the Standards: Mandatory FDA Reclassification of Rapid Influenza Detection Tests

Meeting the Standards: Mandatory FDA Reclassification of Rapid Influenza Detection Tests

Title: Meeting the Standards: Mandatory FDA Reclassification of Rapid Influenza Detection Tests

Date: Monday, November 6

Time: 1 p.m. ET

Presenters: Sally Hojvat, PhD

Unless otherwise noted, P.A.C.E.™ accreditation will expire six months after the live webinar.

Mandatory FDA Reclassification of RIDTs

Learn the reasons behind the FDA’s recent decision to reclassify rapid serological influenza diagnostic tests (RIDTs) and the impact to your physician office or clinical laboratory in this complimentary, P.A.C.E.-accredited webinar presented by the Fisher Healthcare™ team.

To improve and maintain the overall quality of rapid testing and the reliable diagnosis of influenza, all marketed RIDTs will now be required to meet new minimum performance criteria and annual reactivity testing (using a CDC panel of currently circulating influenza virus strains).

Historically, RIDTs for influenza have shown a significant variability in performance. While they may demonstrate acceptable specificity, they can deliver less-than-optimal sensitivity with respiratory specimens as compared to RT-PCR or viral culture methods.

In some cases (i.e., the H1N1 flu strain in 2009), RIDTs may be unable to detect the virus at all. Therefore, negative RIDT test results should be treated with caution, especially during the community’s peak flu season.

Based on these concerns and in an effort to improve the overall quality of testing for influenza, the FDA began work to reclassify antigen-based RIDTs as Class II devices. The FDA has established certain performance criteria that manufacturers will be required to meet before marketing influenza assays. 

Learning Objectives

This webinar will help you:

  • Learn the details about the FDA reclassification for 2018
  • Understand why the FDA implemented the reclassification
  • Know how to determine whether a specific test meets the reclassification requirements

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This webinar is produced by Whitehat Communications, a provider of continuing education programs in clinical laboratory sciences that has been approved by the ASCLS P.A.C.E. Program. One P.A.C.E. credit hour will be provided for this complimentary, basic-level program.


Presenter

sally-hojvat-17-068-2516

Sally Hojvat, PhD

Sally Hojvat holds a BSc (Hons.) from the University of Wales (UK), an MSc in Microbiology/Food Science from the University of Alberta (Canada), and a PhD in Biochemistry from Loyola University (Chicago, IL). Her post-doctoral work in clinical chemistry at Loyola and in pharmacology at the University of Chicago, as well as certification as a Registered Medical Technologist in Montreal, Canada, led to her long and productive employment (1984 to 2003) with Abbott Laboratories, Diagnostic Division. While at Abbott, she served as Director of Clinical Research and Director of the Medical Affairs Quality System, Compliance, Training and Centralized Specimen Sourcing Program.

In 2003, Dr. Hojvat was recruited by the FDA to serve as the Director of the Division of Microbiology Devices in the Office of In-Vitro Diagnostics and Radiological Health at its Center for Devices and Radiological Health. There she was responsible for the review and safety and effectiveness evaluations of all IVD microbiology devices (reagents, software and instruments) submitted to the FDA for pre-market device clearance/approval/CLIA waiver and emergency use authorization; she also managed pre- and post-market compliance actions associated with IVD microbiology devices. She represented the FDA on human subject protection issues related to the clinical validation of IVDs, was responsible for outreach activities related to IVD infectious disease issues (including emergency responses and antimicrobial resistance). This work involved multiple teams and working groups, including the FDA Commissioner’s Office, other agencies within the U.S. Department of Health and Human Services (CDC/NIH/BARDA), the Department of Homeland Security, the U.S. Department of Defense, and the World Health Organization, and others.

Dr. Hojvat retired from government service in 2015 and continues to assist in international efforts related to the IVD regulations and assessment of related infectious disease. She became a Senior Consultant with Partners in Diagnostics in 2016.