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What’s the impact of flu test reclassification?
In February 2017, the U.S. Food and Drug Administration issued a final order reclassifying antigen-based RIDTs (rapid influenza virus antigen detection test systems) from Class I into Class II devices. The reclassification to Class II – a higher-risk designation – is intended to improve the quality of testing for influenza.
Microbiologist/Biochemist Sally Hojvat, Ph.D., addressed some of the key points and concerns surrounding the reclassification in a recent webinar “Meeting the Standards: The Impact of Flu Tests Reclassified,” sponsored by Sekisui Diagnostics. Dr. Hojvat spent 12 years with the U.S Food and Drug Administration as the Director of the Division of Microbiology Devices. Among the items Dr. Hojvat discussed:
Reasons behind the reclassification. Class I influenza diagnostics don’t always meet the needs of patients, physicians or public health officials, Dr. Hojvat says. “This was seen in particular during 2009-2010 H1N1 influenza outbreak, where only 61 percent of infected patients with that virus strain were actually diagnosed correctly. There was a need to know how to mitigate or reduce the known risks associated with the poor performance of the Class I RIDTs.” This is due to the viral antigenic changes that occur in circulating strains as the influenza virus evolves. The FDA believes that general controls are not sufficient to reasonably assure what’s known as the safety and effectiveness of the RIDT. By reclassifying them to Class II, that allowed the FDA to institute Special Controls to be applied to the RIDTs, says Dr. Hojvat. One of the added benefits was to try establish and maintain the minimum performance criteria for RIDTs throughout their product life cycle.
Special Controls. The first thing the Special Controls say is that (Class II RIDTs) must have a minimum clinical performance requirement, says Dr. Hojvat. They have to demonstrate that by using currently appropriate and FDA acceptable comparison methods. Second, there is a requirement for annual reactivity testing and results reporting. The third Special Control deals with provision for testing in a declared emergency or potential emergency once viral samples are available. For example, if a new strain comes in like H1N1 and viral samples will be made available.
Implementation date. The final order effective date was February 13, 2017. Special Controls compliance date for devices legally marketed prior to February 13, 2017 is January 12, 2018. “The FDA gave manufacturers a year to come into compliance with those Special Controls,” says Dr. Hojvat.
The implications of the reclassification for manufacturers, distributors, physicians and lab facilities. After January 12, the FDA could take actions, such as pursuing seizure of Influenza RIDTs held by a distributor that do not meet the Special Controls. Although a low FDA priority, distributors should manage their inventory so that they only possess and distribute devices that meet the Special Controls as of the compliance date.
Repertoire readers wishing to view the recording of the webinar, can do so here: http://www.repertoiremag.com/meeting-the-standards-the-impact-of-rapid-flu-test-reclassification-webinar.html. To learn more about the OSOM Ultra Flu test from Sekisui Diagnostics, which meets the new FDA Guidelines, click here: http://go.sekisui-dx.com/flureclass-osom