FDA Enabling New Point-of-Care Tests for Ebola Outbreak, Flu Season

Several recent U.S. Food and Drug Administration (FDA) actions are bringing point-of-care (POC) infectious disease tests closer to patient care. These recent regulatory wins are enabling more rapid diagnosis and clinical decision-making—empowering clinicians to improve antibiotic stewardship and enabling public health authorities to improve outbreak responses.

Rapid, Molecular Flu Testing
The 2017-2018 flu season was severe, with the highest number of cases of influenza-associated illness since the 2009 H1N1 pandemic, when an estimated 60 million people were sick with influenza, according to the U.S. Centers for Disease Control and Prevention.

Earlier this year the FDA’s new rapid flu test regulations went into full effect. These efforts were aimed at improving the overall quality of flu testing by improving the test performance of antigen-based rapid influenza diagnostic tests. Despite these improvements, many are moving away from antigen-based testing and towards more accurate, nucleic acid-based rapid molecular flu tests that can be used at the POC. These Clinical Laboratory Improvement Amendments-waived tests can generate results in less than 30 minutes and can be used in near-patient testing sites, like doctor’s offices or walk-in, urgent care clinics.

Just in time for flu season, the FDA granted a CLIA waiver to Abbott for its next-generation Influenza A & B 2 and Strep A 2 molecular assays that are run on the ID NOW platform (formerly Alere i). Results are available in five minutes for influenza and two minutes for Strep A, the company says.

Similarly, Cepheid (Sunnyvale, Calif.) was granted clearance and a waiver for its Xpert Xpress Flu/RSV test back in July. The test can be performed in near-patient settings and provides rapid, accurate molecular detection of influenza A and B viruses, and respiratory syncytial virus RNA from patient specimens in 20 minutes.

“Our first-in class multi-module system deals effectively with the surge of tests demanded by a severe flu season and frees up the laboratory to conduct other more complicated tests,” said David Persing, M.D., Ph.D., Cepheid’s chief medical and technology officer.

Available CLIA-Waived, Nucleic Acid-Based Rapid Flu Tests

• Abbott ID Now Influenza A&B 2 (formerly known as Alere i Influenza A&B 2)
• BioMerieux BioFire FilmArray RP EZ
• Cepheid Xpert Flu + RSV Xpress Assay performed on the GeneXpert Xpress System (GXI)
• Cepheid Xpert Xpress Flu Assay performed on the GeneXpert Xpress System (GXII and GXIV)
• Mesa Biotech. Inc. Accula Flu A/Flu B Test performed on the Accula Dock
• Roche Cobas Liat Influenza A/B Assay (formally known as IQuum Liat Influenza A/B Assay)
• Roche Cobas Liat Influenza A/B+RSV Assay (formally known as IQuum Liat Influenza A/B+RSV Assay)

In a recent CAP Today webinar on preparing for the upcoming flu season, Gregory Berry, Ph.D., from Northwell Health Laboratories (Lake Success, N.Y.) emphasized that having redundant testing platforms is key to surviving drastic spikes in demand, including supply shortages, such as occurred last flu season. He said last year’s severe season led to his laboratory running 600 tests per day. Berry also noted unusually high rates of influenza B and RSV seen during the 2017-2018 season, underscoring the importance of having panels. Additionally, laboratories should be communicating with providers and educating about flu testing algorithms.

Ebola Testing for Low-Resource Areas
The FDA announced on Nov. 9 its second emergency use authorization (EUA) for a rapid, fingerstick test for the detection of Ebola virus. The DPP Ebola Antigen System (Chembio Diagnostic Systems; Medford, N.Y.) is notable because it is the first test available under EUA that uses a portable battery-operated reader, which can enable testing in low-resource settings without equipped laboratories.

The latest Ebola outbreak, in the Democrat Republic of the Congo, is proving challenging to control. Unlike previous outbreaks, it is in a densely populated area marked by conflict and regular population movement is complicating identifying and tracking deaths and active chains of transmission. As of Nov. 16, the U.S. Centers for Disease Control and Prevention reports the outbreak has 311 confirmed cases and 171 confirmed deaths.

With this newest EUA, the FDA has now issued a total of 11 Ebola EUAs—nine for nucleic acid tests and two for rapid diagnostic tests.

“Our FDA team of experts in drugs, vaccines and diagnostics continue to collaborate with our federal, international and industry partners to employ our collective expertise, experiences from previous incidents, and resources to assist in the global response to the Ebola outbreak,” said FDA Commissioner Scott Gottlieb, M.D., in a statement. “By authorizing the first fingerstick test with a portable reader, we hope to better arm health care providers in the field to more quickly detect the virus in patients and improve patient outcomes.”

The DPP Ebola Antigen System is used with blood specimens, including capillary fingerstick whole blood, for individuals with signs and symptoms of Ebola. The test detects viral antigens and provides qualitative results in 15 to 20 minutes with the hand-held, battery-operated DPP Micro Reader. The FDA advises that the DPP Ebola Antigen System should be run in facilities, like treatment centers and public health clinics, where patients are likely to be treated.

“Our patented DPP technology continues to serve as a robust platform for the rapid detection of infectious diseases, and we hope to receive support and funding as we pursue additional regulatory approvals for our rapid Ebola test,” said John Sperzel, Chembio’s CEO, in a statement.

Takeaway: The FDA’s recent actions are enabling expansion of POC infectious disease testing, which ultimately assist in efforts aimed at better antibiotic stewardship and outbreak control.