FDA has granted premarket notification (510(k)) clearance and waived status under the Clinical Laboratory Improvement Amendments of 1988 (CLIA) for the Xpert Flu+RSV Xpress test by Cepheid, Sunnyvale, Calif. The newly cleared test detects influenza A, influenza B, and respiratory syncytial virus (RSV) pathogens from a nasopharyngeal swab, nasal wash, or nasal aspirate specimen.
The test is performed on the company’s GeneXpert Xpress system, a customized system comprising a single test module and a tablet computer, with an ATM-like interface designed specifically for CLIA-waived environments.
The Xpert Flu+RSV Xpress test is the first polymerase chain reaction (PCR) panel test to achieve CLIA-waived status, and the first in a series of reference-quality molecular tests that Cepheid intends to deliver to the point-of-care market over the next several years.
“There are more than 1 billion visits annually to physicians’ offices in the United States and yet, until recently, CLIA-waived testing sites have not had access to the same levels of accuracy found in sophisticated hospital or reference laboratories,” says John Bishop, Cepheid’s chairman and CEO.1 “We believe that point-of-care testing will be well served by the significant step up in accuracy and multiplexing capability of PCR-based molecular assays and are committed to broadening access to these important tests.”
Cepheid’s GeneXpert systems run proprietary Xpert test cartridges. The Xpert test menu spans healthcare-associated infections, sexual health, critical infectious diseases, and oncology, and today offers 23 tests outside the United States, and 18 tests in the United States. Both Cepheid’s Xpert Flu/RSV XC and Xpert Flu+RSV Xpress tests detect and differentiate between influenza A, influenza B, and RSV, in about 1 hour.
“The Flu+RSV Xpress test uses the same design as our lab-based Flu/RSV XC test, which has already shown in several studies to provide performance that meets or exceeds that of other conventional molecular testing run in hospital or reference labs,” adds David Persing, MD, PhD, Cepheid’s chief medical and technology officer.2,3 “Novel design features of this test include high-level multiplexing, redundant target segments, and extended coverage for human and avian influenza strains—a first in the industry for the CLIA-waived market and an important step towards pandemic preparedness.”
Cepheid’s Xpert Flu/RSV XC test has been available for CLIA moderate-complexity customers since November 2014. The Xpert Flu+RSV Xpress test utilizes the same test cartridge as the Xpert Flu/RSV XC test and will be available for customers in CLIA-waived settings in December 2015.
For more information, visit Cepheid.
- National ambulatory medical care survey: 2010 summary tables. Atlanta: Centers for Disease Control and Prevention, 2012. Available at: www.cdc.gov/nchs/data/ahcd/namcs_summary/2010_namcs_web_tables.pdf. Accessed December 10, 2015.
- Popowitch EB, Miller MB. Performance characteristics of Xpert Flu/RSV XC assay. J Clin Microbiol. 2015;53(8):2720–2721; doi: 10.1128/jcm.00972-15.
- Salez N, Nougairede A, Ninove L, Zandotti C, de Lamballerie X, Charrel RN. Prospective and retrospective evaluation of the Cepheid Xpert Flu/RSV XC assay for rapid detection of influenza A, influenza B, and respiratory syncytial virus. Diagn Microbiol Infect Dis. 2015;81(4):256–258; doi: 10.1016/j.diagmicrobio.2015.01.008.