FDA Clears New MRSA Test

Results are available in about an hour

The FDA has given the green light to Xpert MRSA NxG (Cepheid International), a new infection-control test for methicillin-resistant Staphylococcus aureus (MRSA). The molecular assay provides actionable results in approximately one hour.

MRSA has been an infection-prevention challenge for more than a decade, during which time new strains have emerged, often escaping detection by conventional assays, according to Cepheid. The Xpert MRSA NxG test was developed using an extensive library of MRSA strains collected from around the world. Integral to the new test design are updated polymerase chain reaction (PCR) primers and probes that detect both mecA and mecC strains, thereby reducing the frequency of false-positive results due to “empty cassette” strains. The test has been validated for use with both ESwab (Copan) and rayon swabs.

Active surveillance testing using rapid molecular diagnostics, along with standard infection-prevention practices, has been shown to reduce the spread of MRSA in health care settings. MRSA screening programs using on-demand molecular tests helped to:

  • Decrease MRSA infection rates in intensive care units by 62%
  • Reduce isolation days by 44%
  • Reduce overall hospital costs

Xpert MRSA NxG will begin shipping this month.

Cepheid’s GeneXpert systems run proprietary Xpert test cartridges. The Xpert test menu includes health care-associated infections, sexual health, critical infectious disease, and oncology. Twenty tests are available in the United States.

The GeneXpert system’s modular configuration provides the ability to perform from one to 80 Xpert assays at the same time. As a result, the system may be used by customers of all sizes––from point-of-care settings to reference laboratories, Cepheid says.

Source: PR Newswire; December 19, 2016.