Cepheid, a Danaher company, has received CE marking under the European Union’s In Vitro Diagnostic Medical Devices Regulation (IVDR) for its Xpert Respiratory Panel, a multiplex PCR test that can detect 13 common viral and bacterial respiratory pathogens from a single nasopharyngeal swab sample in under 60 minutes.
The test is intended to aid in the diagnosis of suspected infectious respiratory tract infections, in conjunction with other clinical and pathological findings.
Common acute respiratory tract infections are often classified as influenza-like illnesses (ILI) because they present with overlapping, non-specific symptoms such as fever, cough and sore throat. These symptoms can be caused by a range of viral and bacterial pathogens, making clinical assessment challenging.
Certain viral infections and bacterial co-infections are also associated with increased disease severity and adverse outcomes, highlighting the importance of identifying the underlying pathogens to support clinical assessment and treatment decisions.
By enabling clinicians to identify multiple viral and bacterial respiratory infections through a single test, the Xpert Respiratory Panel can support informed treatment decisions and responsible antibiotic use.
The panel runs on existing GeneXpert systems, giving healthcare providers the flexibility to select the appropriate diagnostic test for individual patients.
“The Xpert Respiratory Panel further strengthens Cepheid’s respiratory portfolio, enabling clinicians to choose from targeted single-pathogen tests, mid-plex panels, or broader syndromic respiratory panels on the same GeneXpert system,” said Christoph Martinaud, senior director, Medical Affairs EMEA at Cepheid.
The test is designed to maintain the simplicity of existing GeneXpert workflows, requiring less than one minute of hands-on time while delivering on-demand results.
Cepheid said shipments to countries accepting the CE mark are expected to begin in the coming weeks.
13 Respiratory Pathogens Detected by a Single Test
The Xpert Respiratory Panel detects nine viral and four bacterial pathogens.
Viral pathogens:
- Adenovirus
- Human Parainfluenza
- Coronavirus (seasonal)
- SARS-CoV-2
- Influenza A
- Influenza B
- Human Metapneumovirus
- Respiratory Syncytial Virus
- Human Rhinovirus/Enterovirus
Bacterial pathogens:
- Bordetella pertussis
- Bordetella parapertussis
- Mycoplasma pneumoniae
- Chlamydia pneumoniae
Three-Step Testing Workflow
The test uses a simplified three-step workflow:
- Obtain a specimen stored in an appropriate transport medium.
- Transfer the sample into the test cartridge.
- Insert the cartridge into the GeneXpert system and start the test.
Timely identification of respiratory pathogens is particularly important for higher-risk populations, including children, older adults and immunocompromised individuals, who may be more vulnerable to severe infectious diseases.
By helping distinguish between viral and bacterial infections, the test can support clinically informed patient management and antimicrobial stewardship efforts.
