What the Cepheid Xpert Flu Test Detects
The Cepheid Xpert Flu assay is a rapid molecular test that detects and differentiates influenza A, influenza A 2009 H1N1, and influenza B viruses in approximately 70 minutes using nasopharyngeal swabs or nasal aspirate-wash specimens. 1
Specific Viral Targets
The Xpert Flu test provides multiplexed PCR detection for three distinct targets:
- Influenza A virus (general detection of all influenza A subtypes) 1
- Influenza A 2009 H1N1 (specific identification of the pandemic H1N1 strain) 1
- Influenza B virus 1
This three-target approach allows clinicians to not only confirm influenza infection but also differentiate between influenza types and identify the specific H1N1 pandemic strain. 1
Test Performance Characteristics
The Xpert Flu assay demonstrates superior sensitivity compared to rapid antigen tests, with performance approaching that of reference RT-PCR methods:
- Influenza A sensitivity: 97.3-100% depending on specimen type, compared to only 62-72% for rapid antigen tests 2, 1
- Influenza B sensitivity: 80.7-100%, substantially higher than the 48-55% sensitivity of rapid antigen tests 2, 3
- Specificity: 100% for all targets (influenza A, H1N1, and influenza B) 2, 1
The American Thoracic Society classifies the Xpert Flu/RSV XC as a multiplex PCR assay with 3 targets for influenza A/B plus respiratory syncytial virus. 4
Approved Specimen Types
The test is validated for use with:
- Nasopharyngeal swabs (preferred specimen for older children and adults) 4, 1
- Nasal aspirate-wash specimens 1
- Mid-turbinate nasal swabs (acceptable alternative) 4
The Infectious Diseases Society of America recommends nasopharyngeal specimens as superior to all other upper respiratory tract specimens for detecting influenza viruses. 4
Clinical Context and Timing
Specimens should be collected as soon as possible after illness onset, preferably within 4 days of symptom onset, when viral shedding is highest. 4, 5
For optimal detection:
- Immunocompetent adults: Collect within 5 days of symptom onset, as viral shedding decreases rapidly after this period 5
- Young children: May shed virus for up to 10 days, extending the detection window 5
- Immunocompromised patients: Can shed virus for weeks to months, allowing for extended testing periods 5
Advantages Over Rapid Antigen Tests
The Xpert Flu assay addresses critical limitations of rapid influenza diagnostic tests (RIDTs):
- Sensitivity is 86-100% versus only 10-70% for RIDTs 6
- Provides results in approximately 70 minutes, bridging the gap between rapid antigen tests (10-20 minutes) and traditional RT-PCR (2+ hours) 1
- Minimal hands-on time with automated result interpretation 1
- Near-absence of non-interpretable results 3
The Infectious Diseases Society of America recommends using rapid molecular assays like Xpert Flu over RIDTs in outpatients to improve detection of influenza virus infection. 4
Clinical Applications
This test is particularly valuable for:
- Point-of-care diagnosis in emergency departments and urgent care settings where rapid, accurate results influence immediate clinical decisions 7
- Hospitalized patients requiring prompt diagnosis for infection control measures and antiviral treatment decisions 4
- High-risk populations including immunocompromised patients, elderly individuals, young children, and pregnant women where accurate diagnosis is critical 4, 5
Important Limitations
- Does not detect other respiratory pathogens beyond influenza A, H1N1, and influenza B 4
- Not approved for testing on bronchoalveolar lavage fluid in most versions, limiting utility in mechanically ventilated patients with lower respiratory tract infections 4
- Influenza B sensitivity may be slightly lower (80.7% in one study) compared to influenza A detection 3
For hospitalized patients, the Infectious Diseases Society of America recommends RT-PCR or other molecular assays as the primary diagnostic test, with the Xpert Flu assay serving as an acceptable rapid molecular option. 4, 6