Nucleic acid test for use on the cobas® liat system
?hei=328&fmt=png-alpha)
The cobas® Cdiff is a real-time PCR test that provides accurate, on-demand results in 20 minutes for the detection of toxigenic C. diff in unformed stool specimens from patients suspected of having a C. diff infection (CDI).
The cobas® liat system enables definitive and rapid diagnosis, combining powerful PCR technology with fast turnaround time, 20 minutes or less, allowing sample to answer while patients wait.
| Sensitivity* | Specificity* | |
|---|---|---|
| Cdiff LOD: 45-90 CFU/swab |
93.5 % (95% CI: 88.1% - 96.5%) |
96.4 % (95% CI: 94.6% - 97.7%) |
Rapidly test, triage, and treat your patients with the accuracy, simplicity, and security needed at the point of care.
Traditional diagnostic methods are either time-consuming, labor-intensive or inaccurate when used alone. Testing algorithms have been developed to overcome the shortcomings of individual methods. However, these algorithms are complex and can introduce delays in result reporting, which may adversely impact patient management.
Patient with CDI symptoms
Isolate
Collect sample and send to lab
Process with lab PCR or algo EIA
Positive results: initiate antibiotics
Negative results: admit patient without
isolation and search for symptom etiologies
Patient with CDI symptoms
Collect sample and send to lab
The cobas® liat system provides
accurate results in only 20 minutes
Positive results: isolate and initiate antibiotics
Negative results:, admit patient without
isolation and search for symptom etiologies
Relying on the fast, accurate results from cobas® Cdiff, healthcare professionals are now able to streamline CDI diagnosis to reduce unnecessary isolation, empiric use of antibiotics and to initiate appropriate infection control measures.
The cobas® Cdiff Nucleic acid test for use on the cobas® Liat® System is an automated, qualitative in vitro diagnostic test that uses real-time polymerase chain reaction (PCR) for the detection of the toxin B (tcdB) gene of toxigenic Clostridioides difficile in unformed (liquid or soft) stool specimens obtained from patients suspected of having C. difficile infection (CDI). The cobas® Cdiff Nucleic acid test for use on the cobas® Liat® System is intended for use as an aid in the diagnosis of CDI in humans in conjunction with clinical and epidemiological risk factors.
The cobas® liat system is commercially available in select markets. This product is not registered as an in vitro diagnostic (IVD) in all countries; additional information may be available from your Roche sales representative.
CE-IVD, FDA 510(K) cleared
The cobas® liat system is commercially available in select markets. This product is not registered as an in vitro diagnostic (IVD) in all countries; additional information may be available from your Roche sales representative.
Access package inserts through your country’s Roche Diagnostics Website.
References
COBAS and LIAT are trademarks of Roche.
