cobas® Cdiff

Product image for cobas® Cdiff
See Cdiff sooner

The cobas® Cdiff Nucleic acid test for use on the cobas® Liat® System 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 specimen from patients suspected of having a C. diff infection (CDI).

cobas Cdiff:
 
  • Empower faster informed isolation precautions with results in just 20 minutes
  • Reduce the risk of missing an acute infection with enhanced toxigenic C. diff strain coverage
  • Expand C. diff testing beyond the lab with complete cobas® Liat® System connectivity
 
Clostridioides difficile infection (CDI) is the most common healthcare-associated infection worldwide causing high morbidity, mortality and enormous healthcare burden.1
Rapid and accurate identification of C. diff is needed to enable appropriate treatment and prompt isolation precautions to limit the spread of infection.

Related information

cobas Liat System

Assay Manu for cobas Liat System

 

cobas® Cdiff performance

 

Cdiff

 

LOD: 90 CFU/swab

Sensitivity*

cobas CDIFF graph A

(95% CI: 88.1% - 96.5%)

Specificity*

cobas CDIFF graph B

(95% CI: 94.6% - 97.7%)

*Compared to direct culture
CI=confidence intervals. CFU=colony forming units. TCID=tissue culture infective dose

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.2

 

The cobas® Liat® System vs. conventional methods

 

Traditional testing methods
cobas® Cdiff test

 

 

See C. diff sooner

with cobas® Cdiff to transform your patient care pathway.
 
 
 
cobas® Liat® System

 

Rapidly test, triage, and treat your patients with the accuracy, simplicity, and security needed at the point of care.

Learn more
Dra bilden för att rotera
360 degree images list 360 degree images list 360 degree images list 360 degree images list 360 degree images list 360 degree images list 360 degree images list 360 degree images list 360 degree images list 360 degree images list 360 degree images list 360 degree images list 360 degree images list 360 degree images list 360 degree images list 360 degree images list 360 degree images list 360 degree images list 360 degree images list 360 degree images list 360 degree images list 360 degree images list 360 degree images list 360 degree images list 360 degree images list 360 degree images list 360 degree images list 360 degree images list 360 degree images list 360 degree images list
Intended Use

Intended Use

The cobas® SARS-CoV-2 & Influenza A/B Nucleic acid test for use on the cobas® Liat® System (cobas® SARS-CoV-2 & Influenza A/B) is an automated multiplex real-time RT-PCR assay intended for the simultaneous rapid in vitro qualitative detection and differentiation of SARS-CoV-2, influenza A, and influenza B virus RNA in healthcare worker-collected nasopharyngeal and nasal swabs and self-collected nasal swabs (collected on site with instruction by a healthcare professional) from individuals suspected of respiratory viral infection consistent with COVID-19 by their healthcare provider. Clinical signs and symptoms of respiratory viral infection due to SARS-CoV-2 and influenza can be similar.

 

cobas® SARS-CoV-2 & Influenza A/B is intended for use in the detection and differentiation of SARS-CoV-2, influenza A, and influenza B in clinical specimens and is not intended to detect influenza C. SARS-CoV-2, influenza A and influenza B viral RNA is generally detectable in upper respiratory specimens during infection. Positive results are indicative of active infection but do not rule out bacterial infection or co-infection with other pathogens not detected by the test. Clinical correlation with patient history and other diagnostic information is necessary to determine patient infection status. The agent detected may not be the definite cause of disease. 

Negative results do not preclude infection from SARS-CoV-2, influenza A, and/or influenza B and should not be used as the sole basis for diagnosis, treatment or other patient management decisions. Negative results must be combined with clinical observations, patient history, and/or epidemiological information.

 

Negative results obtained from individuals who are not exhibiting clinical signs and symptoms associated with respiratory viral infection at the time of specimen collection should be interpreted with particular caution. Negative results in asymptomatic individuals cannot be used as definitive evidence that an individual has not been exposed to SARS-CoV-2 or influenza viruses and has not been infected with any of these viruses. 

 

cobas® SARS-CoV-2 & Influenza A/B is intended for use by health professionals or trained operators who are proficient in using the cobas® Liat® System at the point of care (POC) or in a clinical laboratory setting.

CE-IVD, FDA Emergency Use Authorization (EUA)

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.

Respiratory

Respiratory tract infections

The non-specific clinical presentation of respiratory infections poses a considerable challenge to the differential diagnosis of pathogens. What impact can a timely and accurate diagnosis have on patient management?

Learn more
Healthcare associated infections

Healthcare-associated infections (HAIs)

From prolonging institutional stays to creating long-term disability, healthcare-associated infections place a tremendous financial burden on health systems.

Learn more
Antimicrobial resistance

Antibiotic resistance and diagnostic testing

In the battle between bacteria and humans, bacteria seem to have the upper hand..

Learn more

References

  1. https://cdifffoundation.org/2014/11/24/c-difficile-infection-cdi-european-clinician-consensus-report-with-recommendations-for-improved-management-of-cdi, accessed on Feb 28, 2021.
  2. Gupta A, et. al. Extraintestinal Clostridium difficile infections: a single-center experience. Mayo Clin Proc. 2014 Nov;89(11):1525-36. doi: 10.1016/j.mayocp.2014.07.012. Epub 2014 Sep 20. PMID: 25245597.
  3. cobas® Cdiff [package insert], Pleasanton, CA; Roche Molecular Systems, Inc., 2021

Specifications

  • Clinical sensitivity*

    93.5 % ( 95% CI 88.1% - 96.5%)

  • Clinical specificity*

    96.4 % ( 95% CI 94.6%-97.7 %)

  • Analytical sensitivity (LoD)

    90 CFU/ Swab

  • Analytical specificity

    No cross-reactivity with 149 closely related organisms or organisms typically found in stool specimens

  • Positive agreement**

    96.0 %

  • Negative agreement**

    99.1 %

  • Assay target region

    C. difficile Toxin B (tcdB)

  • Strain coverage

    37 toxigenic strains tested

  • Sample type

    Unformed stool in cobas® PCR Media

  • Technology

    Real-time PCR

  • Internal control

    Yes

  • Contamination control

    AmpErase

  • Reagents

    Ready-to-use, pre-package reagent assay tube format

  • Time to result

    20 minutes

* Compared to direct culture

** Compared to a commercially available state-of-the-art NAAT

*** All known C. difficile (Toxinotypes 0 ~ XXXI, except non-Toxigenic Toxinotypes XI), including the BI/NAP1/027 hyper-virulent epidemic strain

Related systems

cobas® Liat® System image

cobas® Liat® System

The cobas® Liat® System is a fast, easy-to-use, compact PCR system designed for on-demand testing in point-of-care* settings such as physician clinics, pharmacy, and...

More