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TheC. DIFF QUIK CHEK COMPLETE ® test

Actionable two-step algorithm results in ~30 minutes

CHOOSING C. DIFFICILE DIAGNOSTICS
A path to better care

C. difficile, the leading cause of nosocomial diarrhea and pseudomembranous colitis, represents a critical challenge in modern healthcare. C. difficile diagnosis is complex, as individuals can carry the bacteria without developing symptoms. Carriers harbor the bacteria without the production of the disease-causing toxins that lead to illness. Unnecessarily treating carriers not only disrupts the body’s natural balance, but can also increase vulnerability to genuine C. difficile infections.

Properly distinguishing between true infections and carriers is crucial to protecting patients from unnecessary treatments and supports antimicrobial stewardship efforts. Rapid and accurate identification of toxigenic C. difficile allows for appropriate treatment when needed, supporting patients as they recover their health, reconnect with loved ones, and reclaim their quality of life.

C. difficile diagnostic testing options

A nuanced understanding of the available tests can help healthcare providers deliver accurate diagnoses, protect patients, and provide the best possible care. By leveraging these diagnostic tools thoughtfully using a multi-step algorithmic approach, healthcare providers can ensure accurate and timely diagnosis for better patient outcomes. This approach not only addresses the immediate medical needs of patients but also allows for a healthcare experience that prioritizes appropriate treatment, recovery, and well-being.

Glutamate Dehydrogenase (GDH): A sensitive screening test
GDH is a protein which all C. difficile bacteria produce, regardless of their toxin-producing ability. Testing for GDH serves as an excellent initial screening marker, providing a starting point for identifying potential infections. However, GDH alone cannot differentiate between harmless carriers and those with toxin-producing strains that cause illness. A follow-up test is essential to ensure patients receive the right treatment and avoid unnecessary interventions.

Toxin test: Distinguishing carrier vs. disease
Toxigenic strains of C. difficile produce toxins A & B proteins, which are directly responsible for the symptoms of the infection. Testing for these toxins offers a closer correlation to the patient’s disease state and clinical outcomes, guiding treatment decisions with greater accuracy. When combined with a sensitive screening test, the specificity of EIA toxin testing plays an important role in diagnosis.

Nucleic Acid Amplification Test (NAAT): Very sensitive toxin gene detection
Molecular testing (NAAT) provides a highly sensitive method to identify whether C. difficile bacteria possess the genes necessary for toxin production. While powerful, NAAT does not indicate whether the toxins are actively present in the patient sample, making it optional part of a multi-step diagnostic algorithm rather than a standalone solution.

TECHLAB produces a panel of in vitro diagnostics for detecting C. difficile and its toxins in fecal specimens from patients suspected of having the disease.

Rapid Test

C. DIFF QUIK CHEK COMPLETE®

Microassay Plates

Tissue Culture Assays

C. DIFF CHEK™- 60
C. DIFFICILE TOX A/B II ™
C. DIFFICILE TOX-B TEST

C. difficile diagnostics details

Product NameCatalog #Suggested CPT Code*Tests/KitAnalyte(s) DetectedFormatTime to ResultFecal Sample Type
C. DIFF QUIK CHEK COMPLETE ®T30525C/30525C, T30550C/30550C, T30525C-J, T30525CM87324 and 8744925 or 50Toxins A&B GDHRapid EIA< 30 minFresh fecal sample (unpreserved) / Cary Blair / C&S
C. DIFF QUIK CHEK ®303908744925GDHRapid EIA< 30 minFresh fecal sample (unpreserved)
TOX A/B QUIK CHEK ®T5033/303948732425Toxins A&BRapid EIA< 30 minFresh fecal sample (unpreserved) / Cary Blair / C&S
C. DIFF CHEK ™ - 60TL5025/30392, 30392B/T5025B8744996GDHMicroplate ELISA1hr, or 30 min
(rapid format)		Fresh fecal sample (unpreserved)
C. DIFFICILE TOX A/B II ™T5015/30397, T5015B/30397B8732496Toxins A&BMicroplate ELISA1hr, or 30 min
(rapid format)		Fresh fecal sample (unpreserved)
C. DIFFICILE TOX-B TESTT50038723096Toxin BTissue Culture24-48hrsFresh fecal sample (unpreserved) / Cary Blair / C&S
Additional C. difficile resources:

Importance of Stool Toxin Testing by J.H. Boone, TECHLAB

Evaluation of Diagnostic Tests for Clostridium difficile Infection by Jonathan Swindells, Nigel Brenwald, Nathan Reading, and Beryl Oppenheim, Journal of Clinical Microbiology

C. DIFF QUIK CHECK COMPLETE® Enzyme Immunoassay Provides a Reliable First-Line Method for Detection of Clostridium difficile in Stool Specimens by Criziel D. Quinn, Susan E. Sefers, Wisal Babiker, Ying He, Romina Alcabasa, Charles W. Stratton, Karen C. Carroll, and Yi-Wei Tang, Journal of Clinical Microbiology

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