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The C. DIFF QUIK CHEK COMPLETE ® test:

A GDH & toxin 2-step C. difficile algorithm in one test – with results in <30 minutes

Understanding C. difficile Infection: Accurate Diagnosis for Better Health and Care

C. difficile infection (CDI) is driven by toxin-mediated disease, where toxigenic strains of C. difficile produce toxins A and B that cause illness. While nucleic acid amplification tests (NAAT) can identify whether a strain has the genes required for toxin production, they cannot determine if these toxins are actively produced in the patient’s gut. Toxins—not just the presence of toxin genes—cause CDI symptoms. When toxins are not actively produced, the patient’s symptoms are likely due to another cause. Misdiagnosing and treating colonized carriers as CDI patients can lead to unnecessary interventions with significant negative consequences.

Supports appropriate isolation and treatment by providing both screening and toxin results at the same time

The C. DIFF QUIK CHEK COMPLETE® test simultaneously provides both the GDH and toxin results of a two-step algorithm in a single test. It improves workflow, speeds turnaround time, and offers significant cost savings over a PCR-first algorithm. The C. DIFF QUIK CHEK COMPLETE® test is a complete stand-alone 2-step C. difficile algorithm in one test.

Why Choose the C. DIFF QUIK CHEK COMPLETE® test?

Rapid clinical decisions are required to properly treat CDI patients, so it is critical to have quick and reliable results for screening and toxin testing. The C. DIFF QUIK CHEK COMPLETE® test consolidates the recommended two-step diagnostic process into a single, comprehensive solution, with results in approximately 30 minutes. By improving workflow, reducing turnaround time, and offering cost savings over PCR-first and PCR-only algorithms, the C. DIFF QUIK CHEK COMPLETE® test helps create a healthcare experience that prioritizes:

  • Efficiency: Supports appropriate isolation and treatment by providing both screening and toxin results at the same time.
  • Safety: Ensuring accurate diagnoses protects patients from unnecessary treatments and potential complications.
  • Trust: Fostering confidence in medical decisions and systems.

Excellence: Streamlined solutions reflect a commitment to innovation and optimal care delivery.

Why does this matter?

Despite numerous prevention efforts, hospital-onset Clostridiodes difficile infection (HO-CDI) remains a leading cause of healthcare-associated infection in the United States, with an estimated incidence of 8.3 cases per 10,000 patient-days.1

What do the guidelines say?

To ensure patients receive appropriate diagnosis and treatment for C. difficile infection, the 2021 American College of Gastroenterology (ACG) Clinical Guidelines2 and the 2018 Infectious Diseases Society of America (IDSA) / Society for Healthcare Epidemiology of America (SHEA) Guidelines3 emphasize the importance of a multistep algorithmic approach comprised of:

  • A Sensitive Screening Test:
    • GDH or Nucleic Acid Amplification Test (NAAT) effectively rules out difficile infection (CDI) with high sensitivity. Studies confirm equivalent clinical sensitivity of both methods in ruling out CDI.4-7
  • A Specific Toxin Test:
    • Toxin enzyme immunoassay (EIA) tests offer excellent clinical specificity, ensuring that diagnoses align with actual
      disease states.

A 2023 update from SHEA/IDSA/APIC announced a proposed modification to the National Healthcare Safety Network’s (NHSN) C. difficile infection reporting guidelines.  In the past, the last test of record defined a C. difficile infection reportable event. The proposed new C. difficile infection event definition includes any positive test and treatment initiated within 2 days of the positive C. difficile test.5

This proposed change is significant because the order of testing in the C. difficile infection testing algorithm no longer impacts whether a positive C. difficile test is a reportable C. difficile infection event.  This change encourages greater clinician discretion and provides laboratories with more flexibility in selecting the algorithm that works best for their specific patient population and workflow.

What do the guidelines say?
To ensure patients receive appropriate diagnosis and treatment for C. difficile infection, the 2021 American College of Gastroenterology (ACG) Clinical Guidelines2 and the 2018 Infectious Diseases Society of America (IDSA) / Society for Healthcare Epidemiology of America (SHEA) Guidelines3 emphasize the importance of a multistep algorithmic approach comprised of:

A Sensitive Screening Test:
GDH or Nucleic Acid Amplification Test (NAAT) effectively rules out difficile infection (CDI) with high sensitivity. Studies confirm equivalent clinical sensitivity of both methods in ruling out CDI.4-7

A Specific Toxin Test: Toxin enzyme immunoassay (EIA) tests offer excellent clinical specificity, ensuring that diagnoses align with actual disease states.

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