"The combination of GDH immunoassay plus toxin EIA (TECHLAB assay) was almost identical in performance to CCNA.”9
Putting C. difficile to the test.
C. difficile is the most common known cause of healthcare-associated diarrhea in industrialized countries and a significant cause of morbidity and mortality worldwide.1 Patients suffering from C. difficile infection (CDI) need accurate and rapid diagnosis and treatment. The demands for C. difficile testing have continued to evolve over the last several years. While the need for highly accurate detection of the organism is clear, there is a renewed focus on the detection of the toxins that cause the disease.
The 2017 IDSA/SHEA Guidelines Underscore the Importance of Accurate C. difficile Diagnosis.
Toxin genes in toxigenic C. difficile may be unexpressed. Patients colonized with these strains of C. difficile may be carriers. If toxin is not present, these patients likely do not have CDI and should not be treated.
Colonized C. difficile carriers are 5-10 times more common than patients with active infections in hospitals. When performed alone, Nucleic Acid Amplification Testing (NAAT) will identify carriers, who do not have CDI as well as active infections as positive because molecular tests only detect the toxin gene, not the toxin itself.4 A positive toxin result is necessary to define clinical disease.4-6
Misdiagnosis of CDI in carriers, who may have diarrhea from other causes, can lead to ineffective treatment and increases the risk to the patient of developing true C. difficile diarrhea.7,8 Hence, the new 2017 IDSA/SHEA guidelines recommend algorithm testing that includes glutamate dehydrogenase (GDH) antigen or NAAT as well as a toxin test to confirm active disease, as the method with the highest PPV for detecting CDI.9
C. difficile is the most common cause of Healthcare Associated Diarrhea in industrialized countries.2
According to a study released by the Centers for Disease Control and Prevention (CDC), nearly half a million Americans suffer from C. difficile infections each year.2
The estimated annual economic burden of CDI is approximately $4.8 billion.3
For the best-performing method (i.e. highest PPV and NPV) to detect patients at increased risk for clinically significant C. difficile infection in commonly submitted stool samples, the IDSA/SHEA recommendations specify using a multistep algorithm.9
For the most sensitive method of diagnosis of CDI in stool specimens from patients likely to have CDI based on clinical symptoms, the IDSA/SHEA recommendations include a multistep algorithm for testing.9
Note: A multistep algorithm is defined as GDH plus toxin; GDH plus toxin, arbitrated by NAAT; or NAAT plus toxin.
Recognizing and treating C. difficile faster.
"GDH testing is the initial screening step in 2- and 3-step algorithms that combine it with a toxin test and/or a molecular test for toxin gene detection.
The combination has allowed for rapid results and improved sensitivity compared with toxin EIA testing alone, and can be economical.”9
Infectious Diseases Society of America (IDSA) and Society for Healthcare Epidemiology of America (SHEA). McDonald et. al. Clin Infect Dis 2018, cix1085.
The C. DIFF QUIK CHEK COMPLETE® Test – GDH and Toxin A & B Detection on a Single Cassette.
The C. DIFF QUIK CHECK COMPLETE® test, which combines GDH and toxin A & B assays on a single cassette, satisfies BOTH recommendations outlined in the 2017 IDSA/SHEA Clinical Practice Guidelines for the best-performing AND the most sensitive method for C. difficile testing.9,10
The C. DIFF QUIK CHEK COMPLETE® test:
- Combines GDH and Toxin A & B assays on a single cassette.
- Satisfies the two new C. difficile testing recommendations; for the best-performing AND the most sensitive method for C. difficile testing.9,10
- Out-performs other toxin assays and provides comparable sensitivity and significantly higher PPV when used as part of a multi-step algorithm vs. single-step NAAT.5, 9
- Helps identify patients with active C. difficile infection to reduce overdiagnosis, inappropriate treatment and increased costs.4,10
- Regardless of the use of (or adherence to) initial stool sample submission protocols, standardizes testing protocols and simplifies compliance with the IDSA/SHEA guidelines for C. difficile testing.9,10
Interpreting two-step algorithm results using the C. DIFF QUIK CHEK COMPLETE® test
C. DIFF QUIK CHEK COMPLETE®
Get the complete diagnostic picture with just one test.
The C. DIFF QUIK CHEK COMPLETE® test is the only rapid cassette assay that simultaneously detects both glutamate dehydrogenase (GDH) antigen and toxins A & B of C. difficile in less than 30 minutes. The test detects C. diff antigen, GDH, as a screen for the presence of C. diff and confirms the presence of toxigenic C. diff by detecting toxins A and B in fecal specimens.
The C. DIFF QUIK CHEK COMPLETE® test has been shown by multiple peer-reviewed studies from N. America, Europe and Asia to be an extremely effective tool to detect CDI.7-12
Quotes from the 2017 IDSA/SHEA CDI Guidelines9:
"A 2- or 3- stage approach increases the PPV vs one-stage testing.”9
"The great majority of patients with suspected CDI do not have the disease.”9
The C. DIFF CHEK™-60 test is an enzyme immunoassay (ELISA) used as a screening test to detect glutamate dehydrogenase (GDH), an antigen produced by Clostridium difficile in fecal specimens.