title: Cost-effectiveness of a modified two-step algorithm using a combined glutamate dehydrogenase/toxin enzyme immunoassay and real-time PCR for the diagnosis of Clostridium difficile infection.
abstract: The analytical performance and cost-effectiveness of the Wampole Toxin A/B EIA, the C. Diff. Quik Chek Complete (CdQCC) (a combined glutamate dehydrogenase antigen/toxin enzyme immunoassay), two RT-PCR assays (Progastro Cd and BD GeneOhm) and a modified two-step algorithm using the CdQCC reflexed to RT-PCR for indeterminate results were compared. The sensitivity of the Wampole Toxin A/B EIA, CdQCC (GDH antigen), BD GeneOhm and Progastro Cd RT-PCR were 85.4%, 95.8%, 100% and 93.8%, respectively. The algorithm provided rapid results for 86% of specimens and the remaining indeterminate results were resolved by RT-PCR, offering the best balance of sensitivity and cost savings per test (algorithm ∼US$13.50/test versus upfront RT-PCR ∼US$26.00/test).
authors.affiliation: Section of Infectious Diseases, Department of Medicine, Rush University Medical Center, Chicago, IL, USA. Electronic address: vasoosushilan.shawn@mayo.edu.
authors.forename: Shawn
authors.initials: S
authors.lastname: Vasoo
authors.affiliation: Clinical Microbiology, Department of Pathology, Rush University Medical Center, Chicago, IL, USA.
authors.forename: Jane
authors.initials: J
authors.lastname: Stevens
authors.affiliation: Clinical Microbiology, Department of Pathology, Rush University Medical Center, Chicago, IL, USA.
authors.forename: Lena
authors.initials: L
authors.lastname: Portillo
authors.affiliation: Clinical Microbiology, Department of Pathology, Rush University Medical Center, Chicago, IL, USA.
authors.forename: Ruby
authors.initials: R
authors.lastname: Barza
authors.affiliation: Clinical Microbiology, Department of Pathology, Rush University Medical Center, Chicago, IL, USA.
authors.forename: Debra
authors.initials: D
authors.lastname: Schejbal
authors.affiliation: Clinical Microbiology, Department of Pathology, Rush University Medical Center, Chicago, IL, USA.
authors.forename: May May
authors.initials: MM
authors.lastname: Wu
authors.affiliation: Clinical Microbiology, Department of Pathology, Rush University Medical Center, Chicago, IL, USA.
authors.forename: Christina
authors.initials: C
authors.lastname: Chancey
authors.affiliation: Section of Infectious Diseases, Department of Medicine, Rush University Medical Center, Chicago, IL, USA; Clinical Microbiology, Department of Pathology, Rush University Medical Center, Chicago, IL, USA.
authors.forename: Kamaljit
authors.initials: K
authors.lastname: Singh
mesh_terms: D000465:Algorithms; D001427:Bacterial Toxins / Q000032:analysis* / Q000235:genetics; D019411:Clinical Laboratory Techniques / Q000191:economics / Q000379:methods*; D016360:Clostridioides difficile / Q000201:enzymology / Q000235:genetics / Q000302:isolation & purification*; D003015:Clostridium Infections / Q000175:diagnosis* / Q000191:economics / Q000382:microbiology*; D003362:Cost-Benefit Analysis; D003955:Diagnostic Tests, Routine / Q000191:economics / Q000379:methods; D005969:Glutamate Dehydrogenase / Q000032:analysis* / Q000235:genetics; D006801:Humans; D007124:Immunoenzyme Techniques / Q000191:economics / Q000379:methods; D060888:Real-Time Polymerase Chain Reaction / Q000191:economics / Q000379:methods*; D012680:Sensitivity and Specificity
chemical_list: D001427:Bacterial Toxins; D005969:Glutamate Dehydrogenase