TECHLAB, Inc., today announced its products meet the updated Clinical Practice Guidelines for Clostridium difficile from The Infectious Disease Society of America (IDSA) and the Society of Healthcare Epidemiology of America (SHEA).

The new recommendations recently published in the journal Clinical Infectious Diseases, emphasize the value of immunoassay toxin testing in accurately identifying Clostridium difficile infection (CDI) and state that multistep algorithm testing is appropriate with or without patient history on all samples due to its high positive predictive value (PPV). The guidelines specifically identify TECHLAB as having nearly identical performance to a gold standard reference method when discussing the advantageous performance of the multistep algorithm.¹

"TECHLAB is pleased to offer highly sensitive and clinically relevant tests in accordance with the IDSA/SHEA C. difficile guidelines," said David Lylerly, Ph.D., Chief Science Officer at TECHLAB. "As noted in the updated recommendations, TECHLAB assays which combine a GDH immunoassay plus toxin immunoassay testing was almost identical in performance to CCNA [cell cytotoxicity neutralization assay], considered a gold standard in C. difficile testing."

Immunoassay toxin testing is clinically important due to findings that patients who were enzyme immunoassay (EIA) toxin positive presented diarrhea of longer duration, exhibited greater CDI-related complications, and suffered increased mortality over toxin negative/PCR positive patients. In line with the recent European C. difficile guidelines, the guidelines note newer EIA tests have improved sensitivity over those examined in older studies.

Molecular testing, which indicates the presence of toxin genes rather than the toxins themselves, exhibits a lower PPV and requires strict adherence to sample acceptance criteria, particularly as the guidelines note that the "great majority of patients with suspected CDI do not have the disease."

"Preanalytical assessment of patients is vitally important to increase the probability or likelihood that the patient has active C. difficile disease," said James Snyder, Ph.D., Professor in the Department of Pathology and Laboratory Medicine and Chief of Microbiology at the University of Louisville Hospital.  "If a patient has a positive toxin test, it is likely that the patient has an active C. difficile infection."

References: 1. Clifford McDonald, Dale N Gerding, Stuart Johnson, Johan S Bakken, Karen C Carroll, Susan E Coffin, Erik R Dubberke, Kevin W Garey, Carolyn V Gould, Ciaran Kelly, Vivian Loo, Julia Shaklee Sammons, Thomas J Sandora, Mark H Wilcox; Clinical Practice Guidelines for Clostridium difficile Infection in Adults and Children: 2017 Update by the Infectious Diseases Society of America (IDSA) and Society for Healthcare Epidemiology of America (SHEA), Clinical Infectious Diseases, , cix1085, doi.org/10.1093/cid/cix1085