Diagnostic Value of Simple Immune-chromatographic Test for Rapid Detection of Clostridium difficile Infection

*Corresponding Author: Sahar M. Fayed Clinical and Chemical Pathology Department, Faculty of Medicine, Banha University Tel.: 01227154603 saharmohamadfayed@gmail.com Background: Clostridium difficile is a very important cause fo antibiotic-associated diarrhea and pseudomembranous colitis. Diagnosis of C. difficile mainly relies on toxin detection in stool specimens from individuals with suspected disease. Objective: is to introduce to our microbiology laboratory of a simple test that may be rapid, cheap and easily manipulated than conventional methods for effective diagnosis of C. difficile infection. Methodology: Stool samples from sixty eight hospitalized patients developing CDI like symptoms were subjected to culture on CCFA, detection of toxins A and/or B by X/pect test (directly from stool samples and from culture isolates) and Real time PCR for detection of tcdA/ tcdB toxin genes. Results: Toxigenic C. difficile was detected in (22.1%) of suspected cases using tcdA/ tcdB real time PCR which was the gold standard method in our study. The positive rate for the direct X/pect test was 13.2% and for the indirect test was 14.7%. The sensitivity of direct X/pect test was 60%, specificity was 100%, PPV was 100%, and NPV was 89.8% with 91.2% agreement between the direct assay and real time PCR. While, the validity values for the indirect test was 66.7%, 100%, 100% & 91.4% for sensitivity, specificity, PP and NP values respectively, with 92.6% agreement between both assays. Antibiotic intake and recent hospitalization were the most commonly encountered risk factors, followed by number of hospitalization days. Penicillins and cephalosporins were the most frequently associated antibiotics, followed by clindamycin Conclusions: Using X/pect test can combine accurate results with simple procedure that offers results within 20 minutes. Although it is accompanied with low sensitivity and high rate of false-negative results, X/pect test may be of great benefit to practitioners particularly when you need STAT testing or 24 hour/ 7 days coverage. Further, it can be used as a preliminary screening approach allowing patients to be treated early and correctly in order to shorten the duration of symptoms and avoid complications.