Content area
Full Text
OBJECTIVE: To compare three Clostridium difficile EIA kits for the detection of C difficile toxins from clinical specimens.
DESIGN: A total of 287 fresh and stored stool specimens were tested using all three assays. Stools with discrepant results were sent to a reference laboratory for tissue cytotoxin assay.
SETTING: Trinity Medical Center, a community hospital with network hospitals
PATIENTS: Patients with diarrhea submitted stools for detection of C difficile toxins
RESULTS: Of the 287 stool specimens, 116 were positive and 171 negative for C difficile toxins. The sensitivity, specificity, and positive and negative predictive values of Meridian EIA assay were 99.1, 97.7, 96.6, and 99.4%; Immuno Card were 100, 98.2, 97.5, and 100%; BioStar OIA assay were 94, 98.8, 98.2, and 96% respectively Immuno Cardato vides the best sensitivity (100%) for C difficile toxins A and B detection. The BioStar OIA rapid test missed seven positive stool specimens possibly due to failure to detect toxin B.
CONCLUSION: Immuno Card has slightly higher predictive values, shorter turnaround time and greater convenience compared to the Meridian EIA Assay ImmunoCard may be cost effective not only in smaller laboratories, but also in high volume laboratories, when used on a STAT basis or single request.
ABBREVIATIONS: C. difficile = Clostridium difficile, EIA = Enzyme Immuno Assay
INDEX TERMS: C. difficile toxins; method comparison
Clin Lab Sci 2009;22(2):81
INTRODUCTION
Clostridium difficile, a spore forming Gram-positive anaerobic bacterium, is the major causative agent of colitis and diarrhea that may occur following antibiotic therapy1. C difficile is acquired primarily in hospitals and chronic care facilities and represents one of the most common worldwide nosocomial infections2. The organism can be cultured from bed rails, toilets and the floors of the rooms of the patients suffering with C. difficile-associated diarrhea, as well as from the hands of health care workers caring for the patients3. Almost all the patients have been treated with antibiotics or chemotherapy within eight weeks prior to the onset of diarrhea. Many antibiotics have been implicated in this process; clindamycin and third generation cephalosporins are the leading antibiotics in most cases4. It is postulated that the administration of broad-spectrum antibiotics causes the disruption of normal gut flora, after which colonization with C difficile occurs by ingestion of spores from...