Considerations in the laboratory diagnosis of antibiotic-associated gastroenteritis.
Clostridium difficile has been shown to be the major cause of antibiotic-associated gastroenteritis in both humans and experimental animals. During the past few years an increasing number of laboratories have attempted to detect, isolate, and identify this organism and its toxin from clinical samples. Direct visualization of C. difficile in patient specimens using immunofluorescent microscopy has been proposed. The major disadvantage of this method was its lack of specificity due to crossreaction with other clostridial species. Attempts to absorb the antisera with crossreacting strains also failed. Laboratory diagnosis of C. difficile in clinical specimens has relied on either culture using one or more selective media or on the detection of specific cytotoxin in stool filtrates. Until recently the cytotoxicity assay was the only procedure available for the routine detection of cytotoxin and, as a result, has limited this test to laboratories with access to tissue culture facilities. As a result, there has been much interest in the development of immunochemical methods for the detection of C. difficile toxins. We originally reported on the detection of C. difficile toxin in stool filtrates using counterimmunoelectrophoresis. We examined 140 fecal specimens submitted for C. difficile toxin assay by counterimmunoelectrophoresis, using both unabsorbed and absorbed antitoxin, tissue culture, and bacterial culture. Using tissue culture assay as the reference method, the sensitivity of counterimmunoelectrophoresis and counterimmunoelectrophoresis-absorbed was 100% and the specificity 63.0% and 77.5%, respectively. Enzyme immunosorbent assays for the detection of toxin A from C. difficile have also been reported, however, at the present time they do not appear to be as sensitive as the cytotoxicity assay for toxin B (cytotoxin).(ABSTRACT TRUNCATED AT 250 WORDS)