Comparison of TechLab Clostridium difficile Tox-A enzyme immunoassay and bartels prima system Toxin-A EIA

We evaluated the Bartels Clostridium difficile toxin A test and the TechLab Tox-A test to detect C. difficile toxin A in stool. The results were compared with C. difficile cytotoxicity assays. Of the 463 specimens tested 82 (17.7%) tested positive by cytotoxicity assay. The sensitivity, specificity, and positive and negative predictive values of the TechLab EIA were 86.6%, 93.7%, 74.7%, and 97.0%, respectively. For the Bartels Prima EIA, sensitivity, specificity, and positive and negative predictive values were 95.1%, 95.5%, 82.1%, and 98.9%, respectively. The differences in sensitivity were statistically significant. Indeterminate results requiring repeat testing were more common with the TechLab EIA than with the Bartels Prima EIA. Of the two kits, the Bartels EIA is preferable, primarily because of its increased sensitivity.