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Multicenter evaluation of the Clostridium difficile TOX A/B TEST
D M Lyerly1, L M Neville, D T Evans
1TechLab, Inc., Corporate Research Center, Blacksburg, Virginia 24060, USA. techlab@bev.net
Journal of Clinical Microbiology
|February 12, 1998
Summary
The TOX A/B TEST accurately detects Clostridium difficile toxins A and B, offering a rapid diagnostic aid for C. difficile infections. This enzyme immunoassay shows high sensitivity and specificity compared to traditional methods.
Area of Science:
- Clinical Microbiology
- Infectious Diseases
- Diagnostic Assays
Background:
- Clostridium difficile is a major cause of hospital-acquired diarrhea.
- Disease severity stems from toxins A and B.
- Current diagnostic methods have limitations.
Purpose of the Study:
- Evaluate the TOX A/B TEST, a new enzyme immunoassay (EIA).
- Compare its performance against the gold standard tissue culture assay.
- Assess diagnostic utility for C. difficile disease.
Main Methods:
- Evaluated 1,152 specimens using the TOX A/B TEST and tissue culture.
- Performed in-house and at four clinical laboratories.
- Resolved discrepant results using toxigenic culture.
Main Results:
- TOX A/B TEST demonstrated 92.2% sensitivity and 100% specificity versus tissue culture.
- Positive and negative predictive values were 100% and 98.6%, respectively.
- Identified two toxin A-negative, toxin B-positive isolates missed by toxin A-specific EIAs.
Conclusions:
- The TOX A/B TEST is a suitable diagnostic aid for C. difficile infections.
- It correlates well with the tissue culture gold standard.
- The test can detect certain toxigenic isolates missed by other assays.