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KMID : 0829320080110020107
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Korean Journal of Clinical Microbiology
2008 Volume.11 No. 2 p.107 ~ p.111
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Evaluation of the VIDAS CDAB Kits for the Detection of the Clostridium difficile Toxins A and B
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Kang Jung-Oak
Shin Bo-Moon
Choi Tae-Yeal
Han Dong-Soo
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Abstract
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Background: Since the emergence of variant Clostridium difficile strains that fail to produce detectable toxin A, diagnostic kits targeted to detect toxin A only showed a considerable rate of false negative results. The aim of this study was to evaluate a toxins A and B (toxins A/B) detection kit recently marketed in Korea, and to compare toxin positive rates before and after introduction of the new kit.
Methods: The results of 5,783 toxin A assays performed during the 7-year period from 2001 through 2007 were analyzed and compared them to the toxins A/B assay data of 519 samples obtained from January to June 2008 in a university hospital. An enzyme-linked fluorescent immunoassay for toxins A/B (VIDAS C. difficile Toxin A & B, bioMerieux SA, France: VIDAS CDAB) and PCR for toxin genes A/B were performed directly in 102 stool samples from hospitalized patients.
Results: The positive rates of toxin A assays tended downward annually from 2001 to 2007 (16.3%, 17.8%, 13.9%, 11.4%, 13.8%, 8.2%, and 5.8%, respectively), but increased to 12.1% in 2008 after changing to the toxin A/B detection kit. The concordant rate of the VIDAS CDAB kit with the PCR method was 82.4%. Compared to the PCR method, the sensitivity and specificity of the toxin A/B kit were 60.7% and 90.5% respectively.
Conclusion: Testing kits for C. difficile toxin A only could result in a misdiagnosis more frequently than the testing kit for toxins A/B. The sensitivity of the newly launched toxin A/B detection kit from bio-Merieux SA needs to be improved, but it showed a good specificity. (Korean J Clin Microbiol 2008;11: 107-111)
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KEYWORD
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Clostridium, difficile, Toxins, Enzyme im-munoassay, PCR
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