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Evaluation of the VIDAS CDAB Kits for the Detection of the Clostridium difficile Toxins A and B

한동수|신보문|강정옥|최태열
대한임상미생물학회 (Korean Society of Clinical Microbiology)|2008.10|Annals of Clinical Microbiology|제11권 제2호|pp. 107-111

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참고문헌

키워드

PCRToxinsEnzyme immunoassayClostridium difficile

초록

배경: 독소 A는 생성하지 못하고 독소 B만 생성하는 Clostridium difficile 변이주의 유행으로 인하여, 독소 A만 검출하는 진단 키트들의 위음성률이 높아지게 되었다. 이에 C. difficile 독소 A와 독소 B (독소 A/B)를 동시에 검출하는 키트를 새로이 도입하여 이를 평가하고자 하였으며, 독소 A만 검출하는 키트를 사용하였던 이전의 결과와 비교하였다. 방법: 한 대학병원에서 2001년부터 2007년까지 7년간 시행한 5,783건의 대변 독소A 검사 결과를 후향적으로 분석하였고, 독소 A/B를 동시에 검출하는 VIDAS C. difficile Toxin A & B (bioMerieux SA, France; VIDAS CDAB)를 도입한 2008년 1월∼6월 시행한 518건의 대변 독소검사 결과와 비교하였다. 또한 대변검체 102개로 VIDAS CDAB검사와 PCR검사를 동시에 시행하여 민감도, 특이도를 분석하였다. 결과: 2001년부터 2007년까지 독소 A 양성률은 연도순대로 16.3%, 17.8%, 13.9%, 11.4%, 13.8%, 8.2%, 5.8%를 나타내어 점차 감소하는 경향을 보여주었다. 그러나 독소 A/B 검출키트를 도입한 2008년 상반기에는 양성률이 12.1%로 증가되었 다. VIDAS CDAB 키트와 PCR검사의 일치율은 82.4%였다. 독소 A/B 검출키트의 민감도는 PCR법과 비교하여 60.2%, 특이도는 90.5%였다. 결론: 국내에도 C. difficile 변이주의 유행으로 인하여 독소 A만 검출하는 진단키트의 위음성률이 높았던 것으로 추정할 수 있으며, 국내에 새로이 도입된 독소 A/B 검출키트인 VIDAS CDAB의 민감도는 개선되어야 할 것으로 생각되었으나 특이도는 우수하였다.

Abstract

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.

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