艰难梭菌毒素A新型酶免疫测定法的评估
Evaluation of a new enzyme immunoassay for Clostridium difficile toxin A.
作者信息
Vargas S O, Horensky D, Onderdonk A B
机构信息
Department of Pathology, Brigham and Women's Hospital, Harvard Medical School, Boston, MA 02115, USA.
出版信息
J Clin Pathol. 1997 Dec;50(12):996-1000. doi: 10.1136/jcp.50.12.996.
AIM
To evaluate a new enzyme immunoassay (EIA) method for detection of Clostridium difficile toxin by comparing it to cytotoxicity assay. To investigate the nature of false negative and false positive EIA results by evaluating clinical and therapeutic parameters.
METHODS
737 consecutive diarrhoeal specimens collected from patients clinically suspected of having C difficile colitis were tested for the presence of C difficile toxin by EIA for toxin A and by cytotoxicity assay. Clinical data were evaluated in all cases positive by either method.
RESULTS
With the cytotoxicity assay as a gold standard, the specificity of EIA for toxin detection was 99.3% and the sensitivity was 62.2%. No false negative EIA specimens were obtained from patients already being treated for C difficile colitis. Among patients with cytotoxicity positive specimens, those with EIA positive samples had no clinical features distinguishing them from patients with EIA negative samples.
CONCLUSIONS
Although specific, the new EIA method directed against toxin A lacks sensitivity compared to cytotoxicity. False negative EIA tests are not associated with concurrent treatment for C difficile colitis nor with any specific clinical features examined in our study.
目的
通过与细胞毒性试验比较，评估一种检测艰难梭菌毒素的新型酶免疫测定（EIA）方法。通过评估临床和治疗参数来研究EIA假阴性和假阳性结果的本质。
方法
对737例临床怀疑患有艰难梭菌结肠炎患者连续采集的腹泻标本，采用EIA检测毒素A以及细胞毒性试验检测艰难梭菌毒素的存在情况。对两种方法检测为阳性的所有病例的临床数据进行评估。
结果
以细胞毒性试验作为金标准，EIA检测毒素的特异性为99.3%，敏感性为62.2%。从已经接受艰难梭菌结肠炎治疗的患者中未获得EIA假阴性标本。在细胞毒性试验阳性标本的患者中，EIA阳性样本的患者与EIA阴性样本的患者相比没有明显的临床特征。
结论
尽管新型EIA方法具有特异性，但与细胞毒性试验相比，针对毒素A的检测缺乏敏感性。EIA假阴性检测与艰难梭菌结肠炎的同时治疗无关，也与我们研究中检查的任何特定临床特征无关。
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