Whittier S, Shapiro D S, Kelly W F, Walden T P, Wait K J, McMillon L T, Gilligan P H
Clinical Microbiology Laboratory, University of North Carolina Hospitals, Chapel Hill 27599.
J Clin Microbiol. 1993 Nov;31(11):2861-5. doi: 10.1128/jcm.31.11.2861-2865.1993.
Four commercial enzyme immunoassays (EIAs) for the detection of Clostridium difficile toxin A have recently been developed and marketed (Premier, Meridian Diagnostics, Cincinnati, Ohio; VIDAS, bioMerierux Vitek, Inc., Hazelwood, Mo.; Tox-A-Test, TechLab, Blacksburg, Va.; and Bartels, Baxter Diagnostics, McGaw Park, Ill.). The performances of these EIAs were compared with those of the tissue culture cytotoxicity assay and a definition of C. difficile-associated disease based on both laboratory and clinical criteria for 329 clinical specimens. Two EIAs (Premier and VIDAS) showed good overall agreement (96 and 95%, respectively) with the cytotoxicity assay. However, they were less sensitive (84 and 71%, respectively) than the Bartels (94%) or Tox-A-Test (93%) EIAs. The Bartels and Tox-A-Test assays were much less specific, resulting in poor positive predictive values (56%) of the two assays when compared with that of the cytotoxicity assay. Tox-A-Test had the added drawback of having a significant number of indeterminate results (6.4%). These data indicate that the four EIAs all have specific shortcomings. When using these EIAs, testing strategies that take these shortcomings into consideration should be developed.
最近已开发并上市了四种用于检测艰难梭菌毒素A的商业酶免疫测定法（EIA）（Premier，Meridian Diagnostics公司，俄亥俄州辛辛那提市；VIDAS，bioMerierux Vitek公司，密苏里州黑兹尔伍德市；Tox-A-Test，TechLab公司，弗吉尼亚州布莱克斯堡市；以及Bartels，Baxter Diagnostics公司，伊利诺伊州麦加公园市）。将这些EIA的性能与组织培养细胞毒性测定法以及基于实验室和临床标准对329份临床标本的艰难梭菌相关疾病定义进行了比较。两种EIA（Premier和VIDAS）与细胞毒性测定法总体一致性良好（分别为96%和95%）。然而，它们的敏感性低于Bartels（94%）或Tox-A-Test（93%）EIA（分别为84%和71%）。Bartels和Tox-A-Test测定法的特异性要低得多，与细胞毒性测定法相比，这两种测定法的阳性预测值较差（56%）。Tox-A-Test还有一个额外的缺点，即有大量不确定结果（6.4%）。这些数据表明这四种EIA都有特定的缺点。在使用这些EIA时，应制定考虑到这些缺点的检测策略。
