Mattia A R, Doern G V, Clark J, Holden J, Wu L, Ferraro M J
Clinical Microbiology Laboratories, Massachusetts General Hospital, Boston 02114.
Eur J Clin Microbiol Infect Dis. 1993 Nov;12(11):882-6. doi: 10.1007/BF02000416.
Nine hundred forty-five stool specimens from patients suspected of having Clostridium difficile disease were examined using a cell culture cytotoxicity assay (CTA), two enzyme immunoassay (EIA) kits (Cytoclone for toxins A and B; VIDAS for toxin A) and a latex agglutination assay (CDT). One hundred nineteen specimens had positive titers (> or = 90) in the CTA; clinical review of 16 discordant samples and 49 controls supported the significance of 90 as the positive cut-off titer. The performance of the two EIAs and the latex assay was assessed relative to CTA titers of the samples. Sensitivity was < or = 50% for all three assays for the 24 specimens with CTA titers of 90, but it reached 97-100% for the two EIAs and 84% for the latex assay at titers of > or = 2,250. The Cytoclone EIA exhibited higher sensitivity at the lower positive titers. Overall, specificity of the methods ranged from 96.7% (CDT latex assay) to 99.1% (Cytoclone EIA).
采用细胞培养细胞毒性试验（CTA）、两种酶免疫测定（EIA）试剂盒（用于毒素A和B的Cytoclone；用于毒素A的VIDAS）和乳胶凝集试验（CDT），对945份疑似艰难梭菌病患者的粪便标本进行检测。119份标本在CTA中的滴度呈阳性（≥90）；对16份结果不一致的样本和49份对照样本进行临床评估，支持将90作为阳性临界滴度的意义。相对于样本的CTA滴度，评估了两种EIA和乳胶试验的性能。对于CTA滴度为90的24份标本，所有三种检测方法的灵敏度均≤50%，但在滴度≥2250时，两种EIA的灵敏度达到97%-100%，乳胶试验的灵敏度达到84%。Cytoclone EIA在较低的阳性滴度下表现出更高的灵敏度。总体而言，这些方法的特异性范围为96.7%（CDT乳胶试验）至99.1%（Cytoclone EIA）。
