Clin Lab. 2020 Apr 1;66(4). doi: 10.7754/Clin.Lab.2019.190713.
Clostridium difficile is an important cause of nosocomial diarrhea and the best standard laboratory method for the diagnosis of C. difficile infection is controversial. In this study, we aimed to investigate the performance of Toxin A + B (Clostridium difficile) DUO kit which detects C. difficile toxin A and B by the immunochromatographic method and C. Diff Quik Chek Complete (QCC) rapid membrane immunoassay kit which determines the presence of glutamate dehydrogenase (GDH) and C. difficile toxin A and B in stool samples, compared with toxigenic culture in the diagnosis of C. difficile infection.
One hundred ninety-three stool samples from patients suspected of having C. difficile infection were included in the study. The performances of two commercial tests were compared with toxigenic culture which was accepted as the reference method.
The sensitivity and specificity of the GDH component of QCC were 94.4% and 97.7%, the sensitivity and specificity of the toxin component were 92.3% and 100%, respectively. The sensitivity and specificity of Toxin A + B (Clostridium difficile) DUO test were found as 53.8% and 87.8%, respectively.
C. Diff Quik Chek Complete test, which is a rapid test with high sensitivity and specificity, can be used alone for the diagnosis of C. difficile infection while Toxin A + B (Clostridium difficile) DUO test cannot be used for the same purpose due to the low sensitivity and specificity of the test.
艰难梭菌是医院获得性腹泻的重要病因，其最佳标准实验室诊断方法仍存在争议。本研究旨在通过免疫层析法检测艰难梭菌毒素 A 和 B 的 Toxin A + B（艰难梭菌）DUO 试剂盒和测定粪便中谷氨酸脱氢酶（GDH）和艰难梭菌毒素 A 和 B 的 C. Diff Quik Chek Complete（QCC）快速膜免疫测定试剂盒，与产毒培养相比，评估其在艰难梭菌感染诊断中的性能。
纳入 193 例疑似艰难梭菌感染的患者粪便样本。将两种商业检测方法的性能与产毒培养进行比较，后者被接受为参考方法。
QCC 的 GDH 组分的灵敏度和特异性分别为 94.4%和 97.7%，毒素组分的灵敏度和特异性分别为 92.3%和 100%。Toxin A + B（艰难梭菌）DUO 检测的灵敏度和特异性分别为 53.8%和 87.8%。
C. Diff Quik Chek Complete 试验是一种具有高灵敏度和特异性的快速检测方法，可单独用于艰难梭菌感染的诊断，而 Toxin A + B（艰难梭菌）DUO 试验由于检测的灵敏度和特异性较低，不能用于相同目的。
