| Autor: |
Tsukamoto N; Department of Clinical Laboratory, Medical Kouhoukai Takagi Hospital., Funashima Y; Department of Medical Technology and Science, Faculty of Fukuoka Health Care, International University of Health and Welfare. Department of Medical Laboratory Science, Graduate school of Health and Welfare Sciences, International University of Health and Welfare Graduate School., Yoshida N; Department of Clinical Laboratory, Medical Kouhoukai Takagi Hospital., Ishikawa A; Department of Clinical Laboratory, Medical Kouhoukai Takagi Hospital., Narita T; Department of Clinical Laboratory, Medical Kouhoukai Takagi Hospital., Iyonaga S; Department of Clinical Laboratory, Medical Kouhoukai Takagi Hospital., Nakashima H; Department of Clinical Laboratory, Medical Kouhoukai Takagi Hospital., Sato K; Department of Medical Technology and Science, Faculty of Fukuoka Health Care, International University of Health and Welfare. Department of Medical Laboratory Science, Graduate school of Health and Welfare Sciences, International University of Health and Welfare Graduate School., Wakamatsu K; Department of Respiratory Medical, National Hospital Organization Omuta National Hospital., Nagasawa Z; Department of Clinical Laboratory, Medical Kouhoukai Takagi Hospital. Department of Medical Technology and Science, Faculty of Fukuoka Health Care, International University of Health and Welfare. Department of Medical Laboratory Science, Graduate school of Health and Welfare Sciences, International University of Health and Welfare Graduate School., Umemura T; Department of Clinical Laboratory, Medical Kouhoukai Takagi Hospital. Department of Medical Laboratory Science, Graduate school of Health and Welfare Sciences, International University of Health and Welfare Graduate School. |
| Abstrakt: |
For Clostridioides difficile infections, highly sensitive rapid diagnostic test kits are necessary for prompt diagnose and infection control. In this study, we evaluated "Quick Chaser CD GDH/TOX" (evaluation kit), a rapid diagnostic kit for C. difficile , using 65 clinical stool specimens, comparing with GE test immunochromato-CD GDH/TOX "Nissui" (GE test) and TECHLAB C. DIFF QUIK CHEK COMPLETE (QUIK CHEK). The results of the evaluation kit showed a high concordance rate; 100% the positive concordance rate (31/31) and 97.1% the negative concordance rate (33/34) of GDH, 94.1% the positive concordance rate (16/17) and 97.9% the negative concordance rate (47/48) of toxin against GE test, respectively. Also 96.9% the positive concordance rate (31/32) and 97.0% the negative concordance rate (32/33) of GDH, 100% the positive concordance rate (12/12) and 90.6% the negative concordance rate (48/53) of toxin against QUIK CHEK, respectively. Additionally, comparison of discrepancy cases between kits based on Nucleic Acid Amplification test, one false negative each for GDH and toxin in the evaluation kit, two false negatives for GDH and one false negative for toxin in the GE test, one false negative for GDH and six false negatives for toxin in QUIK CHEK, and no false positive cases were observed. Therefore, the detection sensitivity of GDH and toxin of the evaluation kit was equivalent to that of two types of comparative kits. |
