Abstract:Objective To explore the diagnostic value of Clostridium difficile (C. difficile) glutamate dehydrogenase (GDH) antigen and toxin detection kit (C. Diff Quik Chek Complete®) in C. difficile infection (CDI). Methods Literatures were screened according to inclusion and exclusion criteria, literatures about CDI diagnosed by C. Diff Quik Chek Complete® were retrieved, quality assessment tool QUADAS for diagnostic accuracy research was used to perform quality evaluation, Meta-DiSc 1.4 software was used to conduct Meta-analysis. Results A total of 8 literatures and 2 852 research subjects were included in the study. The included literatures are of high quality, heterogeneity test showed that there was no threshold effect, but there was non-threshold heterogeneity due to other causes. Meta-analysis was performed with random effect model, results showed that the combined sensitivity, specificity, positive likelihood ratio, negative likelihood ratio, diagnostic dominance ratio (95% CI) of diagnosis of CDI through C. Diff Quik Chek Complete® GDH antigen detection were 0.96 (0.94, 0.98), 0.96 (0.95, 0.97), 20.07 (13.47, 29.92), 0.04 (0.03, 0.07), and 409.35 (168.01, 997.39) respectively; toxin detection for diagnosis of CDI were 0.54 (0.48, 0.59), 1.00 (0.99, 1.00), 64.23 (18.90, 218.33), 0.48 (0.37, 0.62), and 142.74 (40.94, 497.61) respectively. The area under the summary receiver operating characteristic curve (AUCSROC) of GDH antigen and toxin detection for diagnosis of CDI were 0.9877 and 0.9529 respectively, and Q* index were 0.9718 and 0.9228 respectively. Conclusion The sensitivity, specificity, positive likelihood ratio, negative likelihood ratio, and diagnostic dominance ratio of antigen detection by C. Diff Quik Chek Complete® are high, although the sensitivity of toxin detection is not perfect, its specificity is high, which can be used as the primary screening kit for CDI in areas and hospitals lacking professional equipment and conditions.