Evaluation of Two Rapid Diagnostic Clostridioides difficile Infection Tests in a Chinese Hospital: A Real-world Analysis

Abstract

Background: Accurate diagnosis is essential for optimal prevention and treatment of Clostridioides difficile infection (CDI), and various diagnostic methods must be evaluated. Objectives: We aimed to evaluate and compare the performance of VIDAS C. difficile, C. DIFF QUIK CHEK COMPLETE (QCC), and toxigenic culture (TC) tests for diagnosing CDI and further determine the relationships between clinical factors and the toxin status of patients. Methods: Stool samples were randomly selected for VIDAS or QCC testing according to the manufacturer’s instructions between May 2017 and May 2021, and their performance was compared with that of TC. Clinical information was obtained from the hospital’s electronic medical records. Results: Among 10,897 samples tested, 6,435 and 4,462 samples were assigned for VIDAS and QCC tests, respectively. A total of 9.1% (996/10,897) of the samples were positive for TC. The sensitivity, specificity, positive predictive value, and negative predictive value were 36.6%, 98.6%, 72.1%, and 87.6% for VIDAS toxins A and B testing and 31.6%, 98.2%, 64.0%, and 87.8% for QCC toxin testing, respectively. Our results showed that the clinical data of the patients with positive and detectable toxins were not significantly different. Conclusions: The VIDAS and QCC tests provide rapid screening assays for the laboratory diagnosis of CDI. However, a more specific test to detect free toxins is required to confirm the diagnosis for glutamate dehydrogenase (GDH)-positive and toxin-negative samples. The clinical characteristics and outcomes of this cohort were similar, regardless of the results of toxins A and B testing.