Author(s)

Yuping Kang ¹, Shaojin Zhang ¹, Kechao Cheng ¹

Affiliation(s)

¹ School of Medical Technology and Engineering, Gansu Health Vocational College, Lanzhou, Gansu, 730207, China

Corresponding Author

Yuping Kang

ABSTRACT

This clinical validation study comprehensively assesses the diagnostic performance of the Clostridium difficile GDH+Toxin A+Toxin B Combo Rapid Test Cassette (ICD-R635B, Hangzhou Alltest Biotech Co,.Ltd), an in vitro qualitative diagnostic device for simultaneous detection of Clostridium difficile glutamate dehydrogenase (GDH), Toxin A and Toxin B antigens in human fecal specimens. A commercial CERTEST Clostridium difficile GDH+Toxin A+B rapid test kit (CERTEST BIOTEC S.L.) was used as the reference assay for performance benchmarking. A total of 163 archived fecal specimens from patients with suspected Clostridium difficile infection (CDI) were enrolled, including 43 reference-positive and 120 reference-negative samples. The investigational assay yielded robust diagnostic performance: GDH relative sensitivity 97.7% (95% CI: 87.7%–99.9%), specificity 95.0% (95% CI: 89.4%–98.1%), accuracy 95.7% (95% CI: 91.4%–98.3%); Toxin A sensitivity 95.3% (95% CI: 84.2%–99.4%), specificity 97.5% (95% CI: 92.9%–99.5%), accuracy 96.9% (95% CI: 93.0%–99.0%); Toxin B sensitivity 95.3% (95% CI: 84.2%–99.4%), specificity 99.2% (95% CI: 95.4%–99.9%), accuracy 98.2% (95% CI: 94.7%–99.6%). All tests were performed within the validated operating temperature range (2-30°C). Test results were uniformly interpreted via the LF Reader Plus instrument for standardized, objective reading; no manual visual interpretation of test lines was performed per official product specifications, with final positive/negative/invalid results directly displayed on the instrument screen. All cassettes are single-use disposable devices. The investigational kit exhibited high concordance with the reference assay with no obvious cross-reactivity or abnormal invalid rates. This triple-biomarker rapid test provides reliable, fast point-of-care CDI detection for clinical laboratory and bedside screening.

KEYWORDS

Clostridium difficile; CDI; Glutamate Dehydrogenase (GDH); Toxin A; Toxin B; Rapid Test Cassette; Fecal Diagnostic; Point-of-Care Testing

CITE THIS PAPER

Yuping Kang, Shaojin Zhang, Kechao Cheng. Performance Evaluation of Clostridium difficile GDH+Toxin A+Toxin B Combo Rapid Test Cassette (Feces, ICD-R635B) via Clinical Validation. MEDS Clinical Medicine (2026). Vol. 7, No. 3, 9-14. DOI: http://dx.doi.org/10.23977/medsc.2026.070302.

REFERENCES

[1] Bartlett JG. Clostridium difficile: history of its role as an enteric pathogen and the current state of knowledge about the organism. Clin Infect Dis. 1994;18(Suppl 4):S265–S272.
[2] Ramsey L, et al. Fulminant Clostridium difficile: an underappreciated and increasing cause of death and complications. Ann Surg. 2002;235(3):363-372.
[3] Kuijper EJ, Coignard B, Tüll P. Emergence of Clostridium difficile-associated disease in North America and Europe. Clin Microbiol Infect. 2006;12(Suppl 6):2-18.
[4] Lyerly DM, Krivan HC, Wilkins DT. Clostridium difficile: its disease and toxins. Clin Microbiol Rev. 1988;1(1):1-18.
[5] Wilcox MH. Clostridium difficile toxins A and B: biological properties and diagnostic applications. J Med Microbiol. 2003;52(1):1-10.
[6] Willis DH, Kraft JA. Confirmation that the latex-reactive protein of Clostridium difficile is a Glutamate Dehydrogenase. J Clin Microbiol. 1992;30(5):1363-1364.
[7] Crobach MJ, et al. ESCMID data review and recommendations for diagnosing Clostridium difficile infection. Clin Microbiol Infect. 2009;15(12):1053-1066.
[8] Kelly CR, et al. ACG Clinical Guidelines: Prevention, diagnosis, and treatment of Clostridioides difficile infections. Am J Gastroenterol. 2021;116(6):1124–1147.
[9] Burnham CD, Carroll KC. Diagnosis of Clostridium difficile infection: an ongoing conundrum for clinicians and for clinical laboratories. Clin Microbiol Rev. 2013;26(3):604-630.
[10] Sharp SE, et al. Evaluation of the C.Diff Quik Chek Complete Assay, a new glutamate dehydrogenase and A/B toxin combination rapid test assay for rapid diagnosis of Clostridium difficile disease. J Clin Microbiol. 2010;48(6):2083-2089.

Sponsors, Associates, and Links

---

• Journal of Neurobiology and Genetics
  
  
• Medical Imaging and Nuclear Medicine
  
  
• Bacterial Genetics and Ecology
  
  
• Transactions on Cancer
  
  
• Journal of Biophysics and Ecology
  
  
• Journal of Animal Science and Veterinary
  
  
• Academic Journal of Biochemistry and Molecular Biology
  
  
• Transactions on Cell and Developmental Biology
  
  
• Rehabilitation Engineering & Assistive Technology
  
  
• Orthopaedics and Sports Medicine
  
  
• Hematology and Stem Cell
  
  
• Journal of Intelligent Informatics and Biomedical Engineering
  
  
• MEDS Basic Medicine
  
  
• MEDS Stomatology
  
  
• MEDS Public Health and Preventive Medicine
  
  
• MEDS Chinese Medicine
  
  
• Journal of Enzyme Engineering
  
  
• Advances in Industrial Pharmacy and Pharmaceutical Sciences
  
  
• Bacteriology and Microbiology
  
  
• Advances in Physiology and Pathophysiology
  
  
• Journal of Vision and Ophthalmology
  
  
• Frontiers of Obstetrics and Gynecology
  
  
• Digestive Disease and Diabetes
  
  
• Advances in Immunology and Vaccines
  
  
• Nanomedicine and Drug Delivery
  
  
• Cardiology and Vascular System
  
  
• Pediatrics and Child Health
  
  
• Journal of Reproductive Medicine and Contraception
  
  
• Journal of Respiratory and Lung Disease
  
  
• Journal of Bioinformatics and Biomedicine