The Quality Evaluation of Clostridium difficile Toxin A/B Test Kit by Lateral Flow Immunochromatography Method

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Published: Aug 29, 2025
Keywords:
Immunochromatography C. difficile Toxin Feces Real-time PCR Quality

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Kridsada Sirisabhabhorn
Medical Technology Laboratory, Thammasat University Hospital, Pathum Thani 12120
Supaporn Pumpa
Medical Technology Laboratory, Thammasat University Hospital, Pathum Thani 12120
Palakorn Puttaruk
Medical Technology Laboratory, Thammasat University Hospital, Pathum Thani 12120

Abstract

Clostridium (or Clostridiodes) difficile produces both toxins A (TcdA) and B (TcdB), which cause severe diarrhea in patients with C. difficile infection (CDI) and can lead to death. Diagnosis of glutamate dehydrogenase enzymes (GDH) and TcdA/B detection by lateral flow Immunochromatography (IC) test kits requires quality evaluation prior to clinical use. This study aimed to evaluate the performance of an IC test kit by comparing its results with those of real-time polymerase chain reaction (real-time PCR). Methods: A total of 61 fecal post-analysis samples from patients who attended Thammasat University Hospital, Pathum Thani, Thailand, were tested for GDH, TcdA/B using the IC test kit, with results confirmed by real-time PCR. Result: Real-time PCR confirmed that all samples were positive for C. difficile (100.00%). The distribution of toxigenic strains was as follows: TcdA+/TcdB+ (37.70%), TcdA-/TcdB+ (8.20%), and non-toxigenic strains (TcdA-/TcdB-) (54.10%). The IC test kit showed the following performance metrics for TcdA/B detection in CDI cases: sensitivity 50.00%, specificity >99.99%, positive predictive value (PPV) >99.99%, negative predictive value (NPV) 88.89%, and overall accuracy 90.00%. The cycle threshold (Ct) values for TcdA and TcdB were 23.59 and 24.43, respectively. Conclusion: The IC test kit for GDH and TcdA/B detection demonstrated acceptable quality for routine laboratory screening of C. difficile infection. However, confirmation using real-time PCR is recommended for accurate diagnosis.  

Article Details

Issue
Vol.33 No.4 (July-August2025)
Section
Medical Sciences

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