Changes in Clostridium difficile toxin A/B detection results using lateral flow immunochromatography
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Abstract
Toxin types A (TcdA) and B (TcdB) of Clostridium or Clostridiodes difficile (C. difficile) are responsible for causing severe diarrhea in patients with CDI (Clostridioides difficile infection), and can lead to fatal outcomes. Detection of glutamate dehydrogenase (GDH) and TcdA/B using lateral flow immunochromatography (IC) is crucial for CDI diagnosis. However, when immediate testing is not possible, fecal samples are typically stored at 4°C until official analysis, sometimes for up to 5 days. This study aimed to determine the critical day—the first day on which IC test results for GDH and TcdA/B begin to deviate from Day 1 results, potentially affecting clinical decision-making. A total of 61 post-analysis fecal samples from patients at Thammasat University Hospital, Pathumtani, Thailand, were divided into five aliquots per sample, stored at 4°C, and tested for GDH and TcdA/B using the IC method from Day 1 to Day 5. The agreement of test results across the 5 days was evaluated using Cohen’s Kappa coefficient. The results identified Day 2 as the critical day. Overall, IC test result patterns between Day 1 and Days 2–5 showed high agreement (almost perfect concordance). However, beginning on Day 2, a 4.90–6.60% increase in negative results was observed, which may lead to missed diagnoses and delayed treatment. In conclusion, GDH and TcdA/B detection using the IC method should be performed as soon as possible to reduce the lethal rate.
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References
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