Abstract
Abstract Background Clostridium difficile (C.Diff) is a gram positive anaerobe producing Enterotoxin and Cytotoxin (toxin A and B respectively); more than half of million infection is diagnosed yearly with more than 10% of the cases are in patients over 65 years old. Residents in Long-Term Care Facilities (LTCF) are more prone to have C. Diff infection (CDI) because of their age, the frequent use of antibiotics, fragilities, co-morbidity, and living environment. Diagnosing CDI is based on clinical signs and symptoms as well as laboratory tests; however, the enzyme immunoassays are reliable, the tissue culture cytotoxicity is labor intensive. The nucleic acid amplification tests are becoming more the standard as first step in the diagnosis. The BD MAX™ System is a PCR walkaway instrument that provides the sensitivity, specificity and faster turnaround for the C. diff. Methods The BD MAX™ System is an automated in-vitro diagnostic test for the direct qualitative detection of the C. difficile toxin B gene (tcdB) in human liquid or soft stool specimens from patients suspected of having Clostridium difficile Infection (CDI). Premier Toxins A & B is an enzyme immunoassay for the direct detection of Clostridium difficile toxin A and toxin B in stool samples. We collected data from 5,267 samples were collected from resident in LTCF and were run using the EIA assay, 275 samples were ran using the BD Max molecular assay. We had 31 samples that were run using both assays. Statistical analyses were done using Analyse-it. Results Female accounted for 60% of the patients tested; the positivity rate was 13.2% for female and 17.2 for male using the EIA. The positivity rate was 19.2% for female and 30.6% for male when using the molecular assay. The agreement between the EIA and the PCR was 87% based on 31 samples that were run for both assays. Conclusions The BD Max gave the benefit of a fully automated with high sensitivity and specificity for the presence of toxin B producing C. Diff. The difference between the methods could be due to the lack of the sensitivity in the EIA and the fact that the molecular assay might be picking up colonized specimen or the beginning or end of infection. However, the ability to diagnose CDI early and prevent spreading of the disease to other patients is a huge benefit to the facilities. We have to keep in mind also that C.diff infection can be prevented with appropriate use of antibiotics and implementing antibiotic stewardship and infection control plan to prevent and stop spreading of the infection.
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