title: Evaluation of six PCR assays in combination with patient related data for the diagnosis of Clostridium difficile-associated infections.
abstract: BACKGROUND
  The aim of this multicenter study was to establish a diagnostic algorithm using molecular methods for the diagnosis of C. difficile-associated infection (CDI). In addition patient specific data were taken into consideration for the interpretation of the results.
  
  
  METHODS
  We compared the performance of six different commercially available PCR-tests, two toxin immunoassays, and a glutamat-dehydrogenase test by analysing liquid stool specimens from patients with suspected CDI. Toxigenic culture on CLO-agar was used as reference method.
  
  
  RESULTS
  In total 250 stool specimens were collected at two study sites. 77 (30.8%) stool samples were culture-positive for toxigenic C. difficile. 173 (69.2%) specimens showed no growth of C. difficile. As a result, each of the PCR assays tested for C. difficile had a significantly higher sensitivity (94.8% - 100%) and NPV (97.6% - 100%) than the TOX-EIA with a sensitivity of 57.1% and NPV of 83.8%. Specificity of the PCR tests was 94.1% to 96.0% and PPV between 86.5% and 91.6%. The analysis of the patient data revealed a significant difference (p-value 0.0202) between toxin-positive and toxin-negative patients regarding prior antibiotic treatment, especially for cephalosporins.
  
  
  CONCLUSIONS
  Our findings support the recommendation to restrict the use of antibiotics as a cornerstone in the prevention of CDI. We conclude that all of the PCR assays evaluated in this study can be applied in a diagnostic algorithm.
authors.forename: U
authors.initials: U
authors.lastname: Eigner
authors.forename: I
authors.initials: I
authors.lastname: Fenner
authors.forename: A
authors.initials: A
authors.lastname: Veldenzer
authors.forename: R
authors.initials: R
authors.lastname: Schwarz
authors.forename: K
authors.initials: K
authors.lastname: Oberdorfer
authors.forename: M
authors.initials: M
authors.lastname: Holfelder
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000465:Algorithms; D002648:Child; D002675:Child, Preschool; D016360:Clostridioides difficile / Q000378:metabolism*; D003015:Clostridium Infections / Q000175:diagnosis* / Q000235:genetics / Q000382:microbiology*; D005243:Feces; D005260:Female; D005969:Glutamate Dehydrogenase / Q000032:analysis; D006801:Humans; D007124:Immunoenzyme Techniques / Q000379:methods; D007223:Infant; D008297:Male; D008875:Middle Aged; D016133:Polymerase Chain Reaction / Q000379:methods*; D015203:Reproducibility of Results; D012680:Sensitivity and Specificity; D055815:Young Adult
chemical_list: D005969:Glutamate Dehydrogenase