PMID- 23363829
OWN - NLM
STAT- MEDLINE
DCOM- 20130904
LR  - 20211021
IS  - 1098-660X (Electronic)
IS  - 0095-1137 (Print)
IS  - 0095-1137 (Linking)
VI  - 51
IP  - 4
DP  - 2013 Apr
TI  - Evaluation of an algorithmic approach in comparison with the Illumigene assay for 
      laboratory diagnosis of Clostridium difficile infection.
PG  - 1152-7
LID - 10.1128/JCM.03203-12 [doi]
AB  - The following three diagnostic algorithms were evaluated in comparison with the 
      Illumigene assay as a stand-alone test for Clostridium difficile detection: 
      glutamate dehydrogenase antigen screen (GDH) followed by toxin A/B antigen 
      testing (Tox A/B) with the cell cytotoxicity assay for discordant specimens 
      (algorithm 1), GDH followed by the Illumigene (algorithm 2), and GDH followed by 
      Tox A/B with the Illumigene for discordant specimens (algorithm 3). A total of 
      428 stool specimens submitted to three clinical microbiology laboratories in 
      Manitoba, Canada, for C. difficile detection between June 2011 and April 2012 
      were included in the study. The prevalence of C. difficile in the stool specimens 
      was 14.7% (63/428) based on toxigenic culture (microbiologic reference standard). 
      The sensitivity and specificity of the Illumigene for C. difficile detection were 
      73.0% and 99.7%, respectively. The corresponding sensitivities and specificities 
      were 65.1% and 100.0% for algorithm 1, 68.3% and 100.0% for algorithm 2, and 
      69.8% and 100.0% for algorithm 3. Using algorithm 1, a cell cytotoxicity assay 
      was required for toxin detection in 37% of positive tests, prolonging turnaround 
      time. However, the predictive value of a positive test based on a clinical 
      reference standard (all tests positive or cytotoxigenic culture positive and 
      clinical disease on chart review) was slightly higher with algorithm 1 than with 
      the Illumigene assay as a stand-alone test or as part of an algorithm (algorithms 
      2 and 3). Based on a reduction in turnaround time, simplicity, and acceptable 
      sensitivity and specificity, we recommend algorithm 2 (screening with the GDH 
      antigen test and confirmatory testing with the Illumigene).
FAU - Walkty, A
AU  - Walkty A
AD  - Microbiology, Diagnostic Services of Manitoba, University of Manitoba, Manitoba, 
      Canada. awalkty@mts.net
FAU - Lagace-Wiens, P R S
AU  - Lagace-Wiens PR
FAU - Manickam, K
AU  - Manickam K
FAU - Adam, H
AU  - Adam H
FAU - Pieroni, P
AU  - Pieroni P
FAU - Hoban, D
AU  - Hoban D
FAU - Karlowsky, J A
AU  - Karlowsky JA
FAU - Alfa, M
AU  - Alfa M
LA  - eng
PT  - Comparative Study
PT  - Evaluation Study
PT  - Journal Article
DEP - 20130130
PL  - United States
TA  - J Clin Microbiol
JT  - Journal of clinical microbiology
JID - 7505564
RN  - 0 (Bacterial Toxins)
RN  - EC 1.4.1.2 (Glutamate Dehydrogenase)
SB  - IM
MH  - Algorithms
MH  - Bacterial Toxins/analysis
MH  - Clinical Laboratory Techniques/*methods
MH  - Clostridioides difficile/*isolation & purification
MH  - Clostridium Infections/*diagnosis
MH  - Feces/microbiology
MH  - Female
MH  - Glutamate Dehydrogenase/analysis
MH  - Humans
MH  - Male
MH  - Manitoba
MH  - Sensitivity and Specificity
PMC - PMC3666773
EDAT- 2013/02/01 06:00
MHDA- 2013/09/05 06:00
PMCR- 2013/10/01
CRDT- 2013/02/01 06:00
PHST- 2013/02/01 06:00 [entrez]
PHST- 2013/02/01 06:00 [pubmed]
PHST- 2013/09/05 06:00 [medline]
PHST- 2013/10/01 00:00 [pmc-release]
AID - JCM.03203-12 [pii]
AID - 03203-12 [pii]
AID - 10.1128/JCM.03203-12 [doi]
PST - ppublish
SO  - J Clin Microbiol. 2013 Apr;51(4):1152-7. doi: 10.1128/JCM.03203-12. Epub 2013 Jan 
      30.