Ann Lab Med.  2016 Mar;36(2):131-137. 10.3343/alm.2016.36.2.131.

Evaluation of Xpert C. difficile, BD MAX Cdiff, IMDx C. difficile for Abbott m2000, and Illumigene C. difficile Assays for Direct Detection of Toxigenic Clostridium difficile in Stool Specimens

Affiliations
  • 1Department of Laboratory Medicine, Sanggye Paik Hospital, School of Medicine, Inje University, Seoul, Korea. bmshin@unitel.co.kr
  • 2Department of Family Medicine, Haewoondae Paik Hospital, School of Medicine, Inje University, Busan, Korea.
  • 3Department of Internal Medicine, Sanggye Paik Hospital, School of Medicine, Inje University, Seoul, Korea.

Abstract

BACKGROUND
We evaluated the performance of four commercial nucleic acid amplification tests (NAATs: Xpert C. difficile, BD MAX Cdiff, IMDx C. difficile for Abbott m2000, and Illumigene C. difficile) for direct and rapid detection of Clostridium difficile toxin genes.
METHODS
We compared four NAATs on the same set of 339 stool specimens (303 prospective and 36 retrospective specimens) with toxigenic culture (TC).
RESULTS
Concordance rate among four NAATs was 90.3% (306/339). Based on TC results, the sensitivity and specificity were 90.0% and 92.9% for Xpert; 86.3% and 89.3% for Max; 84.3% and 94.4% for IMDx; and 82.4% and 93.7% for Illumigene, respectively. For 306 concordant cases, there were 11 TC-negative/NAATs co-positive cases and 6 TC-positive/NAATs co-negative cases. Among 33 discordant cases, 18 were only single positive in each NAAT (Xpert, 1; Max, 12; IMDx, 1; Illumigene, 4). Positivity rates of the four NAATs were associated with those of semi-quantitative cultures, which were maximized in grade 3 (>100 colony-forming unit [CFU]) compared with grade 1 (<10 CFU).
CONCLUSIONS
Commercial NAATs may be rapid and reliable methods for direct detection of tcdA and/or tcdB in stool specimens compared with TC. Some differences in the sensitivity of the NAATs may partly depend on the number of toxigenic C. difficile in stool specimens.

Keyword

Clostridium difficile; NAAT; Culture; Evaluation; Performance

MeSH Terms

Bacterial Proteins/genetics
Bacterial Toxins/genetics
Clostridium Infections/*diagnosis/microbiology
Clostridium difficile/*genetics/isolation & purification
DNA, Bacterial/*analysis/metabolism
Enterotoxins/genetics
Feces/*microbiology
Humans
*Multiplex Polymerase Chain Reaction
Reagent Kits, Diagnostic
Sensitivity and Specificity
Bacterial Proteins
Bacterial Toxins
DNA, Bacterial
Enterotoxins
Reagent Kits, Diagnostic

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