Prospective comparison of a commercial multiplex real-time polymerase chain reaction and an enzyme immunoassay with toxigenic culture in the diagnosis of Clostridium difficile–associated infections

Hernández-Rocha, Cristian; Barra-Carrasco, Jonathan; Álvarez-Lobos, Manuel; Paredes-Sabja, Daniel; Guzmán-Durán, Ana María

doi:10.1016/j.diagmicrobio.2012.12.010

Cited by 19 publications

(11 citation statements)

References 38 publications

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“…The superscript b after GenϪ/Xpϩ (4.9%) indicates that one culture-positive specimen had a borderline result using the GenomEra C. difficile assay both on the first test and on retest; therefore, the final molecular result was considered negative. (10,15,(17)(18)(19)(20)(21)(22)(23)(24)(25), we found only 1 study evaluating it with the same algorithm as ours and using toxigenic culture as the gold standard (15). The authors found that the Se, Sp, PPV, and NPV of the algorithm were 86.1%, 97.8%, 88.6%, and 97.2%, respectively.…”

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confidence: 65%

Comparison of GenomEra C. difficile and Xpert C. difficile as Confirmatory Tests in a Multistep Algorithm for Diagnosis of Clostridium difficile Infection

Alcalá¹,

Reigadas²,

Marı́n³

et al. 2015

J Clin Microbiol

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We compared two multistep diagnostic algorithms based on C. Diff Quik Chek Complete and, as confirmatory tests, GenomEra C. difficile and Xpert C. difficile. The sensitivity, specificity, positive predictive value, and negative predictive value were 87.2%, 99.7%, 97.1%, and 98.3%, respectively, for the GenomEra-based algorithm and 89.7%, 99.4%, 95.5%, and 98.6%, respectively, for the Xpert-based algorithm. GenomEra represents an alternative to Xpert as a confirmatory test of a multistep algorithm for Clostridium difficile infection (CDI) diagnosis. R apid diagnosis of Clostridium difficile infection (CDI) is crucial for optimal disease control (1, 2). For this reason, many microbiology laboratories used sensitive algorithms based on enzyme immunoassay (EIA) for detection of glutamate dehydrogenase (GDH) with EIA detection of toxins A and B, followed by a confirmatory test based on toxin A or B gene amplification (3-6).C. Diff Quik Chek Complete (QC) (TechLab, Blacksburg, VA, USA) detects by immunochromatography both GDH and toxins A and B as a single procedure device (4). The real-time PCR assay Xpert C. difficile assay (Xpert) (GeneXpert; Cepheid, Sunnyvale, CA, USA) that detects the toxin B gene (tcdB), binary toxin genes, and tcdC 117-nucleotide (nt) deletion (epidemic 027 ribotype) is frequently used as a confirmatory test because of its speed and good internal validity values (7-11).The new assay, GenomEra C. difficile (GenomEra) (Abacus Diagnostica, Turku, Finland), is a promising amplification system that detects the tcdB gene in approximately 1 h using rapid thermal cycling by means of a multiblock thermal cycler and homogeneous time-resolved fluorescence detection technology using lanthanide chelates which has proved to be resistant to background effects (12). This molecular method has the CE mark but is not cleared at this moment by the FDA.The purpose of this study was to compare the diagnostic accuracy of two algorithms based on QC as the screening test and Xpert or GenomEra as confirmatory tests for the rapid diagnosis of CDI.From October 2012 to March 2013, all loose stool specimens sent to the laboratory of the Hospital General Universitario Gregorio Marañón (Madrid, Spain) for CDI diagnosis were tested in parallel with the direct cytotoxicity assay, toxigenic culture, and the two multistep algorithms evaluated. The gold standard was the combination of direct cytotoxicity assay with stool specimens and cytotoxicity assay with isolates as previously described (13). The multistep algorithm consisted of an initial test, QC, performed according to the manufacturer's recommendations. Specimens positive for both GDH and toxins were considered positive, while specimens negative for both antigens were considered negative. Specimens with uncertain (GDH-positive and toxin-negative) results were tested in parallel using Xpert and GenomEra for confirmation. Xpert was performed according to the manufacturer's recommendations. GenomEra was performed by diluting 1 l of sample in a tube with 1 ml of sample buffer...

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confidence: 65%

Comparison of GenomEra C. difficile and Xpert C. difficile as Confirmatory Tests in a Multistep Algorithm for Diagnosis of Clostridium difficile Infection

Alcalá¹,

Reigadas²,

Marı́n³

et al. 2015

J Clin Microbiol

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“…The sensitivities of QCC from stool and CMB testing were similar in value to those reported in previous studies in which the performance of the QCC was compared to either toxigenic culture or the CCNA. 9,10,16,18,19 The detection level of C. difficile toxin by QCC was relatively lower than by GeneXpert when detecting toxin directly in stool samples. Also, when compared with TC, the detection levels of both QCC and GeneXpert were relatively lower in stool samples compared to the detection levels in CMB using TC as the gold standard.…”

Section: Discussionmentioning

confidence: 97%

Comparative performance of the GeneXpert C. difficile PCR assay and C. diff Quik Chek Complete kit assay for detection of Clostridium difficile antigen and toxins in symptomatic community-onset infections

Jamal

Pauline

Rotimi

2014

International Journal of Infectious Diseases

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“…Eighty-one patients were positive for C. difficile and all positive samples were also positive for toxigenic culture of C. difficile, causing cytophatic effects in monolayers of Vero cells, as described previously [7]. This is a teaching tertiary-level healthcare centre with 450 beds, of which 60 correspond to critical care services.…”

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Predominance of Clostridium difficile ribotypes 012, 027 and 046 in a university hospital in Chile, 2012

et al. 2015

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Prospective comparison of a commercial multiplex real-time polymerase chain reaction and an enzyme immunoassay with toxigenic culture in the diagnosis of Clostridium difficile–associated infections

Cited by 19 publications

References 38 publications

Comparison of GenomEra C. difficile and Xpert C. difficile as Confirmatory Tests in a Multistep Algorithm for Diagnosis of Clostridium difficile Infection

Comparison of GenomEra C. difficile and Xpert C. difficile as Confirmatory Tests in a Multistep Algorithm for Diagnosis of Clostridium difficile Infection

Comparative performance of the GeneXpert C. difficile PCR assay and C. diff Quik Chek Complete kit assay for detection of Clostridium difficile antigen and toxins in symptomatic community-onset infections

Predominance of Clostridium difficile ribotypes 012, 027 and 046 in a university hospital in Chile, 2012

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