Comparison of VIDAS CDAB and CDA immunoassay for the detection of Clostridium difficile in a tcdA− tcdB+ C. difficile prevalent area

Shin, Bo-Moon; Lee, Eunjoo; Kuak, Eun-Young; Yoo, Soo Jin

doi:10.1016/j.anaerobe.2009.09.008

Cited by 16 publications

(10 citation statements)

References 26 publications

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“…of Vidas-AB (4)(5)(6)8). In the most complete evaluation of Vidas-AB in the three papers published by Shin et al, the sensitivity (63.3%) and specificity (96.7%) values (compared with toxigenic culture and PCR results for tcdA and tcdB as standards) were similar to those obtained in our study (4)(5)(6).…”

supporting

confidence: 74%

“…In the most complete evaluation of Vidas-AB in the three papers published by Shin et al, the sensitivity (63.3%) and specificity (96.7%) values (compared with toxigenic culture and PCR results for tcdA and tcdB as standards) were similar to those obtained in our study (4)(5)(6). Terhes et al (8) compared Vidas-AB with the BD GeneOhm Cdiff assay, a real-time PCR test based on the detection of the tcdB gene of C. difficile, and achieved sensitivity and specificity values for Vidas-AB of 34.5% and 98.5%, respectively.…”

supporting

confidence: 74%

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Comparison of Immuno Card Toxins A&B and the New Semiautomated Vidas Clostridium difficile Toxin A&B Tests for Diagnosis of C. difficile Infection

et al. 2010

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ᰔWe recently showed the ImmunoCard Toxins A&B test (ImmunoCard) (Meridian) to be as specific as and more sensitive than two widely used immunochromatographic tests to diagnose Clostridium difficile infection (CDI) (1). The Vidas C. difficile Toxin A&B test (Vidas-AB) (bioMérieux) is a new enzyme-linked fluorescent immunoassay (ELFA) that detects toxins A and B. As it is automated, it reduces the workload compared to traditional enzyme-linked immunosorbent assays. Our objectives were to evaluate the performance of Vidas-AB and to compare it with that of ImmunoCard for the diagnosis of CDI in stool specimens.(This study was presented at the 48th Interscience Conference on Antimicrobial Agents and Chemotherapy [ICAAC], Washington, DC, 25 to 28 October 2008.) The combination of the direct cytotoxicity assay from stool specimens and the cytotoxicity assay from isolates was considered the gold standard, so a true positive result was defined as positive by direct cytotoxicity assay or negative by direct cytotoxicity assay and positive by cytotoxic culture (1-3). ImmunoCard and Vidas-AB were performed according to the manufacturers' instructions. Due to the relatively long test time of Vidas-AB, a one-test-per-sample approach was adopted, and the equivocal values obtained with Vidas-AB were considered negative results.During the study period, a total of 487 stool specimens from 412 patients were tested. Toxigenic C. difficile was detected using the gold standard in 62 stool specimens (12.7%) from 53 patients. The sensitivity of the direct cytotoxicity assay was 69.4%. The greater specificity of Vidas-AB compared with that of ImmunoCard was statistically significant (P ϭ 0.019), although there were no statistically significant differences between sensitivities and predictive values (Table 1). Vidas-AB gave 13 equivocal results (2.7% of all results). These were for 2 specimens with toxigenic C. difficile and 11 specimens with negative results. ImmunoCard was the quickest technique: the median time to test 5 stool specimens was 24 min and 10 s using ImmunoCard, whereas Vidas-AB took 80 min and 25 s (P Ͻ 0.0001; twotailed Wilcoxon test for paired samples). The hands-on times for both methods were very similar.To our knowledge, two groups have published evaluations of Vidas-AB (4-6, 8). In the most complete evaluation of Vidas-AB in the three papers published by Shin et al., the sensitivity (63.3%) and specificity (96.7%) values (compared with toxigenic culture and PCR results for tcdA and tcdB as standards) were similar to those obtained in our study (4-6). Terhes et al. (8) compared Vidas-AB with the BD GeneOhm Cdiff assay, a real-time PCR test based on the detection of the tcdB gene of C. difficile, and achieved sensitivity and specificity values for Vidas-AB of 34.5% and 98.5%, respectively. Only two studies have evaluated ImmunoCard using toxigenic culture with or without the cytotoxicity assay as the gold standard (1, 7). In the previous evaluation of ImmunoCard performed in our laboratory (1), the sensitivity (66.7%...

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supporting

confidence: 74%

supporting

confidence: 74%

Comparison of Immuno Card Toxins A&B and the New Semiautomated Vidas Clostridium difficile Toxin A&B Tests for Diagnosis of C. difficile Infection

et al. 2010

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“…The VIDAS-CDAB test is a new ELFA that detects toxins A and B. The sensitivity and specificity of the VIDAS-CDAB test were reported to be 89.8 and 96.7 %, by Eastwood et al (2009), 65.3 and 93.8 % by Shin et al (2009) and 69.4 and 98.1 % by Alcalá et al (2010), respectively. In the current study, the sensitivity and specificity of the VIDAS-CDAB test were 63.9 and 100 %, respectively.…”

Section: Resultsmentioning

confidence: 99%

Detection of Clostridium difficile toxin A/B genes by multiplex real-time PCR for the diagnosis of C. difficile infection

Kim

Jeong

Kim

et al. 2012

Journal of Medical Microbiology

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Toxigenic Clostridium difficile culture is considered to be the standard diagnostic method for the detection of C. difficile infection (CDI). Culture methods are time-consuming and although enzyme immunoassay is rapid and easy to use, it has low sensitivity. In the present study, the AdvanSure CD real-time (RT)-PCR kit (LG Life Sciences) was evaluated for its ability to detect C. difficile toxin A (tcdA) and B (tcdB) genes, simultaneously. A total of 127 fresh diarrhoeal stool specimens, submitted to the clinical microbiology laboratory for C. difficile culture, were tested. C. difficile toxins and toxin genes were detected with a VIDAS C. difficile A&B (VIDAS-CDAB) enzyme-linked fluorescent immunoassay (ELFA) and the AdvanSure RT-PCR kit, respectively, according to the manufacturers' instructions. Their performance was compared with a standard toxigenic culture method as a reference. The sensitivity, specificity and positive and negative predictive values using the AdvanSure RT-PCR kit were 100 %, 98.3 %, 84.6 % and 100 %, respectively, while those of the VIDAS-CDAB system were 63.6 %, 100 %, 100 % and 96.6 %, respectively. Four tcdA + /tcdB + strains of C. difficile were detected with the AdvanSure RT-PCR kit, which offers comparable sensitivity and specificity to the reference method with a turnaround time of~3 hours. INTRODUCTIONClostridium difficile usually produces two toxins, toxin A (TcdA, an enterotoxin) and toxin B (TcdB, a cytotoxin), and is responsible for a range of diseases from mild diarrhoea to pseudomembranous colitis. This micro-organism is the most common cause of healthcare-associated diarrhoea (Bartlett, 2002). In recent years, the incidence of C. difficile infection (CDI) has rapidly increased as has disease severity associated with the emergence of hypervirulent strain BI/ NAP1/027 (McDonald et al., 2005;Kuijper et al., 2008).The gold standards for CDI diagnosis, currently in use, are the cytotoxicity assay and toxigenic culture method. Twostep testing, in which a negative result with one test is considered to be negative but a positive result is subjected to further testing, has also been proposed to combine the benefits of greater sensitivity, rapid turn-around time and reduced cost (Crobach et al., 2009; Cohen et al., 2010). C. difficile culture has the demerit of being time-consuming, taking up to 72 h to produce results. Although various enzyme immunoassays (EIA) have proven to have sensitivities that are less than optimal as diagnostic tests, they . The sensitivities and specificities of these tests have been reported to be 88.5-100 % and 88.0-97.7 %, respectively. Recently, a new RT-PCR kit, the AdvanSure CD RT-PCR kit (LG Life Sciences) was developed. The kit can simultaneously detect tcdA and tcdB genes and easily recognize tcdA 2 /tcdB + strains of C. difficile. To our knowledge, this is the first study to evaluate the AdvanSure multiplex RT-PCR kit for diagnosing CDI. METHODSStool specimens. A total of 127 fresh diarrhoeal stool specimens, submitted to the clinical microbiology ...

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“…The low positivity of the EIA may have been due to the fact that the EIA kit for toxin A alone was used until 2007, and cases with A Ϫ B ϩ isolates might yield false-negative results (19). Compared to the toxin A/B EIA, C. difficile culture was a more sensitive method to detect CDI and was ordered more frequently since A Ϫ B ϩ isolates were reported to be highly prevalent in South Korea (16,17,18).…”

Section: Discussionmentioning

confidence: 99%

“…Enzyme immunoassays (EIAs) for toxin A and/or toxin B. Stool specimens were examined for toxin A (2006 to 2007) and toxin A/B (2008 to 2010) via an enzyme-linked fluorescent immunoassay (Vidas; bioMérieux SA, Marcy l'Etoile, France), as described previously (19). Assay results were positive, negative, or equivocal according to the fluorescence intensity, as described in the relevant package insert, for each assay.…”

Section: Specimensmentioning

confidence: 99%

Characterization of Cases of Clostridium difficile Infection (CDI) Presenting at an Emergency Room: Molecular and Clinical Features Differentiate Community-Onset Hospital-Associated and Community-Associated CDI in a Tertiary Care Hospital

et al. 2011

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Definition of community-onset, hospital-acquired Clostridium difficile infection (CO-HA-CDI) is difficult in patients presenting with diarrhea at hospitals or outpatient clinics, especially 4 to 12 weeks after the last discharge. We performed C. difficile stool culture for 272 diarrheic patients visiting the emergency room (ER) between January 2006 and June 2010. C. difficile was isolated from 36 cases (13.2%), and isolation rates increased year by year, from 10.1% in 2008 to 12.4% in 2009 and 16.7% in 2010. Among 32 toxin-positive isolates, 13 (40.6%) and 19 (59.4%) were associated with CO-HA-CDI and community-acquired CDI (CA-CDI), respectively, if cases with CDI diagnosed within 12 weeks after discharge were considered hospital associated. The majority (70%) of CO-HA-CDI cases occurred within 2 weeks after hospital discharge, although the interval from discharge to onset of symptoms was as long as 10 weeks. We found via tcdA and tcdB and repetitive sequence PCR analysis, that toxin A-positive/toxin B-positive isolates were the most prevalent in both CO-HA-CDI (53.8%) and CA-CDI (94.7%) cases. Toxin A-negative/toxin B-positive isolates were also still highly associated with HA-CDI cases but were also observed in CA-CDI cases. Younger age, fewer underlying diseases, lack of prior antibiotic use, and genetic diversity of isolates in repetitive sequence PCR were the main characteristics in CA-CDI cases visiting the ER.

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Comparison of VIDAS CDAB and CDA immunoassay for the detection of Clostridium difficile in a tcdA− tcdB+ C. difficile prevalent area

Cited by 16 publications

References 26 publications

Comparison of Immuno Card Toxins A&B and the New Semiautomated Vidas Clostridium difficile Toxin A&B Tests for Diagnosis of C. difficile Infection

Comparison of Immuno Card Toxins A&B and the New Semiautomated Vidas Clostridium difficile Toxin A&B Tests for Diagnosis of C. difficile Infection

Detection of Clostridium difficile toxin A/B genes by multiplex real-time PCR for the diagnosis of C. difficile infection

Characterization of Cases of Clostridium difficile Infection (CDI) Presenting at an Emergency Room: Molecular and Clinical Features Differentiate Community-Onset Hospital-Associated and Community-Associated CDI in a Tertiary Care Hospital

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