Evaluation of Diagnostic Tests for
            <i>Clostridium difficile</i>
            Infection

Swindells, Jonathan; Brenwald, N P; Reading, Nathan; Oppenheim, Beryl

doi:10.1128/jcm.01579-09

Cited by 143 publications

(120 citation statements)

References 14 publications

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“…Several reports have documented poor analytical sensitivity of toxin immunoassays in comparison to toxigenic culture and/or various PCR-based assays. [4][5][6][7][8][9][10] The present study supports those findings. Coupled with the fact that many laboratories still use the relatively low-cost toxin EIA as the primary method for laboratory diagnosis, 11,12 medical providers may frequently face the decision whether to initiate therapy in the absence of laboratory confirmation or to repeat laboratory tests.…”

Section: Commentsupporting

confidence: 82%

“…Recent investigations have focused on real-time PCR as a candidate for GDH screen confirmation. Using the same GDH assay described here, Sharp et al 21 and Swindells et al 8 reported excellent performance characteristics of a two-step GDH-PCR algorithm. They observed ,100% sensitivity of the GDH screen component compared with toxigenic culture and/or PCR, as well as excellent correlation between second-step PCR testing and toxigenic culture results.…”

Section: Commentmentioning

confidence: 99%

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Comparison of Analytical and Clinical Performance of Three Methods for Detection of Clostridium difficile

LaSala

Svensson²,

Mohammad³

et al. 2012

Archives of Pathology &Amp; Laboratory Medicine

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difficile infection has undergone considerable and rapid evolution during the last decade. The ideal detection method(s), which should exhibit high analytical and clinical sensitivity and specificity, remains undefined.Objective.-We sought to evaluate the analytical and clinical performance characteristics of three methods for the laboratory detection of C difficile.Design.-This study used 114 consecutive stool samples to compare three methods of C difficile detection: an enzyme immunoassay (EIA) for toxins A/B, a lateral flow membrane immunoassay for glutamate dehydrogenase (GDH), and a qualitative real-time polymerase chain reaction (PCR) assay. Medical records of all patients having $1 positive test result were reviewed to estimate the clinical likelihood of C difficile infection.Results.-Based upon laboratory result consensus values, analytical sensitivity was significantly higher for GDH (94%) and PCR (94%) assays than for toxin EIA (25%). Analytical specificity was significantly higher for PCR (100%) and EIA (100%) than for GDH assay (93%). In contrast, assay performance based upon clinical probability of C difficile infection suggested lower discriminatory power (ie, clinical specificity) of the more analytically sensitive methods.Conclusions.-Higher rates of C difficile detection will be realized upon implementation of GDH assay and/or real-time PCR-based testing algorithms than by testing with EIA alone. Further study is required to elucidate potential downstream costs for higher detection rates.

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Section: Commentsupporting

confidence: 82%

Section: Commentmentioning

confidence: 99%

Comparison of Analytical and Clinical Performance of Three Methods for Detection of Clostridium difficile

LaSala

Svensson²,

Mohammad³

et al. 2012

Archives of Pathology &Amp; Laboratory Medicine

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“…26 In addition, the actual date and time at which C. difficile was acquired is likely earlier than the date/time of the positive test result (the date/time used in our study). Therefore, the time from acquisition to discharge for our cohort may be underestimated.…”

Section: Limitationsmentioning

confidence: 93%

The effect of hospital-acquired infection with Clostridium difficile on length of stay in hospital

Forster

Taljaard

Oake

et al. 2011

CMAJ

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“…This is consistent with the results of several reports. [7][8][9][10] Although CCCN is recommended in the SHEA-IDSA guidelines, 1 this approach is less desirable as a reflex test because of its reduced sensitivity compared with NAATs and toxigenic culture and, from a more practical standpoint, because of its general lack of availability in most hospital laboratories. Although reflex testing using toxigenic culture produces statistically equivalent sensitivity and specificity to NAAT reflex testing, the delay in finalizing results would likely have a negative impact on both infection control costs and, potentially, on the initiation of therapy for patients with CDI.…”

Section: Effect Of Various Testing Algorithms On Isolation Of Patientmentioning

confidence: 99%

Laboratory Diagnosis of Clostridium difficile Infection

Tenover¹,

Baron²,

Peterson

et al. 2011

The Journal of Molecular Diagnostics

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The laboratory diagnosis of Clostridium difficile infection (CDI) continues to be challenging. Recent guidelines from professional societies in the United States note that enzyme immunoassays for toxins A and B do not have adequate sensitivity to be used alone for detecting CDI, yet the optimal method for diagnosing this infection remains unclear. Nucleic acid amplification tests (NAATs) that target chromosomal toxin genes (usually the toxin B gene, tcdB) show high sensitivity and specificity, provide rapid results, and are amenable to both batch and on-demand testing, but these tests were not universally recommended for routine use in the recent guidelines. Rather, two-step algorithms that use glutamate dehydrogenase (GDH) assays to screen for C. difficile in stool specimens, followed by either direct cytotoxin testing or culture to identify toxin-producing C. difficile isolates, were recommended in one guideline and either GDH algorithms or NAATs were recommended in another guideline. Unfortunately, neither culture nor direct cytotoxin testing is widely available. In addition, this two-step approach requires 48 to 92 hours to complete, which may delay the initiation of therapy and critical infection control measures. Recent studies also show the sensitivity of several GDH assays to be <90%. This review considers the role of NAATs for diagnosing CDI and explores their potential advantages over two-step algorithms, including shorter time to results, while providing comparable, if not superior, accuracy.

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Evaluation of Diagnostic Tests for Clostridium difficile Infection

Cited by 143 publications

References 14 publications

Comparison of Analytical and Clinical Performance of Three Methods for Detection of Clostridium difficile

Comparison of Analytical and Clinical Performance of Three Methods for Detection of Clostridium difficile

The effect of hospital-acquired infection with Clostridium difficile on length of stay in hospital

Laboratory Diagnosis of Clostridium difficile Infection

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