GDH and toxin immunoassay for the diagnosis of Clostridioides (Clostridium) difficile infection is not a ‘one size fit all’ screening test

Ashraf, Zuhha; Rahmati, Elham; Bender, Jeffrey M.; Nanda, Neha; She, Rosemary C.

doi:10.1016/j.diagmicrobio.2018.12.010

Cited by 6 publications

(5 citation statements)

References 28 publications

Supporting

Mentioning

Contrasting

Order By: Relevance

“…Discrepancies in performance characteristics for the same C. difficile toxin and PCR assays have furthermore been observed to occur between different geographic sites and strain types [2,14,15], potentially contributing to our observed results. The low sensitivity of the rapid GDH/toxin combination at our institution is described in other studies, though it contrasts with the performance found by others [10,[16][17][18][19], a trend which remained consistent throughout this four-year study period. Our results were similar to those described in a cancer center patient population, in which an AUC of 0.83 was obtained with a Youden cutoff of ≤28.0 cycles (vs. our Youden cutoff of ≤27.8 cycles) for the prediction of CCNA toxin results.…”

Section: Discussioncontrasting

confidence: 79%

“…Several studies have therefore evaluated the cycle threshold (C t ) from real-time PCR amplification of C. difficile tcdB from stool as a potentially rapid predictor of toxin status [6][7][8][9]. In our clinical experience, toxin EIA has performed poorly compared to CCNA [10], and we have not observed an obvious correlation between tcdB C t and toxin status. It was therefore suspected that the predictive ability of tcdB C t values may not be broadly applicable to different toxin assays or patient populations.…”

Section: Introductionmentioning

confidence: 82%

See 1 more Smart Citation

Clostridioides difficile Toxin B PCR Cycle Threshold as a Predictor of Toxin Testing in Stool Specimens from Hospitalized Adults

Lee

Nanda²,

Yamaguchi³

et al. 2022

Antibiotics

Self Cite

View full text Add to dashboard Cite

Rapid, accurate detection of Clostridioides difficile toxin may potentially be predicted by toxin B PCR cycle threshold (tcdB Ct). We investigated the validity of this approach in an inpatient adult population. Patients who tested positive by C. difficile PCR (Cepheid GeneXpert) from December 2016 to October 2020 (n = 368) at a tertiary medical center were included. All stool samples were further tested by rapid glutamate dehydrogenase (GDH)/toxin B EIA and cell cytotoxin neutralization assay (CCNA). Receiver operating characteristic curves were analyzed. The area under the curve for tcdB Ct predicting toxin result by EIA was 0.795 (95% confidence interval (CI) 0.747–0.843) and by CCNA was 0.771 (95% CI 0.720–0.822). The Youden Ct cutoff for CCNA was ≤27.8 cycles (sensitivity 65.0%, specificity 77.2%). For specimens with Ct ≤ 25.0 cycles (n = 115), CCNA toxin was positive in >90%. The negative predictive value of tcdB Ct for CCNA was no greater than 80% regardless of cutoff chosen. In summary, very low Ct values (≤25.0) could have limited value as a rapid indicator of positive toxin status by CCNA in our patient population. A broad distribution of Ct values for toxin-negative and toxin-positive specimens precluded more robust prediction. Additional data are needed before broader application of Ct values from qualitatively designed assays to clinical laboratory reporting.

show abstract

Section: Discussioncontrasting

confidence: 79%

Section: Introductionmentioning

confidence: 82%

Clostridioides difficile Toxin B PCR Cycle Threshold as a Predictor of Toxin Testing in Stool Specimens from Hospitalized Adults

Lee

Nanda²,

Yamaguchi³

et al. 2022

Antibiotics

Self Cite

View full text Add to dashboard Cite

show abstract

“…This study indicates that rapid EIA tests for GDH Ag and toxin may act as confounders for non-compliance in settings where positive NAATs and C. difficile cultures were used as confirmatory tests. The adequacy of these rapid tests in determining a true infection has been debated widely, with inconsistent results depending on the patients involved [ 12 , 13 , 27 ], leaving the decision to sustain the tests questioned. However, our results also showed that these tests were helpful in predicting outcomes such as recurrence.…”

Section: Discussionmentioning

confidence: 99%

“…However, the causes of non-adherence and their impact on outcomes have rarely been explored. Furthermore, since a definitive diagnosis of CDI is difficult to obtain [ 12 , 13 ], multiple factors may have an influence on prescription behavior. Therefore, to enable the estimation of the future burden of CDIs and the implications for future recurrence events we investigated the risk factors of non-adherence with prescription guidelines and their influence on recurrence.…”

Section: Introductionmentioning

confidence: 99%

Description of antibiotic treatment in adults tested for Clostridioides difficile infection: a single-center case–control study

Kim

et al. 2022

BMC Infect Dis

View full text Add to dashboard Cite

Background Diagnosing Clostridioides difficile infection (CDI) is complicated. There have been reports on effects of compliance with anti-C. difficile prescription guidelines on patient outcomes. However, the causes of non-adherence and their impact on outcomes have rarely been explored. Therefore, an investigation on the risk factors for non-adherence with treatment guidelines and their influence on recurrence is important. Methods This case–control study was conducted with patients with a positive C. difficile culture from March 2020 to April 2021. We conducted analysis based on treatment categories using factors associated with recurrent CDI as variables. Univariate and multivariable analyses were conducted to identify risk factors for non-adherence with treatment guidelines. Results In total, culture positive stool samples from 172 patients were analyzed. Having positive glutamate dehydrogenase antigen (GDH Ag), negative toxin enzyme immunoassay (EIA), and positive nucleic acid amplification test (NAAT) (GDH+/toxin EIA−/NAAT +) results were associated with both under- (adjusted odds ratio [aOR] 3.49 [95% CI 1.62–7.51], p = 0.001) and over-treatment (aOR 0.17 [95% CI 0.06–0.48], p = 0.001). Patients with refractory diarrhea were over treated (aOR 2.71 [95% CI 1.02–7.20], p = 0.046). Patients with an increased risk of CDI recurrence were not over treated. Conclusions Our results suggest that non-adherence with CDI treatment guidelines depends on the duration of symptoms and rapid EIA test results. Patients with an increased risk of recurrence were neglected.

show abstract

“…12,14 This study has several limitations. Two-step algorithms based on a GDH screen have a relatively low sensitivity in immunocompromised patients, 15 which may have resulted in underdiagnosis of CDI in this population. We were unable to determine rates for all community-tested CDI because we did not have data from a second laboratory that also tests these samples.…”

Section: Discussionmentioning

confidence: 99%

Clostridioides difficile toxin testing and positivity in Manitoba, Canada

Righolt

Zhang

Hammond

et al. 2020

Infect. Control Hosp. Epidemiol.

View full text Add to dashboard Cite

show abstract

GDH and toxin immunoassay for the diagnosis of Clostridioides (Clostridium) difficile infection is not a ‘one size fit all’ screening test

Cited by 6 publications

References 28 publications

Clostridioides difficile Toxin B PCR Cycle Threshold as a Predictor of Toxin Testing in Stool Specimens from Hospitalized Adults

Clostridioides difficile Toxin B PCR Cycle Threshold as a Predictor of Toxin Testing in Stool Specimens from Hospitalized Adults

Description of antibiotic treatment in adults tested for Clostridioides difficile infection: a single-center case–control study

Clostridioides difficile toxin testing and positivity in Manitoba, Canada

Contact Info

Product

Resources

About