Accuracy of Xpert Clostridium difficile assay for the diagnosis of Clostridium difficile infection: A meta analysis

Bai, Yuanyuan; Sun, Xuejun; Jin, Yan; Wang, Yueling; Li, Juan

doi:10.1371/journal.pone.0185891

Cited by 11 publications

(5 citation statements)

References 41 publications

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“…In our institution, the actual average TAT per sample for the twostep algorithms was just 7.6-8.7 minutes more compared to each of the first step methods (QCC and VIDAS). The TAT of the two-step algorithm using the QCC assay (47.6 minutes) was similar to the one-step method using the Xpert assay (50 minutes) in our institution ( Table 3) the best practice for detecting the C. difficile toxin gene [16] as the widely-used Xpert assay demonstrated good sensitivity and specificity, comparable to CCNA or TC [10,24,32]. Therefore, the use of the Xpert assay as a reference method in this study should not have affected our findings.…”

Section: Discussionmentioning

confidence: 56%

Diagnostic Algorithm for the Rapid and Cost- Effective Detection of Clostridioides difficile Infection: Comparison between C. DIFF QUIK CHEK COMPLETE and VIDAS GDH & Toxin Assay

Yoo

Whang

2020

Lab Med Qual Assur

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Background: We evaluated the analytical performance and cost-effectiveness of lateral flow immunoassays (LFIAs) in detecting Clostridioides difficile glutamate dehydrogenase (GDH) antigen and toxin A/B, followed by a rapid nucleic acid amplification test (NAAT). Methods: A total of 341 unformed stools were tested using a two-step algorithmic approach with C. DIFF QUIK CHEK COMPLETE (QCC) LFIA (TechLab, USA), followed by Xpert C. difficile NAAT (Xpert). The performance of the QCC assay was compared with that of the VIDAS C. difficile GDH and toxin A/B assay (bioMérieux, France), an enzyme-linked fluorescence immunoassay. The clinical performance and cost-effectiveness of the diagnostic algorithms using the QCC or VIDAS assays were compared to the results obtained using the Xpert assay alone. Results: For GDH and toxin detection, the QCC and VIDAS assays demonstrated an almost perfect agreement, with no significant difference in sensitivity (QCC-GDH, 90.5%; VIDAS-GDH, 91.9%; QCC-toxin, 51.4%; VIDAStoxin, 55.4%) and specificity (QCC-GDH, 92.9%; VIDAS-GDH, 89.1%; QCC-toxin, 100%; VIDAS-toxin, 99.6%), compared to the Xpert. The algorithmic approach (GDH and toxin plus Xpert) increased the sensitivity (QCC, 93.2%; VIDAS, 94.6%) and specificity (QCC, 100%; VIDAS, 99.6%). The algorithmic approach reduced the cost compared to the Xpert alone, and the turnaround time of the QCC was shorter than that of the VIDAS assay. Conclusions: Simultaneous detection of GDH and toxin A/B, using QCC or VIDAS assays showed comparable sensitivity and specificity when followed by the Xpert assay. The QCC assay is preferable in turnaround time and cost, which are important considerations for laboratories handling smaller number of samples.

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Section: Discussionmentioning

confidence: 56%

Diagnostic Algorithm for the Rapid and Cost- Effective Detection of Clostridioides difficile Infection: Comparison between C. DIFF QUIK CHEK COMPLETE and VIDAS GDH & Toxin Assay

Yoo

Whang

2020

Lab Med Qual Assur

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“…In recent years, some commercially nucleic acid amplification test (NAAT) products were approved by the FDA, such as the Gene Xpert CD assay (Cepheid, Sunnyvale, USA) directly detecting the tcdB gene in feces by RT-PCR, and widely used in the national world. The Gene Xpert was notable because of its high sensitivity (97%) and specificity (95%) in diagnosing toxigenic CDI both rapidly and simply ( ( Bai et al., 2017 ).…”

Section: Discussionmentioning

confidence: 99%

Prevalence of Clostridium difficile Infection in the Hematopoietic Transplantation Setting: Update of Systematic Review and Meta-Analysis

Luo

Su-mei

Shang

et al. 2022

Front. Cell. Infect. Microbiol.

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Hematopoietic stem cell transplant (HSCT) recipients are vulnerable to Clostridium difficile infection (CDI) due to risk factors such as immunosuppression, antimicrobial use, and frequent hospitalization. We systematically searched PubMed and Embase to screen relevant studies from April 2014 to November 2021. A meta-analysis was performed to identify the association between CDI and hematopoietic transplantation based on the standard mean difference and 95% confidence intervals (CIs). Among the 431 retrieved citations, we obtained 43 eligible articles, which included 15,911 HSCT patients at risk. The overall estimated prevalence of CDI was 13.2%. The prevalence of CDI among the 10,685 allogeneic transplantation patients (15.3%) was significantly higher than that among the 3,840 autologous HSCT recipients (9.2%). Different incidence rates of CDI diagnosis over the last 7 years were found worldwide, of which North America (14.1%) was significantly higher than Europe (10.7%) but not significantly different from the prevalence among Asia (11.6%). Notably, we found that the estimated prevalence of CDI diagnosed by polymerase chain reaction (PCR) (17.7%) was significantly higher than that diagnosed by enzyme immunoassay (11.5%), indicating a significant discrepancy in the incidence rate of CDI owing to differences in the sensibility and specificity of the detection methods. Recurrence of CDI was found in approximately 15% of the initial patients with CDI. Furthermore, 20.3% of CDI cases were severe. CDI was found to be a common complication among HSCT recipients, displaying an evident increase in the morbidity of infection.

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“…These studies demonstrate the potential applications of C t values from the typically qualitative C. difficile PCR. The Xpert assay is generally considered to have excellent sensitivity in organism detection and specificity in ruling out CDI, similar to that of other commercial C. difficle PCR assays [22,23]. It is stressed that such application of C t values is not FDA-cleared for C. difficile PCR testing, including the commonly used Xpert assay.…”

Section: Discussionmentioning

confidence: 99%

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

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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.

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Accuracy of Xpert Clostridium difficile assay for the diagnosis of Clostridium difficile infection: A meta analysis

Cited by 11 publications

References 41 publications

Diagnostic Algorithm for the Rapid and Cost- Effective Detection of Clostridioides difficile Infection: Comparison between C. DIFF QUIK CHEK COMPLETE and VIDAS GDH & Toxin Assay

Diagnostic Algorithm for the Rapid and Cost- Effective Detection of Clostridioides difficile Infection: Comparison between C. DIFF QUIK CHEK COMPLETE and VIDAS GDH & Toxin Assay

Prevalence of Clostridium difficile Infection in the Hematopoietic Transplantation Setting: Update of Systematic Review and Meta-Analysis

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

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